Public Comment Index for the National Alzheimer's Project Act . 2012 Comments

11/20/2017

2012 Public Comments

 


 

NOVEMBER 2012 COMMENTS

M. Janicki  |  11-30-2012

I understand that the FAC meeting for the 14th and 15th has been abridged to the 14th. Either of us will like to offer comments during the comment period on the 14th. Could you slot us in.

PS - By the way, I've attached an Italian version of our NTG report that was recently released. The Italians took our NTG report and translated and accommodated it for the situation in Italy related to dementia and people with intellectual disabilities.

ATTACHMENT:

Dimentica la Disabilità e Guarda Alla Persona [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-dimentica-la-disabilit%C3%A0-e-guarda-alla-persona]


 

OCTOBER 2012 COMMENTS

M. Ellenbogen  |  10-14-2012

I would also like to share with your team a modified article that I had originally written for the World Alzheimer Report 2012. Since that time I had the opportunity to take a 3 week vacation which I truly loved. At the same time it pointed out new weakness in my skills and I realize I have declined a bit more. There was a time that I can follow a map and could easily get from point A to B. Unfortunately this time was different. I had to continuously rely on my wife who was not quite used to taking on this challenge. When I look at the map, I just cannot focus on an area and I just keep seeing all of the streets. You also need to keep into memory where you are coming from and what was the last cross streets, which again I cannot retain. Unfortunately my frustration was passed on to her because I expected her to perform at the level I once could. It's not easy living with a dementia person.

Then there was looking at the menus, I just could not seem to look at menus and make sense because I was being confused by it being into different languages even though one was English. For one reason or another I just could not process that information and had to rely on my wife to know what I like to help me make a choice.

Then there was the train stations. I looked at the boards completely confused and not understanding what my wife was seeing on how and where to get our next train. I just went along for the ride and thank god she knew what she was doing. These are all things I have never had to rely on anyone. In fact I was the one being the leader in my business and personal life when it came to those types of things.

I also use to have a great sense of direction without a map and almost never got lost. But I realized that in order to do that you need to be able to retain when and where you turn so you can keep track of direction. It seems that I lost that because I had to tell my wife to figure out where we were many times. She was not use to that which placed a lot more stress on her. It seems that more and more things are starting to fall on her shoulders and that is a very big burden to have to carry. In fact I realized to late that I had over burden her with even making this trip, which I was once very cable of doing or at least sharing the load. There was so much planning involved and it all fell one her because I cannot even be a bouncing board to check for accuracy anymore.

I always walked around with this fear that I might get lost in a crowd from my wife. But that's why I always made sure to have the business card for the hotel I was staying at. I am telling you all this and sharing the article below because we all hear all the medical terms around dementia issue, but I really believe most people are clueless when it comes to truly understanding what dementia people really have to deal with. I learned this first hand dealing with the supposedly expert health reporters. I want people to become educated and realize that while our disability is not visible, it is by far a very true disability. I hope this will be useful to your team. As always I am willing to speak about this openly and be completely honest no matter how embarrassing it may be.

----------------

"The Realities of Alzheimer's and Overcoming Stigma"

Alzheimer's disease and other forms of dementia affect more than 35 million people worldwide today. An astonishing fact that today someone in the world develops dementia every 4 seconds. By the middle of the century more than 115 million people will be affected by the disease if we do nothing.

My name is Michael Ellenbogen, and I am living with Alzheimer's and trying to make a difference. I was previously a high-level manager in the telecommunication industry. In 2008, I was diagnosed with younger-onset Alzheimer's disease (YOAD) after struggling to get a diagnosis since my first symptoms at age 39. Losing my job and not being able to work had a huge impact on my life as I was a workaholic. I am now an Alzheimer's advocate and a spokesperson for the Alzheimer's Association (U.S.) as a member of its national 2012 Early-Stage Advisory Group.

I am so frustrated, because no one realizes how seriously disabled I am. If I had a loss of limb or some other visual ailment, it would make people realize. I don't want them to feel sorry for me or pity me, just want to be understood. So many people say you do not seem to have Alzheimer's, and that frustrates me. Let me tell you what it's like to live with this debilitating and progressive disease.

Imagine for one minute that your friend, relative or family member has Alzheimer's and has to deal with the following issues. When I go shopping and look at items, most of them never really register in my mind, even though I see it clearly. I have trouble making decisions, because I question whether I am making the right one. I can no longer enjoy my favorite hobbies, because it requires processing skills that I no longer have. I went from being a gadget person, to now being threatened by technology that I no longer can use. This is what I deal with and so much more.

I go to a happy affair only to be tortured by the noise and surrounding conversations, because of the loudness that cannot be filtered out. If people try to speak with me in a public setting where there are many other conversations, I just don't understand what they are saying. This is because all of the people speaking come in at the same volume level. All the words run together, and it sounds like a foreign language.

I went from being extremely proactive to becoming much less active and motivated. I leave things around the house and don't put them away, because I don't know where they go or feel I may not know where to retrieve them again. One moment I am nice and another I may fly off the handle. I can no longer write or speak like I used to. My friends slowly become distant and usually speak to my wife. I do realize this.

I worry every day about the challenges ahead. Or even worse, I am losing my mind and see it happening, but I cannot do anything to change the course. People always say 'if I can do anything just let me know." If I take them up on that offer, they back out of their commitments. I have become extremely surprised by the lack of public commitment to my pleas for support of Alzheimer's disease. While some may be sympathetic in the moment, there appears to be little follow-through. This is very upsetting, because I feel as though it affects me personally as well as the millions of others living with the disease. I was always there for others when they needed it and now I feel alone.

While many people just coast through the day, I have to use 110% of my processing skills to do most things, which increases the stress and frustration. The worst part about this disease is knowing that I am doing all these things wrong and have no way to control or stop it, and it's only getting worse as the days go by. I used to save lots of money by doing so many things around the house. Now I lost the drive, determination and skills needed to do those things. Many times I hurt myself trying or make it worse.

I cannot begin to explain how it tears me up inside to see my spouse struggling to do the things that I once was capable of doing and know I cannot do a thing to help. I realize that one day I may no longer be able to drive and this devastates me. I see my wife becoming stressed, depressed and overwhelmed, but caregivers know it will only continue to get worse. Sadly, they keep telling themselves that they can do it all even when we know they will need help.

I, the patient, see it definitely. My wife is on the road to hell, and she does not even realize it yet, because she is so busy trying to block it all out. The worst part about all this is, I have not even reached the worst stage. That scares the hell out of me.

I have been so surprised by the stigma associated with this disease. It comes at you from all angles. People think they knew what Alzheimer's is, but they don't. I see this not only from people living with dementia but many media health correspondents, physicians and organizations that are geared to helping those deal with the disease. I have learned that I do not want to share my diagnosis with people I meet until they get to know me. If I was to tell them upfront, I would be treated so differently, which I have learned. I kind of see this disease like HIV use to be. The people who have it are so afraid to let others know, including family. I do not get it. We did nothing wrong to get this disease, and we need to speak up to let our voice be heard. We did nothing and no one should be ashamed of having it. I feel so much better when I share it with others than when I try to hide it.

Because of my frustration with existing environment for people with dementia, I realized change was need. I decided to use my few skills left to advocate. I have spent some of my last few years being on television, radio, newspapers, many blogs and working with many politicians. I also had an opportunity to speak at all of the public sessions to develop the first U.S. National Alzheimer's Plan, all this on my own. But that was not enough, because I ran into so many people who just did not want to get involved. I am now a volunteer for the national Alzheimer's Association Early-Stage Advisory Group. If there is something I want you to walk away with it's that you can make a difference, but it will take persistence. Write a letter to your public official or reach out to local support organizations to create needed programs and services. Your voice and your story are powerful tools. Please get involved.

The simple truth is, if you have not been touched by this devastating and debilitating disease yet, consider yourself extremely lucky. Sadly, it's just a matter of time before it touches you. It is my hope that my actions today may prevent future generations from suffering with this disease. So give yourself piece of mind and do something today. I hope that what I am doing will allow me to leave this world knowing that I did everything possible to make that next generation have a fighting chance. There are no excuses for not wanting to help. The human cost factor is too high, and we are all accountable to do something.

There are many organizations out there like ADI and the Alzheimer's Association that can help you. The Alzheimer's Association got me started in many ways with my new journey. It not only helped me, but it also had helped my wife as my caregiver. They have a website with many resources at http://www.alz.org. I encourage you to reach out today if you have not already. I would also encourage you to educate yourself.

Please join me and Go Purple. I wear a purple Alzheimer's bracelet every day. And for those living with Alzheimer's, stop focusing on what you cannot do and join me in the battle to advocate. We still have so much to give, and we need to use our skills at our own speed. There is nothing to be ashamed of. I, and your loved ones, are counting on all of you.


 

W. Naus  |  10-05-2012

Good afternoon -- On behalf of the Council on Social Work Education (CSWE), I am submitting the enclosed written public comment for the October 15 Advisory Council meeting.

The CSWE President plans to also provide oral comment during the meeting.

Please do not hesitate to contact me with any questions.

ATTACHMENT:

On behalf of the Council on Social Work Education (CSWE), thank you for the opportunity to provide written comment on the National Plan to Address Alzheimer's Disease.

CSWE is a nonprofit national association representing about 2,500 individual members as well as nearly 700 graduate and undergraduate programs of professional social work education. Founded in 1952, this partnership of educational and professional institutions, social welfare agencies, and private citizens is recognized as the sole accrediting agency for social work education in the United States. Social work education focuses students on leadership and direct practice roles helping individuals, families, groups, and communities by creating new opportunities that empower people to be productive, contributing members of their communities.

CSWE thanks the Department of Health and Human Services (HHS) and the Advisory Council for incorporating into the National Plan goals and strategies aimed at building a workforce equipped with the necessary skills to meet the needs of those living with dementia, including Strategy 2.A: Build a Workforce with the Skills to Provide High-Quality Care. It is critical that supports and additional training be provided to workers already in practice to ensure that they can adequately meet the needs of those they are serving. However, we remain concerned about the preparation of the future workforce. The goal of producing a workforce that incorporates all necessary players--including social workers--with the necessary skills cannot be achieved without enhanced investment in recruitment, training, and retention of students in the health professions who will be working with older adults. The workforce pipeline must be considered if real progress is to be made and sustained.

To this end, CSWE strongly endorses the recommendations made by the Advisory Council in May 2012 that call on Congress to appropriate additional funding for health professions workforce programs. In particular, we strongly support the Clinical Care Subcommittee's Recommendation 8, which urges the prioritization of geriatrics education and training programs, including the Title VII and Title VIII programs at the Health Resources and Services Administration (HRSA), as well as loan repayment and other incentive initiatives. While social work is recognized throughout the Plan as a contributing member of the care team, without the workforce investments recommended by the Council, the social work profession will not have the capacity to meet such demand. It is estimated that by 2050, the number of social workers needed in long term care will grow to approximately 109,000 (nearly double the current workforce in this area) (DHHS, 2006). In 2009--2010, only an average of 5 percent of all social work graduates completed a specialization in aging (CSWE, 2011).1 This number of graduates cannot begin to meet the workforce demands, especially in light of the retirement of increasing numbers of geriatric social workers. The social work profession will undoubtedly reach a breaking point if new investments are not made today to nurture a social work pipeline that generates a new crop of professionals skilled to work with older adults and specifically with the competencies to work with those with dementia and their family caregivers

Second, as an organization guided by an educational mission, CSWE plays a central role in the development and dissemination of curriculum covering a variety of practice areas. Through our John A. Hartford-funded National Center for Gerontological Social Work Education, we have enhanced the capacity of faculty and prepared students with competencies to work effectively with older adults and their families We applaud the Council's recommendation that HHS partner with health professions programs and organizations to work toward the development and use of geriatrics-specific curricula and would be eager to help disseminate such curricula to our member programs. CSWE has begun conversations with HHS on how we may be able to contribute on behalf of the social work education community and we welcome opportunities to ensure the dementia capacity of our faculty members and their students.

Thank you for the opportunity to express these views on behalf of the Council on Social Work Education. CSWE is hopeful that the updated National Plan will address the pipeline concerns highlighted above. I would be happy to provide additional information about CSWE and our efforts to promote geriatric competencies among social work students. Please do not hesitate to contact me with any questions.

  1. Council on Social Work Education (CSWE). (2011). 2009 Statistics on social work education in the United States. Retrieved from http://www.cswe.org/CentersInitiatives/DataStatistics/ProgramData/47673.aspx National Association of Social Workers (NASW).(2006a). Assuring the sufficiency of a frontline workforce: A national study of licensed social workers--Special report: Social work services for older adults. Retrieved from: http://workforce.socialworkers.org/studies/aging/aging.pdf
    U.S. Department of Health and Human Services (DHHS). (2006). The supply and demand of professional social workers providing long-term care services. Report to Congress. Retrieved from https://aspe.hhs.gov/basic-report/supply-and-demand-professional-social-workers-providing-long-term-care-services-report-congress

 

AUGUST 2012 COMMENTS

P. Murphy  |  08-28-2012

Thank you for your outstanding efforts on NAPA and the May 2012 Alzheimer's Disease Summit.

Below you will find a brief response to a proposal on the use of NAPA funding which has disturbed me sufficiently to immediately respond to both the Alzheimer's Organization and NIH. Specifically, NIA's goal to reduce use of antipsychotics by 15% in the first year and to expand training programs on behavioral intervention.

This is outrageous.

The FDA specifically proscribes the use of antipsychotic drugs other than for their specified purpose and has issued unequivocal warnings of danger up to and including stroke or death to the elderly on misadministration. Medicare specifically proscribes the use of chemical or physical restraints.

The United States Attorney is handling hundreds if not thousands of False Claims Act matters with severe economic penalty against pharmaceutical firms. Local prosecutors are filing criminal complaints against nurses and doctors for the use of anti-psychotics not only in SNF's but, as to children in juvenile detention facilities.

37% of the AD population in Florida is on psychotropic drugs.

First, the act of using a pill or injection in this manner for behavioral control has been characterized by prosecutors as a criminal battery.

Medicare, through Plan D has intimate knowledge of the extent of use by date, duration, dosage and location. If there is extensive use of antipsychotics in a particular facility, the matter should be referred to the United States attorney's office for investigation and appropriate action. Absent referral yet with knowledge, obstruction of justice issues arise.

Individuals don't have the ability to do this. They can only act as to a particular patient in what is essentially a disenfranchised population. Health care surrogates, if any, may or may not be informed of the offensive conduct or attentive to the needs of AD patients who are being abused in this manner.

It is inevitable with an increasingly litigious baby boomer generation that such obstruction of justice charges, conspiracy, RICO and other criminal complaints will be made against the federal government employees, agencies, nursing home operators, nurses and doctors and pharmacies as well as civil actions for damages from injury or wrongful death. It has already started.

Treating this inhuman torture of elderly as an administrative efficiency issue is an abuse as vicious, criminal and sadistic as the act of administering the injection or forcing the pill. I don't know if you have ever sat next to a SNF frail elderly AD with a hip fracture, shaking and crying after administration of an antipsychotic. It will haunt you. One more day is too much.

In one Medicare 5 star facility, an attempt was made in the first week to give a new AD patient an anti seizure drug because the patient was "acting out". The surrogate declined. In this facility, AD were separated from the general population. A friend/aide covering the new patient for an afternoon was a nurse and a former nun from Ireland. She took her to a SNF music recital and was shocked because the rest of the patients were virtually comatose. The surrogate showed up at the facility the next day to find the patient's arms covered with a large hematoma and bruises from wrist to elbow as well as split skin on the forehead. No one had alerted the surrogate to the injury. No staff member would address the injury. The AD patient was pulled out of the facility.

The only way to stop this abuse is to aggressively act. The United States Attorney in Boston took action against J&J and Omnicare under the False Claims Act. It is incumbent upon Medicare and NIH/NIA and AD advocacy organizations to treat this with the same seriousness of purpose and dispense with pharma and nursing home owner/operator handholding. If you as individuals and as a representative of your agency or organization do not have the courage, the talent, the knowledge and the integrity to immediately save these patients from needless continued suffering, don't work in this field.

One doctor advised me that the section of the brain controlling the creative was the last to be destroyed in AD. After months of fruitless research for activities which benefitted AD, I found myself reading the Jerusalem Post on August 5 to find a care center in Israel with a program which made their days enjoyable.

How embarrassing for us that I had to go so far.

Training of Staff

The recommendation to utilize NAPA money on manpower to train nurses and aides in behavioral intervention techniques is a waste of time and an inefficient, inappropriate use of manpower and resources. I don't understand the continuing tolerance of the medical profession feeding itself from subsidies. What is next? Gerontology certification training for attorneys who are not up to speed?

Administrators, nurses and aides are licensed by the state. Prior to licensure, they have to complete training through state approved contractors to insure that they are qualified to perform the function of the profession they have elected to join. If the state, by and through its contractors has not met its responsibility to properly set forth statutory and regulatory qualifications for certification and/or contractors have not met those guidelines in training programs (for which they are compensated), to qualify licensees to meet the needs of the population they service (AD) despite clear demonstrable need, it is incumbent upon the state and its contractors to immediately remedy any training deficiencies.

The professional associations or the Alzheimer's organizations can prepare AD Behavioral Intervention Training materials by disc or online/video cam for sale to state training approved contractors. The state training contractors should incorporate these materials into certification training. If the individual is already licensed, state facility and professional license renewal should be contingent on licensee completion of such continuing professional education.

Tapes are valuable because they can be viewed repeatedly by staff, caretakers and home health care aides at leisure. With all respect to dedicated trainers, sometimes the level of sophistication is not very high and the quality of instruction questionable. Further and often, recommended techniques which fail to address the individual do not work. For example, one newly trained MSW put a group of AD in a room overlooking the garden with peaceful music. One lady was quiet but when they moved her out, she burst out crying. She said they kept her in room next to a desk listening to that "horrible music" because the bill had not been paid and they would not let her go to the bathroom until her family showed up and paid it. She was quiet because she was embarrassed.

Second, agitation and "acting out" are based on inability to communicate physical distress, pain or discomfort, infection, medication side effect or misadministration, fear, frustration, or confusion. Hallucination occurs in the late stages. Behavioral intervention will not be effective if the problem is physical because the underlying cause is not abated. This should be the first step in evaluation.

As experienced nurses will tell you, successful behavioral intervention involves an intimate knowledge of the patient and time consuming one on one attention. Unless and until there is increased staffing in the facility so more than medication administration, dressing, bathing, changing and feeding can be accomplished, no more than lip service will be paid to training efforts. Nurses are furious that, because of budgetary staffing constraints, they may be professionally hurt and their patient's needs are not addressed. Other nurses are so beaten down they are numb and operate on autopilot. Some doctors are clueless. They defer to nurses and pharmain prescription and rarely visit the patient. Yet Medicare pays for their time.

The Florida legislature has declined to increase minimum staffing. Consideration should be given to a mandatory national standard.

Represented decline in the use of antipsychotics is not based on facility compliance with Medicare proscriptions. It is based on the fact that reputable SNF's and AL's refuse to take patients with AD. If a patient develops AD while in the facility and doping is not used, the facility demands 24/7 private care in addition to the facility charges which is paid for by the family as a condition of retention. This is why AD are taken home for private care and lives of caretakers are destroyed.

I have reviewed the financial representations of SNF's and AL's which are on the market throughout the nation. A substantial majority represent a net profit to owners of 35 to 50% of gross income. If a SNF or AL is doping to increase or preserve owner profit, it is time for closure with possible criminal prosecution. Alternatively, federal or state takeover or placement in a form of receivership until compliance is accomplished would be recommended.

I will address specific recommendations including programs and services which actually benefit AD afflicted under separate cover including sources of additional funding for the Alzheimer's Organization.

We had a triple dose of AD in our family. I was responsible for one highly agitated elderly with multiple physical issues for fifteen years, nine 24/7 as well as one late stage dementia. I have used the resources of your site and NIH since it was first accessible on the internet as well as every other medical information site available. I have read deficiency reports for probably 70% of SNF's in Florida, visited facilities, spoken to nurses and other caretakers on a regular and continuous basis and had a front row seat to institutional neglect of elderly AD including a few direct hits.

By way of my qualifications, I am attorney, with a BA University of Notre Dame in government/economics, an MPA NYU, and experience representing the legislative interests of a State Department including Aging, Local Government Services, Housing and Human Services with floor privileges in the Senate and House; in a corporate construction/development operation in a new and heavily regulated industry conforming operations and employment with statutory and regulatory directives; law firm experience including pharma product liability defense; and extensive experience as a mediator.


 

D. Walberg  |  08-21-2012

Would it be possible to receive a copy of the PowerPoint from today's webinar?


 

JULY 2012 COMMENTS

M. Ellenbogen  |  07-21-2012

I want to thank you for allowing me to participate in this NAPA meeting. In this document, and those attached, I write of issues I feel are important to be shared with the committee. When I have the opportunity to speak during the live meeting, I may follow this format, or I may have additional comments or suggestions.

Attached are a few documents that I hope will benefit many dealing with Alzheimer's disease or other dementia. The first document "Hospitals Dealing with Dementia Patients (1)" is based on my experience in staying in the hospital. I would like to think that what happened to me will apply to most hospitals and they all need to be educated.

When I have brought this to the attention of Doylestown Hospital the people were very receptive and realized that further education was needed. They are now discussing how to best approach/ take advantage of my skills and the use of the Alzheimer's Association to better educate their personnel in this facility. My hope is that this hospital can become a model for other hospitals dealing with dementia patients.

Attached is also "Alzheimer's Initiatives - International Association of Chiefs of Police" document. I worked with the Alzheimer's Initiatives Project Manager for the International Association of Chiefs of Police. Some of these issues are being addressed while others are not. It also seems to be open to the local police chiefs to determine if this is something they will need or benefit from. While the Project Manager feels they should all be implemented, there is no way to get all the Chiefs involved. This is all being done voluntarily. While I know the township next to mine is involved, I cannot say that for the police in my township. Multiple calls went unanswered. My suggestions and many others should become mandatory for not only the safety of the patient and the public, but also for the officer.

Since diagnosed with Alzheimer's, I have had the fear that I will suffer in many ways as I die slowly from this disease. How will I suffer? One way, which I recently realized, is from pain that my doctor might not recognize or treat once I am no longer able to effectively communicate my needs. Recently I found a way that makes it easy for people to do two things: To learn how people can suffer from Advanced Dementia and to then make decisions that are legal and moral. Basically, I do not want to continue any treatment that will ONLY prolong my dying and increase the chance of my suffering.

This tool is a set of illustrated cards. It creates a Natural Dying Living Will. The name is thus "Natural Dying Living Will Cards." Each of the four dozen cards describes a single aspect of Advanced Dementia in plain language. Each card also has a line drawing, to explain the text. What I did when I "sorted the cards" is to make a decision about what I wanted for each item: Treat and Feed, or Natural Dying? A video is being created in which I can explain my choices, which my loved ones can view when the time comes. I am glad I have the opportunity to say now what I will want later. I can have confidence that I will not have to suffer a prolonged dying with emotional or physical pain. I do not think this system covers all of my concerns, but it's the best available that I am aware of today. This should be considered for all others.

One of the manifestations of dementia is wandering. Patients rely upon familiarity and can get lost easily. This can create panic for the patient and their loved ones and may sometimes result in injury or death. Today there are many state-of-the-art location based products and services that offer safety and peace-of-mind to families and loved ones. People need to be educated about these products and directed to the ones that are best fit for their application. The medical field needs to embrace these products as they do drugs. These products can lead to the person safely staying at home longer. Therefore these products should be a must for all patients and should be covered by health plans and government plans. We also need to figure out how to bring down the cost so that everyone can take advantage of them.

As a dementia patient living in the spotlight, I am often contacted by people trying to sell or convince me to use a product they have that will either reverse or cure my disease. We all have this hope factor in us and are very willing to do some very stupid things to see if they work. There needs to be a single unbiased source of all proven technology that people can rely on. There should be information on what is known to help and what has been known to fail. Too many people are being scammed by the quacks and we need to help people understand what really works. Now I say this with caution, because we also need to remain open-minded. Some real solutions may come from non-traditional methods. As long as respectable people have done a true trial, following the stringent protocols established, that can also be backed up by the medical field, then it should be added to the list.

And my last and final point and question. What assurances do families have that what you are doing will get us a means of prevention and treatment by 2020 or 2025? I am already concerned by the lack of funding being appropriated for this cause.

Please do not hesitate to reach out to me should you have any questions. I welcome the opportunity to become more involved in this committee and to be able to give my viewpoints as an Alzheimer's/dementia person. I also volunteer to be utilized by this committee and HSS to be a voice for other AD patients.

Thanks and have a great weekend.

ATTACHMENT #1:

At registration, identify a person that can and will be able to be involved in all decision-making, along with the patient.

At registration, identify a person that will be given full access to all records on behalf of the patient.

Patients bring in a list of current medications. If for some reason you must change the drug or dosage for any reason, the issue should be addressed with the patient and caregiver to ensure there are no issues (even if it's as simple as converting to a generic). Sometimes patients cannot take another form of the same drug-ask them.

Example: My doctor switched me to Galantamine rather than Aricept because of side effects. In the hospital, they substituted Aricept. (My wife had Galantamine with her, but of course it is a big deal that you should not take your own meds.)

A special ID bracelet should be placed on this type of individual so the staff is alerted that this patient has some form of dementia. This will help them if the patient is acting confused or wandering or just needs a little extra help or explanation. It may also mean that the patient isn't great at making good decisions. If you need a color, purple is perfect.

Example: I needed a Fleet's enema pre-op. The nurse asked if she should give it to me or if I wanted to use it myself in the bathroom. Of course, I offered to do it myself. I found I had difficulty once I got in the bathroom by myself. Bad decision on my part. The nurse should have not given me the option. (We do not want to appear stupid or show our flaws so we may do something to show we are still capable when we may not be.)

I know they always ask the patient for their full name and birthdate -- that may be hard at times for us. I can become confused on a good day, in the hospital it can be worse because of pain medication or being awakened suddenly. Maybe another way can be figured out. (Before a name tag is placed on a dementia patient it may require 3 or 4 staff individuals to ask the patient for that information and each must identify the same information before the ID is placed. This will insure the wrong tag is not placed on the patient. Use the verbal ask on critical things like surgery and drugs given the first time the nurse may see the patient)

Do not always consider a patient being confused as a part of the dementia, but it could be much worse due to the drugs they are on. When I was on pain killers my wife could not even get a response from me that made much sense, and she knows what's normal for me.

A real concern exists on what type of drugs the patient may receive for Anesthesia. Pain killers will also have a much greater impact on this type of person.

While the ordering food on the menus is simple, it is very overwhelming for me and to keep track of things and what items may even go together or are even needed.

Don't assume we can figure out how to use items in the room, like TV, Phone, call button, and anything else. Please point them out and provide a simple explanation on their use.

Aides should not be the first point of contact. I am not always good at explaining what I need and the aide was not always good at interpreting what I was trying to say. Aides are okay for follow-up or to help with food menus.

When asking a question, give them a minute or two to answer without going on to some other question. You could even ask them to think about it and come back in 5-10 minutes, no longer. We often need a few minutes to gather our thoughts. We might even answer a question right away and then realize a few minutes later that that wasn't what you asked.

Somehow you need to insure the patient response is really correctly given -- they sometimes give an answer just to not appear stupid or show they did not understand. Maybe some visual aid or clues can be given along with the verbal depending on the stage the patient is in.

Try to keep items and things in the room in the same place once they determine the best location for them.

I personally feel these patients should be kept a bit longer than the average person, for observation. This would just be to make certain there are no issues at time of release.

Offer a pen and paper to keep in the room. Tell them to write down questions they want to remember to ask when the nurse comes in the room.

Keep in mind many patients with dementia can no longer spell correctly and may use the wrong context for words.

ATTACHMENT #2:

If someone with Alzheimer's is stopped, for a sobriety test, and they may fail due because they will have trouble following instructions or poor gate. They are also much lower in there response and may even give you a blind stair due to confusion.

A place to store or remove guns from a home when needed - I came up with a simple way that could be accomplished, without too much impact to the police. A gun safety device can be used to secure the guns in the person's home and the key can be given to someone responsible. There were other suggestions made.

Better and improved driving testing methods for Alzheimer's patients, ones that normal people would also not fail. It's very easy to find fault with someone's driving, but is it really related to Alzheimer's. Just think of the foolish things you have done? If do not have Alzheimer we treated one way, but if you do you react so much differently. I know we want to make the roads safe, but that comes at a cost to others lives.

When a call comes into the 911 system, they should have a way for people to register that a person in that house has Alzheimer's. This would prepare them in advance on how to deal with the person and family and eliminate confusion. This of course would be something the resident would need to register. Just think if there is a fire would that person still know what to do. Having that information could and will save lives.

Sometimes Alzheimer's patients get confused or feel threaten and may make accusation that could land someone else in jail. Be prepared to deal with cases like this. They need to be handled very different then the average person.

If an Alzheimer's patient becomes defensive, do to some argument, they can sometimes become very aggressive and even become threaten. That is the wrong time to try to remove them from a home. They need to be calmed down first, before moving on, otherwise it can become a disaster for that person, since they will not understand what is going on and may escalate even more.

Be prepared on how to deal with people who may seek help when they are lost driving. All because we get lost driving, does not mean they cannot drive. These two issues are very confused by many.


 

J. Shufelt  |  07-04-2012

Taking care of a loved one during the progressive stages of ALZ includes specialized meal items and feeding techniques that we practice in long term care. Would it be possible to include some information and allow funding for increased needs for nutrition education to minimize malnutrition risks for ALZ patients or is this already considered?


 

JUNE 2012 COMMENTS

K. Summar  |  06-18-2012

Attached, please find a letter to Secretary Sebelius from the Congressional Down Syndrome Caucus co-chairs. A hard copied was mailed today.

ATTACHMENT:

As co-chairs of the Bipartisan Congressional Down Syndrome Caucus, we have reviewed the National Plan to Address Alzheimer's Disease. We commend you on this historic effort to fight Alzheimer's disease and related dementias and for the inclusion of Down syndrome in this National Plan. We are pleased the Plan establishes a taskforce to address the unique care challenges faced by people with younger-onset Alzheimer's disease. Additionally, we are pleased that the Plan includes steps to improve access to long-term services and supports for younger people, including those with Down syndrome.

Alzheimer's disease attacks adults with Down syndrome at a younger age and with increased frequency when compared to the general population. The pathological findings of Alzheimer's disease have been described in the brains of people with Down syndrome since the 1800s There are genetic factors at play that, in part, explain these pathologic and clinical observations. NIH is funding Down syndrome research using natural history studies and imaging techniques to identify early markers of cognitive decline. These studies will undoubtedly help people with Down syndrome, but they will also have a broader application to those individuals in the general population who are at risk for developing Alzheimer's disease. By recognizing the specific link between Down syndrome and Alzheimer's disease, the National Plan will leverage all of the most current scientific data available. More importantly, millions of American's who are at risk for Alzheimer's disease will benefit from the research that is already underway for those with Down syndrome. This is truly a win-win for the entire community.

Again, we thank you for your inclusion of Down syndrome in the National Plan, but are asking you to go a step farther. We respectfully request that a representative from the Down syndrome research community be added to the Advisory Council on Alzheimer's Research, Care, and Services.


 

M. Ellenbogen  |  06-13-2012

Thanks again for all of your help in the past. This is the most important work, I have ever completed. Please help me make this link below go viral. Please add it to twitter, Facebook, your web site and place it on other websites in comments sections. If this can become viral, this will definitely have a huge impact on Alzheimer's perception.

http://youtu.be/oXKO1Qr5qf0

P.S. If you should receive this message more than once I do apologies. My skills are not as good as they use to be.


 

A. Vann  |  06-09-2012

I am a retired public school principal (age 64) and a caregiver for my wife (age 65), who has Alzheimer's Disease (AD). I have written two articles that have recently been published in American Journal of Alzheimer's Disease & Other Dementias. "Alzheimer's and Baby Boomers" was published in their September, 2010 issue, and "Ten Things You Should Do When the Diagnosis is Alzheimer's" appeared in their March, 2011 issue. I also had a third article published, "Forget the Mental Status Test and Learn to Listen," as a lengthy Letter to the Editor in the May issue of Journal of Family Practice. These three articles were written to help doctors improve their process of diagnosis and treatment of AD patients ... and their caregivers ... based upon my experience to date. I am now writing a fourth article to educate the public on the urgent need to increase federal funding though NIH for research. I have appended a draft of that piece to the end of this email.

I respectfully request that your Advisory Council address the issues raised in my three articles, as well as in the attached draft. Aside from the need to increase AD research funding,

Thank you for your time and consideration.

Alzheimer's ... Our New Cancer?
Allan Vann

Cancer is the second leading cause of death in this country. Earlier this year, the Centers for Disease Control reported that between 1971-2007, the number of cancer survivors in the United States grew tremendously due to "earlier detection, improved diagnostic methods, and more effective treatment," among other reasons. Furthermore, according to CDC, "about 1.1 million of the (cancer) survivors had lived with the diagnosis for more than 25 years."

Alzheimer's Disease (AD) is the sixth leading and fastest growing cause of death in this country, and the only one of the top ten causes with no means of prevention or cure. Unlike with cancer, CDC cannot report any AD survivors. None. Most people only live for 8-10 years after an AD diagnosis, and between 5-10% of those with Alzheimer's are still in their thirties, forties, and fifties when diagnosed.

Our country faces a huge AD crisis in the years ahead. More than 5 million Americans have already been diagnosed with AD, and with so many baby boomers now turning 65 each day this number is expected to triple in the next 30-40 years.

One politician seeking greater funding for AD research is Maine Senator Susan Collins. She noted that, "We spend one penny on research for every dollar the federal government spends on care for patients with Alzheimer's. That just doesn't make any sense." Care for Alzheimer's patients already costs this country nearly $200 billion a year and, according to Senator Collins, "If nothing is done to slow or stop the disease, Alzheimer's will cost the United States $20 trillion over the next 40 years."

This year, our National Institutes of Health (NIH) will allocate more than $6 billion for cancer research ... but less than $500 million for AD research ... just as was true last year. This doesn't make any sense. Despite the need to reduce overall federal spending, we must increase NIH funding for AD research. Aside from the human cost to AD patients, caregivers, and their families, current research spending is penny wise and dollar foolish. As Senator Collins suggested, without major breakthroughs in treating AD, let alone finding a cure, future long term costs to our Medicare system will be astronomical.

My wife was diagnosed with AD at age 63. No treatment or cure will arrive in time for her. But if our country begins to devote funding for AD research as we have for cancer, then perhaps one day some people will be able to say that they are AD survivors. And perhaps our health care system will be that much further away from bankruptcy.


 

MAY 2012 COMMENTS

D. McCracken  |  05-15-2012

Where do I visit online to find out information about participating in this new study?


 

M. Ellenbogen  |  05-15-2012

I had an opportunity to see the new site. While it may be a good start, you have sugar coated to many things. People need to know it all and the truth. Especially that people die from this disease.

==========

Obama Administration Presents National Plan to Fight Alzheimer's Disease

Health and Human Services Secretary Kathleen Sebelius today released an ambitious national plan to fight Alzheimer's disease. The plan was called for in the National Alzheimer's Project Act (NAPA) [https://aspe.hhs.gov/national-alzheimers-project-act], which President Obama signed into law in January 2011. The National Plan to Address Alzheimer's Disease [https://aspe.hhs.gov/national-plan-address-alzheimers-disease] sets forth five goals, including the development of effective prevention and treatment approaches for Alzheimer's disease and related dementias by 2025.

In February 2012, the administration announced that it would take immediate action to implement parts of the plan, including making additional funding available in fiscal year 2012 to support research, provider education and public awareness. Today, the Secretary announced additional specific actions, including the funding of two major clinical trials, jumpstarted by the National Institutes of Health's (NIH) infusion of additional FY 2012 funds directed at Alzheimer's disease; the development of new high-quality, up-to-date training and information for our nation's clinicians; and a new public education campaign and website to help families and caregivers find the services and support they need.

To help accelerate this urgent work, the President's proposed FY 2013 budget provides a $100 million increase for efforts to combat Alzheimer's disease. These funds will support additional research ($80 million), improve public awareness of the disease ($4.2 million), support provider education programs ($4.0 million), invest in caregiver support ($10.5 million), and improve data collection ($1.3 million).

"These actions are the cornerstones of an historic effort to fight Alzheimer's disease," Secretary Sebelius said. "This is a national plan--not a federal one, because reducing the burden of Alzheimer's will require the active engagement of both the public and private sectors."

The plan, presented today at the Alzheimer's Research Summit 2012: Path to Treatment and Prevention, was developed with input from experts in aging and Alzheimer's disease issues and calls for a comprehensive, collaborative approach across federal, state, private and non-profit organizations. More than 3,600 people or organizations submitted comments on the draft plan.

As many as 5.1 million Americans have Alzheimer's disease and that number is likely to double in the coming years. At the same time, millions of American families struggle with the physical, emotional and financial costs of caring for a loved one with Alzheimer's disease.

The initiatives announced today include:

  • Research -- The funding of new research projects by the NIH will focus on key areas in which emerging technologies and new approaches in clinical testing now allow for a more comprehensive assessment of the disease. This research holds considerable promise for developing new and targeted approaches to prevention and treatment. Specifically, two major clinical trials are being funded. One is a $7.9 million effort to test an insulin nasal spray for treating Alzheimer's disease. A second study, toward which NIH is contributing $16 million, is the first prevention trial in people at the highest risk for the disease.
  • Tools for Clinicians -- The Health Resources and Services Administration has awarded $2 million in funding through its geriatric education centers to provide high-quality training for doctors, nurses, and other health care providers on recognizing the signs and symptoms of Alzheimer's disease and how to manage the disease.
  • Easier access to information to support caregivers -- HHS' new website, http://www.alzheimers.gov, offers resources and support to those facing Alzheimer's disease and their friends and family. The site is a gateway to reliable, comprehensive information from federal, state, and private organizations on a range of topics. Visitors to the site will find plain language information and tools to identify local resources that can help with the challenges of daily living, emotional needs, and financial issues related to dementia. Video interviews with real family caregivers explain why information is key to successful caregiving, in their own words.
  • Awareness campaign -- The first new television advertisement encouraging caregivers to seek information at the new website was debuted. This media campaign will be launched this summer, reaching family members and patients in need of information on Alzheimer's disease.

Today's announcement demonstrates the Obama administration's continued commitment to taking action in the fight against Alzheimer's disease.

In 2013, the National Family Caregiver Support Program will continue to provide essential services to family caregivers, including those helping loved ones with Alzheimer's disease. This program will enable family caregivers to receive essential respite services, providing them a short break from caregiving duties, along with other essential services, such as counseling, education and support groups.

For more information on the national plan to address Alzheimer's disease, visit: http://www.alzheimers.gov.

##

National Alzheimer's Project Act https://aspe.hhs.gov/national-alzheimers-project-act
National Plan to Address Alzheimer's Disease https://aspe.hhs.gov/national-plan-address-alzheimers-disease
Alzheimers.gov http://www.alzheimers.gov


 

C. Rodgers  |  05-15-2012

I just realized I never sent you the comments I made at the April 17 meeting. Attached please find both Word and PDF files of my comments, which I am providing for the public record. Thank you,

ATTACHMENT:

Of Alzheimer's, the scientific method & educated guesses

Some of you may recall that in January, I presented my hypothesis that Alzheimer's disease is caused by dental X-rays shortening the lifespan of the brain cells that keep sustain neurons, fatally stranding them (1). The article it was based on was reviewed by scientists specializing in Alzheimer's, neurology or radiology during manuscript development and in the course of peer review before it was published in Medical Hypothesis last July (2).

But that's not what I am here to talk about.

I am here to talk about the scientific method versus expediting answers. Thomas Edison was a great one for applying scientific method. He exemplified how persistence can conquer multiple failures when he had his lab test 10,000 different filament substances before finding tungsten. That was a great feat, but he was only looking for a way to light up the world that was already aglow with candles.

Alzheimer's is different. Darkness is descending on the minds of the elderly and the not-so-elderly with savage rapidity. Every day we fail to discover what is causing Alzheimer's and how to treat it, countless more individuals are doomed to losing their minds and ultimately, their lives in a manner that does not go gently into the night. We don't have the time to test 10,000 possibilities -- we need ask new questions and to make educated guesses that will vault us into new territory.

Clinical trials are the "gold standard" of evidence-based medicine. But when a treatment does not pass a clinical trial, it is not gold, it is lead. Recently one scientist involved with clinical trials of Alzheimer's drugs said that some 100 treatments were in the works, most of which targeted brain plaques. Since more than one clinical trial of a plaques-clearing treatment has been halted for doing more harm than good, it is time to consider that clearing plaques is not the answer and no alchemy can turn it into gold.

Meanwhile, we can't afford the time and money to be as systematic as Edison -- we need educated guesses that, like leaps of faith, close the gap quickly. The answer is probably a simple one; the very speed with which Alzheimer's has become a killer argues against a complex etiology, since the more factors required for an outcome, the more difficult it is to meet all of the conditions necessary to cause it. Plus, simple answers are easily overlooked, which is why it took nearly 300 years for scientists to discover that rickets was caused by a lack of sunshine.

Are dental X-rays causing Alzheimer's? I can't answer that question because my hypothesis has yet to be tested. But I'm told it would take only about $20,000 to launch a pilot study that could bring us closer to the truth. We need to investigate this and other out-of-the-box ideas. While the Research Subcommittee's draft recommendations call for timelines, strict metrics and cooperation among what it terms "industry players," we need to go beyond these business models and find ways to attract and fund fresh avenues of Alzheimer's research. While scientific method is important, if it is not used to explore creative educated guesses it may be a long time before we strike gold.

Thank you.

  1. See earlier comments at C. Rodgers.
  2. http://www.medical-hypotheses.com/article/S0306-9877(11)00118-6/abstract

 

APRIL 2012 COMMENTS

C. Danesi  |  04-30-2012

I AM A DAUTHER,AN AMERICAN , A VOTER AND A CAREPARTNER FOR A PARENT WITH ALZHEIMERS DISEASE AND THESE ARE MY RECOMMENDATIONS FOR THE NATIONAL ALZHEIMERS PLAN:

Goal One is of vital important-To accomplish this goal, it is imperative that a subgroup is formed to accelerate and streamline efforts to isolate and identify potentially viable drugs that can effectively cross the Blood Brain Barrier and stop and preferably regress the Alzheimersdisease process. This group should consist of a representative from all of the top federal and non-federal agencies that are involved in bringing a drug through the development process into human testing and beyond to becoming FDA approved. This subgroup should consists primarily of a representative from HHS,NIH,NIA,WHO,FDA, Doctors and Researchers , as well as Biotech and Pharmaceutical companies. Similar to the Therapeutics For Rare And Neglected Diseases (TRND) Program-this subgroup should stimulate drug development and research by providing an opportunity to partner with one another in a collaborative environment with the goal of moving promising drugs into human trials in a timely, efficient and highly effective manner. This subgroup should use an application and evaluation process to select collaborators. Selected investigators should provide each separate drug candidates starting points and ongoing biological disease expertise throughout the total project. Each drug composition should be studied individually and separately so that the best possible ones can be accurately identified and focused upon. Therefore each potentially valid treatment and or cure for the alzheimersdisease process is regarded as a separate project or entity ,within the main project; the main project's goal being to create a new and better medicine for the alzheimers disease process and or a cure.

The Alzheimers Disease Summit in May 2012 should be looked upon as a breeding group for potentially valid drug candidates. All and any information gathered and disseminated at the summit should be thoroughly analyzed for the absolute best possible viable candidates to be studied by the subgroup, in a supreme effort to accomplish goal one. A representative from each agency involved in the subgroup should be in attendance at the summit so that they can absorb information and use it accordingly.

To increase public awareness of the disease and its various components a public service announcement should be broadcast across the country on every public tv station. This announcement should show a person with the disease, throughout the various progressive stages and explain to America that alzheimersis much more than a loss of memory but instead a progressive degenerative brain disease that is fatal and desperate for public support and a new and better medicine and or a cure.


 

J. Alfano  |  04-25-2012

I am a physical therapy student at Thomas Jefferson University in Philadelphia, PA. I was recently doing some research on Alzheimer's legislation for my "Geriatrics" course when I came across the National Alzheimer's Project Act. After reading more about NAPA online, I was pleased to see that the Advisory Council welcomes public comments. While I understand that the April 17th Advisory Council meeting just passed, if it is at all possible, I would like to include the following comment for consideration at the next meeting.

Having a grandmother with Alzheimer's disease, I understand how emotionally difficult, physically taxing and financially burdensome this disease can be for a family. As my grandfather has become older and less able to take care of her, my mother and aunts have stepped up and given up much of their free time to care for her. However, with all of them working, a home health aide is needed.

Over the past couple of years, my grandmother has had numerous aides because the previous one decided that she could no longer make the commute or take care of my grandmother, among other reasons. While I understand there are legitimate reasons why an aide can no longer work with a particular patient, my family and I often felt that the aides were dictating terms to the home health agency in that they chose when and where they wanted to work and for how long. Their unreliability presented as a burden for my family and was traumatic for my grandmother who has difficulty adjusting to the new people due to her cognitive limitations.

I believe a system that makes the aides more accountable to the individuals they are assigned to care for would be beneficial, possibly through more education or training. I also believe the directors of home health agencies should be required to have a medical background so that they would be better able to understand a patient's needs and assign appropriate aides to the individuals requiring care, especially to those with dementia.

Thank you for your time and consideration of this matter.

 

S. Stimson  |  04-23-2012

In reading number 6 we wanted to add our comments. We have four recommendations:

Our first recommendation is that the committee should be aware of which states are requiring dementia education and how many hours are required. The regulations are different in every state and for each industry, such as Adult Day Care, Hospice, Home Care, Nursing Homes, Assisted Living, Hospitals, Rehab Centers, Psychiatric Facilities and Locked Dementia Units. Some states require more dementia education such as 20 hours and other states and depending on which industry require less dementia education while others do not have a specific number of hours. Some states may require more than 10 hours of dementia education. So at minimum before your recommendation is passed, you should be aware of what each state is requiring for dementia education and for each industry. At minimum the national standard should be more than 10 hours. We are recommending at minimum 12 hours of Live dementia education for all front line staff and health care professionals.

We recommend live training by a certified Alzheimer's and dementia trainer. In some states the education is permitted per the state regulation via Weimar and video training. We stand against this way of initial Alzheimer's and dementia training because you can not be sure that the person attending the Webinar or video training is in fact that person. Nor can you insure when the material is presented by Webinar or video training that the employee understood the material. "Live Training" is critical in preventing abuse and neglect of our most vulnerable elders by the front line staff and health care professional.

In addition, we recommend ongoing training through out the year to keep the staff up to date on regulatory changes and new advances in all aspects of care. Each year for NCCDP Alzheimer's and dementia Staff Education Week February 14 to 21 and we provide free staff in-services for educators to download from our site which includes the power point, hand outs, pre tests and post tests. This is a free services and is available from November till May. We add many new topics every year. Your recommendations should let the public know of this free service.

Secondly, the wording you have for the education piece is "reliable source". We feel it should be spelled out to specifically state, universities, associations,nationally recognized companies and nationally recognized organizations. such as the National Council of Certified Dementia Practitioner's, National Alzheimer's Association, National Alzheimer's Foundation, Office on Aging, etc. The public should be aware by your office of all of the organizations and companies providing dementia education and not just a select few who are serving on your committee. The institution than can make a choice as to which organization to use for staff training.

Our third recommendation should be that the words "Paraprofessional Caregiver" come out and replace with all Health Care Professionals and Front line staff including Nursing Assistants, Home Health Aides, Personal Care Assistants, Activity and TR professionals, Nurses, Social Workers, Dietary Workers, PT, OT, Speech, Housekeeping, Bus Drivers, Administrators, Assistant Administrators, Pharmacists, Physicians and all other staff who interact with the patient. We feel this needs to be very detailed and specific and not in any way target one specific profession as all professions who interact with the geriatric patient be included in the Alzheimer's and dementia training.

Our fourth recommendation is that Alzheimer's and dementia education be mandated in all colleges, universities, trade schools that provide a medical profession trade or certification or license for any health care related profession regardless if they are entering the geriatric field.


 

M. Ellenbogen  |  04-20-2012

While I agree with some of your statements and there is a flaw. The flaw is not thought my ideas, but the system we created. Many of us think they are god and have the right to make decision for everyone else and they do not look past the religion aspect of things. The perfect world would be based on having doctors put me out based on taken a certain score on the 30 question MMI test (or whatever you call it) they always give you. I am not sure what the number would be, but probably about 15 - 20. That of course would require much more involvement from my doctors so I could truly understand what that all means. It should also be based at taking that test 3 separate times at different times of the day, with at least a week in between. That would all be based by my original request when I was still capable of making a sound decision. I would be happy to discuss it with anyone interested in speaking about it.

==========

From: S. Terman

[Link to comments -- S. Terman]


 

S. Terman  |  04-20-2012

Why physician-assisted suicide/dying cannot help patients who have dementia

Mr. Ellenbogen brings up an important point, one that concerns many people who worry about dementia: Briefly: Is there a way for them to exit in a dignified way that is also timely?

Mr. Ellenbogen expressed this fear well, and I feel compassion for him. His stated problem begs for an effective solution. Yet the one he proposed is seriously flawed from several points of view: the clinical, practical, ethical, moral, and psychological, as well as legal.

The points of agreement and the one point of disagreement that I have with Michael Ellenbogen is within his key paragraph that I copied below and then respond to, point-by-point, by adding my specific comments:

Mr. Ellenbogen wrote: "You need to make plans when you are still able to think clearly. You must figure out a method so you know what to do when the time comes. The scary part for me is knowingwhen the right time may be. You do not want to go earlier then you have to, but you do not want to wait until the point where you may not be able to decide to do it, or remember how to do it. That is why I am a true believer in assisted suicide. It would be nice to let someone know my wishes far in advance, and when we get to that point they would instruct me on what I had to do. This way, my family and I could get the most out of my life without question."

First a general comment: Mr. Ellenbogen expresses what I have been calling the "Dementia Fear," when he writes: "You do not want to wait until the point where you may not be able to decide to do it, or remember how to do it," since by the word, "IT," he really means suicide. More typical is this blunter statement: "If I don't kill myself now (when I can), I won't be able to kill myself later (when I want to)." The consequence of acting on this fear is "premature dying," which violates the principle of the sanctity/preciousness of life. This is the problem for which Mr. Ellenbogen is searching for a solution.

Now, point-by-point:

Yes, I agree: "You need to make plans while you still have the mental capacity to make end of life treatment decision." Let me add: One way to do this is to create a clear and specific Living Will and to appoint a proxy/agent whom you trust to make sure that others will honor the wishes you previously expressed in your Living Will. The document designates your proxy/agent must give the appointed individuals sufficient power to facilitate your last wishes.

Yes, I agree: "You need to figure out a method so you know what to do." To respond: My personal choice, and what I advise my patients to consider is to forgo the continuation of another person's hand to assist oral feeding and drinking. This is what I have been calling "Natural Dying." Important: food and fluid are always placed near enough to reach so that if you regained the ability to eat independently, you could. Forgoing treatment that has become extraordinary or disproportionate is both legal and moral.

Yes, I agree: "The scary part is knowing when the right time may be." Appreciating that you will lose the ability to decide on that time later means you must make this decision while you still can. The goal of TIMELY DYING is possible if you can trust your proxy/agent and your future physician to engage in the process of "shared decision-making." Then, someday, they will compare your future condition with the decisions you expressed in your clear and specific Living Will to decide if it is time for "Natural Dying."

Important: Assisted suicide is not legal for patients who have dementia, even in Oregon, Washington, or Switzerland. While legal in theory, it is very rarely practiced in Holland because physicians do not feel comfortable killing a patient who cannot contemporaneously express the wish to die. Dutch physicians also do not feel comfortable killing a patient whose major issue is their anticipatory fear of greater suffering and burdens in the future; they insist that patients have unbearable suffering which cannot be relieved in any way other than by dying--which is NOT the case for patients in the early or middle stages of dementia. Even for patients who had such terminal diseases as cancer or neurological diseases (which comprise the majority of patients who used Oregon's "Death With Dignity Act"), only 600 people died this way since 1997. Compare this number to the one to two million people who currently are suffering in the advanced stage of dementia--a number that will triple by mid-century. Thus, physician-assisted dying cannot be a practical, legal, or ethical answer for a prolonged dying with much suffering for patients who reach the stage of advanced dementia.

Yes, I agree: "It would be nice to let someone know my wishes far in advance..." and "This way, my family and I could get the most out of my life without question." This laudable goal can be accomplished by effective Advance Care Planning.

But now, a resounding NO, I do NOT agree: "When we get to that point they would instruct me on what I had to do" (e.g., how to commit suicide). Your family members would risk being indicted for a serious crime with severe penalties. They are also likely to suffer from greater moral angst and grief, if they actively helped you die when they were not sure about--as you put it "when the right time... when [I] get to that point." The best way to reduce the emotional burdens on families is to create your gift of a clear, specific Living Will and to make it clear that you are responsible for the ultimate existential decision, not them.

Let me end with a personal note to Michael Ellenbogen: I am sorry you have the diagnosis of dementia. I am glad that you are still functioning at such a high level. Unfortunately, you cannot be sure, just because each dementia patient is different, just how long you will retain your ability to exercise good judgment about end-of-life medical decisions. Now, you do. Someday... unless you die of another disease first, the irreversible, progressive disease of dementia will likely deprive you of that good judgment. (Perhaps an exception is a very well controlled vascular dementia that remains stable.) This is the reason why it is so important that you make your decisions, memorialize them, and appoint surrogates to facilitate them NOW. It would be an enormous shame and waste of your good life, if you were to commit suicide prematurely, just because you still possessed the mental capacity to make medical decisions. I hope you live as long and as well as possible.

Conflict of interest statement: Stanley A. Terman, PhD, MD, has written three books on this subject and created a deck of illustrated cards that people, even those in early dementia, can use to generate a clear and specific Living Will if they want to attain the goal of a timely and peaceful dying. (The books are "The BEST WAY to Say Goodbye: A Legal Peaceful Choice at the End of Life," "Peaceful Transitions: Stories of Success and Compassion," and "Peaceful Transitions: Plan Now, Die Later--Ironclad Strategy"; the cards are "My Way Cards for Natural Dying" or "Natural Dying Living Will Cards." Dr. Terman is the founder and Medical Director of Caring Advocates, a non-profit organization.)

==========

From: M. Ellenbogen

[Link to comments -- M. Ellenbogen]


 

J. Ross  |  04-20-2012

How do I reach out to Dr. Shrank, MD at the CMMI?

Dr. Ling sent me his email but no response as of yet. I wish to apply for a demonstration project to improve the quality of care for patient with AD using a "wrap around" at risk approach which was outlined in m letter to you a few weeks back (see attached).

ATTACHMENT:

I have provided medical care for over 10,000 victims of Alzheimer's Disease since starting my comprehensive geriatric and Alzheimer's Disease practice in 1986. I would like to present my comments on the NAPA plan. I am a member of the advisory panel of NAPA and through my organization, The Memory Enhancement of America we provide an unprecedented level of care and treatment to all those afflicted with memory loss/mild cognitive impairment and dementia due to Alzheimer's Disease.

I would desire to discuss the urgent need to open a demonstration project in our 6th congressional district.

This Memory Evaluation and Treatment Center (METC) will provide complete and comprehensive management for mild, moderate and severe stages of Alzheimer's Disease. Funded in part by the a portion of the 83 million dollars signed into law by President Obama it shall include but not limit itself to providing medical/nursing/social/psychological care of AD patients as well as offer physical and occupational therapy; address the many ethical, financial and legal challenges this deadly disease poses to patients, caregivers and society in general. This METC will show cost effectiveness by reducing unnecessary hospitalization, reducing need for emergency room visits, delay nursing home if not eliminate the need for such placement as well as be a center of excellence for all other 434 Congressional districts in our wonderful nation. Pharmaceutical research of the highest caliber testing safety and efficacy of the latest medications in development will be a further extension of METC.

All at no cost to the patient. I propose that Medicare/Medicaid and a portion of NAPA money be used to test this METC concept and in a randomized study using a group of 200 AD patients assigned to traditional (fragmented and inefficient, standard of care) and comparing them to a similarly matched group of 200 AD patients assigned to METC care.

I and my many colleagues and other professional associates and organizations believe quite strongly and will prove a METC is the only place for AD patients to receive comprehensive, compassionate and welcomed care.

My bio is attached for your review.

I welcome the opportunity to speak at the April 17th meeting on behalf of the nearly 5.5 million victims of AD as well as for those who have died from this dreadful 100% fatal disorder.

Thank you for the time to consider my suggestions,


 

M. Ellenbogen  |  04-20-2012

I am writing to you out of frustration to the letter of Dr. Terman, dated, March 26 2012. While I do not know what his credentials are, I can assure you 100% without doubt that he does not have any understanding of what Alzheimer's patients are capable of doing or not doing. While I have heard from all the smart doctors make the statement that if you know one Alzheimer's patient, you only know one as for their symptoms go.

While I may have trouble writing, speaking, do financing and many of the other things I so dearly miss, I am very capable of making very good judgments. In fact I still help many people who do not have dementia to help them with decisions they are unable to make.

Some people like to be in the public spot light for the wrong reasons, which is the case for this individual. If you are going to make statements, you should understand all sides, not just a one side point of view, maybe perhaps poor judgment on his part.

My wife feels that she would have no problem taking care of me all the way to the end. Since she happens to be an RN she feels she could take off for a year to become my private nurse, if and when I became bad. But I have many fears of reaching that point in my life. First of all, I do not want to be remembered as the person who could no longer talk or take care of himself. I want to leave this world with dignity and not make others feel better about themselvesbecause they kept me around to the end. I do not want to frustrate and burden their lives any more than I have. While we have had a great life, those are the thoughts I want to leave my wife with. I also hope that she finds someone new in her life so she can move on. My daughter lives in another state and I do not want her to feel obligated to move back, close to home, just to help her mother. I do not think my wife realizes what a major undertaking this is. While she may be good at what she does, she cannot handle this type of pressure.

Then of course, I do not want to suffer and be tortured for the rest of my life. There are many times, on a daily basis, when I am not always clear on what I need to do to make myself more comfortable or not suffer from pain. In the middle of the night, while sleeping, I become uncomfortable because I'm hot, so I flip the covers off my feet and feel so much better. A few hours go by, and now my feet are cold, so I replace the blanket. Now imagine that you are hot, and there is no way to remove that blanket. I would go crazy because I could not do that and would suffer. That is exactly what would happen if I could no longer do or think for myself.

My wife seems to think that those types of issues would not bother me. Who really knows? However, I do not want to be the one to find out and suffer. Sure, she can want to think it will not happen, for her peace of mind, but what about me?

Let me give you another example. I have major allergy problems and I constantly have a postnasal drip. Its major impact to me is at night and I frequently wake up gagging and coughing in an effort to clear my nose and throat. Sometimes I can waste 45 minutes before I finally resolve the issue. I actually suffer today and feel tortured at times. Can you imagine if that happens to me and I cannot let someone know what's bothering me and cannot do anything for myself. That frightens me to no end. My allergist has run out of options with me. This problem has really become much worse this year.

One last example. I am particular about how my pillow feels when I go to sleep. I like it to be very fluffed up. Usually once during the night I tend to flip it so that I get the fluffed end again, and it feels so much better when I do that.

People may tell you to wait until it gets worse, but they are wrong. You need to make plans when you are still able to think clearly. You must figure out a method so you know what to do when the time comes. The scary part for me is knowing when the right time may be. You do not want to go earlier then you have to, but you do not want to wait until the point where you may not be able to decide to do it, or remember how to do it. That is why I am a true believer in assisted suicide. It would be nice to let someone know my wishes far in advance, and when we get to that point they would instruct me on what I had to do. This way, my family and I could get the most out of my life without question.

There are many other reasons I can go into, but I need to go to a funeral for a family member who final passed away after years of torture. He finally passed from Parkinson Disease the other day. He was zombie and scared and had no life. He had living will that was over ridden because some family member was going to have a wedding and they decide to put feeding tube in when he would have probably died in another day or two. Now that is poor judgment from people like you.

Please see letter below.

==========

From: S. Terman

[Link to comments -- S. Terman]


 

G. MacInnes  |  04-19-2012

Thank you for the opportunity to provide comments at the meeting of the Advisory Council on Alzheimer's Research, Care, and Services on Tuesday. A hard copy of the oral comments we shared is attached as well as a copy of the written comments we submitted previously.

ATTACHMENT #1:

On behalf of the Eldercare Workforce Alliance, a coalition of 29 national organizations committed to addressing the immediate and future workforce crisis in caring for an aging America, we thank you and the Advisory Council on Alzheimer's Research, Care, and Services for your work to forumulate the Draft National Plan to Address Alzheimer's Disease.

We commend the Council for its recognition of the vital importance of a strong workforce for realizing the goals of the Plan, as demonstrated in strategies 2.A and 2.C, which call for the building of a workforce with the skills to provide high-quality care, as well as the strategies under Goal 3, in support of family caregivers.

While the action items located under Strategy 2.A are significant, we remain concerned that the essential workforce goals identified by the Council cannot be realized without the investment of additional resources. Specifically, the action items calls for additional and enhanced activities within Geriatric Education Centers (GEC), the Comprehensive Geriatric Education Program (CGEP), the Geriatric Academic Career Awards Program (GACA), the Geriatric Training for Physicians, Dentists, and Behavioral and mental Health Providers (GTPD) program, and the Direct-Care Workforce training program. These programs, which are administered through the Health Resources and Services Administration (HRSA) under the Title VII and VIII of the Public Health Service Act, are in constant danger of defunding and have experienced stagnant funding that has not kept up with the pace of inflation, even as the need for preparation to care for older adults has skyrocketed. To implement these additional and enhanced activities in order to realize the goal of enhancing care quality and efficiency for the growing number of older adults with Alzheimer's disease and other multiple chronic conditions additional funding must be invested.

We believe that access to quality health care for older adults with cognitive impairment is vital to healthy aging and we commend you for your efforts. As the work of the committee continues, we welcome opportunities to work with you.

ATTACHMENT #2:

Eldercare Workforce Alliance Comments for
The Advisory Council on Alzheimer's Research, Care, and Services
April 17, 2012

On behalf of the Eldercare Workforce Alliance, a coalition of 29 national organizations committed to addressing the immediate and future workforce crisis in caring for an aging America, thank you for your work to formulate recommendations for operationalizing the Draft National Plan to Address Alzheimer's Disease.

We commend the Council for its recognition of the vital importance of a strong workforce for realizing the goals of the Draft Plan, outlined in strategy 2.A, which calls for the building of a workforce with the skills to provide high-quality care, as well as the strategies under Goal 3, in support of family caregivers.

While the action items outlined in the Draft Plan and the recommendations you have voted on here today are significant, EWA strongly urges the Council to consider the following comments in order to achieve the essential workforce goals identified in the Draft Plan: -

  • EWA strongly supports the Clinical Care Subcommittee's Recommendation #8 to invest additional funding in multidisciplinary geriatrics education and training programs under Title VII and VIII of the Public Health Service Act. Action items under Strategy 2.A of the Draft Plan call for additional and enhanced activities within these programs; however, they have experienced stagnant funding and constant threats of defunding, even as the need for preparation to care for older adults has skyrocketed. Some of the programs authorized in the Affordable Care Act have yet to receive appropriations. To implement the additional activities called for in the Draft Plan to enhance care quality and efficiency for the growing number of older adults with Alzheimer's disease and other multiple chronic conditions, additional funding must be invested.
  • EWA strongly supports the Clinical Care Subcommittee's recommendation to increase funding for loan repayments and other incentives for those who study geriatrics and gerontology. We recommend that geriatrics and gerontology be made permanently eligible via statute for federal loan forgiveness and other efforts to boost enrollment in these medical disciplines.
  • EWA strongly supports the Council's recommendations with regard to promotion of geriatric education offerings and the dissemination of information about Alzheimer's disease, dementia care, and support systems. EWA believes that geriatric competencies and dementia training should be included in training for all primary care clinicians and staff to improve detection, treatment and care for people with Alzheimer's disease.
  • EWA strongly supports the Long-Term Services and Supports Subcommittee's recommendations for health care provider training and for adequate training and compensation for paraprofessional caregivers. More specifically, we recommend that certified nursing aides and home care aides and their supervisors be required to take at least 120 of training, including explicit geriatric care and gerontological content; and that minimum training standards/competencies for non-clinical direct-care workers should be created and that they should be adequately compensated.
  • EWA urges the Council to consider more specific recommendations on improving access to Medicare and Medicaid funded home- and community-based care services to allow individuals with Alzheimer's disease to stay in their homes as long as possible.
  • EWA strongly supports the Council's recommendations to expand and increase funding for AoA programs such family planning and social services, research and development projects, and training in the field of aging; respite care; support services for family caregivers that can help reduce their burden.

We believe that access to quality health care for older adults with cognitive impairment is vital to healthy aging and we commend you for your efforts. As the work of the Council continues, we welcome opportunities to work with you to achieve the goals of the National Plan.


 

M. Harpold  |  04-18-2012

I am writing to follow up on my previous email below that included attached comments concerning the Draft National Alzheimer's Plan, to make sure that you did receive my email & comments (I have also attached another copy to this email). I understand that the next NA Plan Advisory Council meeting is scheduled for tomorrow, April 17, and also wanted to be sure the copy of my comments was submitted to the Advisory Council for consideration and appropriate discussion.

Could you confirm?

I understand the Advisory Council meeting tomorrow will be available for live streaming via the internet; am I correct that there will be no teleconference of the meeting or opportunities for external input?

Are there other recipients (or postings) relevant to the development of the Plan to which it would be appropriate to provide these comments?

==========

From: M. Harpold

[Link to comments -- M. Harpold]


 

S. Coffey  |  04-17-2012

Family Caregiver Alliance would like to submit the attached comments into the official record for today.

ATTACHMENT:

I am writing on behalf of family caregivers throughout the United States who are struggling to provide care for their loved ones with Alzheimer's disease and related dementias. The National Center on Caregiving at Family Caregiver Alliance supports many of the recommendations contained in the presentation handout and would like this letter submitted for the formal record.

Long-Term Services and Supports Subcommittee Recommendations

1) HHS should provide Federal Funds to support a state lead entity in every state and territory. This entity would coordinate available public and private LTSS, conduct service gap analysis, identify opportunities for efficiency, and enable ongoing stakeholder input to address needs across all sectors and systems. Bullet point #7: HHS should fully fund the costs of cognitive impairment and caregiver surveillance through the Behavioral Risk Factor Surveillance System (BRFSS) in every state.

FCA: We support using the caregiver module in BRFSS in every state. However, in our communication with states that have included the caregiver module in their BRFSS, not all states had the funding or infrastructure to properly analyze the data after it was collected. Therefore, HHS should also include funding for the analysis of the data after it has been collected.

4) Fully fund Caregiver Supports under AoA. AoA currently has a Caregiver Support Program, a component of which can be expanded to better meet the needs of caregivers of individuals with Alzheimer's disease and other dementias.

FCA: An article in American Family Physician, released in 2011, ("Caregiver Care") focused on the importance of caregiver assessment. In it, the authors noted that the National Family Caregiver Support Program (NFCSP) received $154 million in federal funding in FY 2009, "approximately one-twentieth of 1 percent of the value of caregiver contributions." Family Caregiver Alliance strongly supports fully funding this program that helps families navigate the many complexities of long-term care for a loved one.

5) Assure a robust, dementia capable system of Long Term Services and Supports (LTSS) is available in every state. Bullet Point #6: CMS should provide guidance to all states on adding adult day services as a state optional service under Medicaid.

FCA: Caregivers in California were faced with the elimination of the Adult Day Health Care program (stopped only by a lawsuit) in 2011 because it is an "optional" benefit in Medi-Cal. Given the nature of caregiving for a person with dementia, especially in its advanced stages, services like adult day programs are not "optional" for caregivers. They are vital sources of respite for families who may also be balancing jobs and raising children. Therefore, we believe that the conversation should focus on how to ensure that every family has access to adult day services. When a service like Adult Day Health Care is considered "optional," it often lands on the chopping block during economic downturns, (as California caregivers experienced in 2011) and families are left to try and piece together alternatives.

12) HHS and State Lead Entities should assure that caregiver physical health/ behavioral health risk is assessed and addressed regularly. Caregiver illness and mortality contribute to the enormous personal and financial cost of Alzheimer's disease. The health and well-being of a caregiver has a direct impact on the health and quality of life of a person with Alzheimer's disease.

FCA: While we support assessing caregivers and connecting them with services, we also advocate for a person and family-centered approach to care. While the health of the caregiver does have an impact on the health and quality of life of a person with Alzheimer's disease, the opposite is also true. People who become caregivers face increased risks of depression, stress, exhaustion, cognitive decline, and higher mortality rates. Instead of viewing the caregiver's needs merely in relation to how this will support their caregiving role, it is also important to recognize caregivers and their health (psychological, emotional, physical, and financial) as a separate priority in addition to the care receiver.

Family Caregiver Alliance is grateful for the opportunity to provide our input on ehalf of the over 15 million Americans currently caring for a loved one with lzheimer's and related dementias.


 

C. Morrison  |  04-17-2012

Attached, please find comments relating to the National Plan to Address Alzheimer's Disease from national public health organizations. These comments address the public health elements of the Plan. A paper copy of the comments were also sent on April 6, 2012.

ATTACHMENT:

As national public health organizations representing state and local public health practitioners, educators, providers, agency officials, and academicians, we are writing to urge you to ensure that the National Plan to Address Alzheimer's Disease includes public health as a key feature of its structure and implementation.

We applaud the department's effort to utilize the resources of the aging network traditionally drawn upon in dealing with Alzheimer's disease. However, the Plan does not fully engage the public health community at federal, state, and local levels. This risks overlooking the work of the Centers for Disease Control and Prevention (CDC) and specifically the Healthy Aging Program's work. Additionally, states have begun to use their public health networks to confront Alzheimer's as broadly as possible. We believe the most successful implementation of the Plan will be through a population based, public health approach.

Therefore, as your agency develops the final version of the Plan, we urge you to include these critical elements:

(1) A clear statement of Alzheimer's disease as a public health crisis and its burden. Alzheimer's and other dementias are a major public health issue and will increasingly affect the health and well-being of the population until effective interventions are available. In the United States, 5.4 million Americans are living with Alzheimer's disease, costing society an estimated $200 billion this year. In addition, more than 15 million friends and family members provide unpaid care to those with Alzheimer's and other dementias -- care valued at over $210 billion. Public health takes a broad view of health care and seeks to achieve lasting change in the health of entire populations, extending far beyond the medical treatment of individual people. The tools and techniques of public health are expansive in scope and required for successful implementation of the Plan.

(2) Addressing the connection between Alzheimer's and other multiple chronic conditions from a public health perspective. At least three-quarters of people with Alzheimer's and other dementias have one or more other chronic conditions. Yet, the National Plan to Address Alzheimer's Disease does not mention chronic disease or multiple chronic conditions from a public health perspective. Additionally, the Plan does not mention the HHS Initiative on Multiple Chronic Conditions, which includes both individuals with cognitive impairment and their caregivers as important considerations. The role of state and local health departments in coordinating efforts to reduce disabilities, improve functioning, and enhance quality of life for individuals with multiple chronic conditions is vital to the implementation of the Plan. Examples of these programs include Chronic Disease Self-Management and Falls Prevention programs. The importance of recognizing, effectively treating, and minimizing the impact of multiple chronic conditions, including the impact that Alzheimer's has on managing other chronic conditions, could be highlighted in Goals 2 and 4.

(3) Surveillance. The Plan rightly includes Goal 5 to improve data to track progress, but it omits important surveillance and data collection work by the CDC and its state level partners. Work conducted through the Behavioral Risk Factor Surveillance Survey (BRFSS), the world's largest telephone-based health interview survey, now allows states to conduct surveillance on cognitive impairment (CI) and caregiving. These data are essential to understand the burden and impact of Alzheimer's, cognitive impairment, and caregiving at state and local levels -- data that does not currently exist. With similar data in the areas of obesity, diabetes, and arthritis, state and local leaders have been able to make impressive gains in public health programs and policies using BRFSS information. The CDC has been a leader in the development and implementation of these questions, with a majority of states now having used or currently using the CI module. The CDC Healthy Aging Program is working with partners, including the states, to ensure that all 50 states have used the module at least once by 2013. An additional action should be included in Strategy 5.A to support the important surveillance work being conducted by the CDC and its partners.

(4) A rigorous, public health-driven awareness campaign. As written, the Plan either relies on the aging network or does not comment on available public health resources to disseminate and educate the public on early diagnosis, reducing stigma around Alzheimer's, and caregiver services. For example, the CDC Healthy Aging Program has studied diverse groups of older adults to understand communication strategies. State public health officials are skilled in working with aging adults and caregivers, efforts that could inform the Plan. Consideration of the role of public health should be included in Action 3.C.1 and Strategy 4.A.

We appreciate your commitment thus far on the issue of Alzheimer's and on the development of a strong National Plan to Address Alzheimer's Disease. The public health community at the local, state, and federal level is vital to the successful implementation of the Plan and to improving the lives of individuals affected by Alzheimer's disease and their caregivers.

Thank you for considering our recommendations.


 

B. Sexton  |  04-17-2012

I would like to include the following comments for discussion at the Research Subcommittee Recommendations, Points 7 and 12.

I'm very concern about point 7, specifically sub-points (A & B), recommending HHS use existing authority to reduce drug development and taking immediate steps by HHS to go after patents and intellectual property. If the goal of this committee is to spur innovation and drug development then why attack businesses incentive to invest in the disease? If this point is passed, it may have a chilling effect for small pharmaceutical and private research organizations who's members demand a "return on investment".

And again for Point 12, the aspect of industry being made to share intellectual property because this committee votes on a process or mechanism to side step inventors patent rights or industries trade secrets will again send a chilling signal to the investment community by making investors think twice about investing in Alzheimer's Disease research and thereby creating the opposite effect this committee is trying to accomplish.

Overall, this committee needs to be pragmatic in the understanding that a cure will be discovered when a group of factors is satisfied not because of a lofty marketing idea of a cure by 2020. These factorsinclude, advancement in medical technology, better understanding of human genetics, and overall better medical training.


 

M. Ellenbogen  |  04-15-2012

Attached is my letter to be read at the NAPA April 17 meeting. I tried to keep it as short as possible, but I was afraid I would lose part of the message I was trying to convey. I would have liked to focus on only one or two points, but I felt they were all very important. Maybe some were in the middle of reading you can slam a book down to get everyone's attention to refocus at my request since I am not there to get their attention. I'll be watching.

Is there a way I can send you an email to a blackberry or something if I hear something that I would like to bring up last minute as I attend the meeting from home?

Thank you again for all this. You have no idea what it means to me to be able to be a participant in this project.

ATTACHMENT:

I cannot express enough the Urgency and need for interim goal at 2020 or earlier, victims cannot wait for treatment.

Resources ... 2020/2025 is goal critical but we need to mobilize the will, the plan and the resource to get there as quickly.

Save time, money and lives, by not reinventing the wheel. Use the finished HIV model. I am a firm believer that the people before us have laid the framework needed to get started so we are not wasting a lot of time on the basics. The only approach I always followed along with that is, to delete, enhance and critique to make the plan even better. Ask the previous plan makers what they did wrong and what would they do different. Ninety percent of that framework came from the best of many minds. I really believe the input and suggestions made by Bruce Lamb, in his letter from January 13, 2012 should be discussed when building this framework.

One thing that keeps coming to mind is the disparity issue related to AD. Am I the only one that sees this, or do we all just not want to talk about it? For example, AD was first identified and named in 1906, while AIDS was identified in 1981. I see us now in the same stages as HIV was in 1988, when a focused effort was begun towards treatment or cure, with the creation of The Office of AIDS Research. It took an additional 5 years to strengthen this OAR (The NIH Revitalization Act), which really made a huge difference. Within three years of that day and by 1996 we started to finally have an impact on AIDS.

Let's not make a similar mistake as we did with HIV. Let's create a diseased focused agency for AD, with all the necessary strength, as of day one. Just think you can make up for the disparity that has been created and just maybe we could have a cure in less than 5 years.

Leadership ... the President himself needs to speak out because we need everybody at the table -- not just Federal government, but industry, research community, victims and affected families, people of all ages -- and only he is in a position to provide that leadership.

Government should consider offering a large sum of money to anyone who can come up with the cure for this disease first. While I am not sure what that amount should be, it can be in cash and partial tax credits. I think that will drive many more into this arena and more efforts if the pie is big enough.

Bruce Lamb shared his viewpoints on January 13, 2012, which were very interesting. I really like these paragraphs below and we should all learn from them. Bruce makes very good points on how to evaluate the adequacy of Alzheimer's funding.

If one assumes that funding for HIV/AIDS was right sized to enable translation of basic discoveries to successful therapies, then given the lack of effective AD therapies, one possible implication is that funding for AD has been insufficient. A quick comparison of funding levels for HIV/AIDs relative to AD in the United States suggests this may be at least one factor that has hindered the translation of AD discovery to effective therapies. Based on publicly available data, National Institute of Health funding for HIV/AIDS in the United States is currently approximately $3 billion [5]. With approximately 1 million HIV-positive subjects in the United States, this equates to $3,000 of NIH funding per person with HIV/AIDs. In contrast, current NIH funding for AD is at a level of approximately $450 million [5], with perhaps another approximately $100 million to $200 million in NIH funding that might have some relevance to the study of AD (cognitive decline in aging, related neuro degenerative conditions). With a current prevalence of approximately 5 million individuals affected with AD in the United States, this equates to a maximum of $130 of NIH funding per person affected with the disease. So, on a per affected individual basis, NIH funding for HIV/AIDs is 23 times the level of that for AD.

Of course, there are many different ways to evaluate proportional or relative funding. Another one that is quite germane is economic impact. For AD in the United States this is estimated at more than $170 billion per year (and worldwide at $600 billion per year) [6]. Again focusing only on the United States, the yearly funding for research by the NIH represents 0.4% of the yearly costs of the disease in the United States. In other words, for every $2 the disease costs the United States, we spend less than 1 cent on research.

I would like to thank everyone for their hard work to date, but even more important is for you to actually follow through on the promises and plans. I am counting on you!


 

unnamed  |  04-14-2012

I was asked to comment on the NAPA which I did. However, a more serious situation has arisen where Medicare has placed an unsurmontablehurdle in the treatment of and research with early Alzheimer's patients. I would hope you could direct my information to the appropriate groups.

I would like to inform you that National Government Services, the large carrier for Medicare in the Northeast and Midwest, has reversed their previous position and now DO NOT allow treatment of Alzheimer's patients with cognitive rehabilitation services including memory training. Despite the NIH report and AA recommendations as well as the National Alzheimer's Project Act calling for the dropping of hurdles in Medicare, NGS has removed cognitive rehabilitation as an acceptable treatment for memory loss IF it is due to a chronic disease such as Alzheimer's. If the brain disease is due to injury it is still allowed. The clear purpose of this change in the Rehabilitation LCD is to exclude Medicare recipients who suffer with AD from the services they require

I would greatly appreciate it if you could post this on a blog or other vehicle that can be read by Alzheimer advocates


 

M. Ellenbogen  |  04-12-2012

Maybe you could share this article with your people. I knew a new person gets Alzheimer's in the US every 68 seconds, but this report that just came out yesterday blew me away. I have attached it for your viewing and sharing. This was copied from an article.

Have a great day?

I know realize my mission is even more important than ever. Please, please help me.

ATTACHMENT:

Alzheimer's News 4/11/2012

Alzheimer's Association commends recognition of Alzheimer's and dementia as global health threat

The Alzheimer's Association strongly supports the call to action in the newly released World Health Organization (WHO) report Dementia: A Public Health Priority, which asks for all nations to develop and implement a national Alzheimer's plan, conduct greater efforts in early detection and diagnosis, and increase support of Alzheimer's disease research.

The Alzheimer's Association is pleased that the WHO, in partnership with Alzheimer's Disease International (ADI), has released its first-ever major report on Alzheimer's disease and dementia. Alzheimer's and dementia affects more than 35 million people worldwide today, and the report reveals the astonishing fact that today someone in the world develops dementia every 4 seconds; by the middle of the century more than 115 million people will be affected by the disease.

It is hoped that the comprehensive report will serve to elevate much-needed international attention to the grave health threat Alzheimer's and dementia pose to the global community today and in the years ahead.

"The World Health Organization lending its powerful voice and support to elevating awareness and understanding about Alzheimer's and dementia is very significant," said Harry Johns, Alzheimer's Association president and CEO. "It underscores the organization's recognition that Alzheimer's is a public health crisis requiring urgent global attention and action. These conditions will continue to be a major public health threat increasingly affecting the social and fiscal well-being of the global community until a concerted international effort is launched to combat it."

Already, the global cost of Alzheimer's and dementia consumes one percent of the global Gross Domestic Product (GDP), according to an ADI report. In the United States, the direct costs of Alzheimer's disease to American society will escalate from an estimated $200 billion this year to $1.1 trillion in 2050, largely due to baby boomers at increased risk for developing the disease as they age. In addition to the $200 billion dollars in care costs largely borne by government programs, Medicare and Medicaid, more than 15 million family members and friends provide unpaid care valued at $210 billion.

The new report urges countries to take a public health approach to addressing the Alzheimer's and dementia crisis while developing and strengthening policies that improve the quality of life for those living with Alzheimer's. Other goals included strong surveillance systems that allow for earlier detection of dementia and a stronger commitment to support scientific research that could one day lead to effective treatments that could stem the crisis.

The report discusses efforts in countries throughout the world to develop national plans, including highlighting the steps that the Alzheimer's Association took to mobilize advocates to urge passage and enactment of the National Alzheimer's Project Act. This legislation authorized the process currently underway in the United States to create this country's first national Alzheimer's plan. The Alzheimer's Association continues to work closely with U.S. leaders to shape a strong national plan, which will hopefully serve as a model for other countries. Fourteen countries, including France, Australia, Northern Ireland and Japan, currently have national Alzheimer's/dementia plans.

The Alzheimer's Association has long recognized the international impact of Alzheimer's and other dementias and has made significant contributions globally toward the goal of a "world without Alzheimer's." As the world's leading Alzheimer's nonprofit, the Alzheimer's Association provides premier global forums for the greatest minds in Alzheimer's science to collaborate, connect across disciplines, address common challenges and share new discoveries. This is most notably demonstrated through the Alzheimer's Association International Conference, the largest gathering of Alzheimer's scientists and researchers annually. This year's conference will take place on July 14-19 in Vancouver and is expected to be attended by nearly 5,000 of the world's foremost Alzheimer's researchers.

The Alzheimer's Association International Grants Program has been instrumental in advancing the scientific enterprise and shaping the ever evolving Alzheimer's landscape. The Association currently fund grants in 24 countries across the spectrum of Alzheimer's research from molecular biology to medical systems investigations and has awarded grants in excess of $292 million to more than 2,000 projects. In March, the Alzheimer's Association awarded its largest ever research grant -- nearly $4.2 million dollars over four years -- to the Dominantly Inherited Alzheimer's Network-Therapeutic Trials Unit (DIAN-TTU), based at Washington University School of Medicine in St. Louis, to enable the program to move forward more quickly with innovative drug and biomarker trials in people with genetically-based, young-onset Alzheimer's disease.

"The Alzheimer's Association applauds the leadership of both the WHO and ADI in their efforts to elevate global attention to Alzheimer's and dementia. It signals an understanding that the knowledge, insights and resources of all nations must be leveraged to confront the daunting public health threat of Alzheimer's and dementia," said Johns. "The Association remains committed to working with these organizations, other international bodies and countries throughout the world to illuminate the human and economic toll of the disease until the vision of a world without Alzheimer's is realized."

Alzheimer's Association
The Alzheimer's Association is the world's leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimer's disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer's. For more information, visit http://www.alz.org.


 

M. Durocher  |  04-10-2012

I am writing to you because of a request from USAgainstAlzheimer's, however, I'd like to make you aware of a book that has been written by M.T. Newport, MD titled "Alzheimer's Disease, What if There Was A Cure?". She has done research on Coconut Oil which has shown significant change in her husband's Alzheimer's. In her book, she mentions that she attempted to attend an International Conference on Alzheimer's Disease.

They would not let her speak at the conference or allow her to pass out information on her research.

I find that inexcusable.

I lost my eldest sister in 2008 of the disease. It was one of the worst things I have ever been through after losing another older sister of ALS in 1996.

Thank you for you attention to this matter.


 

A. Dolfay  |  04-10-2012

Although the official comment period has closed for the NAPA draft plan, I'm writing today to urge you to go bolder with the final plan to be released by HHS later this month.

Alzheimer's is a cruel disease. It slowly steals one's intellect, ability to communicate, independence, and dignity, even control over basic bodily functions like eating and caring for personal hygiene. It also places an overwhelming burden on caregivers -- emotionally, physically, and financially.

The commitment to a 2025 deadline in the draft NAPA plan represents a major step forward in the fight against Alzheimer's. I am pleased that the plan recognizes the need for increasing enrollment in clinical trials, compressing the drug development process, accelerating targeted research, and better coordinating activities with other countries.

However, I am one of many concerned Alzheimer's advocates who believe that this first draft fails to present a strategy aggressive enough to achieve the goal of preventing and treating Alzheimer's within 13 years. It lacks specificity in terms of timelines and deadlines, provides no path to providing significantly greater resources, and does not hold a single high-level office or individual accountable for the overall plan.

I hope that HHS will address these issues so that the next version of the plan will be bolder.

With the number of Alzheimer's patients expected to triple in the coming decades, we must embrace a plan that eschews a "business-as-usual" approach and tackles Alzheimer's with the urgency and aggressiveness it requires. If not, we stand to lose millions more lives -- and trillions of dollars -- to this disease.

There now appears to be evidence that Alzheimer's is related in part to silver filling i.e. mercury. Please see below reference; http://articles.mercola.com/sites/articles/archive/2012/04/07/dangers-of-mercury-contamination.aspx?e_cid=20120407_DNL_art_1

Story at-a-glance

Studies show that mercury is the MOST toxic heavy metal to your body; this excellent new documentary film, Mercury Undercover, exposes the dangers of mercury contamination to human health and to the environment

The number one source of mercury pollution is coal-fired power plants. Second position is held by dental practices due to amalgam fillings, which are 50 percent mercury

Dental amalgams, used for more than 150 years, continue to be used by half of the dentists in North America despite a mountain of evidence they slowly leak toxic mercury into your body, and are particularly dangerous for children and pregnant women

Mercury becomes a "biochemical train wreck in your body," causing your cell membranes to leak, and inhibit key enzymes your body needs for energy production and removal of toxins. Mercury toxicity can lead to major inflammation and chronic illnesses such as Alzheimer's disease and Parkinson's disease

The FDA, in partnership with the ADA, have been successful for many years in concealing the dangers of amalgam from the public, but organizations such as the Consumers for Dental Choice are making inroads toward getting mercury banned from dentistry worldwide--but they need your help

By Dr. Mercola

I strongly encourage you to watch the new documentary film Mercury Undercover, which exposes just how far those in power will go to prevent you from learning the truth about mercury contamination from dental amalgam--all in the name of money.

Dental amalgam is a primitive, pre-Civil War product that is 50 percent mercury, still commonly used in dental fillings.


 

C. Martin  |  04-09-2012

I am pleased to see that Alzheimer's and other dementias are on the minds of our elected officials. As an adult protection worker and daughter of a mother with dementia I have seen what these diseases/illnesses can do to individuals and to their families. What is needed, especially in rural areas, is funding for more support programs/providers and education of families and providers to better understand the individual and to serve them with dignity. Each individual is unique in their deterioration, their needs, and how they should be served. Please keep the focus on Alzheimer's and other dementias in the forefront, it WILL affect you or someone you know.


 

J. Ross  |  04-06-2012

I have provided medical care for over 10,000 victims of Alzheimer's Disease since starting my comprehensive geriatric and Alzheimer's Disease practice in 1986. I would like to present my comments on the NAPA plan. I am a member of the advisory panel of NAPA and through my organization, The Memory Enhancement of America we provide an unprecedented level of care and treatment to all those afflicted with memory loss/mild cognitive impairment and dementia due to Alzheimer's Disease.

I would desire to discuss the urgent need to open a demonstration project in our 6th congressional district. This Memory Evaluation and Treatment Center (METC) will provide complete and comprehensive management for mild, moderate and severe stages of Alzheimer's Disease. Funded in part by the a portion of the 83 million dollars signed into law by President Obama it shall include but not limit itself to providing medical/nursing/social/psychological care of AD patients as well as offer physical and occupational therapy; address the many ethical, financial and legal challenges this deadly disease poses to patients, caregivers and society in general. This METC will show cost effectiveness by reducing unnecessary hospitalization, reducing need for emergency room visits, delay nursing home if not eliminate the need for such placement as well as be a center of excellence for all other 434 Congressional districts in our wonderful nation. Pharmaceutical research of the highest caliber testing safety and efficacy of the latest medications in development will be a further extension of METC.

All at no cost to the patient. I propose that Medicare/Medicaid and a portion of NAPA money be used to test this METC concept and in a randomized study using a group of 200 AD patients assigned to traditional (fragmented and inefficient, standard of care) and comparing them to a similarly matched group of 200 AD patients assigned to METC care.

I and my many colleagues and other professional associates and organizations believe quite strongly and will prove a METC is the only place for AD patients to receive comprehensive, compassionate and welcomed care.

My bio is attached for your review.

I welcome the opportunity to speak at the April 17th meeting on behalf of the nearly 5.5 million victims of AD as well as for those who have died from this dreadful 100% fatal disorder.

ATTACHMENT:

Biographical Sketch:

J.S. Ross, M.D., FACP, AGSF, CMD CPI - Dr Ross is a Primary Care Geriatrician and Principal Investigator at Memory Enhancement Centers of America located in Eatontown, Monroe Township and Toms River, New Jersey. Dr. Ross is the Founder and Chief Executive Officer of the Memory Enhancement Centers of America which are state of the art facilities dedicated to improving the quality of lives of those struggling with dementia such as Alzheimer's Disease including the caregivers. By working closely the pharmaceutical industry and the Food and Drug Administration our centers conduct the most state of the art diagnostic and therapeutic intervention using latest medications under development.

Dr. Ross has been Principal Investigator or Sub-investigator on nearly every medications tested for Alzheimer's disease in clinical trials since 1994 including the four FDA approved medications: Aricept/Exelon/Razadyne and Namenda. Dr Ross has conducted over one hundred Alzheimer's Disease research protocols as the Principal Investigator. He has lectured worldwide on Alzheimer's Disease. Dr Ross received his medical degree from Downstate Medical Center, Brooklyn, New York, where he graduate Cum Laude. He completed his internship and residency at Nassau County Medical Center, in East Meadow, New York, where he then became Chief Resident. He is certified in Geriatric Medicine, Internal Medicine and a Certified Physician Investigator by the Association of Clinical Research Professionals. He was the founding member of the geriatric fellowship program at Jersey Shore Medical University and in 2000 was recognized as an "advocate for excellence" as program director-Geriatric Residency at Jersey Shore Medical University. Dr Ross was awarded the "top doctor" in the field of Geriatric Medicine in New Jersey by his peers.

Dr. Ross has an adjunct Associated Professor of Medicine appointment to Mount Sinai Medical School New York, New York since 2002 and is a Clinical Associate Professor of Medicine at UMDNJ-School of Osteopathic Medicine, Stratford, New Jersey since 1996. Dr Ross was appointed to the Drexel University School of Medicine as a Clinical Adjunct Professor of Medicine in 2009. He is on the staff of Monmouth Medical Center, Long Branch, NJ.

Dr Ross received the Humanitarian of Year Award in 2011 from the Alzheimer's Disease Caregivers of Central NJ.


 

unnamed  |  04-06-2012

As national public health organizations representing state and local public health practitioners, educators, providers, agency officials, and academicians, we are writing to urge you to ensure that the National Plan to Address Alzheimer's Disease includes public health as a key feature of its structure and implementation.

We applaud the department's effort to utilize the resources of the aging network traditionally drawn upon in dealing with Alzheimer's disease. However, the Plan does not fully engage the public health community at federal, state, and local levels. This risks overlooking the work of the Centers for Disease Control and Prevention (CDC) and specifically the Healthy Aging Program's work. Additionally, states have begun to use their public health networks to confront Alzheimer's as broadly as possible. We believe the most successful implementation of the Plan will be through a population based, public health approach.

Therefore, as your agency develops the final version of the Plan, we urge you to include these critical elements:

  1. A clear statement of Alzheimer's disease as a public health crisis and its burden. Alzheimer's and other dementias are a major public health issue and will increasingly affect the health and well-being of the population until effective interventions are available. In the United States, 5.4 million Americans are living with Alzheimer's disease, costing society an estimated $200 billion this year. In addition, more than 15 million friends and family members provide unpaid care to those with Alzheimer's and other dementias -- care valued at over $210 billion. Public health takes a broad view of health care and seeks to achieve lasting change in the health of entire populations, extending far beyond the medical treatment of individual people. The tools and techniques of public health are expansive in scope and required for successful implementation of the Plan.

  2. Addressing the connection between Alzheimer's and other multiple chronic conditions from a public health perspective. At least three-quarters of people with Alzheimer's and other dementias have one or more other chronic conditions. Yet, the National Plan to Address Alzheimer's Disease does not mention chronic disease or multiple chronic conditions from a public health perspective. Additionally, the Plan does not mention the HHS Initiative on Multiple Chronic Conditions, which includes both individuals with cognitive impairment and their caregivers as important considerations. The role of state and local health departments in coordinating efforts to reduce disabilities, improve functioning, and enhance quality of life for individuals with multiple chronic conditions is vital to the implementation of the Plan. Examples of these programs include Chronic Disease Self-Management and Falls Prevention programs. The importance of recognizing, effectively treating, and minimizing the impact of multiple chronic conditions, including the impact that Alzheimer's has on managing other chronic conditions, could be highlighted in Goals 2 and 4.

  3. Surveillance. The Plan rightly includes Goal 5 to improve data to track progress, but it omits important surveillance and data collection work by the CDC and its state level partners. Work conducted through the Behavioral Risk Factor Surveillance Survey (BRFSS), the world's largest telephone-based health interview survey, now allows states to conduct surveillance on cognitive impairment (CI) and caregiving. These data are essential to understand the burden and impact of Alzheimer's, cognitive impairment, and caregivingat state and local levels -- data that does not currently exist. With similar data in the areas of obesity, diabetes, and arthritis, state and local leaders have been able to make impressive gains in public health programs and policies using BRFSS information. The CDC has been a leader in the development and implementation of these questions, with a majority of states now having used or currently using the CI module. The CDC Healthy Aging Program is working with partners, including the states, to ensure that all 50 states have used the module at least once by 2013. An additional action should be included in Strategy 5.A to support the important surveillance work being conducted by the CDC and its partners.

  4. A rigorous, public health-driven awareness campaign. As written, the Plan either relies on the aging network or does not comment on available public health resources to disseminate and educate the public on early diagnosis, reducing stigma around Alzheimer's, and caregiver services. For example, the CDC Healthy Aging Program has studied diverse groups of older adults to understand communication strategies. State public health officials are skilled in working with aging adults and caregivers, efforts that could inform the Plan. Consideration of the role of public health should be included in Action 3.C.1 and Strategy 4.A.

We appreciate your commitment thus far on the issue of Alzheimer's and on the development of a strong National Plan to Address Alzheimer's Disease. The public health community at the local, state, and federal level is vital to the successful implementation of the Plan and to improving the lives of individuals affected by Alzheimer's disease and their caregivers.


 

B. Southworth  |  04-05-2012

Attached are my comments on the draft HHS plan for the National Alzheimer's Project Act. My contact information is in the attached comments should you have any questions.

Thank you for the opportunity to comment on HHS's draft plan.

ATTACHMENT:

COMMENTS ON THE UNDATED DRAFT
NATIONAL PLAN TO ADDRESS ALZHEIMER'S DISEASE

March 31, 2012

INTRODUCTION

The comments presented in this paper are based on my experience as the primary care giver for someone with Alzheimer's dementia and on a book that I read as part of my research on Alzheimer's dementia. The book is titled The Myth of Alzheimer's Disease by Dr. Peter Whitehouse, a leading researcher in Alzheimer's disease for over 30 years.

Eight years ago at age 60, my wife was diagnosed with Alzheimer's Dementia (AD). She lived at home for four and a half years, and has lived in an assisted living facility for the past three years and nine months. She has had three different kinds of brain scans (CAT, MRI, and PET), been evaluated for vitamin B-12 deficiency, been evaluated for "water on the brain", been evaluated at the University of Virginia and John Hopkins University, seen four different neurologists, and has taken both of the medications typical given to people with AD all to no avail. I concluded several years ago that the only thing left was to ensure that she is taken care of. Not only to pay for the care but to participate in it, which I do on a daily basis.

Dr. Whitehouse's book summarizes most of the experiences that I have been through in the last eight years and confirms my conclusion about care for my wife. In my view, everyone who has a loved one diagnosed with AD should read this book. I also believe that Dr. Whitehouse should be considered for inclusion on the Advisory Council established by the National Alzheimer's Project Act (NAPA).

The last part of this paper contains a brief discussion of a grant program through which funding could be provided for the care of people with AD.

GENERAL COMMENT

I agree with the goals in the draft plan. I do not agree, however, with the distribution of funding for the goals. Of the $156 million dollars included in the draft plan, $130 million (83 percent) are allocated for research. Only $26 million are allocated for care. In my view, the funds for research and care should be reversed. At some point, everyone with either AD or another type of dementia is going to need care. That is where most of the federal funds and private funds should be spent.

The final plan should include more details for each of the goals. This includes the office responsible for each strategy and the tentative completion date, funds, and expected outcomes or products for each strategy. Without the details, there is no way to tract the progress on each strategy. The plan also should indicate who will provide oversight for each strategy.

SPECIFIC COMMENTS

1. Care

As mentioned above, I concluded several years ago that the only thing that I can do for my wife is to see that she is taken care of. For this reason, I believe that the first goal on Page 6 of the national plan should address care and that care should be the major theme throughout the plan.

I am not recommending that no research be done on AD. Certainly, research should continue on AD, but not at the funding distribution in the draft plan (i.e., 83 percent of the total amount in the draft plan). In my view, the only way to find a cure for AD is to find a cure for the aging process. This is highly unlikely.

2. Use of the Word "Disease"

In his book, Dr. Whitehouse concludes that Alzheimer's is not disease. It is aging of the brain that can be caused by a number of factors (e.g., stroke, lifestyle, injury, or environmental exposure). Because it is not a disease, there is no cure for AD.

I recommend that the work "disease" no longer be used to describe Alzheimer's dementia . Use of the word stigmatizes the person with AD often resulting in depression, loss of friends, and lack of understanding on what is really occurring. Even though the end result is the same (all persons with AD and other dementias need care), calling the condition what it really is (i.e., dementia) is a better approach for dealing with the condition. In his book, Dr. Whitehouse described an approach whereby the patient and the patient's family are told that the patient has dementia and then given help through a team approach. The team consists of the doctor, a dietitian who helps the patient improve their diet, a physical therapist who works with the patient to increase their physical activity, and a social worker who emphasizes the importance of staying connected both mentally and socially. Use of the team approach is more compassionate then just telling the patient they have Alzheimer's disease, and to take Aricept and come back for another doctor's visit in six months, which is what happened to my wife. Using the word "disease" to describe AD implies there is a cure for AD. This gives the patient and the patient's family false hope because, as previously mentioned, I do not believe there is a cure for AD.

3. Ethnic and Racial Minority Populations

During the eight years that I have had direct involvement with AD, I have never read anything or had any experiences that indicate ethnic and racial minority populations have higher cases of AD than the general population. Unless there is compelling evidence that those populations do experience disproportionate cases of AD, I recommend that this issue not be emphasized in the national plan. In my view, it is more important to spend funds on the care of all people with AD.

4. Assisted Living Facilities

The draft plan fails to recognize that a viable option for people with AD is care in a secure area at an assisted living facility. My wife has been cared for in such facility for three years and nine months, and I expect her to continue to be cared for in an assisted living facility for many more years (she is very healthy except for AD).

An issue related to caring for a person with AD in an assisted living facility is cost. Funds are not available from either Medicare or Medicaid for people who receive care in an assisted living facility. In my view, there is no difference between care of a person with AD in a nursing home and care of such a person in a secure area of an assisted living facility. This disparity needs to be addressed. An example of the cost of care in an assisted living facility is the $75,600 annual fee for my wife plus the cost of incontinence supplies and medications. At present, my long term care insurance pays for part of these costs and I pay the remaining part. When my long term care insurance expires, I will have to pay the total costs.

5. Strategy 2.A

Emergency Medical Technicians (EMTs) and emergency room personnel should be included in the healthcare providers who receive education in AD. In my experience, general physicians also need to be educated about AD. All too often, they just want to prescribe a medication. For example, seroquel often is prescribed for people with AD. Every article that I read on seroquel said that it is not recommended for people with dementia. When I told the doctor that, he said they give it to people with AD anyway.

6. Action 2.A.4

The training discussed in this action should be made available to all direct-care workers and not just workers in nursing homes. In particular, direct-care workers in assisted living facilities and those who provide home care should receive this training.

7. Action 2.B.2

My wife was diagnosed with AD through a process of elimination. In her first visit to a neurologist, she could not pass some simple tests. At later appointments, those same tests were given to her with worst results that the results of the earlier tests. Eventually, the neurologist concluded she had AD. In my view, this process is most likely the only way to diagnose AD.

8. Action 2.E.2

In my experience, the cost of home care for a person with AD is not that much less than the cost of care in an assisted living facility. In addition, home care is much more difficulty for the primary care giver even with the help of direct-care personnel who come to the home. In too many cases, the primary care giver is the one who suffers the most when care is provided in the home.

9. Strategy 2.H

As mentioned above, I have not seen that racial and ethnic minorities are affected disproportionally by AD. All people with AD need care no matter what their race or ethic group. The available resources should be spent on improving care for all AD patients instead of focusing on any racial or ethnic group.

10. Action 3.D.1

It is extremely important that primary care givers understand the legal documents a person with AD should have. These include a general power of attorney, a medical power of attorney, a will, and, where appropriate, a trust. Also, the primary care giver should ensure their name is on the appropriate bank accounts. The importance of these documents should be stressed in the plan.

11. Goal 5

I agree that it is important to track progress on all of the strategies in the plan. As part of that effort, oversight on all strategies and actions must be provided. Without oversight, there is no way to assess progress.

CARE PROPOSAL

Throughout the above comments I have emphasized the importance of care for people with AD. To provide quality care, funding is required. One way to provide that funding is through a grant program.

To help defray the cost of care for people with AD, a grant could be provided to nursing homes, assisted living facilities, home heath care companies, and, potentially, to individuals. Such a program could be administered by the Department of Health and Human Services or funds could be provided to a state and they could administer the program. To receive a grant, specific requirements would have to be met. In addition, oversight would have to provided to ensure that the grants funds are spent properly.

  • Grant funds could be used to.
  • Develop standards of the care of AD patients.
  • Develop design standards for new facilities or modifications to existing facilities where care for people with AD is provided.
  • Construct new facilities or modifications to existing facilities where care for people with AD is provided.
  • Train direct-care workers
  • Provide funds to increase the pay of direct-care workers. . " Provide funds to defray the costs that family members have to pay for care.
  • Provide funds for the oversight of the grant requirements and to ensure quality care is provided.

To receive a grant, an entity would have to submit an application to the agency who administers the grant program. The application would have to contain detailed information about on the facility and the care they provide.

Thank you for the opportunity to submit the above comments.


 

C. Arradaza  |  04-02-2012

Thank you for the opportunity to comment on the draft National Plan to Address Alzheimer's Disease. Attached are FasterCures'comments for your consideration. Please confirm that you have received this submission.

Please let me know if you have any questions.

ATTACHMENT:

Thank you for the opportunity to comment on the draft National Plan to Address Alzheimer's Disease. We at FasterCures have been observing with great interest the development of this agenda for some time and were significantly engaged in providing feedback on its precursor, the plan of the Alzheimer's Study Group.

FasterCures' mission is to improve the medical research system irrespective of disease area, to speed up the time it takes to get important new medicines from discovery to patients. As a result, our concerns often relate to the importance of tackling problems with the research process as well as the science. While we might wish that the language in the Plan were a little bit stronger and more direct on this score, we are pleased that many of the process issues we care about and raised with the Alzheimer's Study Group are reflected in it, including:

  • Promoting a more outcomes-oriented approach to research, particularly translation and drug development. (The Plan does not, however, offer specific ideas about the changes necessary for this to happen -- e.g. how might this impact the traditional investigator-initiated model of grantmaking by the NIH?)
  • Mapping the landscape of current Alzheimer's disease (AD) research, not just within federal agencies but by all players;
  • Identifying priority areas for research investment;
  • Encouraging and facilitating collaboration among sectors; and
  • Building patient awareness of and participation in research.

There are other issues we see as critical to progress toward new treatments that we do not believe are adequately reflected in the Plan, including:

  • Creating shared resources available to AD researchers. There are occasional references to this subject in a number of places in the plan, but we believe it should be an important focus. Any inventory of AD research investments should explicitly include resources such as databases, electronic health records collections, and tissue banks that already exist and should be shared, and any effort to identify research priorities should explicitly include new shared resources that need to be created.
  • Engaging regulators in strategizing about how to accelerate approval. Again, the plan does mention FDA on occasion, but in our view there is not enough emphasis on the importance of this. Approval of new therapies can be significantly accelerated if regulators can be involved in discussions about clinical trials at early stages, so that time is not lost at the end of the process having to go back to the drawing board. The Foundation for the NIH's Biomarker's Consortium is an excellent example of the utility of involving FDA at the earliest stages of research.
  • Making sure that all existing federal efforts (not just those already specifically targeted at AD) are applying themselves to the challenges faced by AD. For example, the new National Center for Advancing Translational Sciences (NCATS) at NIH, the FDA's focus on improving regulatory science at the agency, and the efforts of the Office of the National Coordinator for Health IT at HHS to accelerate the adoption of electronic health records and information exchange. These are significant efforts by the federal government that will have an impact on the research environment and should reflect the priority the federal government is placing on AD.
  • Examining the pipeline of clinical researchers in AD. There is appropriate emphasis in the Plan on training of providers and caregivers, but not on the future research corps. AD already suffers from a shortage of clinicians trained in the complex care of elderly patients, and the shortage of clinical researchers in this area is probably even more dire. Attention should be paid to the recruitment and training of researchers capable of working in this field.

Thank you once again for the opportunity to comment on what we believe is a strong draft National Plan to Address Alzheimer's Disease. We are happy to discuss our views further with HHS or the Advisory Council on Alzheimer's Research, Care and Services at any time.


 

G. Suess  |  04-2-2012

I am very impressed by the Draft National Plan to Address Alzheimer's Disease (and Related Dementias). It is well written and quite comprehensive from my perspective. But I do have some concerns and suggestions.

My wife was diagnosed with Alzheimer's Disease in February 2010. I am her primary caregiver and health advocate. Fortunately, long-term care insurance has afforded us the opportunity to have two very good caregivers thus providing me the ability to work part time as a research scientist at CNA, a Federally Funded Research and Development Center (FFRDC). My wife and I have experienced both the classical, traditional clinical medical approach and, more recently, the alternative complementary medical approach. In addition, I am a member of two caregiver support groups: one offered by a Ministry to the Aging at my church, and the second offered by the Alzheimer's Family Day Center of Fairfax, VA.

From this base of experience and education, I offer my observations and suggestions:

  1. The plan seems to lack a sense of urgency. While the goal "to prevent and effectively treat AD by 2025" is laudable, the selection of 2025 along with the general tone of the plan does not convey the urgency I believe is necessary. Selecting either 2020, because it's sooner and a nice round number, or 2022, as it comes 10-years after the release of the National Plan and is akin to President Kennedy's announcement in 1960 of manned flight to the moon by the end of that decade, would be better. Both years signal a message of boldness and ambition more so than does 2025. I believe caregivers and family members would be encouraged by such ambitious goals.
  2. The plan appears to display certain biases that may restrict the search for alternative solutions.
    1. First, there seems to be an emphasis on searching for "pharmacological" solutions. Certainly, the plan recognizes other approaches, e.g. "While research on AD has made steady progress, there are no pharmacological or other interventions to definitively prevent, treat, or cure the disease" and "non-pharmacological management of physical, cognitive, and behavioral symptoms." But it does not clearly state what such "other, non-pharmacological" approaches might be. This suggests to me a bias toward pharmaceutical solutions and therefore a favoring of the pharmaceutical industry, which seems to be more motivated by profits than solutions. I encourage that these other approaches be specified. The effectiveness of public health communications necessitates clear, plain-English language.
    2. There also seems to be a bias toward the time-consuming approach of clinical trials. The plan clearly recognizes the need to the pharmaceutical bias, I think.
    3. The plan rightly includes "related dementias" in defining Alzheimer's Disease. But it identifies only Lewy body, frontotemporal, and vascular dementias as examples. Unless recognized but not stated by the drafters, I suggest including other neurological diseases such as Parkinson's, Huntington's, ALS/Lew Gehrig, and MS. Such an expansion might introduce synergies and efficiencies and potentially a considerably more significant effect.

Admittedly, my own personal research into AD is limited. I have only recently begun to dig more deeply into the subject. Much of my motivation comes from frustration over the silence and apparent helplessness of the traditional medical community toward my wife's disease. I have recently read two books that have strongly influenced me: "Alzheimer's Disease---What If There Was a Cure"---The Story of Ketones" by Dr. Mary Newport, and "Stop Alzheimer's Now! How to Prevent and Reverse Dementia, Parkinson's, ALS, Multiple Sclerosis and Other Neurodegenerative Disorders" by Dr. Bruce Fife.These books introduced me to the "Type 3 Diabetes" aspect of AD, which I find most intriguing and compelling. If what they say is true about insulin-deficiency and insulin-resistance in the brain and the resultant "starvation" of neurons, and that nutritional substitutes in the form of ketone bodies from medium-chain triglyceride fatty acids already exist on the shelves of health food stores in the forms of coconut oil and MCT oils, THIS IS HUGE. Considering that I might be "starving" my wife's neurons by not providing this source of fuels (already used by neonatologists, according to Dr. Newport and in pediatrics, according to my RN daughter), ignoring this evidence is morally unconscionable to me. Also if true, this nutritional approach could be a "silver bullet" of vast consequence.

Thank you for soliciting comments from the public in reaction to the draft plan. I apologize for missing the March 30 deadline. Such tardiness has become commonplace for me as an Alzheimer's caregiver and health advocate. And thank you for your contribution to this important work.


 

G. Vianni  |  04-01-2012

I am a retired RN. However, I now provide non-medical home care to individuals with Dementia and Alzheimer's Disease at a reasonable cost.

I also serve as their healthcare advocate, assisting the family to find good medical care for their loved one.

I think the world of you. Thank-you for attending to the needs of the aging population.

I am 66 years old. My client is also Sixty-Six, and requires constant care and attention. She is also a Registered Nurse. She responds so well to loving care. I am so fortunate to have these skills.


 

MARCH 2012 COMMENTS

D. Larsen  |  03-31-2012

This is an excellent document and we applaud your initiative and efforts to make this comprehensive and inclusive. It is with that objective in mind that we make the following observations:

Under Action 1.B.5 you note the importance of clinical trials on "Pharmacologic interventions." In B.6. you mention the importance of these for "lifestyle interventions."However, another key area is dietary or nutritional interventions. While this is often assumed by some under lifestyle, it is not always understood as such, especially by the public, and in light of recent research seems significant enough to warrant it's own mention. At least in terms of prevention, diet and nutrition is arguably at least as important, if not much more so, than any pharmaceutical intervention yet devised. (see evidence below). The rationale for it not being assumed under lifestyle is as follows:

Dictionary.com defines lifestyle as: the habits, attitudes, tastes, moral standards, economic level, etc., that together constitute the mode of living of an individual or group.

While tastes may imply dietary choices, that's not necessarily so, as they could imply one's taste for clothing, cars, companionship, etc., which do not equate to food or nutritional choices.

Dictionary.com provides this example of it's use in a sentence: Much of what we're told about diet, lifestyle and disease is based on epidemiologic studies.

Here you see they clearly do not consider "diet" to be synonymous with "lifestyle."

Perhaps this oversight, or confounding of the variables, is due to the heavily biased and fretfully flawed FDA tendency to lump anything therapeutic under the heading of pharmaceutical or "drug." That however is confusing and misleading to the public, and we feel a disservice to the thousands of great scientists who have worked and are working with nutrition and nutritional formulas -- many of whom your agencies have funded, who in the past have made better inroads into preventing or arresting AD symptoms than the pharmaceutical industry. In fact, Dr. William Grant in his landmark epidemiological study of "what causes Alzheimer's," including studies from 11 different countries, argued strongly that Alzheimer's disease was "primarily caused" not by genetics, which you pay great attention to, but by unhealthy dietary choices.[1] Moreover, the experimental peer reviewed studies, also show that findings in the field of nutrition have been more promising to date,[2], [3], [4], [5], [6], [7], [8], [9] at least for the prevention of Alzheimer's than the much more costly pharmaceutical trials. It is logically inconsistent therefore to emphasize pharmaceutical trials in the context of prevention and neglect to even use the words diet, nutrition or exercise in this proposal.

So, wouldn't it be appropriate in light of the above noted research, to include here "nutritional" or "dietary" in para 1.B.6 before "lifestyle" as the dictionary has above. In other words to note "the importance of clinical trials on nutritional or dietary interventions." And encourage the FDA to expedite the approval, implementation and public awareness of positive outcomes in these areas, instead of dragging their feet as they historically have done, in this area. Or worse yet proposing a moratorium on new formulations, as they recently have proposed. (If you would like evidence of this let me know.)

We recommend, as you discuss prevention and early intervention, that you at least make mention of the fact that Alzheimer's is seen by many good researchers as a condition of elderly malnutrition,[10], [11] and there is a great deal of good research, such as that conducted by Dr. Craft at the University of Washington, which the Alzheimer's 'Association highlighted in their 2010 ICAD conference and in their HBO series, which suggests that healthy foods and the nutrients they contain, may be among the most important factors to consider in our efforts to prevent Alzheimer's. In fact in that video she notes that by following some simple dietary guidelines people "could at the least delay the onset of Alzheimer's" and by doing so "reduce the number of Alzheimer's cases nearly in half" -- thus enabling you to achieve your objective.

Of course we're just using Dr. Craft as an example. In fact that Assoc and NIH have sponsored many good studies which suggest that various nutrients, like folic acid, grape seed and other antioxidants, key amino acids, etc can make a major dent in preventing Alzheimer's. Remember the famous Cache Senior memory study where they found that high consumption of antioxidants -- C and E "reduced AD prevalence by about 78% (adjusted odds ratio, 0.22; 95% confidence interval [CI], 0.05 - 0.60) and incidence by about 64% (adjusted hazard ratio, 0.36; 95% CI, 0.09 - 0.99)."[12] Then there were the Chicago fish studies5 and the MIDAS study presented in the 2009 ICAD conference which showed fish and DHA's potential to reduce risk by more than half. And we could go on -- see the references noted above.

You get our point. If you are going to specify pharmaceutical and lifestyle trials, we feel you should also note dietary or nutritional trials.

References

  1. Grant, W B, (1997) Dietary Links to Alzheimer's Disease. Alzheimer's Disease Review 2, 42-55.
  2. Karin Yurko-Mauroa, McCarthya, D., Romb, D., Mary Stedmand, on behalf of the MIDAS Investigators, et al. Beneficial effects of docosahexaenoic acid on cognition in age-related cognitive decline. (Nov 2010) Alzheimer's & Dementia: The Journal of the Alzheimer's Association, Vol 6, Issue 6, Pp 456-464
  3. Ellinson, M, Thomas, J, Patterson, A.. A critical evaluation of the relationship between serum vitamin B12, folate and total homocysteine with cognitive impairment in the elderly. J Hum Nutr Diet. 2004;17:371-383.
  4. Smith, AD, Smith, SM, de Jager, CA, Whitbread, P, Johnston, C, et al. 2010 Homocysteine-Lowering by B Vitamins Slows the Rate of Accelerated Brain Atrophy in Mild Cognitive Impairment: A Randomized Controlled Trial. PLoS ONE 5(9): e12244. doi:10.1371/journal.pone.0012244
  5. Scarmeas, Nicholas Mediterranean Diet, Alzheimer's Disease, and Vascular Mediation. Archives of Neurology, vol 63, Dec 2006, 1709-1717.
  6. Morris MC, Evans DA, Bienias JL, et al. Consumption of fish and omega-3 fatty acids and risk of incident Alzheimer disease. Arch Neurol. 2003 Jul;60(7):940-6. Morris MC, Evans DA, Tangney CC, Bienias JL, Wilson RS. Fish consumption and cognitive decline with age in a large community study. Arch Neurol.2005 Dec;62(12):1849-53.
  7. Zandi, PP, Anthony, JC, Khachaturian, AS, et al. Reduced Risk of Alzheimer Disease in Users of Antioxidant Vitamin Supplements. Arch Neurol. 2004;61:82-88.
  8. Chan A, Paskavitz J, Remington R, Rasmussen S, and Shea TB, Efficacy of a vitamin/nutriceutical formulation for early-stage Alzheimer's disease: a 1-year, open-label pilot study with an 16-month caregiver extension. Am J Alzheimers Dis Other Demen, 2008. 23(6): p. 571-85.
  9. Karp, Anita; et al. "Mental Physical and Social Components in Common Leisure Activities in Old Age in Relation to Dementia: Findings from the Kungsholmen Project." Presented at the Alzheimer's Association 9th International Conference on Alzheimer's Disease and Related Disorders, Philadelphia, Penn., July 17 - 22, 2004. Abstract published in Neurobiology of Aging, July 2004, Vol. 25, S2: p. S313.
  10. Shatenstein B, Kergoat MJ, Reid I (2007) Poor nutrient intakes during 1-year follow-up with community-dwelling older adults with early-stage Alzheimer dementia compared to cognitively intact matched controls. J Am Diet Assoc 107, 2091-2019.
  11. Shea, TB, Remington, R, (2012) Nutrition and Dementia: are we asking the right questions? J Alzheimer's Disease, in press. See also David Perlmutter, M.D. (2004) The Better Brain Book, Riverhead books; and Mark Hyman, M.D. (2009) The Ultra Mind Solution.
  12. Barclay, L (MD) Vitamins E, C May Reduce Risk of Alzheimer's Disease, Medscape Medical News 2004. Jan. 20, 2004 commenting on the article that appeared in the Archives of Neurology. 2004;61:82-88.

 

E. Haviland  |  03-31-2012

My dad died with dementia. It's not a pleasant thought to look forward to!


 

S. Russell  |  03-31-2012

Unless you have cared for a family member throughout their demise due to Alzheimer's, you cannot possibly imagine the horror and sadness this disease inflicts upon a family. It took eleven years for our beloved mother to finally succumb to this wretched disease. It completely destroyed our father, as the primary caregiver, depleted ALL of our parents' savings, and left our family penniless and in a shambles. Our dear father's health was so comprised as her caregiver, that he is now in a nursing home, dying. I cannot stop crying. We have not only lost both parents, but also all hope of any chance of happiness for their children and grandchildren. I hope you do not have to experience this first hand before you understand how devastating Alzheimer's truly is. Turning your back on an opportunity to stop this dreadful disease will surely prove to be a failure to act to save someone in your OWN family from this tragedy. Alzheimer's is no respecter of persons. Please help.


 

E. Hely  |  03-31-2012

I had worked in nursing homes as an Activities Assistant for years, and saw the debillitating effects of the disease on the people who had the disease, as well as their loved ones. I also have an aunt with the disease, and know of the toll this is taking on her children. We need the HHS to take action to find a way to prevent this disease and cure it.

There needs to be more research done on Alzheimer's Disease, so that this disease may be combatted.


 

J. Madsen  |  03-30-2012

Dr. Oz backs the research behind this existing drug to treatAlzheimers. This article explains it better than I can. My mother was recently diagnosed and it is a painful disease to watch. The mental decline in someone so vibrant and otherwise very healthy is devastating. Please support an aggressive pursuit of this new promising treatment for Alzheimers.

http://www.doctoroz.com/blog/mike-roizen-md/alzheimer-s-breakthrough-shows-promise


 

N. Kouros  |  03-30-2012

My father died a slow death from Altzheimer's, essentially losing his life before it actually killed him. In the process, it drained my mother's life to the point where she neglected her own health to devote 100% of her time to his care, and she died soon after. It drained me and my brother's as well, and now we live in fear of developing this disease ourselves.

The current NAPA plan, though well intentioned, is as effective as a Get Well Soon card. Please work to make the next version of the plan effective by putting some muscle behind it. It is hard to believe even in the current partisan environment that it would not receive bi-partisan support.


 

K. Lowe  |  03-30-2012

My mother once spoke four languages, got her master's from Tufts School of International Law and Diplomacy and had one of the sharpest wits ever.

She's 89 now, and think she thinks I'm an overly friendly nursing home staffer who kisses her and tells her how much Istilllove her. She has disappeared so slowly, I'm not even sure when I said goodbye to the mother I once knew.

I am saddened and scared. I am scared now that I, too, will suffer this fate. And that my children will one day wonder where I went and who is this apparition is who looks like me but seems lost at sea.

I am heartened by the commitment to a 2025 deadline in the draft NAPA plan to fight Alzheimer's. The clinical trial are crucial and I am strong believer in targeted research and coordinating resources. We cannot afford to waste resources!

But I fear good intentions without benchmakrs will mean wasted time, effort and money. We need timelines, deadlines and accountability.

I hope that HHS will tackle this issue in the coming months the only way to address this disease -- with courage, coordination and bold action.


 

M. Berg  |  03-30-2012

Alzheimer's is a cruel disease. It slowly steals one's intellect, ability to communicate, independence, and dignity, even control over basic bodily functions like eating and caring for personal hygiene. It also places an overwhelming burden on caregivers -- emotionally, physically, and financially.

Sadly it seems the Republican party is inflicted with this horrible disease. If for no other reason, do it for the GOP!


 

S. Smith  |  03-30-2012

I feel sure you have been exposed to Alzheimers there are very few people now that haven't been affected by it, so there is no need to explain what it does, all we need is help.

Once the damage is done it can't be reversed, so please encourage urgent research to stop Alzheimers.


 

A. Baker  |  03-30-2012

For the past 3 years I've watched my partner of 48 year decline into the darkness of Alzheimer's disease. His physical condition is to the point that I must place him in a nursing home. This is by far the most difficult decision I have ever made. I want a time to come that no one must make such a decision because of Alzheimer's disease.

I am pleased that your draft plan recognizes the need for increasing enrollment in clinical trials, compressing the drug development process, accelerating targeted research, and better coordinating activities with other countries.

From what I can tell there needs to be more resources promised and some more explanation of the steps to be taken.

I hope that HHS will address these issues in the coming months so that the next version of the plan will be bolder. Our nation cannot afford the costs of inaction.


 

G. Carson  |  03-30-2012

Alzheimer's is a traumatic way to end one's sacred time here on this planet. The disease is paralleled with strong (negative) personality shifts and loss of memory related cognitive abilities in all types of memory. Further fueling this disease is the social treatment of it. Family members interact cautiously, and the person suffering Alzheimer's disease often witnesses their social structures disappear. My grandma, who suffers Alzheimer's, has been fighting with my grandfather for two years now, convinced that he is slyly stealing all of her things. My grandfather cannot even be in the same room alone with her anymore without being emotionally trampled. This is not her, and this is not the person my whole family grew up with. This has happened with both my grandmothers.

This needs to be dealt with, and it can. Research has identified many of the neural and microbiological mechanisms behind this neurodegenerative disease. If we can learn to cure this, that would be amazing. However, more funding can allow us to really treat it, which involves both traditional AND preventative medicine. Education of our public is highly important. Teaching appropriate and healthy behaviors (nutrition, physical AND mental exercise, having social relationships, etc.) which are highly linked to prevention are important. Funding of projects both in research and education is of extreme importance, especially given the future financial costs all of us will be covering for these individuals.

It is our national duty to fix this. Please take the necessary steps forward! Thank you for your time.


 

T. Horowitz  |  03-30-2012

The devastation caused by Alzheimer's disease to so many families is well known. Please see to it that the resources needed to really push this plan forward are made available. We're depending on you.


 

D. Novak  |  03-30-2012

My Mother died of Alzheimer's, it was a long, cruel and horrible spiral to death....so sad.


 

T. Sutton  |  03-30-2012

Alzheimer's is a cruel disease. I saw my Grandma go from an active, sweet person to a woman who thought the person reflected in her mirror was another woman. I saw my Grandpa's heart break as the person he planned to spend the rest of his life with dwindled away to a woman who thought he was her father.

It's time for something to be done to eradicate this disease. It is a cruel disease that robs a person of their dignity and leaves the family feeling angry and cheated.

Please do what is needed to stop this disease.


 

J. Winslow  |  03-30-2012

Having been associated with the Alzheimer Society of Washington for thirty years I have seen many changes in the recognition, support and care for person affected by dementia. The scope of the Draft National Plan makes it clear that leaders in the nation have recognized the need to bring together governmental and private agencies to develop a plan. I applaud the work that has been done and have only a few comments:

  1. Even though the prevalence of Alzheimer's disease and related dementias (AD) increases with age it is not an "aging" issue. AD is a chronic disease and designating many of the programs that serve people affected by dementia to, or through, the National Institutes on Aging or through Older Americans Act programs shifts a chronic health problem to an aging issue. The National Institutes of Health (NIH) could be assigned to oversee all Chronic Disease and Disability programs -- then AD supportive services could fall under the auspices of NIH. This action would make AD more likely to be seen as a chronic disease and should elicit preventive health-related responses, even though there is not currently a cure for AD.
  2. While this report addresses reducing stigma and bringing better understanding to the needs of people with dementia, it still reflects the medical bias that can occur in so much of health care. In the Draft National Plan, Action 2.A.4: Strengthen the direct-care workforce it says, "The training will be released in Spring 2012, and will be available to all nursing homes to share with their staff." I recommend the language be changed to say,"...will be available to all "organizations providing dementia care." My reason for expanding the beneficiaries of the training is that many organizations in the community provide care to people with dementia. Offering training to all organizations that provide supportive services, daycare and home care, and less medically-oriented care, and not limiting the training to nursing homes, can help the person with dementia remain in the community longer -- and reduce healthcare costs.
  3. Funds designated for research should specifically include Social Innovations. As I indicated in the paragraph above, there are many organizations that are providing support to people affected by dementia.

Our organization has sponsored two such innovative social programs:

  1. The Early Memory Loss (EML) program, conducted at least yearly, is for the person with dementia and his/her care partner(s). The initial program lasts ten weeks. Participants gather, then are divided. People with dementia are in one group; the family care partners are in another. The same topic is addressed in each group, but in a way that is appropriate for the person with dementia or the family members. Upon completion of the weekly EML program the group "graduates" into a follow-up support group that is made up of attendees from previous classes and meets monthly.
  2. The second program is called "Staying Connected" and is for people with early memory loss. Participants attend a small (up to 8 people) 3-hour weekly group that provides physical, social and mental stimulation. Over the past three years many of the participants have retained their mental capacity and have continued to benefit from the program. Their care partners have benefitted, too, by having this supportive community program.

Research into Social Innovations could help provide credibility and more support for these kinds of programs.


 

M. Roherty  |  03-30-2012

The National Association of States United for Aging and Disabilities (NASUAD) appreciates the opportunity to comment on the Department of Health and Human Services (HHS) Draft National Plan to Address Alzheimer's Disease, as published on February 22, 2012.

NASUAD represents the nation's 56 state and territorial agencies on aging and disabilities. As part of the National Aging Network, each of our members oversees the implementation of the Older Americans Act (OAA), through funds awarded by the Administration on Aging (AoA). Additionally, many member-states also serve as the operating agency for Medicaid home and community based services (HCBS) waivers that serve older adults, and in some cases, individuals with disabilities. The Association's principal mission is to design, improve, and sustain state systems delivering home and community based services and supports for people who are older or have a disability, and their caregivers.

The enactment of the National Alzheimer's Project Act (NAPA) has created a long-overdue opportunity to focus the nation's attention on Alzheimer's disease, and the Association applauds the Administration's recognition of both the vital need to address the many challenges facing people with the disease, their families, and caregivers; and the urgency with which this must be done. Additionally, we find the draft plan's guiding principles, which seek to optimize existing resources and improve and coordinate ongoing activities, to support public-private partnerships, and to transform the way we approach Alzheimer's disease, to be an appropriate reflection of the ambitious, yet attainable, goals embodied by the plan itself.

Guided by a vision of a nation free of Alzheimer's disease, the Draft National Plan to Address Alzheimer's Disease outlines goals, strategies and actions that directly affect the Aging Network. Consequently, NASAUD respectfully submits for your consideration the following comments and recommendations.

Action 2.A.5: Strengthen state aging workforces.
NASUAD applauds the Department's efforts to strengthen state aging workforces that are "capable and culturally competent" through AoA. While implementing this action, it is important that efforts to improve state strategies do not further burden states' abilities to apply for and utilize funds from AoA. States should maintain flexibility to implement strategies that address the unique needs of the state populations through their state infrastructures.

Action 2.A.6: Support state and local Alzheimer's strategies.
NASUAD applauds states for recognizing the need to develop comprehensive plans to address Alzheimer's disease, but we are concerned that these plans are being conceptualized and developed without involvement from the Aging Network. State agencies on aging and disabilities play a critical role in the oversight and delivery of services that are designed to support older adults, including those with Alzheimer's disease, in their homes and communities. For these reasons, NASUAD recommends that state agencies on aging and disabilities, and other relevant stakeholders, should be involved at all stages of Alzheimer's state plan development.

Additionally, in accordance with the Older Americans Act, state agencies must develop a State Plan on Aging, which is envisioned by AoA as a comprehensive plan document that articulates the direction in which state long-term care efforts are moving, key strategies to address the strong desires of the rapidly growing new generation of long-term care consumers to be served in their homes and communities, and how the state will address the challenges of America's budgetary constraints and competing priorities in today's society. Given these existing requirements, State Plans on Aging may be the most appropriate place for states to describe their short and long-term strategies for addressing Alzheimer's disease. The integration of Alzheimer's state plans into State Plans on Aging would align with the need for a holistic approach to combatting the disease itself, as well as AoA's intent that State Plans serve as valuable tools for planning and tracking all of the state's efforts on behalf of older adults.

Action 2.B.1: Link the public to diagnostic and treatment services.
NASUAD supports the Department's approach of expanding linkages between existing disease support and community information centers supported by AoA and the National Institutes of Health (NIH). In order to successfully connect members of the public with the necessary services and supports, NASUAD recommends that HHS also examine the capacity of these existing structures, particularly those within the Aging Network, such as ADRCs, I&R/A, and SHIPs, to ensure that these resources are adequately funded to meet the needs of this growing population.

Action 2.C.2: Enhance assistance for people with AD and their caregivers to prepare for care needs.
NASUAD recommends that any strategy to strengthen the Aging Network's capacity to provide families and people with AD access to appropriate services and specialized long-term care planning should be implemented in such a manner that does not overly burden these existing systems. Rather, any approach should provide the Aging Network with the necessary resources to meet these unique needs and to develop innovative practices for doing so. In addition, HHS should compile an inventory of tools to assist caregivers from federal and state agencies, as well as patient advocacy organizations, and make these tools readily available within the next year for distribution through the Aging Network.

Action 2.F.2: Implement and evaluate new care models to support effective care transitions for people with Alzheimer's disease.
NASAUD supports the Department's recognition of the potential for the ADRC Evidence Based Care Transitions program to implement evidence-based care transition models that meaningfully engage older adults, individuals with disabilities, and their informal caregivers. Throughout this evaluation process, NASUAD recommends that HHS consider the impact that additional resources could have on the ability of ADRCs to build their capacity and successfully support effective care transitions for people with Alzheimer's disease.

Action 2.F.3: Develop an AD-specific toolkit on care transitions.
NASUAD recommends that this toolkit be developed in consultation with state agencies on aging and disabilities, and be available for distribution throughout the Aging Network within the year.

Action 2.H.2: Identify steps to ensure access to long-term services and supports for younger people with AD.
NASUAD supports the proposed collaboration between the Administration on Aging (AoA), the Office on Disability, and Administration on Developmental Disabilities (ADD) to address access to long-term services and supports across the lifespan, and believes these agencies should be consulted as stakeholders throughout the plan's development and implementation.

Action 3.A.1: Identify culturally sensitive materials and training.
NASUAD supports HHS efforts to give caregivers the information and training that they need in a culturally sensitive manner, and recommends that plans to do so include input from the Aging Network. To facilitate the identification and distribution of culturally-appropriate materials to caregivers, NASUAD recommends that within the year, HHS should convene an expert panel to develop an inventory of culturally-sensitive materials and trainings that are currently available, and identify gaps that should be filled by government and patient advocacy organizations.

Action 3.A.2: Distribute materials to caregivers.
NASUAD recommends that HHS utilize its current inventory of federal agency programs and materials and make these resources readily available to all caregivers through the Aging Network.

Action 3.B.2: Identify and disseminate best practices for caregiver assessment and referral through the long-term services and supports system.
NASUAD recommends that HHS distribute the identified best practices in a manner that recognizes the variance in long-term services and supports systems across, and within, states. Since what may be a promising practice in one state may be ineffective in another, NASUAD encourages HHS to recognize the importance of state flexibility in meeting the unique needs of individuals within each state.

Action 3.B.3: Review the state of the art of evidence-based interventions that can be delivered by community-based organizations.
NASUAD recommends that this action include identifying interventions that are successful in improving the health and wellness of people with Alzheimer's disease and other dementias. Many successful evidence based programs have been proven to work for both people with Alzheimer's and other dementias, so it is important that the evaluation of such programs not be limited to only Alzheimer's specific interventions.

Action 3.B.4: Develop and disseminate evidence-based interventions for people with Alzheimer's disease and their caregivers.
To successfully implement the strategies defined in Action 3.B.3, NASUAD recommends that HHS quickly work to ensure that more people with Alzheimer's disease, and their families, have access to successful evidence based intervention programs. There are existing programs that NASUAD recommends HHS should expand as part of this effort:

  • Older Americans Act -- Reauthorization of this legislation would ensure grants to states for community planning and social services, research and development projects, and personnel training in the field of aging. Funding should also be increased for the programs funded by the Act.
  • Lifespan Respite Care Act -- Reauthorization of this legislation would authorize grants to statewide respite care service providers. Grants can be used for various purposes, including training and recruiting workers and volunteers, training family caregivers and providing information about available services. Additional funds should be allocated to the Act.
  • National Family Caregivers Support Program -- At a minimum, funding levels should meet the recommended levels of the President's FY12 budget ($192 million). This program provides grants to states and territories to pay for a range of programs assisting family and informal caregivers to care for loved ones at home and for as long as possible.

Action 3.B.5: Provide effective caregiver interventions through AD-capable systems.
As HHS works to connect caregivers with appropriate supportive services, NASUAD recommends that HHS build upon the existing capacity of ADRCs to serve as "No Wrong Doors" through which individuals, their families, and caregivers can access available services and programs.

Action 3.B.6: Share lessons learned through VA caregiver support strategies with federal partners.
NASUAD recognizes and applauds the successes of the VA in providing home and community based care, and realizes the importance of sharing lessons learned from the implementation of these programs across agency and state lines. NASUAD recommends that the quarterly meetings identified in this action step commence as soon as possible, so that important information is gathered and shared not only among federal programs, but also throughout the Aging Network.

Action 3.C.1: Examine awareness of long-term care needs and barriers to planning for these needs.
Once HHS completes this barrier-identification process, NASUAD recommends that HHS work with federal stakeholders, including CMS and AoA, as well as state and local agencies on aging, to develop and implement solutions to the identified obstacles.

Action 3.C.2: Expand long-term care awareness efforts.
In looking to expand public outreach and awareness about Alzheimer's disease and the importance of long-term care planning, NASUAD recommends that HHS build upon the successes of the Aging Network in providing outreach and education, such those achieved by ADRCs, I&R/A, SHIPs, and state and local agencies.

Strategy 3.D: Maintain the dignity, safety and rights of people with Alzheimer's disease.
To successfully implement this strategy, NASUAD recommends that HHS consider implementing the Elder Justice Act (EJA), as established by the Affordable Care Act (ACA). The EJA fully realizes the need to protect our most vulnerable citizens from financial exploitation, as well as from physical and emotional abuse and neglect, and it creates structures and programs for doing so. Though the EJA was signed into law in 2010, it has yet to receive any federal dollars. Without a strong financial commitment to address the growing problem of abuse and neglect among older adults, it will be impossible to fully secure the dignity, safety, and rights of people with Alzheimer's disease. NASUAD recommends that HHS work with Congress to fully fund the Elder Justice Act.

Action 3.D.1: Educate legal professionals about working with people with Alzheimer's disease.
NASAUD recommends that these efforts take into consideration the existing framework and resources for legal services that are available through the OAA. Additionally, training should be offered to legal professionals throughout the Aging Network, and the curriculum should address the importance of cultural competence. Training should also be extended to state Adult Protective Services workers as well as to other individuals as appropriate.

Action 3.D.2: Monitor, report, and reduce inappropriate use of anti-psychotics in nursing homes.
To leverage existing successful systems, NASUAD recommends that federal and state representatives from AoA's National Long-Term Care Ombudsman Program be involved in this collaborative effort.

Action 3.E.1: Explore affordable housing models.
NASUAD recommends that this action include the evaluation of innovative interventions aimed at helping older adults and individuals with disabilities, including those with Alzheimer's and other dementias, remain in the community rather than in institutional settings. With a focus on programs and strategies undertaken by AoA, state agencies on aging and disabilities, and area agencies on aging, NASUAD recommends that HUD and HHS work with the Aging Network to identify innovative practices, barriers to success, and solutions to these barriers.

New Recommendation: Ensure adequate resources for programs and services supported by AoA's Alzheimer's Disease Supportive Services Program (ADSSP).
ADSSP's focus is to expand the availability of diagnostic and support services for persons with Alzheimer's disease and other dementias and their caregivers, as well as to improve the responsiveness of the home and community based care systems to persons with dementia. The program focuses on serving hard-to-reach and underserved persons using proven and innovative models. In order to achieve Goal 3 in the Draft Plan, funding for ADSSP should be increased rather than reduced so that evidence based programs can continue to support the growing number of people with Alzheimer's disease and other dementias and their families at the community level.

New Recommendation: Include services for mental and behavioral health services.
Mental and behavioral health services must be included in the wide array of necessary health services available to individuals with Alzheimer's and other dementias, their families, and their caregivers. Mental and behavioral health providers should be represented on interdisciplinary health care teams that work with these individuals, their families, and caregivers in primary care, institutional, and home and community based settings. Cognitive impairment alone does not preclude the ability to benefit from various forms of effective behavioral and mental health interventions.

Action 4.A.1: Design and conduct a national education and outreach initiative.
NASUAD recommends that HHS use existing "No Wrong Door" systems, such as ADRCs, to link individuals to accurate information, resources, services, and supports, in a manner that recognizes the potential need to enhance the capacity of ADRCs.

Action 4.B.1: Convene leaders from state and local governments.
NASUAD recommends that HHS include state directors on aging and disabilities in this collaboration, as well as state long-term care directors.

On behalf of NASUAD, I thank you for the opportunity to comment on this proposed rule. We look forward to continuing to work with HHS to develop a National Plan to Address Alzheimer's Disease that seeks to achieve the vision of a nation free of the disease, while maintaining the dignity and independence of those with Alzheimer's disease, their families and their caregivers. Please do not hesitate to contact me or NASUAD's Director of Policy and Legislative Affairs to further discuss any of these issues.


 

S. Scanland  |  03-30-2012

Please confirm that you received this message. I know today is the last day for submission.

I was hoping to get it in earlier, but my dad passed away recently.

Thank you for this opportunity to include our comments!

ATTACHMENT:

Comments on NAPA from an Alzheimer's expert with 30 years of dementia experience

NAPA's outline is a comprehensive masterpiece which I am grateful for the opportunity to offer comments...I've waited decades for this!

I want to thank President Obama, for keeping the promise he made in response to my Town Hall question in Scranton PA during his initial campaign. My question to him was: "What do you plan to do about the Alzheimer's epidemic?"

Action 2.A.2: Encourage providers to pursue careers in geriatric specialties
Only 1% of physicians specialize in geriatrics; even fewer are experts in Alzheimer's and dementia. Less than 5% of nurse practitioners are certified as gerontological nurse practitioners. Similar statistics exist for psychiatrists who specialize in geriatrics or dementia care. We are about 13,000 geriatric physicians short now: the American Geriatrics Society estimated it will get worse: a 36,000 deficit of geriatric physicians by 2030. Is there hope?

The lack of Medicare reimbursement for comprehensive geriatric assessment, dementia assessments, family caregiver support, counseling and education have deterred young medical students from entering geriatrics. Geriatricians' salaries are considerably than physicians in sub-specialties. If the annual threat to cut Medicare continues, elders and Baby Boomers will suffer even further access to elder care specialists. If NAPA has any influence in this area, it is essential to have Alzheimer's experts for the dementia bubble ready to burst!

I, as a Gerontological Nurse Practitioner, taught family medicine residents Alzheimers and dementia care in nursing homes, assisted living facilities and on house calls between 1987-1999. Most medical students during the nineties were graduating with less than 10 hours of lectures specific to geriatrics: with no little or curriculum on Alzheimer's, dementia or geriatric pharmacology. Geriatric rotations were not common in many primary care residencies at that time. Even today, primary care provider attendance is lacking at continuing education programs on Alzheimer's disease. I suggest that NAPA offers funding for Alzheimer's CE programs to be offered by geriatric educators. I recommend at least four hours of annual mandatory CE for practicing physicians and other primary care providers on the following topics:

  1. Geriatric Prescribing: This should include emphasis on the Beers List of potentially inappropriate medications in elders. Adverse drug events affect elders more than any other age group. Persons with Alzheimer's disease are at even greater risk for delirium due to their low levels of brain acetylcholine. There are over 6 million elders on one or more potentially inappropriate medications for elders. Adverse drug reactions in seniors are a leading cause of ER visits and hospitalizations; hence further driving up US health care costs. Many providers remain uneducated re the Beers list. This has been confirmed by many nurses who participated in my 600+ seminars in over 40 states).
  2. Alzheimer's Disease (Late Onset and Early Onset) Vascular Dementia, Lewy Body Dementia, Parkinson's Dementia, and Frontotemporal Dementia: Primary health care providers need to be comfortable diagnosing and differentiating the major types of dementia, performing a dementia workup and treating Alzheimer's Disease/dementias using clinical guidelines. There are simply not enough dementia specialists for PCP's to refer to. The waiting times for families to see a dementia expert are much too long!
  3. Behavioral and Psychological Symptoms of Dementia: All prescribers treating elders need to fully understand the risks of antipsychotic therapy, paradoxical effects of benzodiazepines in frail elders, and the non-pharmacological approaches to dementia behaviors. Providers should become familiar with the evidence-based research on these topics. This will enable them to help patients and their families learn the benefits of antidementia medications and the risks of antipsychotics and benzodiazepines in elders.

Action 2.A.4: Strengthen the direct-care workforce
With a rate of 50% turnover of nursing assistants and direct care staff in states like my own (PA), we need to make LTC a setting where staff remain, ensuring continuity for resident care. Direct care workers are at risk of physical injury and disability. Administrators face rising workman's compensation costs when behaviors of dementia re not optimally treated. Staffing issues, poor retention, burnout and lack of dementia education contribute.

I request that national dementia experts who are entrepreneurs have opportunities to partner in business with governments and state agencies in educating the direct care workforce. I feel that at least 50% of training should be live; to allow staff to ask questions relevant to the patients they serve. Video and online learning can be a supplement, but should we not give the best to the staff that spend the most time with Alzheimer's residents? The #1 reason they resign is because they don't feel that they are respected. Honoring their efforts with live dementia education is an excellent strategy that will save money that is being spent on training a transitory workforce.

Many of us have been working in the community trenches of Alzheimer's care, outside of academic or research settings for decades and want to share our wealth of knowledge and experience. I've been educating nursing assistants, nurses and interdisciplinary staff for 12 years! The National Council for Certified Dementia Practitioners offers a full-day live curriculum that could lead national certification as a CDP: Certified Dementia Practitioner.

Dementia education should not be limited to nursing assistants. It should be available and funded for LPNs (who run most LTC units). Dementia research changes daily to weekly, so updates need to be shared with RN's, administrators, social workers, pharmacists, physical, occupational, recreational and speech therapists, social workers, and dieticians. Only through interdisciplinary education will senior communities be on the "same page" for best practices in long-term care, assisted living, CCRC's and home and hospice care.

I request that dementia education businesses that have clinical experience in dementia care be included in the force to strengthen the direct care workforce.

Action 2.A.5: Strengthen state aging workforces
HHS will coordinate with states to develop aging workforces that are AD-capable and culturally competent.
AoA will ask states to specify strategies to improve the AD-capability of the workforce.

I would request that state agencies will have grants and opportunities to partner with for-profits dementia education corporations, especially those that are reaching families currently though the power of social networking.

Strategy 2.B: Ensure timely and accurate diagnosis
I have been diagnosing Alzheimer's and dementia for 30 years. I still see nursing home residents, home care patients or nursing home residents who are not yet diagnosed until the moderate or late stage of Alzheimer's disease. I've met families in which loved ones were killed in auto accidents due to a driver with undiagnosed dementia, spouses who have been bankrupted by their husband's undiagnosed Alzheimer's disease. Part of the problem is family denial, apathy, fear, and helplessness. The remaining problem is that some health care providers lack knowledge of the dementia workup and evidence-based clinical guidelines for treatment. Continuing education is essential for providers: families need to be educated of the warning signs and know where to go for help.

Supporting people with Alzheimer's disease and their families and educating the public and providers.
This is HUGE. Families are starved for direction, information, support and resources. I have provided approximately 200 caregiver workshops in 40 states across the country. The lack of information on Alzheimer's disease causes family turmoil and division. I've seen cases of anger and elder abuse between family members who misinterpreted the personality changes of Alzheimer's as intentional behaviors. Many families have shared with me their frustrations with dementia care in the current health care setting. Seminars should be funded in the community, in senior centers, or in faith communities; where access is easy for stressed families and friends.

Action 1.E.3: Educate the public about the latest research findings
Translating research on dementias to professionals and the public has been the main focus of my dementia and geriatric education businesses for the past 12 years. I would request that HHS, VA, federal agencies, ADEAR will also partner with for-profit businesses who have been sharing Alzheimer's information in their businesses.

Action 2.C.1: Educate physicians and other healthcare providers about accessing long-term services and supports
Action 2.E.1: Evaluate the effectiveness of medical home models for people with AD

Interdisciplinary collaboration needs to be initiated at the undergraduate level in the health sciences, including pre-med. I have taught graduate level geriatrics for 25 years. Evidence-based studies on quality of life, morbidity and mortality, functional state in elders consistently show that the interdisciplinary team approach offers better outcomes than standard medical care. Teams consistently outperform the hierarchical model of care. This should not be surprising, as Alzheimer's care and general geriatric care is functional, medical, psychological, pharmacological, social, spiritual, legal and financial. Alzheimer's care needs to be shared jointly, not "directed" by a single profession. Re the medical home concept, I would request that nurse practitioner with Alzheimer's or gerontological experience, be included as leaders in the Alzheimer's medical home model.

Action 3.B.2: Identify and disseminate best practices for caregiver assessment and referral through the long-term services and supports system
I would request that Medicare reimbursement codes be established for comprehensive caregiver assessments and that providers can choose the caregiver assessment instrument that works best for them; rather than be directed by a 3rd party. Suggested instruments are the The Zarit Burden Interview or the Modified Caregiver Strain Index (CSI). Reimbursement should be allowed for both initial diagnosis and counseling as well as ongoing caregiver assessment and support.

Action 3.D.1: Educate legal professionals about working with people with Alzheimer's disease
I feel that for-profit Alzheimer's/dementia education corporations, non-profit dementia educators; Alzheimer's Association chapters should have the ability and financial incentives to educate attorneys. My opinion is that only attorneys who are CELAs (Certified Elder Law Attorneys) should be able to title themselves as elder care experts. There is a national examination and certification for other attorneys who are committed to the senior population who desire this certification.

Action 3.D.2: Monitor report and reduce inappropriate use of anti-psychotics in nursing homes
I have prescribed medications in LTC units over three decades. Over the past 20 years, OBRA had some impact on dementia antipsychotic use in nursing homes, but not as much as was hoped for. Despite a nearly doubled risk of mortality (1.7x) due to stroke, pneumonia, cardiovascular disease, antipsychotics are still routinely prescribed for behaviors related to dementia. Many prescribers are not aware that antipsychotic effectiveness for dementia was less than 20% effective in the CATIE study. Several studies revealed that staff dementia education was more effective than antipsychotic treatment for dementia behaviors. Funding should be available to educate prescribers regarding risks of antipsychotics for dementia. 88% of reimbursement claims submitted to Medicare for antipsychotic drugs prescribed for nursing home residents during a six-month review period (January to June 2007) were for residents diagnosed with dementia! So I applaud the recent work of Dan Levinson and the Office of Inspector General to reduce antipsychotic use for behaviors in dementia.

Please contact me if my 30 years in the "dementia trenches" will be of assistance to your remarkable action plan.


 

G. Glazner  |  03-30-2012

Please find attached a letter for the public comments on the National Alzheimer's Project Act.

ATTACHMENT:

Arts and Aging Research

Thank you for inviting the public to comment on the U.S. Department of Health and Human Services "Draft Framework for the National Plan to Address Alzheimer's Disease." As a pioneer in Art and Aging programming and recipient of the 2012 MetLife Foundation Creativity and Aging in America Leadership award in the category of Community, the Alzheimer's Poetry Project welcomes the opportunity to provide recommendations for your consideration.

We believe that the five goals outlined in the plan which form the foundation of the National Plan is well formulated and seeks to offer a comprehensive and multi-faceted approach. In comparing the National Plan to the most recent work of the three Sub-Committees, we felt the need to underscore a role for arts and aging research.

While our ultimate goal is a world without Alzheimer's, we recognize those living with the disease today and tomorrow will require the best possible care we can offer. We are concerned that the ultimate research agenda will be too narrow in scope and leave research relative to care practices as a back-burner issue, instead of integrated as a significant component.

Among the areas in NAPA that arts programming could be especially effective include educating family and the public about the disease and under lessening the stigma of the disease. A number of arts groups including the Alzheimer's Poetry Project have this effect when we hold workshops for family members and students. Our public arts events such as "Alzheimer's Poetry Day" held at among other locations, the National Hispanic Cultural Center held in Albuquerque, New Mexico on November 5th 2011 in English and Spanish is one such example.

A few arts programs serving people living with Alzheimer's disease and related dementia and their families, that have extensive experience in helping to educate caregivers and in demonstrating the role that creativity can play in the health of people navigating memory loss, that have show promise in research studies include:

  • "Meet Me at MoMA," The Museum of Modern Arts dementia program.
  • "Time Slips," a Storytelling project with people with Alzheimer's disease and their caregivers.
  • SONGWRITING WORKS., which engages elders, older adults and families in hands- on songwriting and performance using an internationally recognized method proven to restore health and community.
  • "The Dancing Heart," Kairos Dance, which vitally engages those with mid-to-late stage Alzheimer's, in a weekly dance and storytelling playshop that has shown to positively improve the health of participants.

One agency missing from the list of participating inter-agency departments and government agencies tasked to help support the development of the national plan is the National Endowment for the Arts (NEA). Recently, this agency partnered with the U.S. Department of Health and Human Services in creating the white paper "The Arts and Human Development: Learning across the Lifespan," which frames a national research agenda for the arts, health and well-being. We recommend that the NEA have an opportunity to weigh in and support efforts in creating NAPA.

In the NEA, "Creativity and Aging Study The Impact of Professionally Conducted Cultural Programs on Older Adults," 2006 they write, "...In conclusion, these results point to powerful positive intervention effects of these community-based art programs run by professional artists. They point to true health promotion and disease prevention effects."

In addition, we would like to bring to your attention to two among many studies that show the impact of non-pharmaceutical interventions in improving the health and quality of life for people living with Alzheimer's disease and related dementia including: "Singing while caring for persons with dementia1," and "Using poetry to improve the quality of life and care for people with dementia.2"

We must ask our selves what immediate help can we provide to people living with Alzheimer's disease and related dementias and how can we help them to continue to actively participate in the life of a community. Arts based dementia programming offers a chance to improve the quality of life of people living with dementia and their caregivers today. Thank you for the opportunity to share our thoughts and recommendations.

  1. "Singing while caring for persons with dementia," Lena Marmsta°l Hammara,b*, Eva Go..tella,b and Gabriella Engstro..mc aMa..lardalen University, School of Health, Care and Social Welfare, Va..stera°s, Sweden; bKarolinska Institute, Department of Neurobiology, Care Science and Society, Division of Nursing, Stockholm, Sweden;cMa..lardalen University, School of Health, Care and Social Welfare, Eskilstuna, Sweden Arts & Health Vol. 3, No. 1, March 2011, 39.50
  2. "Using poetry to improve the quality of life and care for people with dementia," Helen Gregory University of Gloucestershire, Natural and Social Sciences, Cheltenham, UK (Received 9 December 2010; final version received 20 March 2011), Arts & Health Vol. 3, No. 2, September 2011, 160.172

 

N. Emerson Lombardo  |  03-30-2012

Thank you so much for signing NAPA and putting creation of our first National Plan to Address Alzheimer's Disease on the fast track.

I preface my comments with brief personal history.

I joined the national Alzheimer's Association early in 1980, co-founded both the Chicago and Detroit area chapters as I moved around the country, joined the National Board of Directors circa 1981 and rose to become a national Vice Chair and Chair of the Public Policy Committee. In 1984 I co-founded the Alzheimer's Disease International. I am also proud to have single-handedly suggested the idea of what became the federally funded program to states to create innovative Alzheimer's programs with special emphasis on serving minority populations. While Chair of the Public Policy Committee for the national Alzheimer's Association I was also successful in getting our board to hire full time professional public policy staff, create our annual spring "Public Policy Forum" to bring our citizen advocates to Washington DC to be educated and meet with their Congressional representatives. We also developed our first coalition efforts, e.g. with the then Long Term Care campaign, and the National Citizen's Coalition for Nursing Home Reform and helped support the nursing home reform bill that became law (OBRA 1987). We also held our first meetings with members of the CBO and Medicare/Medicaid administration officials to examine what information was needed to start developing a plan for how to meet the service and funding needs of people with dementia and their families. Later, in the 1990's while at Wellesley Centers for Women we looked at the scary prospects of the diminished numbers of people available (the baby bust era e.g. my children's birth cohort) to serve as care partners to those baby boomers who would be developing Alzheimer's and other brain/body diseases in 2040-2050. I then was asked to join Boston University's NIH funded Alzheimer's Disease Center and Department of Neurology to continue my clinical intervention studies; I currently have a small phase I trial of nutritional supplements underway, funded by the U.S. Alzheimer's Association.

My work over the past 30 plus years on behalf of Alzheimer's disease and now the broader field of brain health, is all inspired by my mother Frances Fink Emerson who developed Alzheimer's disease in her early 50's, lived 25 years and died in 1990 with no ability for willed action or movement of any sort, and a brain shrunk to half its original size. She received great care both at home -9 years-and in a nursing home -- 16 years- (and thus lived a long time despite her disabilities....no other health issues) in an era when we knew only a fraction of what we know now, thanks primarily to the work of the Alzheimer's Association, and research funding by NIH, Alzheimer's Association and WHO and other organizations and caring people around the world.

Today I am an Alzheimer's researcher connected with Boston University School of Medicine, actively serve on my local chapter board (Alz. Assn of Massachusetts and New Hampshire) as member of the Medical Scientific Advisory Committee, serve as a Board Member Emeritus of the national Alzheimer's Association (an inactive role), and actively attend and present scientific papers or posters at the Alzheimer's Disease International. I also have a small business that brings evidence-based knowledge about brain healthy lifestyles to organizations and individuals and families. My centerpiece is the evidence-based Memory Preservation Nutrition program, which I am proud to be bringing to 6 Boston area Assisted Living communities to help them improve the healthfulness of the foods their residents are served and eating. I am also a popular speaker, mainly on the topic of "Healthy Eating for a Healthy Brain and Body." And was featured as part of a Medical Journal TV news report on Boston Channel 5's Chronicle on March 20, 2012 and November 18, 2011.

I am excited by the breadth and content of the draft national Alzheimer's plan and want to make just a few pointed comments about moving forward. I am also attaching a couple documents that might be of interest in summarizing some of the recent work related to brain healthy lifestyles and reducing risk of Alzheimer's and other brain diseases. Here also is the direct link to the article I wrote for Sage Encyclopedia 'Alzheimer's Disease: Encyclopedia of Lifestyle Medicine and Health' See it at: http://www.sage-ereference.com/abstract/lifestylemedicinehealth/n18.xml

First, I am gratified that the draft plan calls for research and program development in the realm of healthy lifestyles, not just innovations in the realm of pharmaceutical and medical research, which of course is needed as we would all like to find the magic bullet(s) to prevent and cure this disease. But given the complexity of this mysterious disease and the delicacy and intricacy of the brain, such magic bullets may not exist. Alzheimer's may be as challenging to reduce risk as has been heart disease, stroke and diabetes, since they are all interrelated in ways we are still seeking to understand. Thus major public health initiatives based on evidence uncovered in the fields of nutrition, physical exercise, sleep, stress reduction and much more may be what works to help our society avoid the catastrophe of doubling, then quadrupling the numbers of Americans with Alzheimer's disease as the numbers of people who could serve as care partners and paid professional providers shrinks in relative numbers.

Second, as an active member of the international Alzheimer's research and practice communities I strongly urge that the HHS Administrative offices charged with designing, refining and implementing the plan be in close liaison with international efforts to combat Alzheimer's disease. People in the US are often very parochial and have no idea of the great strides being made elsewhere. Also, because our healthcare system is presently dominated by for-profit organizations and pharmaceutical companies, it is harder for us to see clearly public health priorities that might be the best use of resources. The international community faces graver restraints in resources but at the same time has the power of being able to find collective solutions that benefit the most people. For instance at our most recent conference of ADI, held in London, the closing debate was whether enough evidence now exists to mount a major public health initiative targeting improvements in healthy lifestyles for middle-aged adults....vs. an even broader public health initiative to improve the health and wellbeing, especially nutrition, of babies and pregnant women and through that route decrease the numbers of future adults with brain diseases. Meanwhile we are all gearing up to try to be ready to serve the millions of adults who already have Alzheimer's, who will develop it if we don't find a way to slow down the progression and delay the age of onset.

Alzheimer's Disease International's small but very competent staff (Mark Wortman is the CEO, based at the UK Alzheimer's offices in London) and with several groups of collaborative research groups who are keyed in on finding practical solutions to this world wide crisis we are all facing together.

One of these research groups is called "10-66" which receives both NIH and WHO funding to conduct important cross-cultural studies in the developing world to establish true and comparable prevalence/incidence rates of both Alzheimer's disease and Mild Cognitive Impairment, has conducted international clinical trials of caregiver interventions to determine usefulness and costs in a variety of different countries and financial settings, and is now looking at some broader public policy and public health issues. Their annual reports can be found on the ADI website:

In addition, there is a collaborative effort of several country based large research projects examining whether certain lifestyle interventions could help reduce the incidence and prevalence of Alzheimer's disease, or delay the age of initial symptoms. Each initiative has different founding sources and different specific research objectives and methods, but by combining and collaborating they hope to increase the robustness of their findings. One of the three studies is taking place in Finland, led by Miia Kivipelto with major funding from Finland's Health Department, and some additional funding from the U.S. Alzheimer's Association and perhaps other sources as well. I touch on that study in one of the two papers I have attached to this email.

Another perspective that was discussed at this last London meeting was, how best to proceed in planning CARE in the depressing scenario that we can't prevent most of the cases of Alzheimer's. What public policy is best. One that is disease specific, or that is based on disabilities, across diseases and health conditions. This was very interesting to me arising among a group of people who has fought hard for over 25 years to get their home countries to give proper recognition to Alzheimer's disease and other dementias, and to develop national plans. But once one has raised awareness, achieved sufficient specific research dollars and developed specific care programs, then one is freer to look at the broader public policy perspectives and see what is the best use of resources for a country, and what is most likely to be politicall feasible.

As you could gather from my resume, I stand ready to volunteer my time and attention to helping you in your efforts should you see a way I could be helpful.

In the meantime I applaud all the work you are doing and say THANK YOU. You all are fulfilling a dream I've held since the 1980's of a true national effort to combat Alzheimer's disease, both through research, public health and programmatic efforts at the local, state and federal levels.

ATTACHMENT #1:

Alzheimer's Disease & Lifestyle

Entry Citation:

Lombardo, N.B. Emerson. "Alzheimer's Disease." Encyclopedia of Lifestyle Medicine and Health. Ed. James M. Rippe, MD. Thousand Oaks, CA: SAGE, 2012. 120-42. SAGE Reference Online. Web. 29 Feb. 2012. 6000 words on-line accessed 2 29 2012

This entry (a) describes the evolving definition of Alzheimer's disease (AD) and its prevalence; (b) summarizes evidence for nutrition, physical exercise, and other healthy lifestyle interventions that may delay onset, prevent occurrence, or slow the progression of AD and other dementias and maintain the emotional and physical health of both the person with dementia and his or her care partners; (c) identifies key lifestyle strategies for preserving brain health--both cognitive and emotional--and how they may be related to body health strategies; and (d) highlights some clinical trial results and introduces a groundbreaking multi-domain study under way in Finland and the body of evidence leading to this seminal trial.

Readers may take away confirmation of the importance of some of the things they are already doing and gain ideas and motivation to adopt brain-healthy nutrition and lifestyles.

Prevalence

The World Alzheimer Report 2010: The Global Economic Impact of Dementia, published by Alzheimer's Disease International, reported that around 0.5% of the world's total population live with dementia, predominantly AD, and that the total estimated worldwide costs of dementia were US$604 billion in 2010, equivalent to around 1% of the world's gross domestic product. The Alzheimer's Association reports that there are nearly 15 million caregivers for Alzheimer's and dementia patients in the United States. AD is currently the sixth leading cause of death in the United States and the one growing most rapidly (by 50% from 2000 to 2007). The growth rate of this epidemic is expected to further accelerate with the aging of the baby boomer generation, increasing personal costs to families, which provide the bulk of care, and rapidly escalating economic costs from $172 billion today to more than $1 trillion by 2050. The U.S. National Alzheimer's Project Act was enacted into law in January 2011 to create a coordinated national strategy to address this national public health emergency with widespread social and economic consequences.

Definition of AD and Diagnostic Criteria

AD is the most common form of dementia, causing multiple impairments in thinking and cognition, including planning and organization (executive function), attention, short-term episodic memory (especially the recording of events and experiences), and sometimes visual-spatial function. The pathological hallmarks of AD are extracellular plaques composed of a protein called beta-amyloid (also called "A-beta") and the intracellular accumulations of neurofibrillary tangles, the insoluble paired helical filaments of an abnormally phosphorylated tau protein, and a cytoskeletal protein critical to the brain cell structure. Studies suggest that the soluble forms of A-beta, not the more visible plaques, are the toxic form. The normal function of A-beta is to kill microbes, as part of the innate immune system. It is the large amount of A-beta present in AD that is abnormal. Moreover, plaques and tangles appear to be late-stage developments and may or may not reflect the initiating biological sequelae, which may include injury, inflammation, disruptions of cell signaling pathways, oxidative stress, and disruptions in glucose and/or lipid metabolic processes.

New Criteria for Diagnosing and Redefining AD

National Institutes of Health/Alzheimer's Association working groups in 2010-2011 updated the criteria for diagnosing Alzheimer's dementia, added criteria for diagnosing mild cognitive impairment (MCI) due to underlying Alzheimer's pathology, and set the framework for identifying and testing biomarkers that in the near future could be used to diagnose "preclinical AD." Thus, the definition of AD has expanded beyond dementia and cognitive impairment to include a presymptomatic stage of the disease.

Biomarkers may improve the accuracy of diagnoses of both Alzheimer's dementia and MCI due to Alzheimer's pathology during life and serve as clinical trial end points. Prominent among the new biomarkers are neuroimaging (e.g., of A-beta levels, glucose processing, and the size and shape of brain structures) and measuring the presence of A-beta and tau in cerebrospinal fluid. These criteria will replace those established in 1984 as the "NINCDS-ADRDA" criteria. These criteria, developed by the National Institute of Neurological Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA), were universally adopted and have been in use, without modification, for more than 25 years. One of the challenges of prevention and treatment trials, both with preclinical AD and in MCI, is the inadequacy of cognitive tests to catch early changes reliably. The emergence of other outcome markers, namely brain imaging, and other biomarkers, is revolutionizing the field.

Scientists participating in the work groups formulating the new guidelines note that the updates were urgently needed for establishing the next generation of clinical trials for possible pharmaceutical and nonpharmaceutical interventions. In medical practice, the proposed changes represent refinements of existing criteria for the diagnosis of Alzheimer's dementia. The guidelines suggest, for example, that physicians recognize that complaints of loss of memory may not always be the first or most prominent presenting symptom. A decline in other aspects of cognition (e.g., word finding, vision/spatial issues, and impaired reasoning, judgment, and problem solving) may be the first presenting or the most prominent symptoms. Many research scientists in the field are concerned that current biomarker criteria give too much emphasis to A-beta and tau (especially A-beta) and too little to the role that oxidative stress, inflammation, vascular pathology, white matter, and other lesions or injuries may play in cognitive decline, in clinical symptoms of dementia, and in the development of abnormal levels of A-beta and tau. Ignoring a large body of evidence could hinder identifying proper treatments and preventive interventions, particularly lifestyle interventions. It is also important to guard against reductionist AD theories because what is now called "Alzheimer's disease" may be one or more multifactorial disorders and thus may require "multitherapies."

The evolving understanding of AD includes the recognition that individuals with a diagnoses of AD and MCI can still learn new information and acquire new habits, using a variety of preserved functions such as other forms of memory (e.g., visual, emotional, procedural). In addition, it is important to realize that while people with Alzheimer's may have lost many brain cells and synapses, they still retain many healthy brain cells, so it is important to work with them to maintain brain health in the hope of slowing progression, maintaining positive emotion, and improving quality of life.

Possible Causes or Etiology of AD as Related to Lifestyle

The exact causes and etiology of AD are still not fully known. As of 2011, there are still no methods of perfect diagnosis during life or ways to cure or completely prevent AD. Age remains the biggest risk factor for AD, with (lower) education levels the only other consistent risk factor across all ethnic groups. However, much has been learned in the past 30 years, lifestyles are at the heart of this new knowledge.

Research now recognizes AD as a complex chronic disease with many environmental and genetic factors, whose pathology may begin to accumulate 10 to 30 or more years before the appearance of noticeable clinical symptoms. With such a long prodromal stage, preventive interventions are needed that can be safely used for decades. While a few families have an autosomnal dominant form of AD, most individuals have what is called the "sporadic" form, without clear genetic patterns. The APOE4 type of allele confers a dose-related risk for persons of European origin but not typically for those of African origin. While other risk-conferring genes have been identified, most scientists have found that environmental factors are probably at least as important as genetic ones. Recognition of the importance of lifestyle flows directly from the multiple studies that have shown that brain and cognitive health is dramatically affected by the rest of the body, especially the cardiovascular, glucose metabolism, and cell energy systems.

Observational and prospective studies have confirmed this logical relationship and spawned numerous animal studies to explore the relationships between particular lifestyle factors, cognition, and the mechanisms of action. For instance, physical exercise as well as many nutrients and food substances with anti-oxidant or anti-inflammatory properties have proven to lower the amount of A-beta in animal models and also lower inflammation. Some nutrients also improve neuronal cell signaling, lipid metabolism, and glucose metabolism and/or decrease oxidative stress.

This sort of evidence, together with numerous observational studies with a variety of human populations in different countries, has established that appropriate nutrition and physical activity are good candidates for helping reduce the risk of dementia, cognitive decline, and AD in humans. In 2010, gold-standard randomized clinical trials for integrated evidence-based nutrition programs had not yet been undertaken, and those for various forms of exercise had just begun. These kinds of lifestyle interventions are very difficult to get funded and then carry out, so scientists cannot yet say with certainty that the various lifestyles indicated by an array of other studies will be sufficient to delay the onset of cognitive symptoms or slow progression. However, scientists have already proven with certainty the link between nutrition, physical exercise, and certain other lifestyle factors to prevent, slow, or even reverse other related chronic diseases such as stroke, other cardiovascular diseases, diabetes, and insulin resistance. Therefore, most researchers and clinicians are ready to recommend lifestyle approaches as these offer probable additional benefits to cognitive health. Lifestyle interventions are also of keen interest since, given the multiple decades of presymptomatic development of AD-related pathology, preventive interventions need to be safe and tolerable.

A growing body of research suggests that a variety of nutritional factors, social engagement, mental stimulation, physical exercise, complex activities incorporating multiple domains, and management of stress and depression all help preserve brain health. Managing both emotional and physical stress is important because heightened cortisol levels have been connected to cognitive decline as well as to faster rates of decline in persons with Alzheimer's dementia. Moreover, research reports an association between cortisol levels, hippocampal shrinkage, and insulin resistance. Adequate sleep is also essential for a healthy brain, neuroplasticity, and memory. Music, art, acupuncture, T'ai Chi, meditation, and certain other spiritual practices, as well as having a meaning and purpose in life, also appear to enhance brain health. Many of these lifestyle factors are related to neuronal plasticity and the generation of new brain cells as well as prevention of deterioration of existing brain cells.

Research indicates some common factors for both cognitive and emotional health. Intervention studies indicate the independent and synergistic efficacy of nutrition, cognitive rehabilitation, physical exercise, and various alternative medicine practices in improving cognition, mood, and quality of life of persons who already live with AD or other memory or brain disorders. The challenge is in actually making behavioral changes to adopt these protective lifestyles.

Why Lifestyle Factors Are Important to Brain Health

Epidemiological studies show that the prevalence of AD doubles every 5 years after the age of 65 (with 13% of individuals over the age of 65 having AD and about 40% over 85 years having AD). If lifestyle interventions can delay the onset of AD by 5 years, the prevalence of the disease would be halved, along with all the attendant human and financial costs.

Evidence suggests that healthy brain tissue is better able to withstand the ravages of age, genetic vulnerabilities, environmental stresses, accidents, toxins, and disease. Further, healthy lifestyles help enhance and strengthen neurons, dendrites, and other body and brain cells.

Many studies, including gold-standard clinical trials in the case of many other chronic diseases, have suggested that a healthy lifestyle, especially with regard to nutrition and exercise, may help prevent and treat most human chronic diseases. Thus, healthy lifestyles are helpful to both the person with dementia and his or her care partners, who are at extra risk of depression and illness because of caregiving.

Cardiovascular health and normal glucose metabolism contribute to brain health, while the rise in obesity and other chronic illnesses has a direct negative impact on brain health. Dozens of studies have established that each vascular risk factor adds to the risk for AD and severity of dementia.

Diabetes and prediabetes increase the risk of cognitive decline, MCI and dementia, and, according to some scientists, AD in particular. Studies using imaging techniques in adults and teenagers show that diabetes, prediabetes, or abnormally high insulin resistance as measured by glycosylated hemoglobin (HbA1c) shrinks the hippocampus, the major site for short-term memory and spatial memory, encoding of new information and experiences, as well as some aspects of emotional function. These findings should raise serious public health concerns because study results show that the hippocampi are already shrinking in obese teenagers with type 2 diabetes mellitus as well as in middle-aged nondiabetic adults with insulin resistance. Cognitive impairments in nondiabetic adults were found to be associated with the degree of insulin resistance. Related memory impairments and related white-matter changes were observed in adults with type 2 diabetes mellitus and brain-derived neurotropic factor (BDNF) levels were reduced in adults with insulin resistance.

Inflammation is believed to play a key role in the etiology of AD and has been associated with an increased risk of AD. Existing inflammation, as well as inflammatory events such as infections, surgery, or heart attacks, hastens progression in people with AD. Oxidative stress also plays a key role in AD etiology, including increasing inflammation and oxidation of brain lipids. In addition, mitochondrial dysfunction is part of AD etiology and relates to the energy systems within the brain cells.

In summary, whatever hurts the heart and blood vessels harms the brain. Problems with glucose metabolism and insulin levels also threaten the brain. The organ and disease silos are disintegrating, with increasingly similar clinical recommendations for better nutrition and exercise and for managing stress to treat or prevent a wide range of chronic diseases affecting nearly every organ in the body.

Recommended Lifestyle Approaches for Cognitive Health

Many leaders in the field of brain health believe that the evidence is already sufficient to suggest that regardless of personal risk factors, and with or without pharmacologic intervention, a healthful lifestyle is likely to reduce risk, delay onset, and slow the progression of AD and vascular dementia. Some of these researchers and clinicians conclude that the evidence suggests that it is the combination of vascular lesions (e.g., microstrokes or white-matter lesions) with Alzheimer's pathology that together result in symptoms of MCI and dementia. If these hypotheses are correct, then they offer another argument in favor of practicing healthy lifestyles to reduce cognitive decline.

Nutrition, physical exercise, and other lifestyle interventions work on multiple pathways to improve overall health in multiple organs with minimal or no side effects, even over many decades, which is important since scientists now believe that the pathology of AD--that is, the development of excess A-beta and abnormal phosphorylated tau--begins several decades before the appearance of cognitive symptoms.

Multiple lifestyle factors can have synergistic or additive effects. One of the most interesting trials involved the 2-year study of aged beagle dogs conducted by Carl Cotman's group at the University of California, Irvine, which showed that an enriched diet alone improved performance on a cognitive task from 25% in the control group to 67% of the experimental animals. A third group, with increased physical activity and social play, improved performance to 80%, while combining enriched diet and exercise-play interventions resulted in 100% of a fourth group of dogs being able to perform the difficult learning task.

Given the well-established connection between cardiovascular disease, insulin resistance, and diabetes and cognitive function and cognitive decline, and the evidence-based certainty that good nutrition, physical activity, and certain other lifestyle changes help treat or prevent these diseases, more and more people in the AD field have concluded that it is good clinical practice to recommend these healthy lifestyles to persons concerned about their brain health or who already have a diagnosis of MCI or dementia, including AD.

Multidomain Lifestyle Study Under Way in Finland

Many people in the field agree that the preventive intervention most likely to be effective will be multifaceted to be potent enough to delay the onset of AD or slow it down. There is one such multicenter randomized clinical trial under way in Finland, called the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) Trial, under the leadership of Miia Kivipelto and funded by the Finnish government, the U.S. National Institutes of Health, and the national Alzheimer's Association (clinicaltrials.gov/ct2/show/NCT01041989). Persons between 60 and 77 years of age who are determined to be at increased risk of cognitive decline and dementia are randomized to a control group (standard health counseling at baseline) or to a preventive intervention for 2 years. The latter receive multidisciplinary treatment that includes nutritional guidance, physical exercise, cognitive training and social activity, and intensive monitoring and management of metabolic (e.g., diabetes) and vascular risk factors. Importantly, each intervention includes a coach to guide and encourage the implementation of each lifestyle change. In addition to cognitive end points, a variety of potential biomarkers are monitored in relationship to any cognitive change, including biochemical markers of inflammation or oxidation, hormones controlling blood sugars and fats, as well as brain imaging.

Dr. Kivipelto's study reflects the combined wisdom of many leaders in the field, including the International Academy of Nutrition and Aging. The FINGER study builds on more than a decade of research, suggesting the importance of each domain of this combined program. The collective findings of some of these studies are summarized in the next section.

Selected Findings of Lifestyle Studies

Observational studies have established that each of the following lifestyle behaviors may be independently related to a lower risk of dementia: (a) nutrition, (b) physical fitness, (c) social activities and social engagement, (d) organization memberships, (e) productive (meaningful) activities, (f) mental activities (e.g., reading, word spelling/recognition, numbers, and other games), and (g) management of stress. Several researchers, using meta-analyses, have concluded that the most potent activities are complex activities that involve multiple domains, especially activities that include physical activity and social interaction as well as cognitive challenge, such as dancing and golf. Examples of activities involving 2 domains are board or card games, knitting, gardening, T'ai Chi, chi gong or yoga, and doing exercise in a group. Complex and novel activities such as learning a new language, especially sign language, traveling to new places, and playing a musical instrument, especially a new one, are also particularly recommended.

A 2010 Institute of Medicine Consensus conference and a Cochrane review of certain lifestyle interventions for preserving cognitive health concluded that there was insufficient evidence on which to base clinical recommendations. The Cochrane reviews and the Institute of Medicine, however, used very strict criteria for acceptable clinical trials, and for physical exercise, they reviewed only a few clinical trials of very small size or pilot in nature, which were underpowered. Both panels tended to be overly conservative and looking backward rather than forward in a brand new research field where rigorous clinical trials were just beginning to be designed, funded, and reviewed and where, logically, these interventions might have their biggest impact in the preclinical or MCI stage of AD, where outcome measures are still under development. Most reviews also do not integrate the combined weight of observational studies with clinical trials in animal models of AD, which are the first phase of testing some of the factors observed in human longitudinal studies and of researching mechanisms of action. Nutritional trials, especially those with integrated complex nutritional programs, are difficult to design and gain adherence to, and physical exercise programs to some extent suffer the same challenges. Published randomized controlled trials in the nutrition field as of 2011 were limited to single substances or small groups of vitamins.

Nonetheless the body of evidence is growing rapidly.

Nutrition

One well-structured prospective study published in 2010 found that persons with the highest levels of all 8 forms of vitamin E (tocopherols and tocotrienols) had half the risk of AD, whereas previous studies and intervention trials, less knowledgeable about the necessity of all forms of vitamin E in the brain and body, had looked at only a-tocopherol. This Karolinska Institutet (Sweden) study concluded that it was the combination of the 8 vitamin E forms that was important to brain health.

Various nutritional studies using animal models have shown the power of various single nutrients to lower A-beta levels, reduce oxidative stress, and improve cognitive function. Clinical trials of persons with MCI or AD have been few in number and show mixed results but some limited promise. A Swedish clinical trial of fish oil capsules using a daily dose of 1.7 mg of docosahexaenoic acid and 0.6 mg of eicosapentaenoic acid (2 long-chain omega-3 fatty acids abundant in the human brain) reported preliminary results suggesting a slowing of cognitive decline in persons with early-stage AD. A larger trial of just algae-derived docosahexaenoic acid had no effect across all AD patients. One study of 3 B vitamins (B6, B12, and folate) had no effect in persons with AD, but another using lower doses of the same 3 B vitamins improved cognition in people with MCI, but only in those with high homocysteine levels. These results suggest that while combination dietary programs may produce stronger effects on cognition than current pharmacological treatments for AD, single nutrients may be insufficient, and nutritional interventions may have more effect in MCI and very early-stage AD. Continued clinical research is needed.

Of greater interest for clinical study is combining multiple nutrients since the most recent observational studies have suggested that it is combinations of whole foods, such as in the Mediterranean or DASH (Dietary Approaches to Stop Hypertension) diets, that really make a difference. A 2006 integrative review presents evidence of how various nutrients appear to work on the multiple different pathways leading to AD and/or dementia, including inflammation, oxidative stress, glucose or insulin abnormalities, levels of A-beta and tau, cell signaling, and mitochondrial dysfunction. A recent animal study showed that a combination of whole foods-based nutrients, including vegetable, fruit, and herb and spice nutrients combined with fish oil, appears to restore mitochondrial dysfunction in triply transgenic AD mice, and a clinical trial is now under way in healthy older adults. A series of pilot studies with both mice and humans conducted by Thomas Shea and colleagues have shown preliminary success in improving short-term memory and attention in both cognitively normal adults and patients with AD, with a novel combination of vitamins and nutrients: namely, vitamin E, folic acid, vitamin B12, N-acetyl-l-cysteine, acetyl-l-carnitine hydrochloride, and S-adenosylmethionine. These preliminary studies suggest an important focus for continued studies in nutrition and brain health.

Physical Activity

Most of the meta-analyses of physical activity that had less strict criteria for study inclusion than the Cochrane reviews reported consistently positive results, backing up the observational studies that had linked physical activity to reduced incidence of AD and slower rates of conversion from MCI to AD dementia. An array of intervention studies in healthy older adults, people with MCI, and people with early AD, all found evidence of decrease in the rates of cognitive decline.

Animal studies have established that physical activity increases cognitive function and identified at least 2 newer mechanisms of action beyond the known cardiovascular mechanisms: (1) decrease in levels of A-beta in the brain and (2) increased amount and rates of neurogenesis, especially in the hippocampus. Human studies have established that people who exercise more have higher levels of hippocampal BDNF, a brain chemical related to neurogenesis. Increased serum BDNF levels have been correlated with larger hippocampi and better memory performance.

Kirk I. Erickson's randomized controlled study using magnetic resonance imaging as an outcome measure established that aerobic exercise (specifically 1 year of walking 3 times a week for 40 minutes) can increase the size of critical brain structures. Consistent with the expected 1% to 2% annual hippocampal loss in dementia-free seniors, the control group (which spent an equal amount of time stretching) lost about 1.4% volume in this brain region by the end of the 12-month trial. In contrast, the hippocampi of the walkers grew by roughly 2%. In addition, researchers found that greater elevations in serum BDNF were linked to greater gains in hippocampal volume.

The benefit of walking exercise seemed specific to the anterior part of the hippocampus (including the dentate gyrus). Similar effects did not appear in the thalamus, caudate nucleus, or posterior hippocampus. The dentate gyrus is the most metabolically active part of our brain and is involved in spatial memory, short-term memory, and new learning. Neurogenesis is most prominent in this part of the adult brain; many surmise that it is so because creation of new brain cells and dendritic connections is essential to the production of new memories.

Meditation and Spiritual Practices

Stress management and spiritual practices may also contribute to brain health. For example, a recent study using magnetic resonance imaging of the brain in live human participants reported that persons participating in an 8-week mindfulness meditation program experienced measurable increases in the hippocampus regions associated with memory, sense of self, and empathy while reducing areas of the amygdala associated with stress. Numerous studies demonstrate that other spiritual practices such as forgiveness improve emotional and mental health. By relieving stress and depression and decreasing cortisol levels, such practices may also improve cognitive health.

Cognitive Training, Cognitive Rehabilitation, and Cognitive-Kinetic Interventions

With regard to cognitive training and cognitive rehabilitation strategies to improve and preserve cognition, the evidence is particularly strong. Observational studies suggested that "use it or lose it" applies to keeping one's mind active. The groundbreaking ACTIVE randomized clinical trial study demonstrated that even short-term cognitive skills practice interventions had persistent effects in the healthy elderly. A number of later studies suggest that the most effective interventions combine modalities--for example, cognitive training with physical exercise and support groups.

Multifaceted Relationship Between Physical Activity and Cognition

In population and clinical studies, physical activity and exercise have been shown to have a positive effect on cognitive function in people of all ages. Recent studies have found that physical exercise stimulates a positive increase in executive control processes, including planning, scheduling, working memory, inhibitory processes, and multitasking. The impact of physical activity on cognitive abilities also continues through the entire lifespan. Physical exercise, for example, has been found to be a key facilitator in neurogenesis, particularly in the hippocampus as well as in other areas of the brain. In general, the rate of neurogenesis and other cognitive benefits is related to the intensity, novelty, and dose of physical activity and exercise. Both endurance (aerobic) and strength (resistance training) exercise benefit both cognitively intact and cognitively impaired individuals.

With regard to improvement in individuals with MCI and AD, substantial clinical trial evidence suggests that various cognitive rehabilitation and training strategies may help restore lost function and slow progression of cognitive decline. Different strategies appear to have more or less potent effects in only one area or in multiple areas. For example, a cognitive training strategy targeting episodic memory benefited only episodic memory. A more holistic strategy that combined physical movements based on kinetic/cognitive theory with cognitive training benefitted areas of attention, spatial abilities, language, memory executive functions, and daily functions. Arkin's pioneering study, initially published in 1999, found a combination of simultaneous physical exercise and conversation, and language practice and word games, interspersed with volunteer activity, particularly effective.

Barriers to Adopting Lifestyle Initiatives

There are several barriers to adopting lifestyle changes, including cultural and psychological barriers. Cultural challenges include the overdependence of the American health care system, and therefore of most individuals, on pharmaceuticals and surgery, which have limited preventive roles for many chronic diseases or could be more potent if combined with lifestyle changes. Perhaps the biggest challenge for implementing these interventions as standard clinical practice is financial. Generally, lifestyle interventions are not covered by most current health insurance plans, although the concept of health promotion and prevention of illness is starting to develop. For instance, because research has established that having a "coach" or personal trainer helps individuals make lasting lifestyle changes, some private insurers will supply a free "health coach" even if the actual interventions are not reimbursed.

To promote brain health, prescribed cognitive training and physical activity may be the modalities most likely to be recognized with some incentives. Nutrition for brain health promotion is not currently covered, although individuals with diagnoses may find some limited coverage for counseling with licensed nutritionists. For families working together to provide a healthier home environment for both a patient with brain disease and his or her care partners, one possible source of funding is the National Family Caregiver Support program, which can be accessed online at http://www.aoa.gov/prof/aoaprog/caregiver/caregiver.asp. Individuals who have long-term care policies also may be able to gain coverage for these services. The future major solutions lie in the realm of public health, public education, public policy, and research envisioned with the 2011 passage of the National Alzheimer's Project Act.

Further Readings

Alzheimer's Disease International. World Alzheimer Report 2010. http://preview.alz.org/documents/national/World_Alzheimer_Report_2010.pdf. Accessed July 8, 2011.

Arkin S Language-enriched exercise plus socialization slows cognitive decline in Alzheimer's patients. Am J Alzheimer's Dis Other Dement. 2007; vol. 22 no. (1): pp. 1-16.

Aronson MK Ooi WL Morgenstern H, et al. Women, myocardial infarction, and dementia in the very old. Neurology. 1990; vol. 40 no. (7): pp. 1102-1106.

Aton SJ Mechanisms of sleep-dependent consolidation of cortical plasticity. Neuron. 2009; vol. 61: pp. 454-466.

Ball K Berch DB Helmers KF, et al. Effects of cognitive training interventions with older adults a randomized controlled trial. JAMA. 2002; vol. 288 no. (18): pp. 2271-2281. doi:10.1001/jama.288.18.2271.

Bennett DA Schneider JA Wilson RS Bienias JL Arnold SE Neurofibrillary tangles mediate the association of amyloid load with clinical Alzheimer's disease and level of cognitive function. Arch Neurol. 2004; vol. 61: pp. 378-384.

Boyle PA Buchman AS Barnes LL Bennett DA Effect of a purpose in life on risk of incident Alzheimer disease and mild cognitive impairment in community-dwelling older persons. Arch Gen Psychiatry. 2010; vol. 67 no. (3): pp. 304-310.

Bruehl H Sweat V Hassenstab J Polyakov V Convit A Cognitive impairment in nondiabetic middle-aged and older adults is associated with insulin resistance. J Clin Exp Neuropsychol. 2010; vol. 32 no. (5): pp. 487-493.

Calon F Lim GP Yang F, et al. Docosahexaenoic acid protects from dendritic pathology in an AD mouse model. Neuron. 2004; vol. 43 no. (5): pp. 633-645.

Chan A Rogers E Shea TB Dietary deficiency in folate and vitamin E under conditions of oxidative stress increases phospho-tau levels: potentiation by APOE4 and alleviation by S-adenosylmethionine. J Alzheimers Dis. 2009; vol. 17 no. (3): pp. 483-487.

Chen H Chan DC Mitochondrial dynamics--fusion, fission, movement, and mitophagy-in neurodegenerative diseases. Hum Mol Genet. 2009; vol. 18: pp. R169-R176.

Clare L Woods RT Moniz-Cook ED Orrell M Spector A Cognitive rehabilitation and cognitive training for early-stage Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2003(4): pp. CD003260. doi:10.1002/14651858.CD003260.

Craft S Insulin resistance and Alzheimer's disease pathogenesis: potential mechanisms and implications for treatment. Curr Alzheimer Res. 2007; vol. 4 no. (2): pp. 147-152.

Csernansky JG Dong H Fagan AM, et al. Plasma cortisol and progression of dementia in subjects with Alzheimer-type dementia. Am J Psychiatry. 2006; vol. 163: pp. 2164-2169.

Emerson Lombardo NB Dresser MVB Malivert M, et al. Acupuncture as treatment for anxiety and depression in persons with dementia: results of a pilot feasibility and effectiveness study. Alzheimers Care Q. 2001; vol. 4 no. (2): pp. 28-41.

Emerson Lombardo NB Volicer L Auerbach SH Matson W Matson S Valla J Nutritional supplement combination therapy feasibility, safety and biomarker clinical trial in cognitively normal adults. J Nutr Health Aging. 2010; vol. 14 no. (9): pp. 800.

Emerson Lombardo NB Volicer L Martin A Wu B Zhang XW Memory preservation diet to reduce risk and slow progression of Alzheimer's disease. In: Vellas B, Grundman M, Feldman H, Fitten LJ, Winblad B, eds. Research and Practice in Alzheimer's Disease and Cognitive Decline ; 2006: pp. 138-159.

Erickson KI Voss MW Prakash RS, et al. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011; vol. 108 no. (7): pp. 3017-3022.

Glass CK Sijo K Winner B Marachetto MC Gage FH Mechanisms underlying inflammation in neurodegeneration. Cell. 2010; vol. 140: pp. 918-934.

Gu Y Luchsinger JA Stern Y Scarmeas N Mediterranean diet, inflammatory and metabolic biomarkers, and risk of Alzheimer's disease. J Alzheimers Dis. 2010; vol. 22 no. (2): pp. 483-492.

Herrup K Reimagining Alzheimer's disease: an age-based hypothesis. J Neurosci. 2010; vol. 30 no. (50): pp. 16762-16755.

Heyn PC Johnson KE Kramer AF Endurance and strength training outcomes on cognitively impaired and cognitively intact older adults: a meta-analysis. J Nutr Health Aging. 2008; vol. 12 no. (6): pp. 401-409.

Holmes C Cunningham C Zotova E, et al. Systemic inflammation and disease progression in Alzheimer disease. Neurology. 2009; vol. 73 no. (10): pp. 768-774.

Hölzel BK Carmody J Vangel M, et al. Mindfulness practice leads to increases in regional brain gray matter density. Psychiatry Res. 2011; vol. 191 no. (1): pp. 36-43. doi:10.1016/j.pscychresns.2010.08.006.

Igbal K Grundke-Igbal I Alzheimer's disease, a multifactorial disorder seeking multi-therapies. Alzheimers Dement. 2010; vol. 6 no. (5): pp. 420-424.

Karp A Paillard-Borg S Wang H-X Silverstein M Winblad B Fratiglioni L Mental, physical and social components in common leisure activities in old age in relation to dementia: findings from the Kungsholmen Project. Neurobiol Aging. 2004; vol. 25 no. (S2): pp. S313.

Khachaturian ZS Revised criteria for diagnosis of Alzheimer's disease: National Institute on Aging-Alzheimer's Association diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011; vol. 7 no. (3): pp. 253-256. doi: 10.1016/j.jalz.2011.04.003.

Kounti F Bakoglidou E Agogiatou C Emerson Lombardo NB Serper LL Tsolaki M RHEA, a non pharmacological cognitive training intervention in patients with mild cognitive impairment (MCI): A pilot study. Topics in Geriatric Rehabilitation. In Press.

Luchsinger JA Reitz C Honig LS Tang M-X Shea S Mayeux R Aggregation of vascular risk factors and risk of incident Alzheimer disease. Neurology. 2005; vol. 65: pp. 545-551.

Mangialasche F Kivipelto M Mecocci P, et al. High plasma levels of vitamin E forms and reduced Alzheimer's disease risk in advanced age. J Alzheimers Disease. 2010; vol. 20 no. (4): pp. 1029-1037. doi:10.3233/JAD-2010-091450.

Milgram NW Head E Zicker SC, et al. Learning ability in aged beagle dogs is preserved by behavioral enrichment and dietary fortification: a two-year longitudinal study. Neurobiol Aging. 2005; vol. 26: pp. 77-90.

Morris MC Evans DA Bienias JL, et al. Dietary intake of antioxidant nutrients and the risk of incident Alzheimer disease in a Biracial Community study. JAMA. 2002; vol. 283 no. (24): pp. 3230-3237.

Remington R Chan A Paskavitz J Shea TB Efficacy of a vitamin/nutriceutical formulation for moderate-stage to later-stage Alzheimer's disease: a placebo-controlled pilot study. Am J Alzheimers Dis Other Demen. 2009; vol. 24 no. (1): pp. 27-33.

Rovio S Spulber G Nieminen LJ, et al. The effect of midlife physical activity on structural brain changes in the elderly. Neurobiol Aging. 2010; vol. 31 no. (11): pp. 1927-1936.

Scarmeas N Luchsinger JA Schupf N, et al. Physical activity, diet, and risk of Alzheimer disease. JAMA. 2009; vol. 302 no. (6): pp. 627-637.

Smith AD Smith SM de Jageri CA, et al. Homocysteine-lowering by B vitamins slows the rate of accelerated brain atrophy in mild cognitive impairment: a randomized controlled trial. PLoS ONE. 2010; vol. 5 no. (9): pp. e12244. http://www.plosone.org. Accessed July 8, 2011.

Tsolaki M Kounti F Agogiatou C, et al. Effectiveness of non-pharmacological approaches in patients with mild cognitive impairment. Neurodegener Dis. 2011; vol. 8: pp. 138-145. doi:10.1159/000320575.

Vellas B Lauque S Ousset PJ Poor nutritional status is a risk factor for rapid loss of Mini Mental State Examination (MMSE) in Alzheimer's patients: results of the Elsa Study. J Nutr Health Aging. 2004; vol. 8 no. (5): pp. 424-426.

Verghese J Lipton RB Katz MJ, et al. Leisure activities and the risk of dementia in the elderly. N Engl J Med. 2003; vol. 348: pp. 2508-2516.

Wan CY Schlaug G Making music as a tool for promoting brain plasticity across the life span. The Neuroscientist. 2010; vol. 16 no. (5): pp. 566-577.

Entry Citation:

Lombardo, Nancy B. Emerson. "Alzheimer's Disease." Encyclopedia of Lifestyle Medicine and Health. Ed. James M. Rippe, MD. Thousand Oaks, CA: SAGE, 2012. 120-42. (2 Volumes 1296 total pages)

SAGE Reference Online. Web. 29 Feb. 2012.

ATTACHMENT #2:

4.2.0. Memory and Cognitive Impact of Foods

Research is proceeding rapidly on the connection between diet, including individual nutrients, on memory and other aspects of our thinking.

Most of the research to date has examined how foods relate to memory and cognition. This research has consisted of either animal studies of specific foods or nutrients, or of epidemiological studies of large groups of people (which can show an association, but not prove a direct cause). These studies have explored the relationship between aspects of what we eat and the likelihood or risk of developing general cognitive problems, mild cognitive impairment (including of the amnestic type i.e. involving memory problems), any kind of dementia (i.e. problems in thinking in multiple areas serious enough to cause problems in daily life or work) or specific diseases such as Alzheimer's disease.

The mechanisms of action (for how specific foods might help or hurt the brain) identified to date appear to vary, and in the case of many whole foods, multiple actions could be working simultaneously (See for example, Emerson Lombardo NB et al. 2006, Sun AY et al 2008. Tian J et al 2010, Howes and Perry 2011, Williams RJ, 2011). Some ways specific foods could enhance brain health include increasing the availability of the memory neurotransmitter acetylcholine in the brain (apple juice, sage, Melissa, saffron) (e.g. by directly increasing production, slowing its metabolic breakdown, similar to the action of the cholinesterase inhibitors currently on the market), anti-oxidant and/or anti-inflammatory action, regulating amount of various forms of Abeta peptides, slowing or preventing oligomerization or fibrilization of the Abeta molecule (Wang 2008, Frydman-Marom, A.,2011), protecting omega-3 fatty acids in brain cell membranes or fatty acids, regulating blood sugar and insulin, and/or cholesterol, estrogenic effects that can be neuro-protective, promoting creation of new brain cells or connective parts, or slowing their destruction, improving neuronal signaling and synapse activity, restoring mitochondrial function (related to energy) of brain cells, and retarding tau pathology (the "other" problem protein in AD) (Green 2007) . This list is only partial!

The number of human clinical trials is still small but growing.

The body of evidence suggests a clear connection between foods, overall diet and our brain health, including memory and other cognitive skills such as attention and executive function (ability to organize and plan), and is growing each year.

This website and our brain healthy newsletters will keep you informed of this growing body of evidence.

Here are some highlights:

Several studies using various mouse models of Alzheimer's disease demonstrated the positive effects of a wide variety of food substances chosen for their believed health benefits such as strong anti-oxidant properties. Each food type may be comprised of thousands of nutrients. Foods tested that improved cognitive behaviors and/or lowered Abeta levels in TG mice include: apple juice, blueberries, spinach, strawberries, green tea, melatonin, DHA, plum juice, Concord grape juice, resveratrol, grape seed extract and others (Chan A et al, 2006, Rogers EJ et al.2004, Joseph JA. Et al. 1999, 2009, Lee JW, et al 2009, Mandel SA et al. 2011, Calon, F et al, 2004 and Green et al, 2007, Shukitt-Hale B et al, 2009, Shukitt-Hale B et al 2006, Lagouge, M., et al, 2006, Wang et al., 2008). Both almonds and walnuts helped Alzheimer transgenic mice perform better in cognitive tests and lowered levels of A-beta (Chauhan N et al. 2004, Muthaiyah B, et al, 2011 - no published citation for almonds- see continued work by Neelima Chauhan, PhD, of the University of Illinois-Chicago, as reported in 2005 by Society for Neuroscience. http://www.sfn.org/index.aspx?pagename=news_111405). An unrelated Indian study in aged rats reported almond paste reversed scopolamine-induced amnesia, reduced cholinesterase activity in the brain, and also significantly reduced cholesterol and triglycerides in these aged rats (Kulkarni KS, et al. 2010).

Epidemiological studies have also identified a long list of brain healthy foods. More recently, innovative studies have begun to identify GROUPS of foods that appear to reduce risk of cognitive decline and onset of dementia, MCI or Alzheimer's disease, such as foods typical of the Mediterranean diet (Féart, C et al 2009, Gu Y, et al 2009, Scarmeas N et al., 2006, 2009a, 2009b, or the DASH (Dietary Approaches to Stop Hypertension) Diet (LINK http://dashdiet.org/dash_diet_book.asp?google&gclid=CMDj8qOMsq0CFUTc4Aodvz0FlQ ) (see unpublished study led by Heidi Wengreen, RD, PhD, Assistant Professor of Nutrition at Utah State University).

Combination supplement studies are also gaining interest. Professor Thomas Shea, Ph.D., Director of the Cellular Neurobiology and Neurodegeneration Research Centerat U Mass Lowell (http://www.uml.edu/research_labs/Cellular_Neurobiology/Staff.html ) is examining, first in mice and now in humans with and without memory impairments, a combination of certain B vitamins, amino acids and anti-oxidants, with some encouraging results. Another study led by Jon Valla in Arizona uses a combination of fruit and vegetable powers, anti-inflammatory spices and herbs, and fish oil, yielding some positive results in TG mice. A similar combination with the addition of vitamin D is currently undergoing a pilot Phase I clinical trial with healthy older adults at Boston University. Also, Nutricia, a subsidiary of the French Danone Company, is pursuing human clinical trials in both Europe and the US, of Souvenaid® (http://souvenaid.com/) a combination of neuron building substrates identified (and patented) by Dr. Richard Wurtman at MIT, together with anti-oxidant isolated vitamins (Kamphuis and Scheltens, 2010), featured at a company sponsored symposium at MIT (http://web.mit.edu/newsoffice/2010/fighting-alzheimers.html). The consumer needs to be aware of the differences between medical foods such as Souvenaid, and nutritional supplements such as "Great Mind, as the rules of evidence and FDA regulations are different. The Alzheimer's Forum engaged in an excellent discussion of this topic in 2009, http://www.alzforum.org/new/detail.asp?id=2258

A Swedish placebo-controlled clinical trial using fish oil containing both DHA and EPA reported that fish oil appeared to slow cognitive decline only in a few persons with early stage Alzheimer's disease. In persons with mid stage disease the main positive effect was to reverse weight loss, which can be a serious problem in some people (Freund-Levi Y. et al, 2006). A larger, more recent clinical trial of just DHA derived from algae, in persons with AD, reported no significant effect on cognition; however the trial neglected to include EPA, the more highly anti-inflammatory long chain Omega 3 which, in nature, usually occurs in conjunction with DHA and which humans typically consume (and synthesize) along with DHA. Since other AD research has established that AD has an inflammatory aspect to its etiology, we believe that EPA may prove to be as important as DHA in its treatment and prevention. Also, psychiatric and attention-deficit disorders research has established that EPA rather than DHA appears to be the active long chain Omega 3 in achieving the desired treatment effect. See for example Jazayeri S, 2008 (http://www.ncbi.nlm.nih.gov/pubmed/18247193 ) and work by Andew Stoll, MD (http://www.amazon.com/Omega-3-Connection-Groundbreaking-Anti-depression-Program/dp/0684871386) and Ned Hollowell, MD. (http://www.amazon.com/Delivered-Distraction-Getting-Attention-Disorder/dp/034544230X).

Cinnamon helps lower cholesterol and blood sugar, is a potent anti-oxidant (see ORAC chart...link) and is anti-inflammatory, and thus through these 4 pathways is thought to be positive for brain health. A January 2011 publication of an animal study (transgenic mice and flies) by a group of Israeli scientists suggests that cinnamon may also have a positive direct brain effect - cinnamon helps retard the development of Alzheimer's pathology by preventing the oligomerization ("clumping") of single Abeta molecules, leading to toxic forms that kill brain cells (Frydman-Marom A). To learn more, see our newsletter on the topic (Link to Cinnamon newsletter CHANGE THIS TO NEW WEBSITE POSITION http://healthcareinsights.net/home/newsletter-2011/august-2011-newsletter/). Grape seed extract also prevents or slows oligomerization and fibrilization.

A proof of concept RCT in 12 older adults with MCI found significant improvements in one test of memory (verbal learning) in the 6 randomized to drinking Concord Grape Juice for 12 weeks (Krikorian R et al 2010).

Three small pilot randomized controlled studies of three different spices/herbs in Alzheimer's patients, all led by the same medical researcher in Iran, all published in reputable peer-reviewed journals, suggested positive effects in slowing cognitive decline compared to placebo (sage and lemon balm, also known as melissa) or slowing at same rate as a current prescription drug, without the usual gastro-intestinal side effects (saffron). (See Akhondzadeh, S. et al. 2003a, 2003b, 2010)

Diets high in sugar and/or saturated fats appear to be harmful for the brain. A preclinical study in AD transgenic mice demonstrated that simply spiking water with 10% sugar (while offering same healthy mouse chow to two groups of identical, randomized mice) resulted in speedier cognitive decline of the mice drinking the sugared water, higher levels of Abeta in the brain, and abnormal cholesterol levels. Cao D et al. 2007, Suzanne Craft group's proof of concept randomized clinical trial in 50 older adults for just 1 month demonstrated that a high glycemic index, high saturated/high fat diet, compared to a low glycemic, low saturated fat/low fat diet, resulted in significantly worse cognitive performance (using a visual memory test), and undesirable changes in levels of Abeta in cerebral spinal fluid. (Bayer-Carter JL et al. 2011).

References:

Akhondzadeh S, Shafiee Sabet M, Harirchian MH, Togha M, Cheraghmakani H, et al. A 22-week, multicenter, randomized, double-blind controlled trial of Crocus sativus in the treatment of mild-to-moderate Alzheimer's disease. Psychopharmacology (Berl). 2010 Jan; 207(4):637-43. Epub 2009 Oct 20.

Akhondzadeh S, Noroozian M, Mohammadi M, Ohadinia S, Jamshidi AH, Khani M. Salvia officinalis extract in the treatment of patients with mild to moderate Alzheimer's disease: a double blind, randomized and placebo-controlled trial. J Clin Pharm Ther. 2003 Feb;28(1):53-9.

Akhondzadeh S, Noroozian M, Mohammadi M, Ohadinia S, Jamshidi A, and Khani M. Melissa officinalis extract in the treatment of patients with mild to moderate Alzheimer's disease: a double blind, randomized, placebo controlled trial J Neurol Neurosurg Psychiatry. 2003 Jul;74(7):863-6.

Bayer-Carter JL, Green PS, Montine TJ, VanFossen B, Baker LD, Craft S, Diet Intervention and Cerebrospinal Fluid Biomarkers in Amnestic Mild Cognitive Impairment Arch Neurol. 2011;68(6):743-752. doi:10.1001/archneurol.2011.125

Calon, F., Lim, G.P., Yang, F., Morihara, T., Teter, B., Ubeda, O., Rostaing, P., Triller, A., Salem, Jr., N., Ashe, K.H., Frautschy, S.A., Cole, G.M., 2004. Docosahexaenoic acid protects from dendritic pathology in an Alzheimer's disease mouse model. Neuron. 43, 633-645.

Cao D, Lu H, Lewis TL, Li L. Intake of sucrose-sweetened water induces insulin resistance and exacerbates memory deficits and amyloidosis in a transgenic mouse model of Alzheimer disease. J Biol Chem, (2007) 282(50):36275-82. Epub 2007 Oct 17.

Chan A. Graves V. Shea TB. Apple juice concentrate maintains acetylcholine levels following dietary compromise. J Alz. Dis. 2006 9 (3) :287-91.

Chauhan N, Wang KC, Wegiel J, Malik MN. Walnut extract inhibits the fibrillization of amyloid beta-protein, and also defibrillizes its preformed fibrils. Curr Alzheimer Res. 2004 Aug;1(3):183-8.

Emerson Lombardo, N.B., Volicer L., Martin A., Wu B., Zhang X.W., 2006. Memory preservation diet to reduce risk and slow progression of Alzheimer's disease, in Vellas, B., Grundman, M., Feldman, H., Fitten, L.J., Winblad, B. (Eds.), Research and Practice in Alzheimer's Disease and Cognitive Decline, vol 9, pp. 138-59.

Féart, C., Samieri, C., Barberger-Gateau, P., et al. Or Féart C, Samieri C, Rondeau V, Amieva H, Portet F, Dartigues JF, Scarmeas N, Barberger-Gateau P. Adherence to a Mediterranean diet, cognitive decline, and risk of dementia JAMA 2009;302(6):638-648.

Freund-Levi Y, Eriksdotter-Jonhagen M, Cederholm T, Basun H, Faxen-Irving G, Palmblad J.et al. Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer disease: OmegAD study: a randomized double-blind trial. Arch Neurol 2006 63(10): 1402-8.

Frydman-Marom A, Levin A, Farfara D, Benromano T, Scherzer-Attali R, Peled S, Vassar R, Segal D, Gazit E, Frenkel D, Ovadia M. Orally administrated cinnamon extract reduces ?-amyloid oligomerization and corrects cognitive impairment in Alzheimer's disease animal models. PLoS One. 2011 Jan 28;6(1):e16564

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V. Floyd  |  03-30-2012

My wish would be that all persons with Alzheimer's could have a safe haven. This would be a great benefit for all family members that have this disease in their lives. I hope we can get something past that will give them a safe haven.


 

B. Duke  |  03-30-2012

Attached please find comments from the Pennsylvania Department of Aging on the Draft National Plan to Address Alzheimer's Disease.

We are grateful for the opportunity to offer comments.

Pennsylvania is a state with an increasing population of older persons and is home to persons and families living with Alzheimer's Disease.

The Commonwealth is also home to leading researchers and providers of care across the continuum.

We look forward to opportunities to join in the dialogue and planning process.

Please let me know if we can offer any further information or clarification.

ATTACHMENT:

On behalf of the Pennsylvania Department of Aging, I am respectively submitting comments on the Draft National Plan (Plan) to Address Alzheimer's Disease. In general, I believe the Plan is well timed, comprehensive, and ambitious and our Department supports the Plan. Accomplishing the Plan goals will require collaboration with many different service systems, and the Department of Health & Human Services will likely face challenges in coordinating efforts across these systems.

While achieving the vision of eliminating Alzheimer's Disease (AD) by 2025 is the ultimate goal, the immediate need is appropriate care for those with AD and relief for caregivers. Further, research needs to be expanded into areas that are supportive to caregiving. The Plan should also address the issues and propose solutions of excess deficits that cause unneeded anguish to both the person with dementia and their formal and information caregivers.

Because of the scope and complexity of needs of those with dementia, I believe it is helpful to prioritize those areas of need. First and foremost, there is a wealth of knowledge that enables clinicians to diagnose and treat persons with memory disorders. However, the greatest need is gavubg adequately trained physicians to diagnose and provide care for dementia residents. This issue isn't new; it has been known for the past 10 years. With only 7,162 trained geriatricians in the country or one geriatrician for every 2,620 residents over 75 years of age, there isn't an adequate supply of geriatricians to provide geriatric educational needs among the US medical schools.

There is discussion in the draft plan about the need to expand and prioritize research aimed at developing new pharmacological interventions for preventing and treating Alzheimer's Disease. There is also some mention about reducing the use of antipsychotic medications for treating the symptoms of AD in institutional settings. Both of these action items are laudable. What is missing is a recommendation to reduce the current widespread, wasteful and in some cases harmful, overuse and misuse of the cholinesterase inhibitors and related combination therapies in treating AD. Practice guidelines for cost effective and efficacious pharmacological interventions in the treatment of AD are available but not widely adhered to.

In Pennsylvania, there discussions are currently being held about the Behavioral Risk Factors Surveillance System. Numbers of people are not now being identified; therefore a module asking respondents if someone in their home has dementia and the follow-ups would greatly help us identify the numbers outside of proper care, care-home settings, etc., that currently suffer dementias.

For your consideration, together with the above general recommendations, I respectively offer more specific comments. For example, although the Plan makes mention of emergency rooms, there needs to be "best practice" models that are shared with the thousands of hospital emergency rooms in the US. In addition, I propose these suggestions on specific goals, strategies, and actions:

Strategy 1.E: This priority deals with translating findings into medical practice and public health programs. There should be a separate action item that addresses the shortcomings in the current pharmacological treatment of AD and guidance to prescribers on how to remedy this problem.

Action 1.A.1: This priority is not just important, it is essential if we expect to slow progress, delay onset and prevent AD. It needs to be a collaborative effort that is international in scope (Strategy 1.D) with high level commitment and energy that includes public and private resources and their networks interconnected. Money for research alone will not achieve what is needed. We need to look at past models of disease threats like tuberculosis, polio and HIV that had a grass roots demand for a cure.

Action 1.B.3: This is also essential; we need some fast "wins" through medical research that energize the world-wide community committed to eliminating dementia illnesses. And, in addition to expanding the enrollment of all racial and ethnic populations, we need to have several drug investigations on an urgent fast-track that not only give people hope but the belief that we are doing everything possible to get these issues under control.

Action 1.E.3: ADEAR (Alzheimer's Disease Education and Referral) needs to be a more widespread publically funded resource; there needs to be, for example, posters advertising it in post offices, libraries, and other public spaces.

Goal 2: The lack of adequately trained providers is addressed by dedicating "6 million dollars over two years for provider education and outreach." This is a limited amount of money to fix the national issue of solving the access to care issue with competent geriatricians. Further, there needs to be expanded roles for Advance Practice Registered Nurses in geriatric care.

Strategy 2.A: This strategy has a direct connection to PDA programs. PDA has done some work through the Long-Term Living Training Institute and Direct-Care Worker initiatives around educating and strengthening the direct care workforce to ensure workers are dementia-capable. PDA would welcome additional support in this area.

Action 2.A.4: PDA supports this action and sees the need for additional resources to train more direct workers in nursing homes and professionals that provide services in home and community based settings. PDA has provided funding to the Delaware Valley Alzheimer's Association to provide dementia specific training to those professionals that provide in-home care. The training is designed to improve care techniques that can be directly applied to day-to-day care in the home which can reduce the stress and burden on both professionals and family caregivers.

Strategies 2.C and 3.B: Contained in Pennsylvania's assessment for services for older adults is a 24-question assessment of caregiver status and needs. PDA would be interested to learn what other states are using and their best practices in terms of caregiver assessment instruments.

Action 2.H: PDA supports this action and sees the need for additional resources to improve care for certain populations, specifically those with intellectual disabilities. PDA currently co-chairs the Joint Committee on Aging & Intellectual Disabilities (ID) with the Office of Developmental Programs. The committee was formed to improve services and supports available to older persons with ID by working together through interagency coordination and collaboration. As the number of people aging with ID continues to grow, education for both professionals and caregivers along with proper supports should be a focus and be given special consideration to ensure the proper care for this population.

Strategy 3.E: PDA supports this action and sees a great need for increased housing options for individuals with AD. Affordable, safe housing is a special problem during the early to middle stages of the disease for individuals who live alone and do not have informal caregivers to provide support.

Strategies 4.A and 4.B: Public awareness campaigns and pooling/compiling resources should be organized around a single, nationally recognized association/entity related to Alzheimer's disease.

In conclusion, some components of the Plan have a direct connection to PDA programs, such as support of caregivers and enhancing the knowledge of direct care workers. Other components of the Plan such as methods for diagnosis, direct treatment, and research, do not have a direct connection to our programs. However, as I stated above, our Department supports the Plan and, while recognizing that there is no one quick, easy solution to dealing with such wide, complex needs, I feel my comments and suggestions are important for improving the Plan and thereby improving the lives of those with Alzheimer's Disease and their families and caregivers.

I thank you for the opportunity to provide input and look forward to hearing from you regarding my comments.


 

C. DeMatteis  |  03-30-2012

Please accept this comment letter on behalf of the Partnership to Fight Chronic Disease.

ATTACHMENT:

Congratulations on the development of a thorough and thoughtful draft of the National Plan to Address Alzheimer's Disease (National Plan). The Partnership to Fight Chronic Disease appreciates the opportunity to comment on the draft and looks forward to seeing the final plan implemented. PFCD is a national coalition of patients, providers, community organizations, business and labor groups, and health policy experts committed to raising awareness of the number one cause of death, disability, and rising health care costs in the U.S.: chronic disease.

Alzheimer's Disease and related dementias (AD) presents a public health crisis in every sense and as such requires an unprecedented collaborative effort to address it effectively. A robust National Plan and the resources needed to implement it are required to assure we achieve, as the National Plan states, a "nation free of Alzheimer's Disease." To help support these efforts, we offer the following comments on the draft National Plan:

Expanding Research to Prevent and Effectively Treat Alzheimer's Disease by 2025

The National Plan includes a solid framework for enhancing research efforts to find ways to prevent and better treat AD. In discussions over research priorities for AD, we encourage consideration of ways to improve care management, care coordination, long-term care, and other aspects of the delivery of care for people with AD in addition to traditional clinical research efforts. For example, programs funded by the Centers for Medicare and Medicaid Innovation and similar demonstration efforts targeting delivery system reforms should include consideration of patient-centered care models for people with AD and ways to enhance coordination between inpatient and outpatient medical care, community-based services, and long-term care, including managing transitions of care between providers and care settings. The National Plan should specifically recommend inclusion of delivery system research on the national research agenda.

Given the rapid pace of scientific research and knowledge gained, tapping into the expertise from both the public and private sector on a regular, ongoing basis will be critically important to making significant progress by 2025. We applaud the National Plan's call for greater collaboration through Public-Private Partnerships as effective partnerships will play critically important roles in realizing progress in the prevention and treatment of AD, and urge that the final Plan include specific plans to engage public and private stakeholders on an ongoing, regular basis to further develop and implement the plan.

Public-private partnership efforts could prove particularly useful in the development, implementation, and updating of the national research agenda; clinical trial recruitment and development of patient registries; and the development of biomarkers for AD diagnosis and monitoring progression and developing clinical trial endpoints. Public-private partnerships can also enhance regulatory science efforts and informed review processes for potential new treatments by assuring that regulators and other decision-makers are up-to-date on the latest scientific understanding, research challenges, and progress made on AD. These partnerships also offer the opportunity to develop consensus-based best practice recommendations for every setting where people with AD are served to increase quality and efficiency. We recommend that the final National Plan specifically encourage greater public-private collaboration in these critical areas and regularly engage a wide variety of stakeholders including medical, clinical, and public health professionals, patients and family caregivers, community organizations, the biomedical research industry, public and private payors, long-term care providers, and employers.

We also commend the inclusion of efforts to facilitate the translation of research findings into medical practice and public health programs and to educate the public about the latest research findings. We recommend that the National Plan include recommendations that information be presented in ways and through vehicles that are both understandable and actionable to providers, public health professionals, payors, and the public.

Supporting Family and Friend Caregivers

We commend the National Plan for recognizing the tremendous burden AD places on family and friend caregivers and the need to do more to support them, including educating healthcare providers on the need to evaluate caregivers for signs that their own health is at risk. Providers' ability to do that effectively, however, depends upon them being able to identify family and friend caregivers. Encouraging providers to document on medical records that a person is a family caregiver for someone with AD or another chronic condition would assist that outreach greatly. Likewise, the ability to facilitate better coordination of care, including care occurring outside medical facilities, would be enhanced if providers noted the name of the primary caregiver(s) on the AD patient's medical record. We recommend that the final National Plan include outreach to providers to incorporate such documentation into the medical records for both family caregivers and the people to whom they provide care.

Early detection and diagnosis of AD will help significantly with care planning and aligning support for the person diagnosed and his or her family. An additional step in early detection should be engaging the person with AD and family caregiver in advance care planning, so that the person with AD can have substantive input while they have the capacity to do so. We encourage the inclusion of this step in your recommendations. The National Plan includes efforts to educate providers, caregivers, and attorneys on AD, disease progression, and the costs associated with care. We suggest that educational efforts also include financial advisors, as the costs of care and long-term nature of the disease necessitate careful financial planning.

Assure Adequate Funding to Realize the Promise of the National Plan

An excellent National Plan is only a set of great ideas without the funding to make them a reality. The Administration's recent announcement of additional funding for AD research and support for people with AD and their families represents a good start, but much more will be needed to implement the National Plan. One near-term opportunity is assuring better coordination of clinical care with community resources at the state and local level. States and communities should be supported to facilitate this coordination to streamline access to essential services for families and increase the efficiency of the systems at the state and local level. Many states are actively engaging public health resources to address the burden of AD. The National Plan should build on these efforts and those at the Centers for Disease Control to fully engage public health resources to evaluate the AD burden and work to address it. This suggestion is in concert with existing policy such as the Strategic Framework on Multiple Chronic Conditions.

When evaluating the need to devote resources to implementing the National Plan, we urge the Administration and congressional appropriators to consider the significant budgetary toll AD exacts. According to the Alzheimer's Association, AD will cost the United States more than $200 Billion in 2012 with the trajectory increasing to more than $307 Billion in just 15 years and almost $1.1 Trillion by 2050. In times of tight budgets, we understand that finding the resources to implement the National Plan will be increasingly difficult, but given the tremendous toll AD takes not only on those afflicted and their families, but also state and federal budgets, these are investments we simply must make.

We applaud your efforts in the development of a National Plan to Address Alzheimer's Disease. The draft represents a well-considered, comprehensive approach. We appreciate the opportunity to review and comment on the draft Plan, and look forward to starting the hard work of implementing the final Plan to make a significant difference.


 

C. Connolly  |  03-30-2012

Thank you for the opportunity to provide comments on the Draft National Plan to Address Alzheimer's Disease. We appreciate the work of the Advisory Council and the recognition of the need for a well-trained workforce.

If you have any questions, please do not hesitate to contact me.

ATTACHMENT:

On behalf of the Eldercare Workforce Alliance, a coalition of 29 national organizations committed to addressing the immediate and future workforce crisis in caring for an aging America, we thank you and the Advisory Council on Alzheimer's Research, Care, and Services for your work to forumulate the Draft National Plan to Address Alzheimer's Disease.

We commend the Council for its recognition of the vital importance of a strong workforce for realizing the goals of the Plan, as demonstrated in strategies 2.A and 2.C, which call for the building of a workforce with the skills to provide high-quality care, as well as the strategies under Goal 3, in support of family caregivers.

While the action items located under Strategy 2.A are significant, we remain concerned that the essential workforce goals identified by the Council cannot be realized without the investment of additional resources. Specifically, the action items calls for additional and enhanced activities within Geriatric Education Centers (GEC), the Comprehensive Geriatric Education Program (CGEP), the Geriatric Academic Career Awards Program (GACA), the Geriatric Training for Physicians, Dentists, and Behavioral and mental Health Providers (GTPD) program, and the Direct-Care Workforce training program. These programs, which are administered through the Health Resources and Services Administration (HRSA) under the Title VII and VIII of the Public Health Service Act, are in constant danger of defunding and have experienced stagnant funding that has not kept up with the pace of inflation, even as the need for preparation to care for older adults has skyrocketed. To implement these additional and enhanced activities in order to realize the goal of enhancing care quality and efficiency for the growing number of older adults with Alzheimer's disease and other multiple chronic conditions additional funding must be invested.

We believe that access to quality health care for older adults with cognitive impairment is vital to healthy aging and we commend you for your efforts. As the work of the committee continues, we welcome opportunities to work with you.


 

J. Hitchon  |  03-30-2012

Attached please find comments from the American Occupational Therapy Association (AOTA) in response to the US Department of Health and Human Services ' Draft National Plan to address Alzheimer's Disease pursuant to the National Alzheimer's Project Act (NAPA). Should you have any questions or need additional documentation, please do not hesitate to contact me.

ATTACHMENT:

The American Occupational Therapy Association (AOTA) is the national professional association representing the interests of more than 140,000 occupational therapists, students of occupational therapy, and therapy assistants. The practice of occupational therapy is sciencedriven, evidence-based, and enables people of all ages to live life to its fullest by promoting health and minimizing the functional effects of illness, injury, and disability. Occupational therapy practitioners do important work with individuals who have Alzheimer's disease (AD) and their families, and AOTA appreciates the opportunity to provide comments to the Department of Health and Human Services (HHS) as it works to implement the National Alzheimer's Project Act (NAPA).

Occupational Therapy and Alzheimer's Disease

Five goals form the foundation of the Draft National Plan: (1) Prevent and effectively treat AD by 2025, (2) Optimize care quality and efficiency, (3) Expand supports for people with AD and their families, (4) enhance public awareness and engagement, and (5) track progress and drive improvement. AOTA sees the profession of occupational therapy as a key partner in each of these five areas. Occupational therapists and occupational therapy assistants work with individuals who have AD and with their families to maximize occupational engagement, promote safety, and enhance quality of life. A variety of skilled techniques are used when working with an individual who has AD, depending on the focus of the intervention, the stage of the disease process, and the treatment setting.

An occupational therapist's evaluation of a person with AD begins with an occupational profile of the individual's valued occupations, roles and routines, as well as his or her current level of occupational performance. Often the caregiver is crucial in supplying this information as the person with AD may be unable to provide accurate information, or may be unaware of his or her own deficits. It is essential to identify the remaining abilities of the person with AD rather than to focus solely on what he or she can no longer do. Some examples include:

  • Identifying performance patterns (i.e., habits and routines) that can be maintained which will prolong independence and assist with adjustment to new living settings such as a health care facility or a daughter's home. Practitioners also consider information stored in the patient's procedural memory, which often remains stable for the longest period of time in someone with AD. Performing well-learned basic activities of daily living (ADLs), such as combing one's hair, is an example of utilizing procedural memory. Practitioners learn what the client's hobbies and occupations are which will help with planning the intervention to stimulate patient interest and active participation.
  • Determining what type of cueing strategies the individual best responds to, and instructing staff on how and when to utilize these strategies during various activity demands. (E.g., does the patient require a one-step verbal command or does he or she need tactile cueing in addition to verbal cues? Can the client follow multi-step commands?)
  • Determining the time of the day that the person is most alert to maximize performance with activities. (E.g., if the client's typical routine pre-illness was working at night and sleeping during the daytime, then changing that routine may be challenging. The optimal time for engagement in activity may be late afternoons.)

Other areas of consideration include accompanying conditions such as visual loss, or hearing loss. Education of the caregiver (e.g., family or facility staff or both) is a priority and expertise of occupational therapy practitioners, and the therapist should include identification of caregiver concerns about occupational performance and handling difficult behaviors as part of the evaluation. See attachments 1 and 2.

For a person in the early stage of AD, occupational therapy intervention may focus more on compensation for the loss of cognitive abilities and recognition of remaining abilities rather than on the remediation of deficit areas. This is helpful since new learning may be impaired or absent as the dementia progresses.

For persons in the later stages of the disease, the intervention focus may become adaptation of the environment and instruction of caregivers to promote continued occupational performance, as well as learning ways to minimize any unwanted behaviors (such as agitation, combativeness during caretaking) or complicating conditions (such as weight loss, or falls). Addressing the safety of the person with AD is paramount.

The ultimate goal of occupational therapy intervention for someone with AD is to set up a program to promote independence, participation in the community, utilize retained abilities for as long as possible, ensure safety, and enhance quality of life.

Goal 1: Prevent and Effectively Treat AD by 2025

In the absence of a cure, this goal seeks to develop effective prevention and treatment modalities by 2025. Toward this end, HHS proposes to convene an AD research summit with national and international scientists (Action 1.A.1) and convene a scientific workshop on other dementias in 2013 (Action 1.A.4). AOTA asks that you include occupational therapy in these events. HHS also plans to solicit public and private input on AD research priorities (Action 1.A.2) and continue clinical trials on the most promising lifestyle interventions (Action 1.B.6). In these areas, AOTA asks HHS not to neglect research on effective treatment, education, and support for caregivers and to study lifestyle interventions for caregivers

Outreach efforts to more effectively inform the public about research findings and results are also planned, and AOTA reminds the department to take advantage of using professional associations to educate members and providers (Action 1.E.3).

Goal 2: Optimize Care Quality and Efficiency

HHS recognizes that high-quality care for people with AD requires an adequate supply of qualified, culturally-competent professionals with appropriate skills and expertise. AOTA notes that the Draft Plan places the bulk of its emphasis on physician providers, when patients will be seeing many other allied health care professionals in the new health care system. It is the nonphysician practitioners, such as occupational therapists, who provide most of the support for patients with AD and certainly their caregivers. The $6 million dollar investment of the Obama Administration for provider education and outreach should include specialized training for occupational therapy, and other efforts by both the Veteran's Administration (VA) and Health Resources and Services Administration (HRSA) should include support not only for physicians and nurses, but other qualified and licensed professionals (Strategy 2.A.2).

As far as dementia-specific work (Action 2.A.3; 2.D.1), occupational therapy has a proven track record in caring for patients with dementia and is working with the American Medical Association (AMA) --convened Physician's Consortium for Performance Improvement (PCPI) to develop and manage quality measures for dementia. See Gitlin, L. N., Winter, L., Dennis, M. P., Hodgson, N., & Hauck, W. W. (2010). A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers. Journal of the American Medical Association 30(9), 983--991; Strzalecki, M. (2010). The dementia care difference. OT Practice 15(12), available: http://www.aota.org/Pubs/OTP/2010/OTP071210.aspx.

In examining improved care transitions through Medicare's Community-Based Care Transitions Program and the Aging and Disabilities Resource Center (ADRC) Evidence-Based Care Transitions Program (Action 2.F.2), AOTA reminds decision-makers that occupational therapy has an established role in discharge planning, home evaluation, safety, and caregiving training that is an asset in these areas.

Goal 3: Expand Supports for People with AD and their Families

This third goal acknowledges the important role that caregivers plan in the life of a person with AD: they provide care and support, help lessen feelings of depression and stress, and help delay nursing home placements. To further support caregivers, HHS plans to partners with private organizations to review the state of the art of evidence-based interventions that can be delivered by community-based organizations (Action 3.B.3). Occupational therapy should be part of these private-public partnerships.

HHS has also noted that medications, including anti-psychotic drugs, can be used inappropriately to manage the difficult behaviors of nursing home residents who have AD. Occupational therapy practitioners would like to be part of collaborative efforts to reduce inappropriate and off-label use of behavior modifying drugs and agents. AOTA encourages the use of occupational therapy interventions to address inappropriate behaviors without the use of pharmaceuticals.

Goal 4: Enhance Public Awareness and Engagement

In order to further its goal of enhancing public understanding of AD and engagement stakeholders who can help address the challenges faced by persons with the disease and their families, HHS plans, in part, to work with state and local governments to improve coordination and identify model initiatives to advance AD awareness and readiness (Strategy 4.B). AOTA applauds plans to involve state and local governmental entities to further the National Plan, but we wish to note the importance of involving professional associations at the state level in these efforts.

Goal 5: Track Progress and Drive Improvement

Finally, HHS plans to identify the gaps in existing data and pursue roads to expand and enhance the data infrastructure in this field and to make data more easily accessible to federal agencies and researchers (Strategy 5.A). Occupational therapy practitioners are also cognizant of information gaps related to the study of AD, and will be interested to access and utilize any improvements HHS is able to make, particular in the area of new quality measures, participating in new data collection efforts, or more easily viewing improved data sets or links between data sets.

Conclusion

AOTA looks forward to working with HHS to implement NAPA. AOTA's Occupational Therapy Practice Guidelines for Alzheimer's Disease are en route via U.S. mail, and additional materials about occupational therapy contributions to the field are available upon request; please do not hesitate to contact us with questions.

Attachments:

  1. AOTA Tips for Living Life to Its Fullest: Living with Alzheimer's Disease [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-aota-tips-living-life-its-fullest]
  2. AOTA: Caring for the Adult Caregiver [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-caring-adult-caregiver]

 

C. Adamec  |  03-30-2012

Thank you for the opportunity to comment on the Draft National Plan to Address Alzheimer's Disease. The comments of the Alzheimer's Association are attached.

If you wish to discuss this or any other Alzheimer's issue, please feel free to reach out to Rachel Conant, Alzheimer's Association Director of Federal Affairs.

ATTACHMENT:

Alzheimer's Association comments on the Draft National Plan to Address Alzheimer's Disease

Thank you for the opportunity to comment on the U.S. Department of Health and Human Services (HHS) Draft National Plan to Address Alzheimer's Disease. The Alzheimer's Association is committed to ensuring that the full potential of the National Alzheimer's Project Act (P.L. 111-375) is realized, and we stand ready to support the successful implementation of the law. Founded in 1980, the Alzheimer's Association is the world's leading voluntary health organization in Alzheimer's care, support and research. Our mission is to eliminate Alzheimer's disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health.

Today, there are an estimated 5.4 million Americans living with Alzheimer's disease and 15.2 million unpaid caregivers. Alzheimer's is the 6th leading cause of death and the only cause of death among the top 10 in America without a way to prevent, cure, or even slow its progression. Currently, there are no survivors. Alzheimer's kills more Americans than diabetes, and more than breast cancer and prostate cancer combined. Individuals with Alzheimer's and other dementias are high consumers of hospital, nursing home, and long-term care services. Average per person Medicare costs for those living with Alzheimer's and other dementias are nearly three times higher and Medicaid spending is 19 times higher than for those without these conditions. Care for those living with Alzheimer's and other dementias is estimated to cost Medicare and Medicaid $140 billion this year alone. 1

Alzheimer's cannot wait. Individuals living with this devastating disease and their families cannot wait. Strengthening the financial underpinnings of Medicare and Medicaid cannot wait. We are at a critical moment. Barring the development of medical breakthroughs to prevent or treat the disease, Alzheimer's impact on our country will grow year by year. By 2050, as many as 16 million Americans will have the disease, and the escalating cost of care will reach $1.1 trillion annually (in today's dollars). Costs to Medicare and Medicaid are estimated to increase nearly 500 percent over this period.

However, this does not need to be our future. If the federal government makes a meaningful commitment to finding a treatment and cure through the National Alzheimer's Plan, the long-term payoff will be substantial. For example, a treatment that delayed onset of the disease by five years (similar to the effect of anti-cholesterol drugs on preventing heart disease) would cut government spending on caring for those with Alzheimer's by nearly half in 2050.2 Similarly, profound advances can be achieved through improvements to Alzheimer's care quality and effectiveness and through improved supports for individuals with Alzheimer's and their families. The challenge and the potential promise of the National Alzheimer's Plan is our opportunity to change the trajectory of this heartbreaking disease.

The Alzheimer's Association is pleased the important strengths contained within the Draft Framework were preserved in this initial draft of the National Alzheimer's Plan. As was the case with the Framework, this first draft is comprehensive in scope, addressing many of the issues that are critically important to the Alzheimer's community. We do see key opportunities to further strengthen this draft plan prior to its next iteration. The Association's comments address specific areas to fortify; for instance, palliative care and transportation issues, which are particularly important for the one in seven Americans with Alzheimer's who live alone.3

In addition to the specific comments that follow, the Alzheimer's Association would like to emphasize several broader themes.

Research:
The Alzheimer's Association strongly urges that the National Alzheimer's Plan build on the momentum of the Administration's recent, commendable action on Alzheimer's research funding by indicating in the plan the full scale and scope of research funding required to achieve the Administration's goal of preventing and effectively treating Alzheimer's disease by 2025. To this end, we believe recent work by leading Alzheimer's researchers to be available in April 2012 will provide a very solid foundation for these projections.4 As we previously noted in our comments submitted for the Draft Framework, we believe that the firm deadline of 2025 is bold and transformative. While intermediary milestones are needed, the Department is to be commended for including a clear, accountable goal for the availability of urgently-needed treatment advances.

Economic burden:
The bipartisan, unanimously passed National Alzheimer's Project Act calls for the identification of priority actions to reduce the economic impact of Alzheimer's disease on the Medicare and Medicaid programs, as well as on American families, while improving health outcomes. In addition to the estimated $140 billion in Medicare and Medicaid costs this year, families caring for people with this heartbreaking disease will still incur high out-of-pocket costs for care -- an estimated $33.8 billion in 2012. Given the high costs of adult day centers, assisted living facilities and nursing home care, and the duration of the disease, individuals affected by Alzheimer's will often deplete their savings and assets, and ultimately come to rely on Medicaid for assistance. Though the theme of better health outcomes is present in several places in this draft, the attention to addressing the economic burden is, in our judgment, insufficient. The distinct financial burdens of Alzheimer's disease were a pervasive theme among the more than 40,000 Americans who participated in the Alzheimer's Association public input process on the National Alzheimer's Plan last year. We urge this be directly addressed in the next draft.

Public health:
While we applaud the draft plan's emphasis on strengthening the Aging Network to deal with the burden of Alzheimer's disease, it does little to frame Alzheimer's as a top national public health challenge and to engage the full resources of the public health community at the federal, state and local levels. In this regard, the draft can draw from an important and encouraging trend in leading states where the public health network has been actively evaluating the burden of Alzheimer's. It also can draw from important work developed by the Centers for Disease Control and Prevention (CDC) assessing the public health dimensions of Alzheimer's. The Alzheimer's Association strongly believes public health surveillance and comprehensive data collection are crucial to understanding the burden of the disease and assessing ways to reduce its impact. Complementing the strong emphasis on the Aging Network by highly engaging the CDC in the National Alzheimer's Plan will ensure Alzheimer's is addressed as a public health priority.

Accountability:
It would be difficult to overstate just how critical we believe Strategy 5B, "Monitor Progress on the National Plan," is to securing important outcomes in the first year of the plan's implementation. We urge this monitoring be done in a timely, transparent way to ensure accountability for both the implementation of action steps and the meaningfulness of this activity. This is important for several reasons. First, this transparency is a clear expectation of Congress as expressed in and embedded throughout the statute (P.L. 111-375). Second, this is necessary for the Advisory Council if the Council is to fulfill its obligation under the law to meaningfully report directly to Congress and to the Secretary of Health and Human Services on an annual basis. Finally, it is a fundamental expectation of the Alzheimer's community. Accountability is a precondition for the successful pursuit of all that follows throughout the plan.

Specific Comments
The following are specific comments on the various proposed goals and actions as outlined in the Draft National Plan to Address Alzheimer's Disease.

Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025
As previously stated, establishing a firm deadline of 2025 is bold and transformative. However, research funds must increase to the Alzheimer's research community's recommendation of $2 billion in order to achieve this goal.

Action 1.A.1: Convene an Alzheimer's disease research summit with national and international scientists to identify priorities, milestones, and a timeline.
The Alzheimer's Association believes it is good to set and update priorities by garnering outside input. We also believe in addition to the National Institute on Aging (NIA), all Institutes and Centers of the National Institutes of Health (NIH) that are funding Alzheimer's research should be an integral part of this planning process, including the National Center for Advancing Translational Sciences (NCATS) and the National Institute of Neurological Disorders and Stroke (NINDS). We look forward to additional details as to how the priority setting activities will feed through to the peer review process so suitable funds are recommended for appropriate studies, and how the planning process will inform decision-making across the entire NIH and not just the NIA. We also look forward to a detailed research plan and timeline for activities soon following the May Summit.

Action 1.A.3: Regularly update the National Plan and refine Goal 1 strategies and action items based on feedback and input
In addition to informing the implementation of the National Alzheimer's Plan with feedback from the Alzheimer's Research Summit and the Request for Information (RFI), HHS and its federal partners should also seek input from the public and experts in the field when regularly updating the plan.

Action 1.A.4: Convene a scientific workshop on other dementias in 2013
The Alzheimer's Association commends the National Alzheimer's Plan for addressing other dementias, in keeping with the intent of P.L. 111-375.

Action 1.A.5: Update research priorities and milestones
The Advisory Council meeting should be held each year at a time most relevant to informing the President's annual budget for Alzheimer's research.

Action 1.B.1: Expand research to identify the molecular and cellular mechanisms underlying Alzheimer's disease, and translate this information into potential targets for intervention
The development of effective treatments that can delay, prevent and treat Alzheimer's will require a significant investment in our basic understanding of the disease. It will be critical that basic science receive sufficient funds to ensure adequate fundamental knowledge of the disease. To make this action meaningful and effective, the plan must include additional details on how this important research will be prioritized and expanded, what networks and mechanisms will be used to expedite translation of the basic science, and what level of funding will be committed in the future.

Action 1.B.3: Increase enrollment in clinical trials and other clinical research through community, national, and international outreach
The Alzheimer's Association strongly believes that increasing enrollment in clinical trials is critical to developing new treatments and eventually overcoming Alzheimer's disease. Groundbreaking research that could have a substantial impact on individuals with the disease now and in the future is significantly slowed by a lack of volunteers for Alzheimer's clinical trials. Recruiting and retaining trial participants is now the greatest obstacle, other than funding, to developing the next generation of Alzheimer's treatments. We believe HHS can expand registries through the promotion of existing Alzheimer's disease clinical trial matching services such as the Alzheimer's Association TrialMatch service.

The Alzheimer's Association TrialMatch is a free service that makes it easy for people with Alzheimer's, caregivers, families and physicians to locate clinical trials based on personal criteria (diagnosis, stage of disease) and location. The Alzheimer's Association TrialMatch lets interested individuals search trials quickly and easily, and narrows results to those trials where there is a reasonable chance to be accepted for enrollment, saving time for both the participant and the researcher.

Action 1.B.4: Monitor and identify strategies to increase enrollment of racial and ethnic minorities in Alzheimer's disease studies
Monitoring enrollment of racial and ethnic minorities in Alzheimer's disease studies should not be limited to the NIH. Tracking race and ethnicity should also be encouraged in the outreach recommended in Action 1.B.3. This tracking should also be done by the private sector.

Action 1.B.5: Conduct clinical trials on the most promising pharmacologic interventions
The Association encourages greater specificity regarding the intent of this action as the norm in drug development is for clinical trials on the most promising pharmacologic interventions to be conducted by private industry. Although there is a government role in clinical development of non-proprietary interventions, we urge care be taken not to divert resources to areas already well covered by private industry at a time when research resources for Alzheimer's are stretched so thin.

Action 1.C.1: Identify imaging and biomarkers to monitor disease progression
While there have been great strides in the use of imaging and biofluids biomarkers over the last several years, to ensure this action is successful, significant research is still needed and will require a substantial investment. This action should also require assembling and maintaining a large cohort of subjects in all stages of the disease, including preclinical.

Action 1.C.2: Maximize collaboration among federal agencies and with the private sector
Collaborations must include multi-disciplinary partners, including experts in clinical care, epidemiology, and public health. The Food and Drug Administration (FDA) should be an active participant in these collaborations.

Action 1.D.1: Inventory Alzheimer's disease research investments
The research ontology is an important classification system that provides a framework for collective portfolio analysis and introduces opportunities for coordinated strategic planning and initiatives among partner organizations and research funders. The Association was pleased to work with the NIA on this important project and is looking forward to the possibilities of having a global view of what Alzheimer's research is being conducted.

Action 1.D.2: Expand international outreach to enhance collaboration
As a global leader in Alzheimer's research, the Alzheimer's Association operates in a spirit of inclusiveness, seeking partnerships throughout the scientific community to propel the field of Alzheimer's research forward. In addition to connecting with the countries listed in the Action, connecting with established international organizations, such as Alzheimer's Disease International (ADI), would be valuable. We look forward to additional details on how the information gathered from this meeting will be turned into additional action plans and new research partnerships.

Action 1.E.1: Identify ways to compress the time between target identification and release of pharmacological treatments
This Action should also include a review of regulatory science needs, biomarker qualification, clinical trial infrastructure barriers, new or adaptive clinical trial design and guidance on designing/approving prevention or disease-modifying trials. In addition to NIH, FDA and the Office of the Assistant Secretary for Planning and Evaluation (ASPE), the consultation list should include private and non-profit funders of Alzheimer's research as well as the Department of Defense (DoD). A well-defined timeline for meetings and an action plan for this group should be established to ensure accountability and progress.

Action 1.E.2: Leverage public and private collaborations to facilitate dissemination, translation, and implementation of research findings
The Alzheimer's Association encourages the Secretary of HHS, the Secretary of Veteran Affairs, and the Secretary of Defense to work together to reduce barriers to working with private entities on agreed upon national strategic goals in Alzheimer's research. The federal government must increase its engagement with the private sector to move science forward as quickly as possible. Public-private partnerships present a key opportunity to leverage both public and private resources in this scarce fiscal environment. Government funders of Alzheimer's science should make available contracts, grants, or cooperative agreements to facilitate new and innovative partnerships between public and private entities. This may include private or public research institutions, institutions of higher education, medical centers, biotechnology companies, pharmaceutical companies, disease advocacy organizations, patient advocacy organizations, or academic research institutions.

We believe that effectively achieving this strategy requires a single, dedicated office to oversee and manage this coordination, particularly internationally. This office could also be charged with coordinating all Alzheimer's-related efforts across the federal government, including care and support, thereby fulfilling the charge of the National Alzheimer's Project Act (P.L. 111-375) to ensure "coordination of Alzheimer's research and services across all Federal agencies."

Action 1.E.3: Educate the public about the latest research findings
The CDC's Healthy Aging Program, specifically the Healthy Brain Initiative (HBI), is an important example of their role in educating the public about the latest research findings connected to Alzheimer's disease.

Goal 2: Enhance Care Quality and Efficiency
The Alzheimer's Association appreciates the Administration's announcement that $6 million will be dedicated over two years for provider education and outreach. While the $6 million is a great first step, we urge the Administration to dedicate additional funds for this endeavor to be successful.

To begin work under this area, the Association recommends targeted outreach to various provider groups. We believe HHS should promote an understanding of dementia among health care providers through a variety of mechanisms including the development of guidelines and quality measures. Once these guidelines are created, the development of online training modules would be most efficient. Additionally, it is important to develop Alzheimer's disease-specific quality measures so care can be evaluated. Assisted living facilities should be added to the list of settings where high-quality care should be provided.

Action 2.A.1: Educate Healthcare Providers
The Alzheimer's Association strongly supports a robust and well-educated workforce as an essential component to providing high-quality care to those with Alzheimer's disease. An adequate number of health care providers who are properly trained to understand the complexities of dementia will help ensure individuals with Alzheimer's disease have access to coordinated, quality care and ultimately drive us toward a dementia-capable health care system.

While the Association applauds the efforts outlined in the plan, we are concerned that the education component within this strategy may be limited. Many individuals with Alzheimer's disease enter the health care system through their primary care provider. To reach this target population, we encourage the Centers for Medicare and Medicaid Services (CMS) to play a major role in educational outreach, particularly to the Medicare provider community. CMS should issue guidance to providers outlining information that should be discussed with individuals and their caregivers after a diagnosis such as managing dementia with other chronic illnesses and referrals to existing community supports and services. CMS could partner with relevant stakeholders, such as the Alzheimer's Association, to develop resources to share with providers. Providers' education should also include guidance on the appropriateness and benefits of palliative and end-of-life care services, such as hospice, for individuals with Alzheimer's disease. This effort should include how and when providers should discuss the issue with the individual and their representative.

We also encourage the plan to address educating physicians and other health care providers on the value of an early diagnosis. Too often providers do not see or understand the value of an early diagnosis and therefore fail to diagnose and/or document Alzheimer's disease. Even among willing providers, a lack of training on the use of assessment tools and methods to encourage follow-up often delays detection of cognitive impairment and diagnostic evaluations.

It should also be noted that state and local public health departments should be included in this action item. The public health community is very good at educating health care providers. There are a number of evidence-based interventions for educating providers in a variety of settings that can be applied to Alzheimer's disease. We encourage HHS to support the necessary infrastructure to help state and local departments offer this type of education in public health settings.

Action 2.A.2: Encourage providers to pursue careers in geriatric specialties
Funding and incentives for individuals interested in pursuing careers in geriatric specialties, particularly those that care for people with dementia, should be expanded.

Action 2.A.3: Collect and disseminate dementia-specific guidelines and curricula for all provider groups across the care spectrum
We believe this strategy is vitally important, particularly with regard to the development of quality indicators. HHS should promote existing evidence-based guidelines and curricula. Where unavailable, HHS should work with relevant stakeholders who have developed evidence-based quality care guidelines, such as the Alzheimer's Association's Dementia Care Practice Recommendations, which incorporate the latest research and field evidence. Once appropriate quality indicators are identified and validated, efforts should be undertaken to integrate them into the health care system.

In addition, the Alzheimer's Association urges HHS to ensure that content within the proposed clearinghouse is current and easily accessible.

Action 2.A.4: Strengthen the direct-care workforce
Section 6121 of the Affordable Care Act (ACA) requires that all certified nursing aides (CNAs) that work in nursing homes receive training on care for persons with dementia. As implementation of this provision progresses, the Association urges CMS to include a mechanism that ensures any recommended education materials are fully understood and absorbed. Further, CMS should publically establish the survey guidelines that will accompany this new requirement to ensure CNAs are appropriately trained.

The Association would like to see the plan also recommend that all direct care workers, including those in assisted living facilities and home- and community-based settings, be required to meet a similar standard.

Action 2.A.5: Strengthen state aging workforces
HHS should coordinate with states to develop Alzheimer's disease coordinators and workforces in state and local public health departments that will develop and implement Alzheimer's disease strategies. Strategies may include early detection and diagnosis campaigns, provider education campaigns, surveillance work, implementation of state Alzheimer's disease plans, and other essential public health services. HHS should also work with Aging Network staff to recognize the warning signs of dementia and be trained to assist individuals and their families when they seek appropriate medical care for detection and diagnosis.

Action 2.B.1: Link the public to diagnostic and treatment services
To continue connecting families and people with symptoms of Alzheimer's disease to Alzheimer's-capable resources and meet growing demand, the Administration on Aging's (AoA) National Alzheimer's Call Center will require additional funding. The National Alzheimer's Call Center provides 24-hour, 7 day a week, year-round telephone support, crisis counseling, care consultation, and information and referral services in 140 languages for persons with Alzheimer's disease, their family members and informal caregivers. Trained professional staff and master's-level mental health professionals are available at all times. Since 2003, the National Alzheimer's Call Center has served more than 2 million people in the community. Additionally, it is important to note that the Alzheimer's Disease Centers, funded by NIA, are only available to certain areas of the country. As such, we urge HHS to include a solution in the final plan to ensure areas without resources have access to assistance, such as the Call Center.

Action 2.B.2: Identify and disseminate appropriate assessment tools
To diagnose an individual with Alzheimer's disease, cognitive impairment must first be detected in a clinical setting. As discussed, the ACA created the Medicare Annual Wellness Visit (AWV) which includes the detection of cognitive impairment. To enhance the AWV, the Association believes the CDC should revise the model Health Risk Assessment (HRA), which is part of the AWV, to include questions about memory and other indicators of cognitive impairment.

We also recommend including a strategy on enhancing detection in a clinical setting in addition to the Medicare Annual Wellness Visit. While the draft plan refers to some of the issues involved in detecting cognitive impairment -- namely, assessment tools -- we believe it is important to emphasize detection of cognitive impairment as the precursor to a comprehensive diagnostic evaluation for Alzheimer's disease.

Action 2.C.1: Educate physicians and other healthcare providers about accessing long-term services and supports and Action 2.C.2: Enhance assistance for people with AD and their caregivers to prepare for care needs
The Alzheimer's Association strongly believes health care providers should be educated about available supports for newly-diagnosed individuals and their caregivers to provide better counsel through this difficult disease. This should include information medical and non-medical supports and services. Further, the Association believes Medicare should cover a visit in which a health care provider discusses current and future care planning, with the caregiver, with or without the beneficiary present, to ensure families receive vital information to navigate this difficult disease. The Alzheimer's Association stands ready and willing to partner with HHS to develop a list of appropriate resources to share with the provider community. In fact, our chapters are currently conducting outreach on the local level to make providers aware of the available supports in their own community.

As stated in the Association's 2012 Alzheimer's Disease Facts and Figures, at least 800,000 individuals with Alzheimer's disease live alone and as many as half do not have an identifiable caregiver. We strongly encourage HHS to further develop assistance for this particularly vulnerable population.

Action 2.D.1: Explore dementia care guidelines and measures
While developing dementia care guidelines and measures, it is important to develop Alzheimer's disease-specific quality measures so that care can be evaluated. In addition, the guidelines should include criteria and provisions for quality palliative and end-of-life care, including hospice care.

We would encourage HHS to build on existing quality initiatives, such as the Alzheimer's Association's Campaign for Quality Residential Care, which takes a person-centered approach and covers the basics of good care in six areas. The Association supports the development of additional quality measures and evidence-based care guidelines, and can serve as a resource in this effort.

Action 2.E.1: Evaluate the effectiveness of medical home models for people with AD
While the medical home model holds promise, these models of care would need to be flexible to accommodate the specific needs of individuals with Alzheimer's disease, as they may require additional time and services to be effective for the Alzheimer's community. Moreover, it is recommended that care coordination designed specifically for Alzheimer's disease be highlighted for evaluation.

Furthermore, models should focus on aspects that seem to be particularly beneficial for individuals with Alzheimer's disease, including face-to-face meetings with care coordinators and care coordinators located in primary care provider offices. Due to the nature of Alzheimer's disease, coaches and telephone disease management may not be particularly effective for this population.

Action 2.F.1: Identify and disseminate models of hospital safety for people with AD
Acute care settings should implement Alzheimer's disease training for all health care practitioners to facilitate greater safety for people with the disease.

While it is critical to identify and disseminate models of hospital safety for people with Alzheimer's disease, there should be similar action on identifying and disseminating models of safety to be used by nursing homes, assisted living facilities and other residential care settings. Additionally, there should be similar action on this for emergency personnel and first responders.

Action 2.F.2: Implement and evaluate new care models to support effective care transitions for people with Alzheimer's disease
Most notably absent from the discussion of improving care transitions is the importance of making a documented diagnosis in an individual's medical record. Further, an individual should have a list of relevant medications documented in their medical record, especially prior to any care transition. The use of electronic medical records may also facilitate the availability of this information and should be explored particularly in the context of safer care transitions for patients with dementia.

Some individuals have behavioral problems related to Alzheimer's disease. Therefore, appropriate community mental health services should be developed to include systems that strengthen the care needs of individuals with behavioral disturbances.

Action 2.G.1: Review evidence on care coordination models for people with Alzheimer's disease
As mentioned in Action 2.E.1, the focus of these models should include aspects of the models are particularly beneficial for individuals with Alzheimer's disease, including face-to-face meetings with care coordinators and care coordinators located in primary care provider offices.

Action 2.G.2: Implement and evaluate care coordination models
Individuals with Alzheimer's disease who are dually eligible for Medicare and Medicaid are likely to use more health care services and have less desirable outcomes without quality care coordination. For example, people with serious medical conditions and Alzheimer's or another dementia are more likely to be hospitalized than those with the same medical conditions but no Alzheimer's or dementia.

Initially, the evaluation of these integrated models of care should be weighted towards effective care coordination, rather than cost-savings, since individuals may have increased access to services that didn't have before. This is especially important when considering cost increases, which may occur in Medicaid services since individuals with Alzheimer's may not have had previous access to long-term care services and supports due to long waiting lists and state fiscal constraints.

Action 2.H.1: Create a taskforce to improve care for these specific populations
The National Alzheimer's Plan must identify specific action steps to be undertaken to improve the care of those disproportionately affected by Alzheimer's disease. We appreciate the acknowledgement that people with younger-onset Alzheimer's disease, racial and ethnic minorities, and people with intellectual disabilities are disproportionally burdened by Alzheimer's and related dementias.

Goal 3: Expand Patient and Family Support
The National Alzheimer's Plan provides a unique and important opportunity to widely deploy effective, evidenced-based strategies to help family caregivers. Often, financial barriers prevent families from accessing the support they need to provide care for their loved one. Although there are a number of strategies and actions to address support for individuals with Alzheimer's disease and their families, the plan does not clearly address additional funding for respite care -- whether it be in day centers or within the home.

Action 3.A.2: Distribute materials to caregivers
As HHS considers which agencies, federal departments, and state and local networks to distribute materials, it should also consider including the CDC's Healthy Aging Program.

Action 3.B.5: Provide effective caregiver interventions through AD-capable systems
In addition to developing more services, the Alzheimer's Association believes existing services to support caregivers should be promoted, supported, and expanded. Furthermore, while this action mentions respite care, it does so only in terms of providing referrals and does not include increased funding so that families can access such services.

Action 3.B.7: Support caregivers in crisis and emergency situations
HHS should look for ways to promote the National Alzheimer's Call Center and its services as a crisis resource for caregivers.

Action 3.C.1: Examine awareness of long-term care needs and barriers to planning for these needs and Action 3.C.2: Expand long-term care awareness efforts
We encourage the plan to consider addressing all aspects of long-term care, including financial planning, driving, and safety issues. Increasing the awareness of future care planning could help individuals and their families address challenges earlier and help avoid crises later.

We would encourage HHS to examine the barriers to long-term care, which may include studying the availability and impact of long-term care insurance as people with Alzheimer's disease, particularly those with younger-onset, may face unique challenges when trying to purchase insurance.

Action 3.D.1: Educate legal professionals about working with people with Alzheimer's disease
The education of legal professionals should be expanded to include other entities in the legal system, including law enforcement, first responders, prosecutors, and judges.

Broader awareness of Alzheimer's disease may help prevent or reduce arrests of individuals with Alzheimer's who are charged with crimes for which they have no intent, such as unintentional trespassing. Further, it may help legal professionals and first responders to spot abuse -- physical and non-physical -- against people with the disease. In addition, State Adult Protective Service (APS) agencies are overburdened and understaffed, resulting in a limited ability to provide any support except in the most dire of circumstances. We encourage the plan to address the need for additional resources dedicated to protecting the safety and rights of individuals with Alzheimer's.

Finally, the plan must acknowledge the large number of individuals with Alzheimer's who live alone -- many of whom do not even have an identifiable caregiver. In maintaining the dignity, safety, and rights of those with the disease, special attention must be given to this population. We hope that the plan considers guidance for legal professionals seeking to balance autonomy and individual safety.

Action 3.D.2: Monitor, report and reduce inappropriate use of anti-psychotics in nursing homes
Individuals living with dementia may experience behavioral and psychotic symptoms (BPSD) during the course of their disease due to the alterations in processing, integrating and retrieving new information that accompanies dementia. Non-pharmacologic approaches should be tried as a first-line alternative to pharmacologic therapy for the treatment of BPSD. The Association recommends training and education for both professional and family caregivers on psychosocial interventions. Further, we recommend the plan call for similar monitoring and reporting in assisted living facilities.

Action 3.E.1: Explore affordable housing models
At least 800,000 Americans with Alzheimer's disease live alone. Compared to those with Alzheimer's who live with someone else, on average, people with Alzheimer's who live alone are more likely to live in poverty and require assistance performing tasks such as managing money, shopping, traveling, housekeeping, preparing meals and taking medications correctly. We encourage HHS to explore affordable housing models that will allow this unique population to live safely within their communities.

Goal 4: Enhance Public Awareness and Engagement

Action 4.A.1: Design and conduct a national education and outreach initiative
The public awareness campaign in Action 4.A.1 must be culturally-sensitive and reach those in underserved locations.

Goal 5: Improve Data to Track Progress
Obtaining a more definitive picture of Alzheimer's, cognitive impairment, and related caregiving burdens is essential to any successful strategy to combat the disease. Public health surveillance and comprehensive data collection will not only assist the federal government in addressing policy questions and planning new initiatives, they will provide the research, caregiving, and public health communities a better understanding of people with cognitive impairment and Alzheimer's, and identify opportunities for reducing the impact of the disease at all levels of government.

At a minimum, this should include state-by-state public health surveillance on cognitive impairment and caregiver burden, preferably through the Behavioral Risk Factor Surveillance System (BRFSS), coordinated by the CDC. Moreover, this strategy should also include improving existing federal surveys such as the Medical Expenditure Panel Survey and the National Health Interview Survey so that they can adequately capture information about those with Alzheimer's and other dementias.

Action 5.A.1: Identify major policy research needs and Action 5.A.2: Identify needed changes or additions to data
The CDC has been a leader in incorporating measures of cognitive health into other population health monitoring efforts. The CDC Healthy Aging Program has worked on identifying databases, worked with partners to add questions on cognitive impairment and caregiving to the BRFSS and added questions on cognitive impairment to the National Health and Nutrition Examination Survey (NHANES) The CDC is currently analyzing data from these datasets as they become available. In particular, BRFSS data are unique and allow for state- and local-level data that can highlight the needs of diverse populations in the United States.

The CDC Healthy Aging Program developed a 10-question BRFSS module on Perceived Cognitive Impairment. Twenty-two states included the module on their state BRFSS in 2011 and an additional 16 states are including the module in 2012 for a total of 38 states, including the District of Columbia. The CDC Healthy Aging Program is working with partners, including states, to expand the module in 2013 to all 50 states. They are also producing reports and publications regarding these data to inform decision-makers about the perceived impact of cognitive impairment at the state and local levels.

Action 5.A.3: Make needed improvements to data
Using data to improve and track progress is essential and we commend its inclusion in the draft plan. This critical information should be publically available, as well as to the Advisory Council. In monitoring progress, it would be useful to have de-identified data that corresponds to the disease stage (preclinical through end-of-life) to identify areas for improvement in care and services.

Action 5.B.1: Designate responsibility for action implementation
The Alzheimer's Association commends the intent to designate responsibility for each action step. However, we urge designation of individual accountable for each action, rather than simply a "contact person."

Action 5.B.2: Track plan progress
Tracking on plan progress as described in this action step should be provided to the public on no less than a quarterly basis. In general, we urge that the reporting on progress regarding each action be paired with greater clarity and specificity regarding desired outcomes than has been provided in the draft plan.

Action 5.B.3: Update the National Plan annually
The Alzheimer's Association urges that updates to the plan be done with the same transparency and opportunities for comment that has characterized the formulation of this initial National Alzheimer's Plan.

Conclusion:
The National Alzheimer's Plan should allow us, for the first time to answer this simple question: Did we make satisfactory progress in the fight against Alzheimer's disease? For too many individuals living with Alzheimer's and their families, the system has failed them, and today we are unnecessarily losing the battle against this devastating disease. A successful National Alzheimer's Plan offers us the opportunity to change that, and set a new trajectory for this rapidly expanding global epidemic through American leadership.

As we all know, a plan accomplishes nothing without thorough and effective implementation that is coupled with transparency and accountability for those actions. The Alzheimer's Association looks forward to a final National Alzheimer's Plan that is urgent, transformational, achievable and accountable. The recommendations listed above, combined with the recommendations of the Advisory Council subcommittees, will help to build the strongest possible National Alzheimer's Plan to overcome the escalating burden of Alzheimer's disease on American families.

We sincerely appreciate this opportunity to comment on the Draft National Plan to Address Alzheimer's Disease. If you wish to discuss any of these issues further, please feel free to contact the Alzheimer's Association Director of Federal Affairs.

  1. Except as otherwise noted, all statistics regarding Alzheimer's in this report are from: Alzheimer's Association. 2012 Alzheimer's disease facts and figures. Alzheimer's and Dementia: The Journal of the Alzheimer's Association. March 2012; 8:131--168. http://www.alz.org/facts.
  2. Alzheimer's Association. Changing the Trajectory of Alzheimer's: A National Imperative. May 2010. http://www.alz.org/trajectory
  3. For a profile of the particular challenges faced by those with Alzheimer's and other dementias who live alone, see the special report in the Alzheimer's Association's 2012 Alzheimer's Disease Facts and Figures. http://www.alz.org/facts.
  4. Upon release, this report will be transmitted to the Department of Health and Human Services, and will also be available through the Alzheimer's Association website (http://www.alz.org/napa).

 

A. Goldstein  |  03-30-2012

Please accept the attached comments from the American Geriatrics Society on the Draft National Plan to address Alzheimer's disease. Should you have any questions, please don't hesitate to get in touch.

ATTACHMENT:

Comments on National Alzheimer's Project Act (NAPA) - Draft National Plan to Address Alzheimer's Disease

The American Geriatrics Society (AGS) appreciates the opportunity to comment on the Draft National Plan to Address Alzheimer's Disease. The AGS is a membership organization comprised of over 6,000 geriatrics healthcare professionals who are devoted to improving the health, independence and quality of life of all older people. The Society provides leadership to healthcare professionals, policy makers and the public by advocating for and implementing programs in patient care, research, professional and public education and public policy.

As geriatrics healthcare professionals, we are all too aware of the growing shortage of professionals trained to care for the rapidly growing population of older Americans. We are pleased to see that the report recognizes the importance of building a strong geriatrics workforce. As noted under Goal 2 in the report, workforce training and awareness plays an important role in treating and caring for older Americans affected by Alzheimer's disease. We have long advocated for the importance of the entire healthcare workforce to be prepared to care for complex frail elders with multiple chronic conditions as was called for by the Institute of Medicine in its 2008 report, Retooling for an Aging America: Building the Health Care Workforce.

Specifically, the strategy outlined under 2.A. calls for additional and improved activities under several geriatric workforce education and training programs, including the Geriatrics Education Centers (GECs), the Comprehensive Geriatrics Education Program (CGEP), the Geriatric Academic Career Awards Programs (GACA), and the Geriatric Training for Physicians, Dentists, and Behavioral and Mental Health Providers (GTPD) program. Unfortunately, over the past several years, these programs have been essentially flatfunded at a level that is far below what is needed to meet the needs of an aging population. At a time when our nation is facing a critical shortage of geriatrics healthcare professionals across disciplines, we need increased investment in these critical programs. It is unclear from the National Alzheimer's Action Plan whether there will be an increased investment in these programs and we are concerned that without enhanced funding, we will not be able to meet the workforce goals set forth in the draft National Plan.

We urge you to explicitly identify and prioritize increased funding for geriatrics health professions programs under Titles VII and VIII as a priority under NAPA. At a minimum, we need to increase the number of academic clinicians who are funded under the Geriatric Academic Career Awards Program and make this an annual awards program (currently awards are only made every five years). We believe that funding should be increased for all other programs that have as a target increasing the knowledge and expertise of the entire workforce to care for older adults.

From a clinical perspective, we believe that it is important to frame Alzheimer's disease within the context of older adults with multiple chronic conditions. We encourage the Task Force to acknowledge this complexity. The high prevalence of multiple coexisting conditions in individuals with Alzheimer's disease will impact many of NAPA's priority areas. These include development of new models of care, conducting research relevant to the prevention and treatment of Alzheimer's disease, and training across the paid and unpaid workforce. Alzheimer's patients should not be assumed to have a single condition in isolation. Below we have outlined some specific recommendations related to health care delivery, research, and training.

SPECIFIC RECOMMENDATIONS

Care for individuals with Alzheimer's disease and other dementias should take into account the prevalence of other multiple chronic conditions.
The current model, which generally assumes an identifiable onset, a predictable progression, and a taxonomy-driven treatment, is most often a poor fit to what we believe contributes to the management of cognitive decline in older persons. AGS believes that we must promote the recognition of the continuous cognitive changes produced by multiple causes as age increases, while encouraging regular follow-up of cognitive performance in aging during annual prevention visits or physicals. This would provide opportunity for early intervention for preventable loss and counseling regarding ongoing risks related to decline. Furthermore, AGS believes cognitive screening is an appropriate part of the annual prevention and wellness visit that is now provided under Medicare and we continue to support NIA and CMS in their efforts to identify appropriate tools for clinicians to use during the annual prevention visit.

There should be substantial research into health services delivery and better models of care to support older Americans with dementia, their families, and the entire community.
This would provide additional benefits to the greater community, in avoiding expensive nursing home and hospital care, which often times, have questionable benefits on quality of life. Alzheimer's disease and other dementias are unique in that the entire family unit should be considered the "patient." For example, it may be worth considering models used in other countries where family members are paid to be full-time caregivers with home-based education and resources. The draft plan might also want to consider how to recognize the primary family caregiver as a co-patient. Determining the needs and abilities of the family caregiver are equally important in providing quality care for individuals with Alzheimer's disease or dementiai.

Federal agencies should work with stakeholders to identify how existing guidelines and measures are being used and also to better align recommendations in these guidelines and standards set forth in quality measures.
AGS believes that before we develop more guidelines addressing diagnosis, prevention, and treatment of Alzheimer's disease, we need a better understanding of what guidelines currently exist and how these are being used. AGS member leaders recently co-lead an effort to develop quality measures related to the clinical management of Dementia and there is currently an effort to get these into practice. One role that HHS should take is that of a convener of organizations with existing guidelines in order to synthesize the evidence base that supports such guidelines and better align the recommendations. We believe that such an effort should be multi-specialty and multi-disciplinary. This effort would also serve to identify gaps in standards and set forth a multi-stakeholder plan to address these. We believe that this can best be accomplished by federal entities such as the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services.

The National Plan does not mention the importance of addressing conflicts of interest when developing guidelines and quality standards, and we recommend some level of acknowledgement of the ethical issues. Our suggestion is to include a reference to the 2011 Institute of Medicine's (IOM) Clinical Practice Guidelines We can Trustii report, which provides important criteria for evaluating guidelines, as well as quality standards based on such guidelines.

Screening for Alzheimer's disease and other dementias
AGS believes that we need to come to consensus on the public health issue of screening for Alzheimer's disease and other dementias. We believe that there is a role for HHS in leading a discussion whether to screen, when to screen, and with what tools. We believe that the Centers for Disease Control and Prevention (CDC) and the National Institute on Aging (NIA) should play an important role in this conversation.

Enhancing the Workforce Needed to Care for Older Adults
The current and increasing shortfall of specially trained geriatrics health professionals has important implications for the care of older adults with Alzheimer's and other dementias. The Title VII and VIII geriatrics workforce programs are critical to training geriatrics faculty and other healthcare providers to better care for older adults. Specifically, the Geriatric Academic Career Awards (GACA) program supports not only career development for newly trained geriatric physicians in academic medicine, but also junior geriatrics and gerontology faculty in other health professions such as nursing, pharmacy, and social work. Currently, in all disciplines, there is an insufficient number of geriatrics faculty to train upcoming generations and conduct aging research.

In addition, the Geriatric Education Centers provide quality interdisciplinary geriatric education and training to the health professions workforce including geriatrics specialists and non-specialists. Another important program, the Geriatric Training for Physicians, Dentists, and Behavioral and Mental Health Professions supports training additional faculty in these disciplines so that they have the expertise, skills, and knowledge to teach geriatrics and gerontology to the next generation of health professionals in their disciplines. The Comprehensive Geriatric Education Nursing program supports additional training for nurses who care for older Americans and also provides continuing education. Finally, a new program authorized under ACA, the Geriatric Career Incentive Awards Program, offers grants to foster greater interest among a variety of health professionals in entering the field of geriatrics, long-term care, and chronic care management.

The lack of funding for these programs will substantially reduce the amount of training that American healthcare professional students and providers will receive in caring for older Americans. Again, we urge you to prioritize funding for these important programs, especially the GACA awards, as now is the time to ensure that we develop adequate numbers of faculty to provide this training.

In conclusion, the AGS is supportive of NAPA's proposals to improve quality of care for older Americans with Alzheimer's, and ultimately to overcome the disease. The label of Alzheimer's disease can result in premature limitation of an individual's involvement in his/her own care planning, and thus, we aim to encourage emphasis not only on measuring decline, but also in promoting strengths throughout the course of illness.

We greatly appreciate this opportunity to provide feedback. Please do not hesitate to contact the Senior Coordinator of Public Affairs and Advocacy, if we can provide additional information or assistance.

  1. Caregiver Assessment: Principles, Guidelines and Strategies for Change. Report from a National Consensus Development Conference, National Center on Caregiving at Family Caregiver Alliance. April 2006. http://www.caregiver.org/caregiver/jsp/content/pdfs/v1_consensus.pdf
  2. Graham R, Mancher M, Wolman DM et al. Institute of Medicine: Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press, 2011.

 

S. Hedrick  |  03-30-2012

On behalf of Dr. Segall, President, please find attached the Society of Nuclear Medicine's comments on the National Plan To Address Alzheimer's Disease.

ATTACHMENT:

The Society of Nuclear Medicine (SNM), headquartered in Reston, Va., is a nonprofit scientific and professional organization that promotes the science, technology and practical application of nuclear medicine and molecular imaging. SNM strives to be a leader in unifying, advancing and optimizing molecular imaging, with the ultimate goal of improving human health. With 17,000 members worldwide, SNM represents nuclear and molecular imaging professionals, all of whom are committed to the advancement of the field. For more than 50 years, SNM members have developed--and continue to explore--innovations in medical imaging to allow for noninvasive diagnosis, management and treatment of diseases, benefiting countless patients. Members include physicians, technologists, physicists, pharmacists, scientists, and laboratory professionals.

Since the conception of cross-sectional imaging of the human brain in the 1960's, SNM has been a leading international organization to advance imaging methods to better investigate dementing illness and educate physicians about clinical applications. We have witnessed significant advances in brain perfusion imaging, brain metabolism imaging, and now dopamine and amyloid imaging. Molecular imaging is able to improve the diagnosis and management of neurodegenerative brain disorders, including Alzheimer's, Parkinson's and other dementias and movement disorders.

Significant advances in imaging have made it possible to detect the onset of Alzheimer's disease, track its progression, and monitor the effects of treatment. These advances are being leveraged by the National Institute of Aging and the public-private Alzheimer's Disease Neuroimaging Initiative (ADNI) which will help identify and monitor disease progression, even in the early stages before individuals show symptoms of the disease. Empowered with the knowledge of brain pathology, clinicians will be more likely to begin and maintain appropriate treatment.

Despite these great technical achievements, there have been limited advances in treatment and no improvement in mortality related to Alzheimer's disease. Far too many people with Alzheimer's disease are not diagnosed until their symptoms have become severe. The standard clinical diagnostic approach, which is used to infer underlying Alzheimer's disease pathology, has less than optimal specificity and sensitivity, even in expert hands. By the time dementia is obvious, deficits often are so pervasive that the typical phenotype may be difficult to recognize.

Therefore, SNM strongly supports the decision of the President and the Secretary of Health of Human Services to enhance dementia care through the establishment of a National Plan to Address Alzheimer's Disease. We would encourage the President and HHS Secretary to include a greater emphasis on molecular imaging in the plan. Molecular imaging is one of only a few methods that can unveil pathophysiological and pathogenic changes in living human patients. To make future breakthroughs, further investments are critical, including the investigational use of molecular imaging and the effective implementation of imaging technologies in the clinic.

In addition, we suggest that DHHS to consider not only supporting dementia imaging research through NIH NIA/ADNI initiative, but also more broadly investing in basic and translational research to develop new diagnostic tools and advance them to human applications through multiple NIH Institutes (e.g., NINDS, NIBIB), FDA for accelerated review, and CMS for clinical implementation.

Specific comments are:

  • Action 1.B.5: The plan should recognize the importance of molecular imaging as a means to facilitate and accelerate pharmacological clinical trials. Molecular imaging can greatly assist in the development of new therapeutic agents at several different stages. Molecular imaging can be used to better select patients with Alzheimer's disease for clinical trials, to exclude patients with other diseases who might not benefit from the therapy, and to demonstrate the presence of the therapeutic target for anti-amyloid therapies. Properly applied in early clinical testing, imaging data can assist in making a go/no-go decision about the effectiveness of potential new therapies. Utilized in later clinical development, molecular imaging can serve as a biomarker of response, substituting for a clinical endpoint.
  • Action 1.C.1 could be strengthened by expanding the organizations supported beyond ADNI. In order to see significant breakthroughs with regard to pathophysiology and develop new molecular imaging agents that image a range of biological pathways, research investments are needed at a range of academic, private, and public entities, including other NIH Institutes such as NINDS and NIBIB.
  • Strategy 2B would be strengthened by including utilization of existing neuroimaging tools and investment in new tools. Molecular imaging methods can show abnormal patterns in Alzheimer's disease and can help in the differential diagnosis of dementing disorders. Their use would help achieve the goals of facilitating appropriate assessment and giving healthcare providers tools to make accurate and timely diagnoses. Therefore, patients would benefit more rapidly from the increased access to healthcare resources for Alzheimer's disease care that the Affordable Care Act will provide.

 

F. LaFerla  |  03-30-2012

Here is the feedback from the UCI group.

ATTACHMENT:

Questions for the ADC Directors
National Alzheimer's Project Act

Frank M. LaFerla, Ph.D.
UC Irvine

GOAL: Delay onset and slow progression of Alzheimer's disease by 2020

To accomplish this goal:

  1. What do you see as the main obstacles to its achievement? Adequate funding is no doubt an element, but are there other barriers?
    • Generally, the field is too biased and focused on Aß/amyloid, and there needs to be more research oriented towards other potential therapeutic targets such as tau and factors that can improve synaptic connections (e.g., neurotrophic factors or stem cells). In addition, the field needs to focus efforts on the basic mechanism of disease. For example, there is an urgent need to develop better animal models of the disease, particularly those that represent the sporadic form of Alzheimer's disease, and also ones that better mimic co-morbidities, as this disease strikes individuals who are quite aged, and generally suffer from other disorders besides Alzheimer's disease.
      • Educating the public more about the disease would also be useful, with particular emphasis on the effects of midlife modifiers of risk.
      • There also needs to be better realization that a monotherapy is unlikely to be successful for treating such a complex human disease and we need to do a better job focusing on considering combination therapies. I believe there are few complex human diseases that are readily treated by a single therapy.
  2. What do you see as the key areas of emphasis in research needed to accomplish this goal? Please list up to 5 key areas of research in order of importance (e.g., genetics, clinical trials). Within each area, please list one or two examples of more specific items (e.g., a GWAS in a particular population, a clinical trial on a tau-active drug). Please be succinct, realistic and concrete in your responses.
    1. Animal models
      1. Better models are needed of sporadic Alzheimer's disease
      2. Consider using other species besides mice (rats, dogs, rabbits, primates)
    2. Therapies
      1. Targets needed other than Aß (e.g., tau, synaptic connections, autophagy/proteasome)
      2. More than one therapy against more than one target
    3. Biomarkers/Early detection/Better Neuropsychological Batteries
      1. Imaging other than amyloid: synapses, astrocytosis (surrogate biomarkers)
      2. Better identification of individuals likely to develop AD
    4. Study of special human populations/minorities as they can provide important insights into the disease mechanisms
      1. Down syndrome: represent largest group with early onset AD
      2. Oldest old: enable us to elucidate risk factors that may prevent dementia in this group
    5. Clinical trials (people we enroll in the trials don't necessarily represent the generally population)
      1. early treatments and more preventation trials need
      2. consider co-morbidities
  3. Is the existing federal and private research infrastructure sufficient to support adequately current and future national research efforts addressing neurodegenerative diseases including Alzheimer's disease? If not, what suggestions do you have for new infrastructure?
    • Consider developing infrastructure to foster young investigators at all levels (graduate students, postdocs, residents, assistant professors, etc.)
    • Facilitate transfer of IP to better enable partnerships between academics and drug companies/small businesses.
  4. What suggestions would you have for enhancing research collaboration outside of the federal government? That is, what would you recommend toward forging new public-private relationships? Please continue to page 3 5.
    • Consider developing a national IRB so that when multiple sites are used in a clinical trials, the protocol doesn't need to go to 50 different IRBs.
    • Important for their to be a mechanism for publishing negative clinical drug trials (this should almost be mandatory) so that others can learn and we can maximize resources
  5. What role do you see the Alzheimer's Centers playing in the future of research on Alzheimer's disease? How should the Centers Program evolve to meet the expanding needs for the field? 6.
    • Need more large multi-site studies.
    • NACC appears to mainly be a data repository and should evolve to be more of an actual coordinating center and facilitating and initiating true multi-site studies comparable to other coordinating centers.
    • Greater participation in human research studies by patients and controls could perhaps be encouraged if we revealed the results of genetic testing like ApoE and also revealed the results of imaging studies. Obviously, better counseling would also need to be provided.
    • More money for pilot projects and more pilot projects are needed; and also consider increasing the time for some pilots beyond one year.
    • Encourage more high risk and high yield type projects as well, rather than more conservative next step science.
  6. Please provide any additional comments you might have for developing a research plan to reach the stated goal by 2020.
    • Might want to consider working groups that are focused on specific areas. For example, one working group could involve leaders in animal models and coordinate the development of new models that can be widely shared in the field, rather than having individuals compete against each other, often working on very similar things.

 

M. King  |  03-30-2012

Attached is the comments letter from Mr. Shern.

ATTACHMENT:

Mental Health America Comments on Draft National Alzheimer's Plan

As an organization concerned with all aspects of mental health, we are very pleased that the federal government is developing plans to address the needs of people with dementia and their families.

We believe, however, that the plan, as currently drafted, falls short of its goals because of three major concerns: (1) unbalanced distribution of new funding; (2) inadequate attention to research about psychosocial interventions; and 3) the failure to address the behavioral health dimensions of Alzheimer's and other dementias.

Funding:

The draft plan does not specify how much funding will be available to address Alzheimer's and other dementias in the future. It does provide some information about new federal funding that has been committed prior to the completion of the plan. $156 million will be made available for the five major goals of the plan. Of this $130 million (83 percent) is designated for one goal--research. $26 million is designated for enhanced services and supports, provider education, public education, and improved data collection. Of this, $10.7 million is designated for improved care and treatment of 5.4 million people who currently have dementia and their family caregivers. At less than $2 per person, that is not adequate.

Research About Psychosocial Interventions:

As currently drafted, the plan is heavily tilted towards research into finding a cure for Alzheimer's. It focuses much of its attention on bio-medical research and the development of effective pharmacological treatments. We recognize that the slowing of the progression of dementia is important.

However, we believe that the research must pay much greater attention to psychosocial interventions, which can do much to improve the quality of life of people with dementia and their family caregivers. Further research in the area can help produce evidence-based practices that will more immediately benefit patients and caregivers. We strongly recommend that the research plan devote greater attention to research about psycho-social interventions.

Greater Attention to Behavioral Health:

Although the plan notes that people with dementia experience "behavioral and psychiatric disorders and that family caregivers experience tremendous stress and "report symptoms of depression and anxiety and poorer health outcomes," not enough attention is paid to these behavioral needs that are common among people with dementia and their families.

People with dementia often have co-occurring mental health conditions such as major depression, anxiety disorders, and psychosis. Almost all exhibit neuro-psychiatric symptoms such as depression, anxiety, apathy, irritability, delusions, hallucinations, agitation, aggression, and sleep disorders. When this occurs, those who care for people with dementia turn to mental health providers for help. In addition, family caregivers are at high risk for depression, anxiety, and stress related physical disorders. The plan needs to address evidence-based family support interventions that can provide critical support.

Thank you again for the opportunity to comment on the plan. We would be glad to work with HHS to provide the details that are needed to complete a National Alzheimer's Plan that reflects the psychosocial/mental health needs of Americans with dementia and their families as well as their opportunities for improved quality of life.


 

G. Vradenburg  |  03-30-2012

As I mentioned, there is now an Industry Working group on Alzheimer's supportive of the 2025 goal. I will be working to expand the size of this group in the coming months so that HHS has a strong partner in executing our National Plan. Here are their comments on the draft plan.

==========

Patrick --

Attached is a set of comments submitted on the draft plan by the Ad Hoc Industry Working Group

ATTACHMENT:

As you refine the draft National Plan to Address Alzheimer's Disease, leading biopharmaceutical organizations engaged in Alzheimer's and dementia research and drug development are pleased to have this opportunity to offer comment on a strong first draft. The organizations participating in the Industry Working Group on Alzheimer's Disease (Working Group), identified above, represent many of the industry leaders striving to discover and develop therapies and diagnostics to prevent and treat Alzheimer's disease by 2025 if not sooner. We have collectively invested tens of billions of dollars and many decades of energy to change the course of Alzheimer's disease and dementia, and we are all too familiar with the scientific, medical, and financial challenges associated with this pursuit, as well as the human and societal costs. If we are to reach the HHS stated goal of preventing and effectively treating Alzheimer's disease by 2025 -- which we support -- nothing short of a transformational and transparent partnership between the public and private sectors will be required. We look forward to working with you to make this happen.

The immense risks and challenges associated with bringing a drug, biologic, or other therapies to market are well known. The 1 of every 10,000 potential therapies that end up being approved for patient use take on average 13 years and cost well beyond $1 billion each to develop. For Alzheimer's and dementia research, scientific and other challenges have resulted in a very small number of approved treatments. And of the medications currently available, they address only the symptoms of the disease.

As noted above, we strongly applaud you and the Advisory Council on Alzheimer's Research, Care and Services for embracing the bold and appropriate Goal number 1 of preventing and effectively treating Alzheimer's disease by 2025. Given the significant current public health and fiscal challenges -- and the even greater looming health and fiscal threats posed by the disease -- this is indeed an appropriate goal. Fifty years ago, the nation committed to sending a man to the moon within the decade. We believe the time has come for a second moon shot, one focused on preventing and treating Alzheimer's disease. Just as we succeeded in putting a man on the moon ahead of schedule, we believe this goal can be achieved if the right resources -- public and private -- and the right policies -- those that encourage and accelerate the development of safe and effective treatments -- are brought to bear. The challenge before us now is how to achieve this goal.

This Working Group has devoted considerable time and energies studying this question and is pleased to offer the following comments and suggestions to maximize our collective abilities to achieve success. We have targeted our comments and recommendations within five core areas:

  • Strengthening the role of industry in the overall process, particularly by providing continuing and dynamic input into determining our national research priorities and ways to compress the discovery pipeline.
  • Providing greater specificity and detail -- as well as an accurate statement of resources -- that will be necessary to achieve the strategies and goals.
  • Including the policy incentives necessary to attract and sustain robust industry and capital commitments to Alzheimer's and dementia research.
  • Establishing metrics that are useful in driving the desired outcome, are clear, and are measurable.
  • Extending our vision to encompass the global challenge presented by Alzheimer's disease and dementias.

We will comment on each overarching point and then offer a number of more specific comments and suggestions for the next draft of the National Plan.

I. Strengthen the role of industry in the overall process, particularly by providing continuing and dynamic input into determining our national research priorities and ways to compress the discovery pipeline.

We are encouraged to see multiple references from the Administration that this plan be a true National Plan rather than a federal plan, meaning that it will include shared rights, roles, and responsibilities for all stakeholders. To ensure this desire is achieved, the Working Group strongly believes that the next version of the plan must include a more robust and ongoing process of partnership between government -- particularly the National Institutes of Health and the Food and Drug Administration -- and industry.

For example, while we appreciate the upcoming NIH summit and the Request for Information to collect widespread input on the research agenda, we note these actions are limited to one-time occurrences and do not contemplate an ongoing and robust dialogue and exchange with industry partners. Also concerning is that other recommendations -- including sets 1.B, 1.C, and 1.E, which are focused on expanding research, accelerating effort to identify early and pre-symptomatic stages of the disease, and compressing the discovery timeline, call for what may be viewed as token or no industry engagement whatsoever despite the immense value such involvement would bring to the larger effort.

Specifically, action 1.E.1 focuses on identifying ways to compress the time between target identification and release of treatment, but calls for industry to be involved only indirectly. We strongly believe the plan should recognize an explicit role for industry with a direct seat at this and related tables given the predominant role we collectively play in the therapy discovery and development process. In this way, together, we will begin to set a concrete course that characterizes a new, vital and transparent partnership between the public and private sectors, aligned to achieve the 2025 goal.

Beyond the points above, we urge that the draft plan be amended to include the following:

  • Commit to establishing a meaningful partnership with industry and an ongoing process of dialogue between industry and NIH and the National Institute on Aging (NIA) in determining research and related priorities. Inviting industry to the table to identify significant areas of research need and to present perplexing questions in need of basic research will breathe life into the concept of life cycle innovation by providing invaluable input and exchange of ideas. If the government wants to create a truly national plan, we believe this new partnership with the private sector, one that is open, transparent, and ground-breaking, should be at the core of the plan. In terms of specific models, we recommend exploring the Forum for Collaborative HIV Research and related HIV/AIDS models as potential examples, as well as the platforms created through the Therapeutics for Rare and Neglected Diseases (TRND) program for industry engagement.
  • Establish a standing NIH/NIA and Industry Alzheimer's Working Group to provide the institutes with the continuous feedback loop on research and drug discovery issues such as those raised above. One potential model may be the CEO Roundtable on Cancer, which involves a number of industry partners as well as governmental collaborators including the NIH and FDA. Such a partnership could provide the NIH and other federal entities not only with additional voices and input but also with potential resources to support initiatives, such as more regular scientific conferences and inventories.
  • Increase patient enrollment in clinical trials, particularly targeted minority patients. We strongly applaud this aspect of the plan and we urge that industry play a meaningful role in crafting the recruitment action plan, including being consulted on the populations or sub-populations we believe are most in need. This action plan should include specific tools for attaining this increased participation, such as targeted patient registries.

II. Provide greater specificity and detail -- as well as an accurate statement of resources -- that will be necessary to achieve the strategies and goals.

The Working Group embraces many of the research action steps included in the first draft plan. Expanding basic research into the underpinnings of the disease, identifying risk and protective factors, identifying biomarkers, and identifying ways to compress the therapy development timeline are all tremendously important if we are to achieve the 2025 goal. But each of these strategies and actions is only as good as the corresponding action steps required to achieve them, and we believe greater specificity and detail than what is contained in the first draft is needed. We also believe that given the enormity of the challenges before us, the plan must speak to the significant yet realistic financial resources -- both public and private -- that must be brought to bear against this disease to stop it from destroying our health and finances. You have been bold in stating the 2025 goal, so too you should be realistic in setting the expectation for the resources -- and scope of investment across the public and private sectors -- that will be required to meet this goal.

Following are comments in terms of enhanced specificity that we feel would strengthen the plan.

A clear path to the validation of a family of diagnostic and predictive biomarkers

  • Catalogue existing Alzheimer's biomarker initiatives including their focus/type (e.g., inclusion, prognostic, surrogate endpoint) and where they currently lie in terms of their development and review, identify gaps, and establish a plan that seeks to validate specific biomarkers within a certain timeframe.
  • Convene a joint high-level meeting between FDA and European Medicines Agency (EMA) leadership focused on Alzheimer's biomarkers and surrogate endpoints -- including imaging modalities and imaging agents -- and the much-needed harmonization of guidance and approvals.
  • Develop a joint NIH and FDA -- in close consultation with industry -- action plan focused specifically on identifying and validating Alzheimer's biomarkers. This will be a subset of the larger research prioritization and action plan and involve ongoing NIH, FDA and industry dialogue to better understand biomarker needs, to update the biomarkers action plan, and to provide clear and direct guidance to industry on the use of such tools.
  • Engage the National Center for Advancing Translational Sciences (NCATS) on specific initiatives focused on biomarker and surrogate endpoint development and addressing challenges in conducting clinical trials in pre-symptomatic patient populations.
  • Issue, upon biomarker and endpoint approval, unambiguous guidance to industry on their usage.

A reduction in the cost and time of clinical trials and clinical trial processes

  • Create large-scale, open-architected patient registries, with a particular focus on ethnic subpopulations.
  • Engage industry as to population and subpopulation engagement, data, and other needs.
  • Consider the applicability of novel trial designs, such as models used to address rare disease, for Alzheimer's disease.

Improved access to standardized electronic health and clinical trial data

  • Establish a process involving NIH, FDA, and industry to identify core data issues. Topics would include access to data -- including intervention arm data, failed trial data, dormant therapy data, biomarker data and other valuable data sets -- as well as agreeing to and extending the use of common data standards.
  • As part of this process, engage with industry around specific ideas to enlarge the space of appropriate data sharing. Members of the Working Group have each participated in the Alzheimer's Disease Neuroimaging Initiative, in many ways a seminal effort to explore and expand this space. We understand the opportunities afforded by efforts such as these, both to accelerate development where signals are positive and to fail early where signals suggest a dead end. We are prepared to build on these experiences to create new models that serve to advance therapy development across the sector.

Honest assessment of the level of resources necessary to achieve the 2025 goal

  • Include within the strategies and action items a realistic estimate of the resources necessary to achieve success, and a statement as to how the federal government, particularly during financially challenging times, plans to meet its commitment.
  • Extension of the scope and scale of responses to the global scale including a path forward toward a global action plan and fund.

III. Include the policy incentives necessary to attract and sustain robust industry and capital commitments to Alzheimer's and dementia research

The draft national plan is deficient in that while it notes the importance of compressing the discovery timeline, it fails to mention financial and other policy levers that are needed to attract and sustain robust industry and capital commitment to this most challenging area of research. We urge that you speak to the role of smart incentives within the draft plan and lay out a path for addressing these topics near-term. Specific issues we recommend the plan address directly or develop a process involving industry stakeholders to address include:

  • Maintaining and strengthening a patent system that encourages and rewards innovation and protects and provides a fair return on investment.
  • Establishing avenues for the collaboration of the public and private sectors that realistically take into account the genuine needs and strengths of both groups.
  • Ensuring appropriate payment for any successful therapy that takes into account the enormous costs of research and drug development in this critical area. This requires adequate federal reimbursement and payment policies and having the Center for Medicare & Medicaid Services (CMS) at the table whenever warranted.

IV. Establish metrics that are useful in driving the desired outcome, are clear, and are measurable.

The members of the Working Group strongly believe that meaningful and clear metrics and milestones are absolutely essential for implementing any plan and holding responsible parties accountable. In business, clear action plans and corresponding metrics are commonplace and indispensable in keeping projects focused, on schedule, and on budget. All three of these attributes are necessary if the National Alzheimer's Plan is to be successful in achieving its goals, but the current plan falls short in this area, particularly in setting outcomes for action items. For example:

  • The draft plan seeks to increase enrollment in Alzheimer's clinical trials but fails to specify specific numbers, target demographics or interim milestones.
  • It seeks to increase the pace of collaboration between the Departments of Health and Human Services and Veterans Affairs but does not provide a clear timeframe or goals.
  • It seeks to identify biomarkers but does not establish targets or set a timeframe for biomarker acceptance and validation by the FDA.
  • And it speaks to maximizing government and industry collaboration but does not espouse clear goals for this action, only events like meetings and conferences and high-level themes.

While all of these and other actions are meritorious, they require clear metrics and a commitment to aggressive oversight. To that end, the industry Working Group recommends that the plan be amended to:

  • Commit to develop this year specific action steps and metrics for each action starting with the designation of a specific federal official/office to manage each action.
  • Develop and post on the NAPA website a user-friendly "dashboard" to regularly track progress toward each action, strategy, and goal.
  • Work with industry and other appropriate partners to establish metrics that will increase our collective ability to achieve our goals, particularly the goal of preventing and treating Alzheimer's by 2025.

V. Extend our vision to encompass the global challenge presented by Alzheimer's disease and dementias.

In a recent speech, Professor Peter Piot, former Under Secretary-General of the United Nations and former executive director of UNAIDS, called dementia "one of the largest neglected global health challenges of our generation" and called for a global health action plan to address it.1 Alzheimer's disease is an epidemic that respects no national boundaries and that threatens to cripple the health and finances of the world if unaddressed. The statistics are clear: more than 36 million people worldwide currently have Alzheimer's or dementia, and projections estimate this number will skyrocket to 115 million by the mid-century point, according to Alzheimer's Disease International. The economic impact of the current epidemic exceeds $600 billion annually, and nearly two-thirds of all victims live in developing nations that are largely ill-equipped to address the challenge.2

Earlier this year, rating agency Standard & Poors issued an analysis that said "Population aging will lead to profound changes in economic growth prospects for countries around the world, we believe, as governments work to build budgets to face ever greater age-related spending needs."3 If governments fail to address this challenge and amend their social benefits systems, the agency concluded, the systems will become unsustainable." As Professor Piot noted, we must learn from the global approach to combat HIV/AIDS and enact a similar approach to Alzheimer's and dementia. No single country can take on this massive and multi-faceted endeavor alone, and the United States should be forceful and positive in recognizing this.

The draft plan acknowledges the need for greater collaboration between the U.S. and international partners, specifically Canada, the United Kingdom, and other nations that have or are developing National Alzheimer's Plans. This is a solid step that must be built upon with a clear path forward. Specifically, we urge that the global section be built out and contemplate specific measurable steps the U.S. will take to help develop and execute a global action plan as well as a global fund focused on both treatment and therapy development.

Conclusion:

Madame Secretary, the members of the ad hoc Industry Working Group wish to express our deep gratitude to you for taking meaningful actions to address our national and global Alzheimer's epidemic. We believe the draft National Plan to Address Alzheimer's Disease is a strong first step, and we offer the above comments and suggestions as part of a sincere offer to foster a true partnership and collaboration with you and your colleagues to prevent and treat this disease by 2025. We welcome any questions you may have, and we stand at the ready to discuss any of our comments with you and your team directly if desired.

  1. See: http://alzheimers.org.uk/site/scripts/news_article.php?newsID=1169
  2. See: http://www.alz.co.uk/research/files/WorldAlzheimerReport2010.pdf
  3. See: http://www.standardandpoors.com/ratings/articles/en/us/?articleType=HTML&assetID=1245328578642

 

S. Hart Weir  |  03-30-2012

On behalf of the National Down Syndrome Society (NDSS), please find our letter (attached) commenting on the "National Plan" to address Alzheimer's disease and related dementias (ADRD). Please do not hesitate to contact us with any questions.

We look forward to hearing from you.

ATTACHMENT:

On behalf of the National Down Syndrome Society (NDSS), I am writing to urge the Advisory Council on Alzheimer's Research, Care, and Services to ensure that the population of people with Down syndrome (Ds) is specifically identified in the "National Plan" to address Alzheimer's disease and related dementias (ADRD). The NDSS is a nonprofit organization representing the more than 400,000 Americans with Down syndrome and over 350 affiliates worldwide. The mission of NDSS is to be the national advocate for the value, acceptance and inclusion of people with Down syndrome.

NDSS would like to stress the important scientific relationship between Ds and ADRD. Research indicates that virtually all individuals with Down syndrome exhibit the characteristic neuropathology of Alzheimer's disease by age 40, and 25-75% or more of individuals with Down syndrome over age 40 show the signs and symptoms of ADRD and the percentage increases with age. The incidence of ADRD in people with Down syndrome is estimated to be three to five times greater than that of the general population, which according to the Alzheimer's Association is now estimated to be 5.4 million people, 1 in 8 individuals, living with Alzheimer's. In the past several years, important progress has been made by scientists focused on understanding the connection between Ds and ADRD, yet much more research is needed. For many years, the National Institutes of Health (NIH) has invested in programs and studies. Some examples include: a 30-year study on aging and dementia in adults with Ds, a current grant focused on aging of the frontal structures of the brain (including dementia), developing imaging techniques to predict cognitive decline in adults with Ds, and a natural history study on the amyloid deposits in adults with Ds.

A more integral and specific inclusion of Ds in the overall ADRD research efforts, both fundamental and translational, would significantly contribute to progress more broadly and rapidly. To that end, we would respectfully request that a representative from the Ds research community be added to the Advisory Council on Alzheimer's Research, Care, and Services and that the National Plan be amended to incorporate Ds in the research section of the National Plan but also in sections related to public awareness, education and care giver support.

Individuals with Ds and their families deserve to have the need for research and population specific clinical trials identified specifically and clearly as necessary actions in the final ADRD National Plan as well as the care challenges they face that require increased awareness, early recognition and supports.

Thank you for the opportunity to provide input on this important National Plan. Please do not hesitate to contact me with any further questions.


 

G. Olsen  |  03-30-2012

Attached are comments from the NYS Office for the Aging on the above subject matter. If you have any questions, please feel free to email me or call me.

ATTACHMENT:

Thank you for inviting the New York State Office for the Aging (NYSOFA), to comment on the U.S. Department of Health and Human Services, "Draft Framework for the National Plan to Address Alzheimer's Disease." As Acting Director of NYSOFA, the New York State Unit on Aging, I would like to offer for consideration our recommendations to the Draft Framework for the National Plan. These amendments would seek to enhance the role of the aging network in helping to achieve the goals and objectives of the National Plan.

The National Alzheimer's Project Act (NAPA) identifies the urgent need for a national plan to systematically tackle and conquer this fatal illness and scientific research, is the key to finding a cure. NYSOFA supports the efforts of the Advisory Council on Alzheimer's Research, Care and Services which includes, David Hoffman from the New York State Department of Health.

NYSOFA is a member of the New York State Coordinating Council for Services Related to Alzheimer's Disease and Other Dementias, established in 2007, and actively participates in subcommittee activities. In 2011, NYSOFA was awarded a three year Systems Integration Grant from the Administration on Aging (AoA) that provided funding for developing and integrating into service systems, dementia capability - this included care transitions and evidence-based direct services to persons with dementia and their caregivers. In addition, NYSOFA was a recipient of other AoA grants, including Lifespan Respite.

New York State is committed to providing the best possible dementia capable services throughout our aging network. New York will continue efforts to identify best practices and evidence-based interventions that produce positive outcomes impacted by the disease and their caregivers. A recent snapshot of all of NYSOFA's programs/ and services in December 2011, revealed that a significant percentage of the 59 Area Agencies on Aging (AAAs) were serving persons living with cognitive impairments related to dementia.

Of all of NYSOFA's community-based services and supports, social adult day services programs are uniquely suited to providing care and support to individuals with dementia and their caregivers. In these programs, 65 percent of participants have some form of dementia. The average year of age is 83 of a program participant, who requires hands on assistance with at least two activities of daily living (ADLs). They can remain living in their communities by attending an adult day care center for an average of two years following enrollment in the program. This is one example of a service provided by the aging network that persons with Alzheimer's Disease and their caregivers rely on.

For the person with Alzheimer's that lives alone or who does not have a caregiver, the friendly home delivered meal volunteer may be the only daily social interaction they may experience. As noted in the Alzheimer's Association 2012 Alzheimer's Disease Facts and Figures report, one in seven persons with this disease lives alone. The case manager who coordinates services for these individuals often identifies signs or symptoms of illness and communicates with health care providers when they emerge. The aging network plays a significant role in providing community-based services and caregiver supports, which routinely interact with clinicians and health care providers. Considering the demographic shift of the next 30 years, it is vital that the aging network be recognized in the plan and that the plan demonstrates an integration of the health care and aging networks.

Please consider NYSOFA's recommendations for inclusion in the Draft Framework for the National Plan to Address Alzheimer's Disease:

  1. The Aging Network, as noted below in the following statements, should be identified specifically in the following key provisions of the draft plan.

    This is imperative as the aging network is much more than a support system and is better described as a service system of public and private entities that provide a wide range of services targeted to older adults and their caregivers. Many of the direct services, such as Chronic Disease Self-Management Programs and Adult Day Services are "active treatments" for the participants. Please consider including references to the Aging Network in the following statements:

    Page 5: Framework and Guiding Principles -- insert:

    "Individuals with Alzheimer's Disease and their caregivers receive assistance from both the clinical healthcare system and support systems, such as long-term care, home care, legal services, aging and other social services. Both the clinical care and support environments need better tools to serve people with Alzheimer's Disease and their caregivers. Ongoing and future research seeks to identify evidence-based interventions to assist clinicians, persons with Alzheimer's and their caregivers."

    Page 11: Strategy 1.E: Facilitate translation of findings into medical practice and public health programs --insert:

    "Additional steps are needed to highlight promising findings and to facilitate dissemination and implementation of effective interventions to the general public, medical practitioners, the pharmaceutical industry, and public health and aging systems quickly and accurately."

    Page 13: Strategy 2.A: Build a workforce with the skills to provide high-quality care- insert

    "The workforce that serves people with Alzheimer's Disease is diverse and complex. It includes professionals in the aging services network and the licensed health care field - such as primary care physicians; specialists such as neurologists, geriatricians, and psychiatrists; registered nurses and advanced practice nurses; community health workers; social workers; psychologists; pharmacists; dentists; allied health professionals; and direct-care workers like home health aides and certified nursing assistants and, also those who provide consumer directed or informal supports."

    Page 17: Strategy 2.D: Identify high-quality dementia care guidelines and measures across care settings-insert

    "These guidelines should be tailored to the stages of the disease and cover the myriad of care settings in which care is delivered, such as in the home, congregate aging service settings, physician offices, and long-term care facilities."

  2. The aging network relies on non-pharmaceutical evidence based research to continue generating support for service delivery models used to provide care to persons with dementia and their caregivers. The aging network needs clinical trials to better demonstrate the effectiveness of the most promising non-pharmaceutical evidence-based interventions.

    Page 10: Action 1.B 6: Conduct clinical trials on the most promising lifestyle interventions- insert:

    "HHS and its federal partners will continue to conduct evidence based clinical trials to test the effectiveness of lifestyle interventions and risk factor reduction in the prevention of Alzheimer's Disease."

  3. The aging network serves as the foundation on which the Aging and Disability Resource Center (ADRC) is being built to serve as a primary source of information and assistance to persons in need of long term care supports and services.

    Action 2.A. 1: Educate Health Care Providers: insert:

    "Health care providers will learn how to manage the disease in the context of other health care conditions, and about the role of the ADRC in linking people to support services in the community".

  4. In general, persons with Alzheimer's Disease and their caregivers prefer to receive community-based long term services and supports as compared to nursing home placements. Community-based AD care should be routinely referred to in the plan.

    Page 15: Action 2. A. 4: Strengthening the direct-care workforce -insert:

    "HHS will strengthen the nursing home, aging services and long-term services and supports direct-care workforce through new training focused on high-quality, person-centered care for people with Alzheimer's Disease."

    Page 17: Strategy 2.D: Identify high-quality dementia care guidelines and measures across care settings-insert:

    "These guidelines should be tailored to the stages of the disease and cover the myriad of care settings in which care is delivered, such as in the home, aging service settings, physicians' offices, and long-term care facilities. These guidelines should also take into account how care might be modified for diverse populations and in the context of co-occurring chronic conditions in people with Alzheimer's."

  5. The following should be added into Strategy 2. D. on page 17 as an additional action item.

    Adult Day Services implementing evidence-based interventions should be acknowledged as an active treatment for persons with Alzheimer's Disease. There is a substantial need for increased access to dementia capable day centers and in the understanding about the effectiveness of this model by primary care physicians. This undertaking can be enhanced through additional evidence based research on this mode of care. In addition, Medicare should be expanded to reimburse for adult day services for individuals with dementia.

    Although this process is challenging, NYOSFA is confident that the final adopted National Plan will increase positive outcomes for individuals with Alzheimer's Disease and their caregivers, as well as, identifying promising treatments for this ailment. On behalf of NYSOFA, I want to express our appreciation for the consideration of these recommendations.


 

G. Vradenburg  |  03-30-2012

See attached.

==========

From: P. Fritz

[Link to comments -- P. Fritz]


 

N. Manetto  |  03-30-2012

Thanks Mike! I will advise the whole group.

==========

From: J. Simmons Jr.

[Link to comments -- M. Simmons]


 

M. Simmons  |  03-30-2012

Please find attached comments from an industry working group regarding the current draft of the National plan.

ATTACHMENT:

Industry Working Group on Alzheimer's Disease

Eli Lilly & Company
GE Healthcare
Janssen Alzheimer Immunotherapy Research & Development, LLC
Merck & Company, Inc.
Pfizer Inc

As you refine the draft National Plan to Address Alzheimer's Disease, leading biopharmaceutical organizations engaged in Alzheimer's and dementia research and drug development are pleased to have this opportunity to offer comment on a strong first draft. The organizations participating in the Industry Working Group on Alzheimer's Disease (Working Group), identified above, represent many of the industry leaders striving to discover and develop therapies and diagnostics to prevent and treat Alzheimer's disease by 2025 if not sooner. We have collectively invested tens of billions of dollars and many decades of energy to change the course of Alzheimer's disease and dementia, and we are all too familiar with the scientific, medical, and financial challenges associated with this pursuit, as well as the human and societal costs. If we are to reach the HHS stated goal of preventing and effectively treating Alzheimer's disease by 2025 -- which we support -- nothing short of a transformational and transparent partnership between the public and private sectors will be required. We look forward to working with you to make this happen.

The immense risks and challenges associated with bringing a drug, biologic, or other therapies to market are well known. The 1 of every 10,000 potential therapies that end up being approved for patient use take on average 13 years and cost well beyond $1 billion each to develop. For Alzheimer's and dementia research, scientific and other challenges have resulted in a very small number of approved treatments. And of the medications currently available, they address only the symptoms of the disease.

As noted above, we strongly applaud you and the Advisory Council on Alzheimer's Research, Care and Services for embracing the bold and appropriate Goal number 1 of preventing and effectively treating Alzheimer's disease by 2025. Given the significant current public health and fiscal challenges -- and the even greater looming health and fiscal threats posed by the disease -- this is indeed an appropriate goal. Fifty years ago, the nation committed to sending a man to the moon within the decade. We believe the time has come for a second moon shot, one focused on preventing and treating Alzheimer's disease. Just as we succeeded in putting a man on the moon ahead of schedule, we believe this goal can be achieved if the right resources -- public and private -- and the right policies -- those that encourage and accelerate the development of safe and effective treatments -- are brought to bear. The challenge before us now is how to achieve this goal.

This Working Group has devoted considerable time and energies studying this question and is pleased to offer the following comments and suggestions to maximize our collective abilities to achieve success. We have targeted our comments and recommendations within five core areas:

  • Strengthening the role of industry in the overall process, particularly by providing continuing and dynamic input into determining our national research priorities and ways to compress the discovery pipeline.
  • Providing greater specificity and detail -- as well as an accurate statement of resources -- that will be necessary to achieve the strategies and goals.
  • Including the policy incentives necessary to attract and sustain robust industry and capital commitments to Alzheimer's and dementia research.
  • Establishing metrics that are useful in driving the desired outcome, are clear, and are measurable.
  • Extending our vision to encompass the global challenge presented by Alzheimer's disease and dementias.

We will comment on each overarching point and then offer a number of more specific comments and suggestions for the next draft of the National Plan.

I. Strengthen the role of industry in the overall process, particularly by providing continuing and dynamic input into determining our national research priorities and ways to compress the discovery pipeline.

We are encouraged to see multiple references from the Administration that this plan be a true National Plan rather than a federal plan, meaning that it will include shared rights, roles, and responsibilities for all stakeholders. To ensure this desire is achieved, the Working Group strongly believes that the next version of the plan must include a more robust and ongoing process of partnership between government -- particularly the National Institutes of Health and the Food and Drug Administration -- and industry.

For example, while we appreciate the upcoming NIH summit and the Request for Information to collect widespread input on the research agenda, we note these actions are limited to one-time occurrences and do not contemplate an ongoing and robust dialogue and exchange with industry partners. Also concerning is that other recommendations -- including sets 1.B, 1.C, and 1.E, which are focused on expanding research, accelerating effort to identify early and pre-symptomatic stages of the disease, and compressing the discovery timeline, call for what may be viewed as token or no industry engagement whatsoever despite the immense value such involvement would bring to the larger effort.

Specifically, action 1.E.1 focuses on identifying ways to compress the time between target identification and release of treatment, but calls for industry to be involved only indirectly. We strongly believe the plan should recognize an explicit role for industry with a direct seat at this and related tables given the predominant role we collectively play in the therapy discovery and development process. In this way, together, we will begin to set a concrete course that characterizes a new, vital and transparent partnership between the public and private sectors, aligned to achieve the 2025 goal.

Beyond the points above, we urge that the draft plan be amended to include the following:

  • Commit to establishing a meaningful partnership with industry and an ongoing process of dialogue between industry and NIH and the National Institute on Aging (NIA) in determining research and related priorities. Inviting industry to the table to identify significant areas of research need and to present perplexing questions in need of basic research will breathe life into the concept of life cycle innovation by providing invaluable input and exchange of ideas. If the government wants to create a truly national plan, we believe this new partnership with the private sector, one that is open, transparent, and ground-breaking, should be at the core of the plan. In terms of specific models, we recommend exploring the Forum for Collaborative HIV Research and related HIV/AIDS models as potential examples, as well as the platforms created through the Therapeutics for Rare and Neglected Diseases (TRND) program for industry engagement.
  • Establish a standing NIH/NIA and Industry Alzheimer's Working Group to provide the institutes with the continuous feedback loop on research and drug discovery issues such as those raised above. One potential model may be the CEO Roundtable on Cancer, which involves a number of industry partners as well as governmental collaborators including the NIH and FDA. Such a partnership could provide the NIH and other federal entities not only with additional voices and input but also with potential resources to support initiatives, such as more regular scientific conferences and inventories.
  • Increase patient enrollment in clinical trials, particularly targeted minority patients. We strongly applaud this aspect of the plan and we urge that industry play a meaningful role in crafting the recruitment action plan, including being consulted on the populations or sub-populations we believe are most in need. This action plan should include specific tools for attaining this increased participation, such as targeted patient registries.

II. Provide greater specificity and detail -- as well as an accurate statement of resources -- that will be necessary to achieve the strategies and goals.

The Working Group embraces many of the research action steps included in the first draft plan. Expanding basic research into the underpinnings of the disease, identifying risk and protective factors, identifying biomarkers, and identifying ways to compress the therapy development timeline are all tremendously important if we are to achieve the 2025 goal. But each of these strategies and actions is only as good as the corresponding action steps required to achieve them, and we believe greater specificity and detail than what is contained in the first draft is needed. We also believe that given the enormity of the challenges before us, the plan must speak to the significant yet realistic financial resources -- both public and private -- that must be brought to bear against this disease to stop it from destroying our health and finances. You have been bold in stating the 2025 goal, so too you should be realistic in setting the expectation for the resources -- and scope of investment across the public and private sectors -- that will be required to meet this goal.

Following are comments in terms of enhanced specificity that we feel would strengthen the plan.

A clear path to the validation of a family of diagnostic and predictive biomarkers

  • Catalogue existing Alzheimer's biomarker initiatives including their focus/type (e.g., inclusion, prognostic, surrogate endpoint) and where they currently lie in terms of their development and review, identify gaps, and establish a plan that seeks to validate specific biomarkers within a certain timeframe.
  • Convene a joint high-level meeting between FDA and European Medicines Agency (EMA) leadership focused on Alzheimer's biomarkers and surrogate endpoints -- including imaging modalities and imaging agents -- and the much-needed harmonization of guidance and approvals.
  • Develop a joint NIH and FDA -- in close consultation with industry -- action plan focused specifically on identifying and validating Alzheimer's biomarkers. This will be a subset of the larger research prioritization and action plan and involve ongoing NIH, FDA and industry dialogue to better understand biomarker needs, to update the biomarkers action plan, and to provide clear and direct guidance to industry on the use of such tools.
  • Engage the National Center for Advancing Translational Sciences (NCATS) on specific initiatives focused on biomarker and surrogate endpoint development and addressing challenges in conducting clinical trials in pre-symptomatic patient populations.
  • Issue, upon biomarker and endpoint approval, unambiguous guidance to industry on their usage.

A reduction in the cost and time of clinical trials and clinical trial processes

  • Create large-scale, open-architected patient registries, with a particular focus on ethnic subpopulations.
  • Engage industry as to population and subpopulation engagement, data, and other needs.
  • Consider the applicability of novel trial designs, such as models used to address rare disease, for Alzheimer's disease.

Improved access to standardized electronic health and clinical trial data

  • Establish a process involving NIH, FDA, and industry to identify core data issues. Topics would include access to data -- including intervention arm data, failed trial data, dormant therapy data, biomarker data and other valuable data sets -- as well as agreeing to and extending the use of common data standards.
  • As part of this process, engage with industry around specific ideas to enlarge the space of appropriate data sharing. Members of the Working Group have each participated in the Alzheimer's Disease Neuroimaging Initiative, in many ways a seminal effort to explore and expand this space. We understand the opportunities afforded by efforts such as these, both to accelerate development where signals are positive and to fail early where signals suggest a dead end. We are prepared to build on these experiences to create new models that serve to advance therapy development across the sector.

Honest assessment of the level of resources necessary to achieve the 2025 goal

  • Include within the strategies and action items a realistic estimate of the resources necessary to achieve success, and a statement as to how the federal government, particularly during financially challenging times, plans to meet its commitment.
  • Extension of the scope and scale of responses to the global scale including a path forward toward a global action plan and fund.

III. Include the policy incentives necessary to attract and sustain robust industry and capital commitments to Alzheimer's and dementia research

The draft national plan is deficient in that while it notes the importance of compressing the discovery timeline, it fails to mention financial and other policy levers that are needed to attract and sustain robust industry and capital commitment to this most challenging area of research. We urge that you speak to the role of smart incentives within the draft plan and lay out a path for addressing these topics near-term. Specific issues we recommend the plan address directly or develop a process involving industry stakeholders to address include:

  • Maintaining and strengthening a patent system that encourages and rewards innovation and protects and provides a fair return on investment.
  • Establishing avenues for the collaboration of the public and private sectors that realistically take into account the genuine needs and strengths of both groups.
  • Ensuring appropriate payment for any successful therapy that takes into account the enormous costs of research and drug development in this critical area. This requires adequate federal reimbursement and payment policies and having the Center for Medicare & Medicaid Services (CMS) at the table whenever warranted.

IV. Establish metrics that are useful in driving the desired outcome, are clear, and are measurable.

The members of the Working Group strongly believe that meaningful and clear metrics and milestones are absolutely essential for implementing any plan and holding responsible parties accountable. In business, clear action plans and corresponding metrics are commonplace and indispensable in keeping projects focused, on schedule, and on budget. All three of these attributes are necessary if the National Alzheimer's Plan is to be successful in achieving its goals, but the current plan falls short in this area, particularly in setting outcomes for action items. For example:

  • The draft plan seeks to increase enrollment in Alzheimer's clinical trials but fails to specify specific numbers, target demographics or interim milestones.
  • It seeks to increase the pace of collaboration between the Departments of Health and Human Services and Veterans Affairs but does not provide a clear timeframe or goals.
  • It seeks to identify biomarkers but does not establish targets or set a timeframe for biomarker acceptance and validation by the FDA.
  • And it speaks to maximizing government and industry collaboration but does not espouse clear goals for this action, only events like meetings and conferences and high-level themes.

While all of these and other actions are meritorious, they require clear metrics and a commitment to aggressive oversight. To that end, the industry Working Group recommends that the plan be amended to:

  • Commit to develop this year specific action steps and metrics for each action starting with the designation of a specific federal official/office to manage each action.
  • Develop and post on the NAPA website a user-friendly "dashboard" to regularly track progress toward each action, strategy, and goal.
  • Work with industry and other appropriate partners to establish metrics that will increase our collective ability to achieve our goals, particularly the goal of preventing and treating Alzheimer's by 2025.

V. Extend our vision to encompass the global challenge presented by Alzheimer's disease and dementias.

In a recent speech, Professor Peter Piot, former Under Secretary-General of the United Nations and former executive director of UNAIDS, called dementia "one of the largest neglected global health challenges of our generation" and called for a global health action plan to address it. 1 Alzheimer's disease is an epidemic that respects no national boundaries and that threatens to cripple the health and finances of the world if unaddressed. The statistics are clear: more than 36 million people worldwide currently have Alzheimer's or dementia, and projections estimate this number will skyrocket to 115 million by the mid-century point, according to Alzheimer's Disease International. The economic impact of the current epidemic exceeds $600 billion annually, and nearly two-thirds of all victims live in developing nations that are largely ill-equipped to address the challenge.2

Earlier this year, rating agency Standard & Poors issued an analysis that said "Population aging will lead to profound changes in economic growth prospects for countries around the world, we believe, as governments work to build budgets to face ever greater age-related spending needs."3 If governments fail to address this challenge and amend their social benefits systems, the agency concluded, the systems will become unsustainable." As Professor Piot noted, we must learn from the global approach to combat HIV/AIDS and enact a similar approach to Alzheimer's and dementia. No single country can take on this massive and multi-faceted endeavor alone, and the United States should be forceful and positive in recognizing this.

The draft plan acknowledges the need for greater collaboration between the U.S. and international partners, specifically Canada, the United Kingdom, and other nations that have or are developing National Alzheimer's Plans. This is a solid step that must be built upon with a clear path forward. Specifically, we urge that the global section be built out and contemplate specific measurable steps the U.S. will take to help develop and execute a global action plan as well as a global fund focused on both treatment and therapy development.

Conclusion:

Madame Secretary, the members of the ad hoc Industry Working Group wish to express our deep gratitude to you for taking meaningful actions to address our national and global Alzheimer's epidemic. We believe the draft National Plan to Address Alzheimer's Disease is a strong first step, and we offer the above comments and suggestions as part of a sincere offer to foster a true partnership and collaboration with you and your colleagues to prevent and treat this disease by 2025. We welcome any questions you may have, and we stand at the ready to discuss any of our comments with you and your team directly if desired.

  1. See: http://alzheimers.org.uk/site/scripts/news_article.php?newsID=1169
  2. See: http://www.alz.co.uk/research/files/WorldAlzheimerReport2010.pdf
  3. See: http://www.standardandpoors.com/ratings/articles/en/us/?articleType=HTML&assetID=1245328578642

 

M. Wortmann  |  03-30-2012

Alzheimer's Disease International is the worldwide federation of 78 national Alzheimer associations. Attached you may find a letter with our comments to the draft NAPA Act for your consideration.

I have also attached an overview of previous publications by the World Health Organization (WHO) that have any relationship with Alzheimer's disease and related disorders. The WHO will come out with a comprehensive report on 11 April.

ATTACHMENT #1:

ADRD WHO Publications Summary Chart [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-adrd-who-publications-summary-chart]

ATTACHMENT #2:

From a global perspective, the NAPA law, Council and subsequent plan development have given a shot in the arm to the Alzheimer's community which has been pursuing many of the same aims of the act in countries on all five continents. Alzheimer's Disease International (ADI) would like to offer some brief comments to the NAPA planners about the broader context of your work. Though there are major differences in resources and the cost of care between developed and less developed nations, the similarities of challenges around diagnosis, family support, health system development and quality care are universal, as are the aspirations for improved treatment and prevention of Alzheimer's a disease and related dementias.

We offer our comments based primarily in response to draft strategies 1D and 1E, which recommend more international collaboration in the research and public health education sectors, a concept we heartily endorse.

ADI is the international federation of Alzheimer associations around the world, in official relations with the World Health Organization. Each member is the Alzheimer association in their country who support people with dementia and their families. ADI's vision is an improved quality of life for people with dementia and their families throughout the world.

Alzheimer's as a Global Public Health Issue

The global health community is waking up to the size and scope of the problem of Alzheimer's disease and related disorders. These comments review 3 global developments: information reports by our private organisation, Alzheimer's Disease International (of which the Alzheimer's Association is a member), United Nations and World Health Organization reports and actions, which have recently increased and in which the US has played and could continue to play a helpful role.

Since 2009, ADI has issued major data reports about Alzheimer disease and related dementias worldwide. Each report is the product of scientific collaboration, led by an epidemiologist and full research team. I would highlight the most recent report, which provides the latest evidence of the medical and social benefits of an early and accurate diagnosis as a tool on which to base further work to fight the gap between prevalence estimates of 36 million worldwide and actually numbers of people diagnosed. It is estimated that probably no more than 1 in 4 people with dementia have received a formal diagnosis, which has been identified as a significant issue in the US draft plan framework and Healthy People 2020 objectives.

In September 2011 the United Nations held only its second high-level meeting on a health issue in its history. This consultation on non-communicable diseases was held to debate a policy document and the final political declaration urges that member countries: "18. Recognize that mental and neurological disorders, including Alzheimer's disease, are an important cause of morbidity and contribute to the global non-communicable disease burden, for which there is a need to provide equitable access to effective programmes and health-care interventions."

This UN session directed the WHO to develop a series of targets, measures and indicators for reducing non-communicable diseases to be adopted by the World Health Assembly in its May 2012 meeting.

The World Health Organization's involvement in Alzheimer's disease dates back to at least 1982, when it held an expert meeting on senile dementia. For many years most of the focus of the WHO has been through its mental health Programme (mhGap). The programme has produced a steady body of work for international professional and public health audiences about Alzheimer's and dementia. Our summary chart of all WHO publications is appended to these comments.

With WHO now deeply involved in follow-on planning from the NCD summit, efforts are underway to get Alzheimer's disease recognised as the fifth major non-communicable disease. However we need support from the US Government to make that happen and include Alzheimer's disease in the next NCD Strategy 2013-2020! Alzheimer's disease was used as an example of how ageing is a factor in the growing noncommunicable disease challenge in a recent resolution passed at the Assembly's executive meeting in January, and it is certain to be debated at the assembly meeting in May.

WHO Global Report

On April 11 2012 the World Health Organization will release a major global report on Alzheimer's disease and dementia. This is the result of collaboration with over 100 experts around the world to produce a volume similar in size and style to the world report on disabilities. Basic themes of the report will include the need for improved and coordinated research, more professional development of medical and non-medical staff, family caregiver support, and better linkages between health and social services in order to support people with Alzheimer's. The report will also focus on population risk reduction for Alzheimer's disease and dementia, identifying what might be done in the public health sector to better define and reduce population risk of dementia. The prevalence/diagnosis gap is also a theme of the report and it has a section on small subpopulations of people with Alzheimer's disease, such as rural, minority language speaking, or people with Alzheimer's referred to as early or younger onset.

The WHO will signal that we are on the brink of a global health catastrophe. Across the world, 36 million people are living with dementia today. But unlike people with other serious conditions, their plight is very often not recognised. They will argue that their condition attracts only minimal research investment and a lack of awareness about adequate care and treatment mean their condition is often made needlessly worse than it needs to be. As the global population ages the problem will only get bigger.

Scientific Collaborations

Though there are many cross-national, scientific collaborations we suggest the following three that go beyond the bio-medical focus and highlight some of that work as suggestions for additional directions that international collaboration in research could foster.

JPND
The EU supports the European Union Joint Programme - Neurodegenerative Disease Research (JPND) to facilitate trans-European research. The idea was launched in 2008 during the French presidency of the European Union. It is a major effort to improve EU alignment of scientific strategy on Alzheimer's disease and make best use of available resources. It now numbers 24 countries.

JPND major effort to date has been to collaboratively create a strategic research agenda to guide activity and investments. Just released, this strategy is based on the most complete compendium of current country-by-country efforts ever created. It lays out five scientific priorities and a robust set of cross-cutting enabling activities to move the strategy forward, of which two are unique when compared to the draft NAPA framework.

The JPND healthcare and social care research goal identifies the major disconnect between health and social care systems and proposes research activities that may address the gap. Priority activities planned include coordinated studies to validate social care interventions, evaluation of pathways to treatment and support and their effectiveness, the effects of co-morbidity in dementia care and the study of assistive technologies.

The JPND treatments and prevention goal includes a set of activities to examine psychosocial interventions and some population health activities, with a significant public health element of the strategic research agenda is using the planned European Health Examination Study to provide new Europe-wide data on the prevalence of people with early cognitive difficulties. This could be cross-walked with the CDC work on surveillance and compared to the ongoing effort adding cognitive questions to other population health studies such as NHANES, which could to lead to better understanding of population risk factors and the challenges of co-morbid chronic conditions existing with dementia.

Coordinated Prevention and Risk Reduction Studies

We would encourage the NAPA planners to begin to think about Alzheimer's disease as the fifth non-communicable disease, and to take advantage of growing evidence that demonstrates that some of the risk of Alzheimer's and dementia is modifiable, with many of the same risk factors as the other major NCDs.

We support additional careful study and our members are careful not to say "prevention of Alzheimer's" but there is sound science on risk reduction and several more large European dementia prevention studies are targeting cardio-vascular and lifestyle related risk factors which will report in 2012 and 2013. These are:

  • The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)
  • The Prevention of Dementia by Intensive Vascular Care (PreDIVA)
  • The Multidomain Alzheimer Preventive Trial (MAPT)
  • The European Dementia Prevention Initiative is a new (2011) convening body of many of these collaborators. (http://www.edpi.org)

10/66 Dementia Research Group

The 10/66 Dementia Research Group is a collective of researchers carrying out population-based research on dementia, non-communicable diseases and ageing in low and middle income countries 10/66 is a part of Alzheimer's Disease International, and is coordinated by the Institute of Psychiatry, King's College London. All protocols, survey instruments, and de-personalised 10/66 study datasets are available for secondary data analyses, subject to scientific and ethical review. The group has run carer intervention trials as well as validated measures for dementia identification in low resource countries, both of which might find application in the US with cultural or ethnic minorities.

Thank you for the opportunity to offer our comments and support for your efforts.


 

S. Langan  |  03-30-2012

Currently lies in bed at the home she's lived in for many years with my grandfather. I remember christmas with her, going over for sunday breakfast. She helped me study for school. Looked after me when I was small.

Now all she can do all day is lay in her bed and stare at the ceiling. She doesn't remember more then 5 minutes at a time. Gone are all the things I used to love about going to that house, and my poor grandfather has to take care of her, pay for her medical bills and do his best for her even though she's only a shell of his wife. A shell of the once-strong woman who beat cancer numerous times only to have her life taken from her slowly and minutes at a time.

Alzheimer's took my grandmother from me, and I want to support development and research on curing this horrible problem so others don't have to see their families hurt like mine does.


 

C. deVries  |  03-30-2012

Please note the attached document is the American Association for Geriatric Psychiatry's comments on the Draft National Plan to Address Alzheimer's Disease. If you have any questions, please don't hesitate to contact me.

ATTACHMENT:

The American Association for Geriatric Psychiatry (AAGP) is submitting these comments in response to the call for comments to the Draft National Plan to Address Alzheimer's Disease. The American Association for Geriatric Psychiatry (AAGP), established in 1978, is a membership association of nearly 2000 geriatric psychiatrists, geriatricians, nurses, family physicians, psychologists, neurologists, social workers, pharmacists and other health professionals interested in mental health and older adults. AAGP promotes the mental health and well-being of older people through professional education, public advocacy, and support of career development for clinicians, educators, and researchers in geriatric psychiatry and mental health. AAGP's activities include substantial attention to Alzheimer's disease.

Geriatric psychiatrists and others in AAGP are involved in all aspects of national activities addressing Alzheimer's disease. Specifically, members in our organization are principal investigators of federally supported basic science and clinical services investigations regarding Alzheimer's disease; AAGP members are local and national advocates for individuals suffering with dementia and their family caregivers; AAGP members teach and train clinicians at all levels who care for patients with dementia; and, clinician members of AAGP often become the primary coordinator for care management of outpatients with moderate to severe illness, and necessary consultants in residential nursing home care.

From this perspective, AAGP applauds the efforts of the Department of Health and Human Services (HHS) in implementing aspects of The National Alzheimer's Project Act, including the development of the current Draft National Plan to Address Alzheimer's Disease (National Plan). Overall, in AAGP's opinion, the Draft National Plan in its current form has appropriate and commendable goals, and provides an excellent foundation for efforts towards achievement. AAGP remains concerned, however, that this ambitious plan has no explicit funds to implement the goals. The $50 million directed toward this program in 2012 and the proposed additional funding of $80 million will fall billions of dollars short of the appropriations needed to make the National Plan a reality. We urge the HHS to identify sources of funding in order to strengthen it. AAGP would contend that promulgating a plan of this importance without commensurate funding attached to its implementation creates a contradiction in the public's mind and can be demoralizing to everyone impacted by the National Plan including patients, families, clinicians, and the many others involved with the care and support of patients with Alzheimer's disease.

As noted, AAGP members are at the forefront of the research, clinical, and education arenas of Alzheimer's disease in the United States. However, as Constantine G. Lyketsos, MD, and David S. Miller, MD, (both long time members of the AAGP) noted in their article in Alzheimer's & Dementia (2012), Alzheimer's disease is not simply "a memory or cognitive disorder, (as) almost all individuals with AD develop one or more Neuropsychiatric Syndromes at some point in their disease." The lack of discussion in the National Plan of Alzheimer's disease as a mental health issue is startling and one that needs to be remedied. Neuropsychiatric syndromes of Alzheimer's disease are difficult to manage clinically and have a serious and disabling impact on both the patient as well as the caregiver. At the same time, there is a significant lack of knowledge on how to manage these conditions effectively. Health providers must be experts at managing these behaviors with non-pharmacologic therapies until evidence-based pharmacologic interventions are discovered. The National Plan must also recognize that it is the onset of the neuropsychiatric syndromes that often leads to assisted living or nursing home (long-term care) placement for patients with Alzheimer's disease. The current long-term care population includes a majority of patients with dementia and a large percentage of those patients have such behavioral abnormalities. In these settings issues that relate to these syndromes is the central component that worsens quality of life and leads to morbidity and mortality. Research needs to be conducted on a new long-term care model that accommodates these patients in environments that are not only safe, but also can help manage these symptoms so quality of life improves even as Alzheimer's progresses. AAGP believes it is critical that the National Plan both recognizes the existence of AD neuropsychiatric syndromes, and includes research and clinical care strategies on how to address them.

In addition to addressing the mental health of the patient with Alzheimer's disease, AAGP believes it is critical to also address the mental health of the family caregiver. Too often the caregivers of patients with AD suffer from depression, which can lead to disability and/or physical health issues as well as to the development of dementia. In any comprehensive plan on AD, the mental health of the caregiver must be included.

AAGP applauds HHS for including a section on the education of health care providers, recognizing the needs for training specific to the treatment and management of patients with AD. It is well known that all primary care health providers need better education/training in the treatment of patients with AD, but in certain cases subspecialist care by geriatric psychiatrists is necessary. For example, when a patient requires acute psychiatric care with a comorbid diagnosis of AD, a specially trained physician is required. However, due to several factors including insufficient Medicare reimbursement, the number of geriatric psychiatrists in the U.S. is decreasing concurrent with the increasing need for additional specialists to address the growing incidences of dementia. The Institute of Medicine will address some of these issues in its forthcoming report on the needed workforce for mental health of older adults, but the National Plan should also include additional specific strategies for this specialized care. The time is now to invest funds into both training of health care providers as well develop models of care to ensure that there are community care programs to provide quality care for individuals with AD. Although it will require an initial investment of funds, ultimately the community and the health care systems will save money as there will be a decreased burden on the family and health care system.

AAGP offers its assistance to HHS as it begins to implement the National Plan. We are in a position to assist in the dissemination of research as well as actively participate in the education initiatives. We have worked on developing dementia-based curricula as well as conducted hundreds of workshops on the diagnosis and treatment of AD, including the neuropsychiatric syndromes of AD. We offer AAGP as a partner organization to HHS in any and all of these efforts.

We applaud HHS for the development of the National Plan to Address Alzheimer's Disease. We agree that it is necessary for all of us to work together to be successful to address the many challenges facing people with Alzheimer's disease and their families. Please contact us if we can provide further information or support in the execution of the National Plan.


 

M. Sharp  |  03-30-2012

Attached please find comments on the draft plan from the Association for Frontotemporal Degeneration.

We appreciate the opportunity to offer our input on this important project.

ATTACHMENT:

The Association for Frontotemporal Degeneration (AFTD) congratulates the Advisory Council of the National Alzheimer's Project on the creation of the draft National Plan to Address Alzheimer's Disease (AD) (the draft plan). The draft plan is a major step forward in meeting the current and future challenges posed by progressive neurological diseases for the benefit of all who are affected by these devastating illnesses.

AFTD is honored to offer our input on behalf of the thousands of Americans living and working with frontotemporal degeneration (FTD), a group of clinical disorders resulting from a progressive loss of neurons in the frontal and/or temporal lobes of the brain. AD and FTD are related by pathological inclusions, often called neurofibrillary tangles, of the essential brain protein tau but differ in many critical ways. Memory loss, the characteristic symptom of AD, is rare in FTD and, when it does occur, is most often seen only during the later stages of FTD. The initial presentation of FTD can comprise a mix of symptoms, including: changes in behavior and personality diminished cognitive and executive functioning, language and communication problems, as well as motor impairments similar to those found in ALS or Parkinson's disease. FTD progresses unpredictably but inevitably results in complete dependence on medical care to sustain life during the final stages of the disease.

The average age of disease onset in FTD is in the late 50's, about a decade earlier than in AD. This difference poses special challenges shared only by the small percentage of people with the early-onset form of AD. Accessing insurance and finding appropriate health care for a debilitating neurological disease is a tremendous challenge for people under the age of retirement. Furthermore, the stigma associated with cognitive symptoms like dementia for people in their 40's-60's combined with a lack of public and professional awareness of FTD can create an overwhelming sense of isolation for people and families coping with FTD.

As an organization whose mission is devoted exclusively to this "related dementia", we believe that the inclusion of language in the draft plan explicitly addressing the distinct challenges posed by FTD and the related dementias will enable the proposed Actions and Strategies to better meet the needs of those affected by a non-Alzheimer's neurological disease. We strongly urge HHS to solicit input from experts and members of non-Alzheimer's disease communities and to specifically include such individuals as members of the task force detailed by Action 2.H.1 under Strategy 2.H.

Goal 1: Prevention and Treatment by 2025.

AD and FTD are related through a shared underlying pathology. This connection offers exciting research prospects with enormous potential for AD and FTD patients alike. Therapeutic compounds that target the protein tau could have equally effective application for treating both diseases. FTD offers pharmaceutical companies opportunities for drug development not available with AD, such as a larger number of cases related to identified mutations on a small number of genes and a regulatory status to facilitate progress toward clinical drug trials. It is our sincere hope that the draft plan will stimulate aggressive efforts to exploit this point of mutual interest for the sake of both FTD and AD patients and their families.

Goal 2: Care Quality and Efficiency

The primary obstacle to the efficient delivery of high-quality care for FTD in any professional setting is the overwhelming lack of qualified providers experienced in the diagnosis and treatment of FTD. Obtaining a diagnosis of FTD often takes several years, an amount of time equal to ¼ or more of the total life expectancy for some patients, and like AD a definitive diagnosis is still only obtainable by autopsy. Ambiguity in diagnosis during the life of the patient complicates care, clinical trial recruitment, financial planning and all other aspects of coping with a neurodegenerative disease of any kind. Reliable diagnoses that accurately differentiate AD from FTD and all other related diseases would benefit everyone. Once diagnosed, the only professional care available to those with FTD is by providers who advertise services with phrases like "Memory Care" or "Dementia Services" that are intended for people with AD. Some who have FTD, especially people in their 50's or 60's, fail to realize that such resources even apply to them since they do not have memory problems and dementia is widely perceived as a condition that affects only senior citizens. In order to measure and improve care for people affected by FTD any quality improvement tool developed through the draft plan must include data, information, and content addressing the scarcity of professional expertise and knowledge of FTD and recognize the enormous challenge patients and families face in accessing appropriate healthcare services that is not experienced by most of those with AD.

Goal 3: Expanded Support for Patients and Caregivers

Due to the earlier average age of disease onset relative to AD, FTD is more likely to strike people who are still employed and raising a family and inevitably deprives them of their ability to function in either a professional or private capacity. FTD robs families of a parent, and makes experienced professionals incapable of successfully concluding a career. The paucity of public awareness and scarcity of professional expertise can combine with the debilitating symptoms of FTD and throw entire families into personal, financial, and legal turmoil prior to diagnosis. Thus magnifying the impact of FTD on not only the healthcare system, but all other social and legal systems well beyond what is expected of a rare disease. Currently the main source of support for FTD patients and caregivers is extended families, close friends, and perhaps most importantly, other FTD caregivers. The need for strategies and action to expand support for patients and caregivers around the unique challenges posed by FTD is desperate.

Goal 4: Public awareness and Engagement

AFTD respectfully submits that without language explicitly describing the differences between the etiology, demographics and symptoms of FTD and AD, and the distinct challenges these differences impose on patients, caregivers, and the health care system as a whole, the draft plan will not successfully attain this goal for stakeholders involved with FTD. When FTD is subsumed under the phrase "related disorders" critical distinctions are lost, promoting the mistaken belief that dementia is a disease synonymous with AD rather than a symptom with a variety of causes. This, in turn, leads many healthcare professionals across all settings to treat people as if they have AD regardless of their actual diagnosis and provide them with inappropriate care which may even cause harm. Furthermore, when families and patients fail to respond as expected to the inappropriate care they receive they are too often denied care entirely rather than offered alternatives, exacerbating the sense of helplessness and the stigma that is all too common in those diagnosed with FTD. Unless more explicit attention is given to how FTD, and other neurological diseases differ from AD any increase in public awareness and engagement achieved through the draft plan will fail to fully benefit patients, families and caregivers coping with FTD and other neurological disease beside AD.

Goal 5: Improved data infrastructure.

Any data infrastructure created as part of the draft plan needs to be designed to include fields, criteria, and values specific to the impact of FTD, and other non-Alzheimer's diseases, on patients, families, and healthcare systems, if it is to benefit those with a neurological disease besides AD.


 

A. Pomponio  |  03-30-2012

Attached please find feedback from AstraZeneca Pharmaceuticals LP on the Draft Framework of the National Plan to Address Alzheimer's Disease. We thank you in advance for your consideration.

Please do not hesitate to contact us if you have any questions.

ATTACHMENT:

Comments on Draft Framework of the National Plan to Address Alzheimer's Disease

AstraZeneca Pharmaceuticals LP appreciates the opportunity to submit comments on the Draft Framework of the National Plan to Address Alzheimer's Disease. AstraZeneca is a global innovation-driven biopharmaceutical company that discovers, develops, manufactures, and markets prescription medicines that treat the world's most serious illnesses. For decades our scientists have been researching methods to support early diagnosis, stop or slow disease progression, and to alleviate the debilitating symptoms of Alzheimer's Disease.

Dementia research is challenging, and subsequently many pharmaceutical companies have discontinued investment in this area. AstraZeneca remains committed to neuroscience research and has adopted a more flexible R&D model to fully optimize external research partnerships and expertise. In 2012 we announced that our global Neuroscience Innovative Medicines Unit will be headquartered in Cambridge, Massachusetts.

We applaud the government's commitment to strengthen public funding for Alzheimer's disease research thereby accelerating scientific advancement leading to new effective treatments. We support the broader initiative to engage public and private stakeholders around common goals and objectives to optimize existing activity and facilitate public-private sector collaboration. We have a global approach to medicines development and welcome the National Plan's proposal of international collaboration with other countries actively engaging in dementia research.

Disease modifying treatments will remain elusive unless we continue to research the underpinnings of the disease. New genetic, molecular, and cellular targets, beyond recent advances in beta-amyloid, are needed for future pharmaceutical interventions. Ongoing identification, validation, and endorsement of biomarkers enable clinical studies and help demonstrate disease modification. All at-risk patients will benefit from early detection and prevention if diagnostic capabilities are improved and a clear framework to bring effective treatments for this debilitating disease is established. The success of the Alzheimer's Disease Neuroimaging Initiative (ADNI) and the C-Path Institute Coalition Against Major Diseases (CAMD) clearly demonstrate the positive impact public and private sector coordination can have in the development of new treatments for Alzheimer's. AstraZeneca encourages DHHS to continue this spirit of collaboration by including all appropriate stakeholders, including industry, in the overall planning process aimed at minimizing Alzheimer's Disease as a health burden by 2025.

We look forward to working with HHS to pave the way for innovation in Alzheimer's disease treatment and management. Please do not hesitate to contact us if we can be of further assistance.


 

K. Williams  |  03-30-2012

Please find attached comments on the draft National Alzheimer's Plan from the Geriatric Mental Health Alliance of New York. Thank you for the opportunity to comment.

ATTACHMENT:

Geriatric Mental Health Alliance of New York Comments on the
Draft National Plan to Address Alzheimer's Disease

On behalf of the Geriatric Mental Health Alliance of New York, I am writing in response to the draft National Alzheimer's Plan recently released for comment by the Department of Health and Human Services. The Geriatric Mental Health Alliance of New York is a 3,000 member advocacy and education organization formed to improve policy and practice for older adults with behavioral health needs.

We are delighted that a National Alzheimer's Plan is being developed in recognition of the vast growth of the number of people who will have Alzheimer's or other dementias during the elder boom, and we appreciate the opportunity to comment on the draft plan.

However, we believe that the draft plan is inadequate in several critical ways.

Imbalance of Use of Funding: The draft plan does not specify how much funding will be available to deal with Alzheimer's and other dementias in the future, but it does provide some information about new federal funding that has been committed prior to the completion of the plan. $156 million will be made available for the five major goals of the plan. Of this $130 million (83%) is designated for one goal--research. $26 million is designated for enhanced services and supports, provider education, public education, and improved data collection. Of this, $10.7 million is designated for improved care and treatment of 5.4 million people who currently have dementia and their family caregivers. That's less than $2 per person. This is simply not sufficient.

Inadequate Attention to Research About Psychosocial Interventions: The clear tilt of the draft plan is towards research to find a cure for Alzheimer's. It seems to focus heavily on bio-medical research and the development of effective pharmacological treatments. Prevention, cure, or effective slowing of the progression of dementia are, of course, much to be desired. But we do not believe that it is at all likely that this will be achieved by 2025--the goal of this plan--and even if it is, the millions of people who now have or will develop dementia prior to that will not be helped at all.

We know that psychosocial interventions can do much to improve the quality of life of people with dementia and their family caregivers, but we need to know more--to develop truly evidence-based practices. We strongly urge those developing the research plan to pay much more attention to research about psychosocial interventions.

Lack of Attention to Mental Disorders Commonly Experienced by People with Dementia and their Caregivers: People with dementia often have co-occurring mental health conditions such as major depression, anxiety disorders, and psychosis. Almost all exhibit neuro-psychiatric symptoms such as depression, anxiety, apathy, irritability, delusions, hallucinations, agitation, aggression, and sleep disorders. (See Lyketsos, et al) When this happens, those who care for people with dementia turn to mental health providers for help. Yet, the role of the mental health system is barely reflected in the draft plan.

In addition, family caregivers are at high risk for depression, anxiety, and stress related physical disorders. There are evidence-based family support interventions. (See Mittelman). The need for supports for family caregivers is noted in the plan, but briefly and with little substance.

We strongly believe that failure to address issues of mental health will result in continued failure to meet fundamental needs of people with dementia and their families.

Thank you again for the opportunity to comment on the plan. We would be glad to work with HHS to provide the details that are needed to complete a National Alzheimer's Plan that reflects the psychosocial/mental health needs of Americans with dementia and their families as well as their opportunities for improved quality of life.


 

J. Tiller  |  03-30-2012

Bristol-Myers Squibb is pleased to submit the following comments on the Draft Framework for the National Plan to Address Alzheimer's Disease, released by the Assistant Secretary for Planning and Evaluation on January 9, 2012.

We recommend that the Plan include these additional elements:

Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025

  1. Identify Alzheimer's Disease (AD) as a multidecade process eventuating in predementia symptoms and the functional impairments of dementia
  2. Recognize biomarkers as key to diagnosis and treatment
    1. Support partnerships advancing biomarker development and qualification
    2. Develop medical infrastructure for clinical use of biomarkers
    3. Set access standards to ensure access to biomarkers in clinical practice
  3. Ensure that diagnosis and treatment algorithms reflect patient differences, to support individualized treatment for each patient
  4. Promote partnerships of government, academe, industry, and advocacy groups, to foster patient recruitment and AD treatment development programs
  5. Examine routes to both accelerate development of acute treatments, learning from the HIV model, and to support long-term prevention studies.

     

Goal 2: Enhance Care Quality and Efficiency

  1. Establish the optimum age and tests for cognitive screening for all primary care patients.
  2. Evaluate the deployment of specialized memory clinics for early diagnosis, treatment, and clinical trial enrollment, as deployed in other countries
  3. Ensure incentives are in place to secure a sufficient supply of qualified professional and paraprofessional care staff
  4. Ensure access to innovative therapies for AD
    1. Provide comprehensive coding, coverage, and payment for new methods of preventing, diagnosing, and treating Alzheimer's disease at the predementia and dementia stages
    2. Ensure new clinical evidence is adopted into coverage and payment policies in a timely manner so that access and reimbursement is available for advanced treatment options and improved diagnostic tools
    3. Encourage adoption of new approaches to care, such as use of telehealth and increased participation in care by family members and caretakers

       

Goal 3: Expand Supports for People with Alzheimer's Disease and Their Families

  1. Develop and promote care infrastructure, financial planning, and behavior management strategies to support patients in their homes and in residential care.

Goal 4: Enhance Public Awareness and Engagement

  1. Foster AD understanding in a campaign educating payers, patients, families, and health care professionals to recognize and overcome stigma related to AD.

Goal 5: Improve Data to Track Progress

  1. Announce metrics, measureable annual goals and report on them.

We would be happy to expand on these suggestions for improving the Draft Framework to better address the social and medical needs of Americans who have Alzheimer's disease and their families. Please contact me if you would us to provide any additional information.


 

E. Ansello  |  03-30-2012

On behalf of the Area Planning and Services Committee (APSC) on Aging with Lifelong Disabilities, I am sending a letter in response to the Draft National Plan to Address Alzheimer's Disease. We appreciate the opportunity to contribute our thoughts and congratulate you and the council on its initiative.

ATTACHMENT:

The Area Planning and Services Committee (APSC) on Aging with Lifelong Disabilities, which I serve as chairman, respectfully wishes to make comments on the Draft National Plan to Address Alzheimer's Disease. The APSC is a regional coalition comprised of some two dozen organizational and individual members from Chesterfield, Hanover, and Henrico counties and the city of Richmond, Virginia, representing intellectual disabilities, parks and recreation, residential services, blindness and visual impairment, communities of faith, higher education, family caregivers, and more.

The APSC works to address both the opportunities and challenges that present themselves as more adults with lifelong disabilities grow into later life. In effect, the APSC acts as a creative form of de facto public policy, trying to respond in the present to issues that formal regulations have not yet incorporated. For instance, how can aging-related services that are offered only to adults ages 60 and above respond to persons with lifelong disabilities who may manifest "aging" behaviors prematurely? In response, the APSC offers training workshops and statewide conferences, has developed health screening tools and DVDs on healthy diets and nutrition for adults with lifelong disabilities, and more.

Increasingly, service providers and family caregivers are pressing us for more focus on matters related to dementia with intellectual disabilities and other developmental disabilities. Our fall 2011 workshop did and our June 2012 statewide conference will concentrate on dementia care with lifelong disabilities. Adults with Down syndrome and other intellectual disabilities present new challenges to providers and families. Premature expression of Alzheimer's Disease by adults with Down syndrome generally precludes their engagement in aging-related services funded by the Older American Act which stipulates age 60 for eligibility. Dementia disrupts group homes for individuals with lifelong disabilities, for it overwhelms staff's ability to respond in the face of other continuing needs by those without dementia and breaks the bond of community that the adults with disabilities have developed.

At the same time, the overwhelming majority of today's older adults with lifelong disabilities have grown old in family contexts, in the care of their parents, not in an institutional setting. These caregiving parents, now quite advanced in age, are often under-recognized and under-reinforced by outside services, and the presentation of dementia is often more than they can handle. There are today about one million adults with lifelong developmental disabilities who have reached age 60 and beyond. Again, the great majority have done so through the continuing care of the parent and families. These parents and families need and deserve help.

The Draft National Plan does make mention of intellectual disabilities but we respectfully request that the Draft National Plan make a fuller focus, to include at least the following:

  1. Attention to the special circumstances attendant upon the relatively premature expression of dementia among adults with Down syndrome, an expression that occurs before the individual's own eligiblity for aging-related services funded by the Older Americans Act.
  2. Attention to the expression of dementia among adults with other developmental disabilities (e.g., cerebral palsy, non-Down intellecual disabilities) and the consequences of the co-morbidity of dementia and the lifelong disability.
  3. Attention to the growing need of managers, service providers, and policy makers with the developmental disabilities service sector for high quality training on Alzheimer's Disease and other dementias, training that includes both conceptual and practical day-to-day management content.
  4. Attention to the public reliance upon family caregivers as the mainstay of the long-term care system, as it relates to aging with lifelong disabilities, and to the critical needs of thse family caregivers for training in and support about caring for someone with intellectual and/or developmental disabilities who develops Alzheimer's Disease or another dementia.

We thank you for considering our recommendations.


 

B. Brotter  |  03-30-2012

Until sometime early in 2010, patients suffering from Alzheimer's disease were allowed to receive treatment from a psychologist, in the form of a Health and Behavior Intervention Such procedures are used to modify the psychological, behavioral, emotional, cognitive, and social factors identified as important to or directly affecting the patient's physiological functioning, health and well being, or specific disease-related problems. Parkinson's disease and other chronic neurodegenerative conditions still meet criteria for medical necessity, while Azheimer's disease was removed from the list of treatable conditions. While Dementia, Alzheimer's type, or other dementias would not be appropriate to treat with a Health and Behavior Intervention, due to the patient's more severe cognitive impairment, that is not the case for patient with early- mid stage Alzheimer's disease. Advocacy is needed to ensure that these individuals who suffer for years in early stage A.D. are not deprived of the psychological support that patients with other neurodegenerative conditions are provided.


 

L. Julian  |  03-30-2012

Please accept the attached comments on behalf of the Alzheimer's Association, CT Chapter. If you have any questions or concerns, please feel free to contact me.

ATTACHMENT:

National Alzheimer's Project Act (NAPA)

On behalf of the Alzheimer's Association, Connecticut Chapter, we want to thank you for allowing us to provide public comment on the National Alzheimer's Project Act (NAPA).

The Connecticut Chapter is grateful to the administration for making Alzheimer's disease a national priority. We believe the establishment of the plan is a positive step toward beginning to address many challenges, including quality of care, family and caregiver support and the development of new treatments and early detection diagnosis and interventions.

The National Alzheimer's Project Act NAPA

Much of the draft plan focuses on evaluation and assessment of current programs. While these are valuable steps, we encourage the Administration to quickly move from assessment to action for the families touched by this disease.

The plan identifies several challenges that emerged from the Alzheimer's Association's public input process and outlines a framework to begin the implementation process. Ten key issues include: a lack of public awareness, insufficient research funding, difficulties with diagnosis, poor dementia care, inadequate treatments, unprepared caregivers, ill-equipped communities, mounting costs, specific challenges facing diverse communities and those with younger-onset Alzheimer's.

The Chapter thanks the President for taking immediate action to fight Alzheimer's disease with the historic investment of $156 million in research funding with the National Institutes of Health (NIH) and supporting people with Alzheimer's disease and their families in educating the public and providers. On the other hand, statistics suggest $2 billion will be necessary to find a cure to halt the disease. It is the 6th leading cause of death in the United States and the 5th leading cause of death for those aged 65 and older. Alzheimer's is the only cause of death among the top ten in America without a way to prevent, cure or even slow its progression. Furthermore, deaths from Alzheimer's have increased 66 percent between 2000 and 2008, while deaths from other major diseases, including the number one cause of death (heart disease), decreased. Yet, each of these diseases has received between $2 to $8 billion each for the last few years from NIH. Meanwhile, Alzheimer's has been flat-funded at $595 million. It is clear that research funding has helped lower the death rates for other chronic diseases.

The Association is grateful for the administration's goal to prevent and effectively treat Alzheimer's disease by 2025. However, statistics suggest treatments will need to be accelerated to change the trajectory of the disease or it will triple by 2050.

The plan realizes the need for an adequate supply of culturally-competent professionals with appropriate skills, ranging from direct-care workers to community health and social workers to primary care providers and specialists from the point of diagnosis onward in settings including doctor's offices, hospitals, community-based home care and nursing homes. Further, given the complex care needs of people with Alzheimer's disease, high-quality and efficient care is dependent on smooth transitions between care settings and coordination among healthcare and long-term services and support providers. Provider training is essential to effectively detect Alzheimer's disease and caring for people affected by this devastating disease.

Alzheimer's and the Aging Network

The plan provides for HHS to coordinate with states to develop dementia-capable long-term services and support systems and improve the Alzheimer's disease capability of the workforce in their state aging plans. These strategies may include enhancing Alzheimer's disease competencies among Aging Network staff, developing AD-capable community health and long-term care Options Counseling in Aging and Disability Resource Centers, and linking State Long-Term Care Ombudsmen programs to AD-specific training and resources.

Since much of the work required to support caregivers and the direct-care workforce should and will occur at the local level, the state should develop a state plan to tackle Alzheimer's disease. Currently, Connecticut does not have a state plan to address Alzheimer's disease. The state plan would create the infrastructure necessary to build dementia-capable programs for the growing number of people with the disease.

Understanding the enormous stress the disease places on family members and the healthcare system, developing early interventions is necessary to effectively serve and meet the unique needs of people with Alzheimer's disease and their caregivers. A comprehensive assessment and strategy to bring local stakeholders together to address the needs of persons with Alzheimer's disease is recommended on the state level. The collection of testimonials through town forums could be gathered identifying and quantifying the number of individuals with Alzheimer's in the state. The forums could provide the opportunity to elicit the opinions of the general public. As achieved on the national level, an advisory council should be formed in Connecticut. Membership should include: key legislative leaders, the Office of Policy and Management representatives, state agency representatives and community-based groups, persons with Alzheimer's family and professional caregivers, health professionals from hospitals and primary care, residential and community care providers and Alzheimer's Association representatives.

With the multitude of issues to examine as part of state plan development, workgroups can be formed to tackle specialty areas of expertise. In fact twenty-three states have published a state Alzheimer's plan to create the infrastructure to build dementia-capable programs for the growing number of people with the disease.

The Alzheimer's Association, Connecticut Chapter appreciates the opportunity to submit these comments on the National Alzheimer's Project Act (NAPA). In summary, the Chapter agrees earlier diagnosis of the disease and coordinated strategies among the Aging Network for long-term services and supports need to be developed on the state level to meet the growing demands of persons with the disease and their caregivers. Finally, accelerated research and funding for a cure is imminently needed to achieve savings in billions of dollars to the health care system.


 

M. Torres  |  03-30-2012

2.F. Advance Coordinated and Integrated Health and Long-term Care Services and Supports for Individuals Living with Alzheimer's Disease

The Program of All-inclusive Care for the Elderly (PACE) is an outstanding model of care for persons living with Alzheimer's Disease and other memory disorders. As high as two thirds of the PACE participants have cognitive impairment. Utilizing an interdisciplinary team, PACE provides comprehensive, coordinated and integrated care to individuals age 55 and older who meet the nursing home level of care criteria. The goal is to maintain the individual in a non-instituional setting for as long as possible. This program is a three way agreement between the PACE organization, CMS and the state Medicaid agency. Although PACE is currently serving 22,000 individuals nationally, the plan is to significantly increase this program. Research supports the efficacy of this model and should be referenced in your plan.

3.B. Enable Family Caregivers to Continue to Provide Care While Maintaining Their Own Health and Well-Being

More funding is needed for individuals on Medicare that need in-home care. My father was diagnosed with dementia in September of 2010 and passed away in April 2011. During his illness, my mother had to pay out of pocket for three attendants because he did not qualify for Medicaid until the end of his life. The process took several months before a determination was made by the Medicaid Long Term Care Office. Finally, one month before his death, he was deemed eligible with a share of cost. The experience was very challenging for all our family. Moreover, funding for caregiver resources and support have been drastically cut by the State of California. This makes no sense with the anticipated increase of persons with Alzheimer's Disease and other long term illnesses. The federal government needs to step in and assess what states are doing to help caregivers. Otherwise, vulnerable populations will continue to be adversely impacted. It is important for federal entities such as CMS, HRSA and AOA to work together to address these issues and to identify the funding that is vitally needed by families across the nation.

The Napa Advisory Council has been doing excellent work to develop a comprehensive plan that addresses the nationwide epidemic of Alzheimer's Disease

  • It is critical that this plan address the needs of the growing numbers of people living with this disease and their families
  • Several aspects of the plan focus on these issues but do not identify funding for implementation
  • The Alzheimer's Disease Supportive Services Program (ADSSP) which is also known and the Alzheimer's Disease Federal-State Matching Grants Program is the one federal program that has provided focused support for this population in local communities.
  • The NAPA report may want to reference AoA's support through the ADSSP program for sections of the plan including:
    • 2.C.2 Enhance assistance for people with AD and their caregivers to prepare for care needs
    • 2.H Improve care for populations disproportionately affected by Alzheimer's disease and for populations facing care challenges

 

M. Bersani  |  03-30-2012

I would like to thank the Advisory Committee for preparing an excellent draft plan. The Assisted Living Federation of America (ALFA) has submitted comments on a couple of occasions, but I would like to reiterate that our organization is a resource if HHS or the Advisory Committee would like to learn more about the role of licensed assisted living in meeting the needs of individuals with Alzheimer's and related dementia. Our providers have developed special programs that ensure residents have an improved quality of life along with quality of care. We believe these innovative programs should be used to replace the use of psychotropic and other medications that may not be needed. ALFA would just like to request that as the national plan looks ahead to helping individuals with dementia and their family and friends plan for the future, that assisted living be recognized as an appropriate and cost effective option. Thank you.


 

O. Leibman  |  03-30-2012

I just came across an article stating that you are interested in ideas for understanding Alzheimers.

I have been a Clinical Psychologist and College Professor since 1950 and am interested both personally and professionally.

I try to follow the research and have attended regular conferences on Senile Dementia and it seems clear to me that medications have been minimally effective. So far physical exercise, mental stimulation and socialization have proven more effective. In working with older clients the concept of working with the positive-the resources you have -is more effective than focusing on what is lost. In addition meditative techniques are valuable in helping focus and concentration.

As medications seem so limited -it would seem very important to spend some research dollars and involvement in a broad spectrum approach to dealing with Senile Dementia.Thanks for your attention.


 

P. Fritz  |  03-30-2012

Attached please find comments from Leaders Engaged on Alzheimer's Disease (LEAD) on the draft National Plan. Please do not hesitate to contact me if you have any questions.

ATTACHMENT #1:

Leaders Engaged on Alzheimer's Disease (LEAD) commends the Inter-Agency Working Group of the Department of Health and Human Services (HHS) for developing a solid first draft of a National Plan to Address Alzheimer's Disease, a draft that includes goals and actions dealing with the most pressing issues facing people with Alzheimer's disease and their families. LEAD is pleased that a number of priority recommendations previously submitted by the coalition are included in the draft plan.

Organizations from all segments of the Alzheimer's-serving community participated in developing these comments, including non-profits and for-profits, research-oriented and care-oriented, academic and advocacy, among others. LEAD believes strongly that achievement of the goals of preventing and effectively treating Alzheimer's by 2025 and improving the quality of care and of life of Alzheimer's victims and their families will require an National Alzheimer's Team using an 'all hands on deck' approach. LEAD and its participating organizations are prepared to step up as a full member of that Team.

Attached please find LEAD's comments on the first draft of the National Plan. We have organized our comments in the categories of research and drug discovery, clinical care, and long-term care support and services. We hope the Secretary will give strong consideration to including these recommendations in the final National Plan.

Comments provided in this document seek to strengthen the goals, strategies, and actions within the draft plan. As noted in earlier comments, LEAD believes that these goals can be achieved only with a significant increase in investment from the public, private, and non-profit sectors. It is imperative that the actions within the national plan be monitored and tracked to assess the impact of the action steps as well as progress toward the Plan's goals. While we are pleased that HHS will evaluate the data and infrastructure required for implementation of the plan, it is important that there is a model for assessing the impact that strategies within the national plan have on progress toward the desired goals. To that end, LEAD recommends that immediate action be taken to develop a model this year that will allow HHS to accurately assess the impact of the action steps in the national plan and identify areas for course adjustments. We, as a nation, should not pursue implementation steps that are not clearly moving toward our goals. We cannot waste time and resources going down blind alleys. In that regard we recommend that each goal and strategy set forth in the final national plan include a budget, clear milestones and quantifiable metrics to achieving the desired outcome.

LEAD members have also identified a set of other actions within the draft plan that should be implemented immediately, without the need for a national plan. These include activities that are already being undertaken or that leverage current resources and materials. Many of these actions are critical to the success of implementing long-term goals and strategies. Specifically they include disseminating existing tools and guidelines to help healthcare professionals diagnose and care for people with Alzheimer's and their families, as well as expansion of successful interventions that are already proven to improve quality of life for people with Alzheimer's. These actions are highlighted at the end of each section of comments.

Should you have questions or require additional information about this document, please contact the Chief Operating Officer of USAgainstAlzheimer's, or the Vice President of Public Policy at the Alzheimer's Foundation of America. We look forward to working with you on this important effort.

In developing these comments LEAD established three workgroups -- one each in the areas of research and drug development, clinical care and long-term care support and services -- representative of the sentiment and unique needs of the entire Alzheimer's-serving community. Participation in LEAD or in the development of these comments does not constitute an endorsement of each of the recommendations within this document by any particular organization.

Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025

LEAD fully supports this bold goal, with the hope that the goal can be achieved even more rapidly with the right plan and resource commitment. And LEAD is pleased that the Advisory Council has included a number of recommendations submitted by the coalition under Goal 1. Specifically we are pleased that the Advisory Council recommends a strategic approach to focus efforts and resources on "the most promising pharmacological interventions" as well as accelerating efforts to "identify early and presymptomatic stages of Alzheimer's disease." In addition, we are pleased that there is greater emphasis on international coordination and collaboration with commercial and nonprofit partners. However, it is imperative that any goal to prevent and effectively treat Alzheimer's disease include research investments in non-pharmacological treatments. Non-pharmacological approaches to Alzheimer's treatment can improve relevant outcomes including improved behavior and delay of institutionalization.

Below please find LEAD's comments and recommendations for Goal 1 of the draft National Plan:

Action 1.B.5: Conduct clinical trials on the most promising pharmacologic interventions
Strategies to expand research aimed at preventing and treating Alzheimer's disease should reference the very significant contribution that will be made by industry in conducting clinical trials. Strategies should build on the infrastructure that exists in industry for discovering promising new agents for trials and their existing working relationships with regulators to ensure that safe and effective medicines get approved. Strategies should include a statement of what each Federal and industry partner can contribute and where the cost and time of the clinical trial process can be reduced consistent with standards of safety and efficacy.

Action 1.C.1: Identify imaging and biomarkers to monitor disease progression
To further support a strategy to identify early and presymptomatic stages of Alzheimer's disease, government, industry, and patient advocacy organizations should work together to develop a large-scale, open-source patient registry of subjects that can be approached for recruitment in prevention trials, including specifically under-represented ethnic and other sub-populations. Trials focused on identifying early stages of Alzheimer's disease should be based on accepted quantitative clinical trial models designed for studies in early Alzheimer's disease.

Action 1.C.2: Maximize collaboration among federal agencies and with the private sector
With the levels of funding now dedicated by government, academia, and industry to Alzheimer's disease research, it is important to make the most efficient use possible of all partners and resources -- and make the best use of the limited number of patients available for clinical trials. Studies need to be adequately powered, with agents that effectively test mechanisms of action, produce clear evidence of brain target engagement, and really help to advance the state of knowledge. Private industry is ready to support the 2025 goal and should be engaged as a full and equal partner with government and the research community in its achievement.

Action 1.E.1: Identify ways to compress the time between target identification and release of pharmacological treatments
LEAD recommends that this Action include consideration of a uniform patient consent and centralized Institutional Review Board (IRB) to review all multi-center Alzheimer's disease trials to decrease the time for trial start-up and protocol amendments.

Action 1.E.2: Leverage public and private collaborations to facilitate dissemination, translation, and implementation of research findings
Public-Private Partnerships provide an opportunity to overcome many of the challenges associated with taking a basic scientific discovery through development and regulatory approval of a medical product. Partnerships between the private sector, regulatory and other government agencies, academic institutions, nonprofit organizations, and patient groups represent a new model offering innovation and efficiencies in drug development. Many Public Private Partnerships exist around Alzheimer's disease and have helped to overcome barriers to research and drug development. Such partnerships include: the Alzheimer's Disease Neuroimaging Initiative, Coalition Against Major Diseases, FNIH Biomarkers Consortium and the Alliance for Aging Research's ACT-AD Coalition.

LEAD recommends increased support for these partnerships as they seek to establish publicly accessible clinical trial databases that can be mined for information on biomarkers and disease progression. Drug companies can contribute data and conduct prospective trials that may be required to provide the regulatory levels of evidence to assure qualification of new drug tools. Academics can also provide clinical data and analysis to identify optimal biomarkers for qualification. Further as additional data gaps are identified, pre-competitive partnership collaborations can accelerate the pathway toward development of Alzheimer's disease modifying therapies.

New models of Public-Private Partnership cooperation and funding are needed, within or possibly outside of NIH, especially for non-profit organizations, collaborative platforms, and those working toward improving the process of drug development and regulatory review. Infrastructure support for such Alzheimer's partnerships could be provided through HHS or other governmental agency appropriations. Because these partnerships rely upon multi-stakeholder collaborations, it is critical that oversight be provided through multi-stakeholder governance mechanisms to represent the broad spectrum of the various entities (industry, regulatory agencies, government funding, non-profits, academic experts, and patients).

New Recommendation: Address the unique circumstances of individuals with Alzheimer's disease and their ability to provide informed consent for clinical trial participation
LEAD recommends that the final plan includes a process for developing a standardized informed consent to allow participants in clinical trials to authorize their de-identified data be used for research purposes broader than a single study in order to advance understanding, treatment and prevention of Alzheimer's disease. We recommend allowing pooling of individual de-identified data into larger Alzheimer's disease databases to allow data mining and to increase statistical significance, provide information on the natural history of Alzheimer's disease, identify promising biomarkers and response or non-response to treatment. This database would need to address privacy, HIPPA, informed consent and liability issues and need a mechanism to protect proprietary and confidential data. Research activities involving human participants will continue to be conducted in a way that promotes their rights and welfare but include a feature for allowing Alzheimer's patients to opt in and contribute their de-identified data for research as in public databases or opt out for those who do not want to allow their data to be used for research purposes.

New Recommendation: Develop data standards to ensure a uniform approach for collection, transfer, analysis, reporting and archiving of data.
The National Plan should encourage all new and ongoing federally-funded and industry-sponsored Alzheimer's disease clinical trials to use the same Alzheimer's disease data standards developed by the Clinical Data Interchange Standards Consortium (CDISC). Data standards provide a uniform approach for collection, transfer, analysis, reporting and archiving of data. The benefits of using common data standards include improved learning and knowledge generation and a reduction in time, resources and costs. Using these standards will facilitate data sharing and review by the FDA and EMA. In addition, Alzheimer's disease clinical trials data, including data in failed trials, data with respect to dormant drugs, and data rich in biomarker information, should be remapped to the same common Alzheimer's disease CDISC data standards and any federally-funded and industry-sponsored Alzheimer's disease clinical trials data recorded should be shared in a common Alzheimer's disease database for qualified research use.

Actions to be implemented immediately:

Action 1.A.1: Convene an Alzheimer's disease research summit with national and international scientists to identify priorities, milestones, and a timeline
LEAD recommends that all findings from the May research summit be shared with the public for comment and that "strategies and milestones for an ambitious plan to slow progression, delay onset, and prevent Alzheimer's disease" be established within six months of the summit to ensure continued momentum and coordination with the National Plan. LEAD recommends that continuing research summits be conducted every other year in order to monitor progress and adjust priorities in light of funding conditions.

Action 1.A.2: Solicit public and private input on Alzheimer's disease research priorities
The NIA should issue an RFI within six months of the summit as noted above and information be captured and evaluated and considered as the NIA develops priorities for future years.

Action 1.B.3: Increase enrollment in clinical trials and other clinical research through community, national, and international outreach
Within the year HHS should convene representatives from across the federal government, state and local governments, academic medical research institutions, and the private sector to create an action plan for increasing enrollment in clinical trials, including through the building of registries.

Goal 2: Enhance Care Quality and Efficiency

LEAD is pleased that the draft plan includes the goal to enhance care quality and efficiency. A national plan for Alzheimer's disease should focus on developing and continuously improving the care of our citizens in home or community settings by offering the best risk management, prevention strategies, early detection, precise diagnosis, and long-term management available. The strategies outlined for Goal 2 in the draft plan will provide a platform for ensuring that all Americans requiring care for Alzheimer's disease are able to access quality care across various care settings. Below are comments from LEAD regarding the draft plan:

Action 2.A.1: Educate Healthcare Providers
Improved emergency department and inpatient hospital care can be achieved by enhanced recognition of Alzheimer's disease in acute care settings. A key element to achieving this objective is providing information and training for physicians, nurses, nursing aides, and other staff to help manage patient care. This should include psychiatric care for patients with escalating levels of depression, agitation or psychosis, and hospital care for acute agitation or psychosis in public and private hospital settings. Additionally, psychosocial support services must be available to families that allow for the continued home-care of loved ones when illness or other emergency strikes the primary caregiver.

In addition to educating healthcare providers, LEAD recommends that both government and private agencies that regulate, accredit, license and certify residential care and community care providers require training for health and social service professionals caring for people with Alzheimer's disease and other dementias. Such providers should include directors of nursing, nurse supervisors, nursing assistants and respite caregivers. The settings requiring certification should include assisted living, adult day care, nursing home and home care. The training should be based on evidence-based guidelines that have been developed through a consensus processes that includes providers, family caregivers, other advocates and people with dementia.

Action 2.A.3: Collect and disseminate dementia-specific guidelines and curricula for all provider groups across the care spectrum
LEAD recommends that this action be combined with Action 2.D.1 "Explore dementia care guidelines and measures." Both recommendations require input from experts to develop dementia-specific guidelines for dissemination.

Action 2.A.5: Strengthen state aging workforces
LEAD applauds the efforts to strengthen state aging workforces that are "capable and culturally competent" through the Administration on Aging (AOA). While implementing this action, it is important that efforts to improve state strategies do not further burden states' abilities to apply for and utilize funds from AoA. States should maintain flexibility to implement strategies that address the unique needs of the state populations through their state infrastructures.

Action 2.C.2: Enhance assistance for people with AD and their caregivers to prepare for care needs
LEAD recommends that people with Alzheimer's disease and their families are educated about palliative and hospice care by healthcare professionals. Palliative care is specialized medical care provided by a team of doctors, nurses, social workers and other specialists who work collaboratively to provide the best possible quality of life for people facing the pain, symptoms and stresses of serious illness, including Alzheimer's disease. Palliative care relieves suffering while affirming life, regards dying as a normal process, and intends neither to hasten nor postpone death. The integration of the psychological aspects of patient care offers a support system to the patient and, when in need, to help the family cope during the bereavement process.

Action 2.D.1: Explore dementia care guidelines and measures
The Advisory Council should consider merging Action2.D.1 with Action 2.A.3, which calls for the dissemination of "dementia-specific guidelines and curricula for all provider groups across the care spectrum." Both Actions require the convening of an expert panel to develop dementia care guidelines for care providers.

Action 2.F.2: Implement and evaluate new care models to support effective care transitions for people with Alzheimer's disease
To improve coordination of care and to share information on Alzheimer's disease care and best practices, the draft Plan should consider the creation of regional Memory Evaluation and Treatment Centers that leverage existing infrastructure and resources. Memory Evaluation and Treatment Centers should focus on developing, improving and disseminating best practices in clinical care for people with Alzheimer's disease and family caregivers. The Centers are necessary to ensure translation of clinical research into practice. There should be particular focus on advances related to identification of persons with genetic mutations and persons with genetic, biological and environmental risk factors and to the implementation of biomarker-based risk assessments. Such centers would also serve to mobilize assessed populations for clinical trials of new prevention and disease modifying treatments.

New Recommendation: Ensure people with Alzheimer's disease and their families have access to new Alzheimer's therapies
As biologic therapies are approved for Alzheimer's disease, the Centers for Medicare and Medicaid Services (CMS) should consider policy safeguards ensuring Medicare beneficiaries have access to these therapies as health care reform provisions are implemented. This will be particularly important as CMS improves upon the Accountable Care Organization (ACO) program within Medicare. Under current regulations, ACOs will be allowed to share savings with the government to the extent they can achieve savings from an historic baseline trended forward for ACO patients within Parts A and B of Medicare. Due to the absence of any current spending on biologic therapies for Alzheimer's disease in an ACO's benchmark baseline, ACO's may be "penalized" for providing a new treatment to patients. To address this problem, LEAD recommends that CMS create a process under which stakeholders would be able to identify certain high cost or high volume, break-through treatments and request that CMS make a special adjustment to ACO baselines that would remove incentives to underuse those new treatments.

New Recommendation: Primary Care Doctors, Geriatricians, Geriatric Psychiatrists and Neurologists should be adequately reimbursed for patient care and the evaluation of cognitive function including psychometrics and caregiver education and counseling.
Unless doctors are appropriately reimbursed, the complex needs of individuals with Alzheimer's disease will not be addressed. Anticipatory care planning and comprehensive treatment management in a setting where transitions and treatable concomitants of Alzheimer's disease are understood will result in better care. Such practices may delay the onset and progression of disabling clinical symptoms, and allow meaningful function, reduce healthcare costs, and improve the quality of life for individuals with the disease and their family caregivers.

New Recommendation: Develop Quality Care Measures for People with Alzheimer's and their Family
HHS should convene a panel of experts to develop Alzheimer's disease specific quality care measures. Information on these measures should be captured through the use of Health IT tools to track care quality and outcomes.

Actions to be implemented immediately:

Action 2.A.3: Collect and disseminate dementia-specific guidelines and curricula for all provider groups across the care spectrum
HHS should convene a panel of experts to develop guidelines that can be provided to provider groups.

Action 2.B.2: Identify and disseminate appropriate assessment tools
Similar to Action 2.A.3 HHS should quickly convene a panel of experts to develop consensus for appropriate assessment tools and identify strategies for dissemination.

Action 2.C.2: Enhance assistance for people with AD and their caregivers to prepare for care needs
HHS should compile an inventory of tools to assist caregivers from federal and state agencies as well as patient advocacy organizations and make these tools readily available within the next year through the state aging networks.

Action 2.F.1: Identify and disseminate models of hospital safety for people with AD
HHS should convene stakeholders to develop guidelines for hospital safety for people with Alzheimer's and disseminate guidelines through national associations and hospital systems.

Goal 3: Expand Supports for People with Alzheimer's Disease and Their Families

LEAD applauds the draft plan for including goals and strategies that will improve quality care and expand support for people with Alzheimer's disease and other dementias and their families. Specifically, we are pleased that the plan includes recommendations from LEAD to expand proven programs that are in place at the federal, state and local levels that provide adequate care and support for people with Alzheimer's and other dementias and their families. Moving forward it is important that the plan provide adequate resources to be available to support the implementation of these strategies. Below are LEAD comments on Goal 3 of the Draft Plan:

Action 3.A.3: Utilize informatics for caregivers and persons with AD
LEAD recommends that the word "informatics" in the title of this Action be changed to "Health IT" to be consistent with the accompanying language. Identifying and capturing information about caregivers, in particular family caregivers, by health IT applications will help to better coordinate care of both the person with Alzheimer's or other dementias and the caregiver. Capturing information about the health of family caregivers on medical records has an added benefit of supplying data for metrics that can be used to track the impact of programs on both family caregivers and their care recipients. Data would allow for the comparison of patients with and without family caregivers as well as track health impacts on family caregivers.

Action 3.B.3: Review the state of the art of evidence-based interventions that can be delivered by community-based organizations
LEAD recommends that this Action include identifying interventions that are successful in improving the health and wellness of people with Alzheimer's disease and other dementias. Many successful evidence based programs have been proven to work for both people with Alzheimer's and other dementias so it is important that the evaluation of such programs is not limited to only Alzheimer's specific interventions.

Action 3.E.1: Explore affordable housing models
LEAD recommends that this Action include the evaluation of innovative interventions aimed at helping people with Alzheimer's and other dementias remain in the community rather than in long term care or other institutional settings.

New Recommendation: Ensure adequate resources for programs and services supported by AoA's Alzheimer's Disease Supportive Services Program (ADSSP)
ADSSP's focus is to expand the availability of diagnostic and support services for persons with Alzheimer's disease and other dementias and their caregivers, as well as to improve the responsiveness of the home and community-based care system to persons with dementia. The program focuses on serving hard-to-reach and underserved persons using proven and innovative models. In order to achieve Goal 3 in the Draft Plan, funding for ADSSP should be increased rather than reduced so that evidence-based programs can continue to support the growing number of people with Alzheimer's disease and other dementias and their families at the community level.

New Recommendation: Include services for mental and behavioral health services
Mental and behavioral health services must be included in the wide array of needed health services available to individuals with Alzheimer's and other dementias. Mental and behavioral health providers should be represented on interdisciplinary health care teams that work with these individuals, their families and caregivers in primary care, long-term care and community and home-based settings. Cognitive impairment alone does not preclude the ability to benefit from various forms of effective behavioral and mental health interventions.

Actions to be implemented immediately:

Action 3.A.1: Identify culturally sensitive materials and training
Within the year HHS should convene an expert panel to develop an inventory of culturally sensitive materials and trainings available and identify gaps that should be filled by government and patient advocacy organizations.

Action 3.A.2: Distribute materials to caregivers
Utilizing its current inventory of federal agency programs and materials, HHS should make these resources readily available to all caregivers through the state aging programs.

Action 3.B.3: Review the state of the art of evidence-based interventions that can be delivered by community-based organizations
HHS should convene a meeting of partner organizations to identify successful evidence based interventions by community based organizations and quickly work to ensure that more people with Alzheimer's and their families have access to successful programs as identified in Action 3.B.4. There are already programs exist that LEAD recommends that HHS should expand as part of this effort:

  • Older Americans Act - Reauthorization of this legislation would ensure grants to states for community planning and social services, research and development projects, and personnel training in the field of aging.
  • Lifespan Respite Care Act -- Reauthorization of this legislation would authorize grants to statewide respite care service providers. Grants can be used for various purposes, including training and recruiting workers and volunteers, training family caregivers and providing information about available services.
  • National Family Caregivers Support Program - At a minimum, funding levels should meet the recommended levels of the President's FY12 budget ($192 million). This program provides grants to states and territories to pay for a range of programs assisting family and informal caregivers to care for loved ones at home and for as long as possible. In addition, this program should add the family caregiver assessment to the list of services for which states can use program funds.

Action 3.B.6: Share lessons learned through VA caregiver support strategies with federal partners
LEAD recommends that the quarterly meetings identified in this action step commence as soon as possible so that important information is gathered and shared among federal programs and with community based providers.

Goal 5: Improve Data to Track Progress

New Recommendation: Establish a coordinating entity specifically for Alzheimer's disease care, research, and education within the federal government
LEAD members strongly recommended that there be a permanent office or other coordinating entity specifically for Alzheimer's care, research, and education within the federal government. An office in the White House, like that established for HIV/AIDS, would be in a position to coordinate efforts across HHS, DOD and the VA as well as the Departments of Treasury and State and the Office of Management and Budget, in order to assure comprehensive coordination of a national and international effort to prevent and effectively treat Alzheimer's by 2025. Section 2c of the National Alzheimer's Project Act lays the groundwork for a coordinating function with HHS itself by establishing in the Office of the Secretary of Health and Human Services that:

  1. the Secretary or the Secretary's designee be responsible for the establishment and maintenance of an integrated national plan to overcome Alzheimer's; (and)
  2. Provide information and coordination of Alzheimer's research and services across all Federal agencies.

Both the Act itself and those volunteering their time and expertise on the Advisory Council, its work groups, and those assembled by supporting private entities such as LEAD, have envisioned a lasting presence to drive and coordinate Federal and private efforts to defeat Alzheimer's. We recommend that a permanent role be established within the White House as well as in the Office of the Secretary of HHS at the Deputy Assistant Secretary level as National Coordinators of Alzheimer's Plan Implementation. These individuals will be responsible not only for reporting on the progress of the National Plan as provided by the National Alzheimer's Project Act, but also for driving forward aggressive coordination and rationalization of Federal resources with private and global efforts to defeat Alzheimer's by 2025.

The National Alzheimer's Project Act, with bi-partisan support from the Congress, places the responsibility for this function with the office of the Secretary of HHS. A separate person within that office reporting to the Secretary may have a "bully pulpit" but would not have the administrative apparatus to function effectively. Ideally, this role would fall to an official whose full time job is pursuing an end to Alzheimer's in as highly placed a position as possible.

Similarly, locating this HHS responsibility elsewhere within HHS could dilute its importance. The National Institutes of Health, for example, focus on research, not care or education. The Administration on Aging focuses on care and education, not research.

The office of the Assistant Secretary for Planning and Evaluation has begun the implementation of the Plan efficiently and in good time. The professional staff has the institutional knowledge and, all indications are, commitment to the Plan to move it forward. What remains is the appointment of an individual within that office and at the level of a deputy assistant secretary whose full time responsibility is to fulfill the aspirations of the Act, the Advisory Council, Congress, and others who support it.

ATTACHMENT #2:

Data Standards

The Problem
One of the inefficiencies in clinical trials is that data collected by different pharmaceutical companies as well as academic research sites is highly variable. The wealth of data from research holds great potential to advance scientific and regulatory work, but the lack of standardized data creates significant challenges. Variable data can impede a FDA reviewer's ability to perform integral tasks such as rapid acquisition, analysis, storage and reporting of regulatory data. Improved data quality, accessibility and predictability will give reviewers more time to carry out complex analyses, ask in-depth questions and increase review consistency. http://www.fda.gov/.../FormsSubmissionRequirements/ElectronicSubmissions/UCM214120.pdf -

The Solution
Data standards provide a uniform approach for collection, transfer, analysis, reporting and archiving of data. The benefits of using common data standards include improved learning and knowledge generation and a reduction in time, resources and costs. Both FDA CDER and CBER are encouraging the use of data standards by industry into an accepted format such as that created by the Clinical Data Interchange Standards Consortium (CDISC) or Health Level Seven International (HL7). http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm209137.htm

Another potential for use of standardized data is the ability to create larger databases from smaller clinical trials and increase statistical power. Collecting AD data into large databases that can be mined will enable improved clinical trial design and patient selection for research, qualification of biomarkers for use in research, and decisions on the effects of novel therapeutics. An example of how a large database built on pooled AD data can contribute to the knowledge base is the use of modeling and simulation to provide a quantitative model of AD progression as performed by the Coalition Against Major Diseases (CAMD). Indeed, opportunities afforded by AD data standards and data sharing have the potential to reduce costs of clinical trials and accelerate the translation of research into new therapies for the millions of patients and their loved ones affected by Alzheimer's Disease. Making data publically available allows more scientific investigators to perform AD research and provide new insights. A public database can increase collaboration and initiative from multi-disciplinary experts.

Medical research data on Alzheimer's patients should be collected in uniform data standards that are the same if the studies are done in San Francisco, Shanghai or Sydney.

Recommendations
AD Data Standards
Require or strongly encourage all new and ongoing federally-funded and industry-sponsored AD clinical trials to use the same AD CDISC data standards to facilitate data sharing and regulatory authority (FDA and EMA) review.

Remap data AD clinical trial data rich in biomarker data, as ADNI and ADCS, to the same common AD CDISC data standards.

Develop common data standards and measurements for questionnaires that assess cognition and functional status. Engage copyright holders of AD questionnaires to allow an additional layer to capture recording of these instruments into AD CDISC data standards.

Foster the development of standardization of methods for imaging modalities and assays of CSF analytes and establish a resource of appropriate reference samples and reference standards.

Post data from federally-funded and industry sponsored AD clinical trials and recorded in AD CDISC data standards into a common AD database (as the CAMD database) available for qualified research use. Include data from placebo and if possible, active intervention arms

Promote the use of AD data standards in clinical practice/ Electronic Health Records (EHR) to collect data seamlessly that can be aggregated and analyzed for research.

ATTACHMENT #3:

Common informed consent form for AD clinical studies

The Problem
The final report of the Alzheimer's Study Group emphasized that patients are critical contributors to clinical development. There was a call for patients to be made aware that they can speed the search for new treatments by enrolling in clinical trials, contributing tissue samples, and allowing the use of their medical records for research. Human subjects, research funding, and time are all in limited supply. Clinical research on Alzheimer's Disease (AD) must develop methods to assure that resources are used wisely and strategically. The informed consent form is a good place to start.

Currently, patients sign an informed consent form for a single study and specific purpose, rendering the data useless as other ideas become promising. As a result, data are essentially lost and new studies have to be conducted resulting in additional expense, delays and more patients subjected to experimental trials. Even though data sharing is a requirement in NIH funded studies, misunderstandings and overly restrictive consent forms restrict access to data collected under NIH funding and industry clinical trials as well.

The Solution
Obtaining de-identified data from AD clinical trials, multicenter and single site studies, and pooling these data to build large databases is a critical step in providing the necessary research infrastructure to gain an understanding of a disease as complex as Alzheimer's and to examine significant scientific issues such as biomarkers.

Recommendation
We recommend a mechanism to let Alzheimer's patients allow their de-identified data be used for research purposes broader than a single study and that advance understanding, treatment and prevention of Alzheimer's disease. We recommend allowing pooling of individual de-identified data into larger AD databases to allow datamining and increase statistical significance, provide information on the natural history of AD, identify promising biomarkers and response or non-response to treatment. This database would need to address privacy, informed consent and liability issues and need a mechanism to protect proprietary and confidential data. Research activities involving human participants will continue to be conducted in a way that promotes their rights and welfare but include a feature for allowing Alzheimer's patients to opt in and contribute their de-identified data for research as in public databases or opt out for those who do not want to allow their data to be used for research purposes.

The National Health Council has conducted surveys and issued reports such as the Electronic Health Information Exchange: A Live Strong Report describing that "87 percent of patients strongly agree that EHR should provide patients with a way to share their medical information with scientists doing research -- as long as the information cannot be linked to them personally."

ATTACHMENT #4:

Making the case for Public Private Partnerships for NAPA

The Problem
A crisis in medicine today is that there are increasing investments in biomedical research but decreasing numbers of new medical products, especially drugs, that obtain FDA approval and are available to patients.1, 2 In order to respond to this crisis, the field of drug development is undergoing transformational changes.

Taking a basic scientific discovery through development and regulatory approval of a medical product that finally reaches patients faces overwhelming challenges including the long length of research, high rate of failures of potential candidates and enormous costs. This research and development process is so difficult it is called the "Valley of Death." As many as 80-95% of promising drug candidates fail.3, 4 Drug companies will spend tens of thousands to perform research on millions of compounds and spend in excess of a billion dollars over a 10- to 20-year period just to have one drug reach patients.5 A pressing example is Alzheimer's Disease (AD) for which diagnosis is difficult and there are only a few FDA approved treatments to temporarily slow the disease but no cure, at a time when this debilitating disease is exploding in the aging population. In fact, the pace for development and FDA approval of Central Nervous System (CNS) drugs is even longer than other drug classes.6

These challenges mean that companies have to be smarter and more efficient in managing drug discovery and development. Innovation is needed to create greater efficiencies to help move therapies through development, review and approval for patient use. John Castellani, President PhRMA, stated that "The regulatory process is a strategic priority that if done right can reduce time, cost and uncertainty in drug development."4

The Solution:
Increasingly, public private partnerships (PPP) are presenting an opportunity to meet these challenges. Partnerships between the private sector, regulatory and other government agencies, academic institutions, nonprofit organizations, and patient groups represent a new model offering innovation and efficiencies in drug development. Innovation comes from focusing on science that can improve the process of drug development and be applied to regulatory decisions. Efficiencies come from building collaborations and sharing.

The flagship success of PPPs in AD is the Alzheimer's Disease Neuroimaging Initiative 1 (ADNI1), a $60 million, 5-year study to test whether imaging and biological markers, and clinical and neuropsychological assessments could measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). Begun by the National Institute on Aging (NIA) and supported by other federal agencies, private-sector companies and organizations, the ADNI1 investment would have been prohibitive for a single stakeholder. However, ADNI1 has transformed the understanding of the pathophysiology of AD. Additionally, many other PPPs are having an impact in AD, some of which are described below:

ADNI2: Approximately 1,000 people aged 55 to 90 will be followed with imaging and biomarker measures to identify who is at risk for AD, track progression, and devise tests to measure the effectiveness of potential interventions. This ~ $60 million study is funded by NIH and companies.

FNIH Biomarkers Consortium: One project is the first part of a multi-phased effort to utilize ADNI samples to construct multiplex panels in plasma and CSF to diagnose patients with AD and monitor disease progression.

Alliance for Aging Research: The Alliance initiated Accelerate Cure/Treatment for Alzheimer's Disease, a coalition of national organizations representing patients, providers, caregivers, consumers, older Americans, researchers, employers, and health care industries seeking to accelerate development of potential cures and treatments for AD.

Alzheimer's Association Global Standardization: This organization is leading global efforts to standardize Alzheimer's biomarkers with the World Wide AD Neuroimaging Initiative (WW-ADNI) and the Alzheimer's Association Cerebrospinal Fluid (CSF) Quality Control Program.

Alzheimer's Association Research Roundtable: Members facilitate the development and implementation of new treatments for Alzheimer's disease by collectively addressing obstacles to research and development, clinical care and public health education.

Critical Path Institute's Coalition Against Major Diseases (CAMD): CAMD accelerates the development of therapies for AD by advancing drug development tools for regulatory approval. CAMD developed AD data standards with CDISC, a pooled clinical trial database with 6,000 patients, and a clinical disease progression model. CAMD obtained regulatory approval for imaging biomarkers from the EMA and is collaborating with the FDA on CSF and imaging biomarkers.

Critical Path Institute's Patient Reported Outcome (PRO) Consortium: A workgroup is developing and evaluating a PRO instrument on MCI for use in clinical trials designed to evaluate the safety and efficacy of new AD drugs.

IMI PharmaCog: The five-year €20M PharmaCog project, funded under the European Innovative Medicine Initiative (IMI), will provide tools to define the potential of a drug candidate, reduce the development time of new drugs and thus accelerate the approvals of promising new medicines.

While the impact of these PPPs is extensive, there are still significant challenges and opportunities for preventing and treating AD. One challenge is in the regulatory arena. For approval of a new drug, a pharmaceutical company engages exclusively with the regulatory agency and all information within the drug approval process is proprietary. Lessons learned from one AD drug trial are not shared, so any insights on why drugs fail or how particular biomarkers track with disease progression are lost. However, in recognizing the need for change, the FDA established an innovative approach in the Critical Path Initiative. The FDA formalized a process for submitting tools as biomarkers and clinical outcome assessments to be "qualified" for specific uses in supporting drug development.7 Tools that receive a designation of "fit for use" from the FDA's qualification process8 can then be widely shared.

Recommendations
Providing the extensive evidence needed for qualification of tools by regulatory authorities can optimally be carried out through public-private partnerships. PPPs can support publicly accessible clinical trial databases that can be mined for information on biomarkers and disease progression. Drug companies can contribute data and conduct prospective trials that may be required to provide the regulatory levels of evidence to assure qualification of new drug tools. Academics can also provide clinical data and analysis to identify optimal biomarkers for qualification.

The challenge then becomes funding PPPs that move products toward regulatory approval. The cost of qualification for a single biomarker is several million dollars over a time frame of up to 5 years. Such costs require significant investment by both public and private sectors and in-kind contributions in order to be successful. However, the end product is a tool that FDA can have confidence in to produce better data and be used by all drug companies in clinical trials. The result benefits all stakeholders, including patients.

Since not all PPPs conduct research as ADNI does, there needs to be new models of PPP funding, within or possibly outside of NIH, especially for non-profit organizations and those working toward improving the process of drug development and regulatory review. Infrastructure support for such an AD PPP could be provided through HHS or other governmental agency appropriations. Because PPPs rely upon multi-stakeholder collaborations, it is critical that oversight be provided by a multi-stakeholder board to represent the broad spectrum of the various entities (industry, regulatory agencies, government funding, non-profits, academic experts, and patients).

Reference List

  1. Moses H, III, Dorsey ER, Matheson DH, Thier SO. Financial anatomy of biomedical research. JAMA 2005;294(11):1333-1342.
  2. Booth B, Zemmel R. Prospects for productivity. Nat Rev Drug Discov 2004;3(5):451-456.
  3. National Institutes of Health. NIH Announces New Program to Develop Therapeutics for Rare and Neglected Diseases. 2009. Ref Type: Online Source
  4. Pharmaceutical Research and Manufacturers of America (PhRMA). Profile 2008. 2008. Washington DC, PhRMA. Ref Type: Online Source
  5. Moos W. SRI . 2010. Ref Type: Online Source
  6. Impact Report: Pace of CNS drug development and FDA approvals lags other drug classes. Tufts Center for the Study of Drug Development, 201214(2).)
  7. Guidance for Industry: Qualification Process for Drug Development Tools. FDA . 2012. Ref Type: Online Source
  8. Barratt RA, Bowens SL, McCune SK, Johannessen JN, Buckman SY. The critical path initiative: leveraging collaborations to enhance regulatory science. Clin Pharmacol Ther 2012;91(3):380-383.

 

C. McMorris Rodgers  |  03-29-2012

I would like to take this opportunity to comment on the Advisory Council on Alzheimer's Research, Care and Services draft national plan to address Alzheimer's disease. At the outset, let me express my appreciation and gratitude to everyone who is a part of this community: researchers, caregivers, affected individuals, and families who spend day in and day out caring for our loved ones.

I am providing these comments by way of my son Cole, who was born with an extra 21st chromosome. Since his birth, I have learned a great deal about the direct correlation between Down syndrome and Alzheimer's disease. For example, I have learned that Alzheimer's disease attacks adults with Down syndrome at a younger age and with increased frequency compared to the general population. I have also learned that the pathological findings of Alzheimer's disease have been described in the brains of people with Down syndrome since the 1800s and that there are genetic factors at play that, in part, explain these pathologic and clinical observations. I further understand that NIH is funding Down syndrome research using natural history and imaging techniques to identify early markers of cognitive decline. These studies will undoubtedly help people with Down syndrome, but they will also have a broader application to those individuals in the general population who are at risk for developing Alzheimer's disease.

Yet, there is so much more that can be learned from this relationship. I believe that both the Alzheimer's and Down syndrome communities would benefit greatly from additional conversations about this unique scientific correlation. To that end, I would encourage you to include a representative from the Down syndrome research community on the Advisory Council.

It has been just over one year since the National Alzheimer's Project was enacted. By recognizing the specific link between Down syndrome and Alzheimer's disease in the National Alzheimer's Project, the Council would be including all of the most current scientific data available. More importantly, millions of American's who are at risk for Alzheimer's disease will benefit from the research that is already underway in those with Down syndrome. This is truly a win-win for the entire community.


 

L. Williams  |  03-29-2012

Attached is a letter from A. Hinton, Executive Director of the Department of Aging & Adult Services, City and County of San Francisco.

ATTACHMENT:

Thank you for your efforts to develop a national plan to address the growing crisis of Alzheimer's Disease. In 2009 the San Francisco Department of Aging and Adult Services published a Strategic Plan for Excellence in Dementia Care which we are in the process of implementing. Our work has been informed by experts in this field, including the Alzheimer's Association of Northern California and Northern Nevada. As we work to implement our plan we know that a National Plan has the potential to enhance and possibly even advance our efforts locally.

One very clear theme that permeated every workgroup in the process of developing our Strategy for Excellence in Dementia Care was the need for education and training. Not only were family caregivers desperate for education, information and training, but also, first responders, public transportation workers, airport staff, health professionals including physicians and disability agencies, wanted to be better informed and able to refer persons with Dementia and their Care partners to appropriate resources early in the disease process. We currently have a project funded through the Alzheimer's Disease Supportive Services Program that supports the goal of education and training as defined in our Strategic Plan. This project , a partnership between our Department, the Alzheimer's Association, University of California at San Francisco and Kaiser Permanente of San Francisco is testing ways to reduce hospitalizations by providing Caregiver support and education on best practices in Alzheimer's and dementia care to individuals who are part of Kaiser Permanente.

In reviewing the National Plan I do not see any reference to the ADSSP. This concerns me as I believe that ADSSP is the only federally funded program that uniquely targets dementia patients and their families with support and educational services which are as yet not considered "evidenced based practices" but are based on sound assumptions about care

San Francisco is a very diverse city, and yet in our program we are able to target only English speaking Caregivers and persons with Dementia because we do not have enough funding to broaden our study at this time. However, our expectation is that this information gained will give us information that would help fund the part of the plan devoted to populations disproportionately affected by Alzheimer 's disease and populations facing care challenges, such as those from racial and ethnic minorities. This program supports and educates people with the disease and care partners, which is a significant concern addressed in the plan.

We are concerned that the ADSSP funding may be eliminated. I urge you to use the NAPA planning process to assure that funding for programs that are still small and in development but have the opportunity to teach us much about establishing best practices and continues to help develop services for under-served, at-risk populations. This is the ONLY federal program supporting this work for patients with Alzheimer's Disease Care partners and their families.

Thank you for the opportunity to provide feedback on the National Alzheimer's Project Act. It is a wonderful undertaking and we are privileged to be part of the process.


 

N. Hale  |  03-29-2012

I support health and well-being maintenance for family caregivers along with providing funding streams where feasible.

I support developing a plan to establish and include dementia appropriate adult day care services into the scope of long term services. This is much needed, and overdue.


 

D. McCurry  |  03-29-2012

I would like to share with you about our social model, senior adult day center which is certified by the state of Kentucky and is the first social model that is private pay only in Kentucky:

I own Care4Ever Senior Care Center in Elizabethtown, KY. It opened July 1st, 2009 and we have experienced caring for several dementia participants since it opened and how exciting to experience families seeing their loved one with dementia participating in activities in the center, laughing, and being active. One activity so many of those with dementia have liked is the game "Corn Hole". What a simple game, but oh the fun, laughter and exercise that can be gained by that simple bean bag and a hole in a board! Our center was designed to be "like home" and it is comfortable, beautiful and very home-like. Nothing institutional here! I have talked with the VA in Louisville several times about using social model centers for veterans, but to no avail! Medical models are all they use and approve. My other company, Tender Touch Senior Services, which provides in-home, non-medical care to senior adults here in Elizabethtown, serving Hardin Co and the surrounding counties, is in the Homemaker Program with the VA and we go into the homes of nearly 45 veterans in our area and they would get so much more out of coming to the center combined with their homemaking and personal care in their home. My vision reaches so very far, with adult social model day centers, but I get frustrated because so very many people, as they are wearing out from caregiving, only look to nursing homes. We are trying to educate as many people as we can on the wonderful offerings of the social day center, but many times by the time the family gets their loved one with dementia to our center, it is only to buy time until they can place them into a facility. Our staff cries every time someone goes into a nursing home, because we can see that many times they are not ready to go into a facility, but the family is too worn out to even think.

Thanks for reading! I could go on and on!


 

M. Heard  |  03-29-2012

We applaud the efforts of the Council and their Draft National Plan to Address Alzheimer's Disease. This Plan represents a major step forward in the development of a comprehensive strategy for addressing the impact of this devastating condition that affects millions of Americans and their families. At Genworth, we see the effect this disease has every day with our customers.

We were fortunate to have the opportunity to meet with Ms. K. Greenlee and her team on March 6 in Washington DC to discuss the effects of Alzheimer's and how families utilize care providers and services. At that meeting, Ms. Greenlee encouraged Genworth to comment on the NAPA. I have attached our comments in a letter from our Medical Director, Dr. B. Margolis.

Thank you for the opportunity to participate in this important work. Feel free to contact me if we can be of any additional assistance.

ATTACHMENT:

We applaud the efforts of the Council and their Draft National Plan to Address Alzheimer's Disease. This Plan represents a major step forward in the development of a comprehensive strategy for addressing the impact of this devastating condition that affects millions of Americans and their families. While we agree with the overall goals established by the Plan, we offer the following recommendations for your consideration, based on our own experience in the long-term care industry:

  • Under Goal 2, we recommend an additional strategy focused on the creation of a national provider quality database that includes assisted living and home care agencies that are not already monitored by HHS
  • Under Strategy 2.E, we encourage the evaluation of community-based adult day services as an alternative to home or institutional care
  • Under Strategy 2.F, we encourage additional education and resources to help families make the optimal decisions about situs of care and potential timing of transitions
  • Under Strategy 2.G, we encourage incentives based on outcomes for acute care that are designed to help minimize ongoing long-term care costs
  • Under Goal 3, we recommend an additional strategy focused on strengthening people's knowledge of, and access to, long-term care providers and resources.
  • Under Goal 3, we recommend an additional strategy focused on the use of assistive technology to aid in the caregiving and support services for those affected with Alzheimer's
  • Under Strategy 3.B, we recommend focusing more broadly on overall caregiver wellness programs
  • Under Strategy 3.C.2, we recommend leveraging the lessons learned from the "Own Your Future" awareness campaign as a successful model to help drive awareness about long-term care planning
  • Under Goal 5, we encourage engaging the LTCI industry for the purpose of leveraging industry data for potential research partnerships that study type of care, how/where care is delivered, quality of care and change in care needs over time. We believe that industry data represents the single largest identifiable pool of information regarding long term care support services and Alzheimer's.

Again, we appreciate the opportunity to provide our insights and look forward to providing more detailed information regarding our recommendations at your request.


 

J. Gora  |  03-29-2012

Attached you will find a letter urging that people with Down syndrome be included in the national plan to address Alzheimer's Disease.

Please let me know if you have any questions.

ATTACHMENT:

I am writing to urge the Advisory Council to ensure that the population of people with Down syndrome (Ds) is specifically identified in the Draft National Plan to Address Alzheimer's Disease. Currently, this group of individuals, known to be at high risk of developing Alzheimer's and dementia, is given a fleeting reference in the Draft Plan. This omission must be rectified.

In order to better understand the Alzheimer disease process and develop early identification and other practices to treat this devastating disease which often affects individuals with DS early, research is urgently needed. Research of this type will benefit the general population as well as individuals with Down syndrome and those thousands with DS at risk for developing dementia. In addition, as a parent or family member, I am aware of the need to provide special supports for caregivers, often siblings or aging parents, who assume responsibilities for the care needs for individuals with intellectual disabilities and dementia.

It is also case that these individuals have special needs that may differ and require different supports than those provided to individuals in the general population. These needs have been identified by the National Task Group and Intellectual Disabilities and Dementia Practices in an action plan it issued as part of its report: My Thinker's Not Working: A National Strategy for Enabling Adults with Intellectual Disabilities Affected by Dementia to Remain in Their Community and Receive Quality Supports", which has been submitted to the Council.

Individuals with Down syndrome and their families deserve to have the need for research and population specific clinical trials identified specifically and clearly as necessary actions in the final National Plan to Address Alzheimer's Disease as well as the care challenges they face that require increased awareness, early recognition and supports.

We are working with many families who are facing this very issue and the numbers are growing. As Executive Director of one of the largest Down syndrome associations in the country, and as a member of the DSAGC Health Professional Advisory Board who also serves as a consultant for the DSAGC who specializes in helping these families, we strongly urge the Council to consider the aging families who are dealing with aging children with Down syndrome who are most likely going to end up with this painful diagnosis. It is devastating diagnosis for families who have fought so hard to provide lifelong opportunities for their loved one...and then to have those opportunities taken away because of Alzheimer's disease is tragic to watch.

Please include us in the national study.


 

T. Wynkoop  |  03-29-2012

If it's not too much trouble could you please confirm receipt of this document via response to this e-mail message.

ATTACHMENT:

Draft HHS National Plan to Address Alzheimer's Disease. Comments from the Professional Affairs & Information Committee, National Academy of Neuropsychology

We are writing on behalf of the National Academy of Neuropsychology (NAN), a professional association with 3,500 members dedicated to the advancement of neuropsychology as a science and health profession for the benefit of the culturally diverse patients and caregivers that we serve.

Clinical neuropsychologists are licensed, independent doctoral level practitioners with special expertise in the applied science of brain-behavior relationships. We provide neurocognitive assessment, diagnosis, treatment, and integrated support of culturally diverse patients (and their caregivers) suffering from a variety of neurological, medical, neurodevelopmental, and psychiatric conditions, including neurodegenerative diseases such as Alzheimer's disease (AD; cf. Goals 2, 3 & 4 of the Draft HHS Plan). Our patients are referred by a variety of medical specialties. Neuropsychological assessment measures brain functioning with standardized, well-researched tests of attention, processing, memory, language, spatial, motor, sensory, and executive functions as well as social-emotional aspects of behavior and mood (cf. NINCDS-ADRDA, Goal 1 of the Draft HHS Plan). This information aids diagnosis, medical management, placement, and practical life-related patient and caregiver decisions and can stage disease progression and recovery (consequent to future biological interventions). Neuropsychologists are most often located in metropolitan areas, but many have developed part time rural practices to serve outlying communities, and consult with general clinical psychologists and primary care physicians in rural areas.

We thank you for the opportunity to submit comments on the Draft HHS National Plan to Address Alzheimer's disease. We appreciate the effort and diligence of the HHS staff and of the National Advisory Council on Alzheimer's Research, Care, and Services in guiding the agenda for AD research and services which will positively impact the lives of the patients and caregivers that all of us serve. We would also like to thank you for including Psychology in your revised document, given the role that many psychologists play in service to AD patients and caregivers via research, education, and direct services. While neuropsychologists and psychologists share many things in common, neuropsychologists are more specialized in their knowledge of brain-behavior relationships, neuroanatomy, biological bases of cognition and behavior, standardized neurocognitive assessment, and management of neurodegenerative diseases (such as AD). Neuropsychologists frequently consult with their clinical/counseling psychologist colleagues and provide additional highly specialized diagnostic and intervention planning services for the benefit of AD patients and their caregivers. Below we will provide information regarding the critical role that neuropsychological/neurocognitive assessment plays in AD diagnosis, treatment, education, and research, specifically with regard to linking biomarkers to neurobehavioral phenotypes and clinical presentation. Currently neuropsychology and neurocognitive assessment are not acknowledged in the draft HHS plan. We hope to persuade you to redress this omission.

We want to highlight that neuropsychologists already play an active and instrumental role in AD research (e.g., via understanding the neurocognitive and behavioral profile of the disease, determining early clinical signs and symptoms of the disease, and providing the neurocognitive clinical correlates needed for biomarker research). Neuropsychology also plays a key role in education (e.g., to other medical professionals, to patients and caregivers) and direct care of AD patients and their caregivers (e.g., innovative quality of life programs). Your acknowledgement of neuropsychology's role in the future direction of care and research in AD will help to perpetuate neuropsychology's involvement in research and innovative service programs of importance to the Alzheimer's community. Conversely, exclusion of neuropsychologists from the Draft HHS Plan may limit opportunities for neuropsychologists to remain active in AD research, education, and clinical service, and this could seriously disadvantage AD patients and caregivers who are amidst the AD experience.

Specifically, we seek to have neuropsychology included in (1) Strategy 1.C, Action 1.C.1: Identify imaging and biomarkers to monitor disease progression, which stresses the importance of the use of biological markers in the diagnosis of AD. Currently, this section of the document fails to recognize the importance of neuropsychological/neurocognitive markers of the AD phenotype that are currently the gold standard for determining the presence and progression of AD. Additionally, (2) inclusion of neuropsychologists as direct service providers (Strategy 2.A., below) is also critical to AD patients and caregivers needing this help.

1. Strategy 1.C, Action 1.C.1: Identify imaging and biomarkers to monitor disease progression

Regarding Strategy 1.C, Action 1.C.1: Identify imaging and biomarkers to monitor disease progression, we offer the following wording suggestions for your consideration (italics ours):

Under Strategy 1.C: "Significant advances in the use of imaging and biomarkers in brain, blood, and spinal fluids in relation to neuropsychological manifestations have made it possible to detect the onset of Alzheimer's disease, ..."

and/or

Action 1.C.1: "Identify imaging and biomarkers in relation to sensitive neuropsychological measures to monitor disease progression."

In support of these suggestions we offer the following information and references:

Neurocognitive decline is the hallmark of AD, and according to the NIH neurocognitive assessment is essential to the diagnosis of Alzheimer disease, along with clinical history (symptoms and their course), medical tests (such as blood work), and neuroimaging (http://www.nia.nih.gov/alzheimers/topics/diagnosis). Also, While the National Institute on Aging-Alzheimer's Association workgroup on diagnostic guidelines for AD has recommended continued research on biological markers, they continue to consider AD to be a clinical diagnosis based on neurocognitive and functional data,1,2 which are hallmarks of neuropsychological evaluation at very sensitive and detailed levels.

In general, the cognitive screening tests used in the medical context lack sensitivity to early cognitive decline3, and this is further complicated when assessing premorbidly intellectually bright or well-educated patients. Neuropsychological assessment, using standardized and demographically normed tests of cognition, is known to be more sensitive to early cognitive decline.4 Further, neuropsychologists are listed by the NIH along with Geriatricians, Geriatric Psychiatrists, and Neurologists, as specialists in assessment who can provide detailed diagnosis of AD(http://www.nia.nih.gov/alzheimers/topics/diagnosis). In fact, clinical neuropsychologists often field referrals from the other three specialties mentioned by the NIH to provide very detailed assessments to assist in their patient evaluations, and often refer to the other specialists for the benefit of AD patients.

Neuropsychology has significantly advanced the research exploring biological markers of Alzheimer disease through the development of very sensitive neurocognitive tests; tests that are critical to early identification of neurocognitive decline (complementing Strategy 1:C of the HHS draft document).5 In fact, it is not uncommon for a detailed neuropsychological evaluation to detect progressive neurocognitive decline before pathology is observed on neuroimaging such as brain MRI. Such work has assisted countless AD patients and their caregivers to enhance what time they have left, and is now being effectively used by physicians to initiate and monitor the effects of dementia delaying medications (such as cholinesterase inhibitors).

In the final analysis, however, there is still much that needs to be learned of the relationship between AD biomarkers and neurocognitive/functional (neuropsychological) symptoms and outcomes. As Jeffrey Cummings, M.D., noted expert on dementing conditions, has written:

The predictive relationship between biomarker changes and clinical outcomes is critical to their successful utilization in AD drug development programs. This is not known for any AD-related biomarker. Preliminary correlations have been established for some clinical outcomes and some biomarkers; it is unknown if changes in a biomarker (such as reduced MRI ventricular enlargement with treatment) will correlate with reduced decline in cognition or function following treatment (p.1482).6

Dr. Cummings' insightful comments lead to at least three conclusions based on the totality of biomarker research to date. First, more work needs to be done, including continued development of very sensitive standardized neuropsychological measures in relation to biomarkers for earlier identification of AD (as a clinical syndrome). Second, while there may be a correlation between biomarkers and clinical manifestations, the correlation is not perfect. Consequently, AD remains a clinical diagnosis at present, and the measurement of neurocognitive decline or enhancement (based on biological intervention) still requires detailed standardized neuropsychological assessment results (i.e., standardized and objective clinical correlates) to help press forward in biomarker research and to benefit AD sufferers. Third, neuropsychological measures are needed within the research itself as the best current means of characterizing the disease for which biomarkers are sought (i.e., neuropsychological markers remain the gold standard for biomarker research).

2. Strategy 2.A: Build a workforce with the skills to provide high-quality care

Regarding the inclusion of neuropsychologists as direct care providers: While clinical neuropsychology and clinical psychology are related, and often work together in a complementary manner in the community for the benefit of AD patients and caregivers, they are not the same specialty. Consequently, we suggest that you consider including "neuropsychologists" (along with "psychologists") as distinct additional providers within "The workforce that cares for people with Alzheimer's disease..." (Strategy 2.A.), and also in receiving HHS information regarding "...dementia curricula and practice recommendations..." (Action 2.A.3).

In closing, NAN again applauds your efforts to aggressively address AD, and we offer our support and services as researchers and clinicians in this endeavor. Thank you for your time in reviewing our comments. Please direct any comments, questions, or concerns to us via the NAN central office.

References and Annotations:

  1. McKhann, G.M., Knopman, D.S., Chertkow, H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimer's & Dementia, 2011; 7(3):263-269. (From the abstract: "The core clinical criteria for AD dementia will continue to be the cornerstone of the diagnosis in clinical practice, but biomarker evidence is expected to enhance the pathophysiological specificity of the diagnosis of AD dementia.")
  2. Jack, C.R. Jr, Albert, M.S., Knopman, D.S., et al. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimer's & Dementia, 2011; 7(3):257-262. (From the Biomarkers of AD section of the article: "Progression of clinical symptoms closely parallels progressive worsening of neurodegenerative biomarkers," and "In the symptomatic predementia, MCI, phase biomarkers are used to establish the underlying etiology responsible for the clinical deficit." Both of these statements, and others in the article, emphasize the importance and effectiveness of neuropsychological/neurocognitive measures in the identification and tracking of clinical symptoms of AD.)
  3. Stephan, B. C., Kurth, T., Matthews, F. E., Brayne, C., & Dufouil, C. (2010). Dementia risk prediction in the population: are screening models accurate? Nature Reviews, Neurology, 6, 318-26.
  4. Smith, G. E., Ivnik, R. J., & Lucas, J. A. (2008). Assessment techniques: Tests, test batteries, norms, and methodological approaches. In: Textbook of Clinical Neuropsychology. J Morgan and J Ricker (Eds.). New York: Taylor & Francis.
  5. Petersen, R.C., Gill, D.P., Phillips, L.E., & Aisen, P. Early MCI as an imaging target: Data from the National Alzheimer's Coordinating Center. Alzheimer's & Dementia; 6(4): S58.
  6. Cummings, J.L. Integrating ADNI results into Alzheimer's disease drug development programs. Neurobiology of Aging, 2010; 31(8): 1481-1492. (This article includes ample neuropsychological test data.)

Notes:

Special thanks to J.D. Ball, Ph.D., for his editorial comments in the preparation of this document. Submitted electronically by NAN on March 29, 2012.


 

A. Posner  |  03-29-2012

AgeOptions appreciates the opportunity to comment on the National Alzheimer's Plan.

Please see the attached comments.

ATTACHMENT:

AgeOptions, the Area Agency on Aging for the suburban Chicago region since 1974, supports the goals set forth in the National Alzheimer's Plan. The Aging Network plays a strong role in supporting older adults with Alzheimer's and their families and we appreciate our inclusion in many areas of the Plan, including strengthening the state aging workforce and providing education, training and support.

In order to make the National Plan inclusive and responsive to the needs of individuals with Alzheimer's disease and their families, we recommend that the Advisory Council include the following in the Plan:

  • Stronger emphasis on caregiver support services. It is crucial that caregivers are supported in order to ensure that they are able to provide high quality of care and that people with Alzheimer's disease are able to stay in their homes as long as possible. Local Area Agencies on Aging have been providing caregiver support services since 2001 through funding provided by the Older Americans Act. These services include support groups, caregiver counseling, caregiver training programs and respite care options. While these programs are utilized by all caregivers, many clients care for loved ones with Alzheimer's disease. Additionally, Area Agencies on Aging provide outreach and education to caregivers and information and referral services to connect caregivers with appropriate resources.
  • Collaboration at the local level. The National Alzheimer's Plan focuses primarily on national and state organizations. It is essential to include local Area Agencies on Aging, providers, the faith based community and stakeholders in the discussions and plans. Local organizations in our area provide programming and services for people with Alzheimer's and their families, including evidence based programs, case management, support groups, respite care and information and referral. These local organizations must be included in the Plan in order to ensure that individuals in need of Alzheimer's support services have full access to the benefits that will result from this national initiative.

 

D. Friedman  |  03-29-2012

Below and attached are comments I am submitting on behalf of the Healthy Brain Workgroup of the Centers for Disease Control and Prevention-funded Healthy Aging Research Network (CDC-HAN).

==========

Response to Draft National Plan to Address Alzheimer's Disease: Submitted on behalf of the Health Brain Workgroup of the Centers for Disease Control and Prevention-funded Healthy Aging Research Network (CDC-HAN)

The Healthy Brain Workgroup of the Centers for Disease Control and Prevention-funded Healthy Aging Research Network (CDC-HAN) strongly supports the vision statement of the National Alzheimer's Project Act (NAPA) presented by President Barack Obama, which aims to alleviate the suffering and burden associated with Alzheimer's disease (AD) and to "confront the challenge it poses to our public health."

The Healthy Aging Research Network (HAN) was formed in 2001 to help develop and implement a national research and dissemination agenda related to the public health aspects of healthy aging. The HAN consists of a coordinating center, seven member and affiliate universities, and representation from and participation by over 10 national agencies with interests in the well-being of older adults, including AARP, the Alzheimer's Association, the American Medical Association, the US Administration on Aging, the National Association of Chronic Disease Directors, the National Council on Aging, and the U.S. Environmental Protection Agency. This network has played a vital role in national initiatives to ensure the inclusion of AD, cognitive impairment, and cognitive health promotion in the Healthy People 2020 Older Adult objectives. The network has also worked successfully to inform the National Public Health Road Map to Maintaining Cognitive Health, released in June 2007 by the CDC and the Alzheimer's Association [1].

Between 2005 and 2009, the HAN conducted community-based research with over 600 diverse older adults, caregivers, and healthcare providers. Interviews and focus groups were conducted in English, Spanish, Mandarin, Cantonese, and Vietnamese, with representation from African American, American Indian, Asian American, Hispanic, and Non-Hispanic White communities, in urban and rural locations across nine states. [2-4]. Theseolder adults and those who care for older adults represent the stakeholders to whom NAPA is targeted. Findings from this large-scale, multi-site initiative (published in The Gerontologist, volume 49, supplement 1, June 2009) indicated that older adults, regardless of gender, race, ethnicity, language, or geographic region, agree that cognitive health is essential to healthy aging [5, 6]. Older adults also stated that existing media messages about cognitive health and its association with lifestyle factors can be conflicting and confusing [7]. It is imperative that researchers, educators, and policymakers continue to examine communication strategies to better inform the public about the evolving science of maintaining cognitive health and reducing the risk of cognitive impairment. Based on its strong track record, the HAN is well positioned to participate in such efforts.

As currently written, the NAPA does not explicitly state the impact of AD and other dementias on public health or the role that public health can play in this important area. We therefore strongly recommend the explicit inclusion of HAN expertise in public health research and practice in addressing each of the goals outlined in the NAPA. This document provides recommendations for roles that the HAN might fill in implementing the Plan.

  1. Prevent and Effectively Treat Alzheimer's Disease by 2025

    Public health has a long history of fielding prevention research and educational efforts in multiple chronic diseases such as heart disease, musculoskeletal disease, and cancer. HAN member centers have helped develop, evaluate, and implement successful health promotion programs in primary care, senior centers, and other community-based organizations. HAN researchers, in partnership with community collaborators, have developed and tested effective, evidence-based, and widely-used older adult exercise programs, including EnhanceFitness[8-9], Fit and Strong! [10, 11], and A Matter of Balance [12-14] and have demonstrated chronic illness risk reduction and improved health outcomes in these investigations. Although research is still needed about the impact of such lifestyle changes on AD [15], epidemiological and early randomized clinical trials (RCTs) show promise [16]. A cadre of experts within the HAN can help advance this work, both by conducting focused reviews of existing literature and large datasets, and by planning and implementing large scale lifestyle-enhancing initiatives. In addition, as noted above, the HAN has a proven track record in partnering with diverse groups who represent the growing numbers of racial and ethnic minorities in the US and recruiting them to participate in research and the implementation and dissemination of evidence-based findings.

  2. Optimize Care Quality and Efficiency

    Initiatives focused on expanding dementia-specific capabilities in primary care settings are already underway within the HAN. HAN centers have examined primary care providers' perceptions and practices regarding AD and cognitive impairment [17, 18]. A current CDC-funded Special Interest Project (SIP 10-37; PI: M. Snowden) is reviewing the scientific literature to determine the impact of cognitive impairment on co-occurring chronic illnesses, including morbidity, mortality, and how AD and dementias influence the medical care that an individual receives. The project will also identify and catalogue the elements of existing research databases for use in future studies to better understand the relationship between dementia and chronic conditions. The HAN member centers' established associations with racial and ethnic minority, low income, and rural populations provide resources and expertise for assessing and addressing the complications and obstacles faced by these groups who are at high risk for inadequate health care.

  3. Expand Supports for People with Alzheimer's Disease and Their Families

    There is a need for more broadly distributed evidence-based services through involvement of a variety of service providers, including State Health Departments, Area Agencies on Aging, non-profit organizations, faith-based organizations, and other facilities within local communities. Public health has a long history of working within these organizations, and can help mobilize communities to meet these challenges. HAN members and affiliates are actively engaged in working with the Administration on Aging (AoA) in this effort (e.g., University of Washington HAN investigators are currently working with the states of Washington, Oregon, and Ohio on translating evidence-based interventions for individuals with dementia and their family caregivers into existing community health systems [19]).

  4. Enhance Public Awareness and Engagement

    The Department of Health and Human Services should take advantage of the formative investigation already conducted by the HAN that was cited earlier [2-7]. This investigation found low health literacy and lack of access to culturally relevant information about cognitive health across all ethnic and language groups, and in both rural and urban environments. Older adults often reported that recommendations that they heard were ambiguous, contradictory, or impossible to comply with, and recommendations from health providers were often vague and lacked specific planning processes [7]. Thus, there is an urgent need for culturally and educationally appropriate materials and resources for individuals with cognitive impairment, individuals at risk for dementia, caregivers, and providers. The HAN comprehensive data set can provide guidance about messages and media that will be most effective in disseminating this information. The HAN has tremendous reach for public health and aging focused message testing and awareness campaign development, implementation, and evaluation.

    In addition, each HAN site has worked for over 10 years with community advisory groups to facilitate communication between and among state and local government agencies, nonprofit partners, racial and ethnic minority service providers, and academic public health researchers. These partnerships have actively developed and disseminated healthy aging programs, and can be leveraged to promote dementia-prevention education and intervention programs.

  5. Track Progress and Drive Improvement

    Public health researchers have long been instrumental in evaluating large-scale programs to promote health in older adults, including both lifestyle (e.g., exercise, nutrition) and primary prevention (e.g., immunization) interventions. Any effort to measure and evaluate the impact of NAPA on health outcomes for older adults and caregivers and on policy change must be informed by public health, taking advantage of existing expertise in population-level evaluation planning, data collection, analysis, interpretation, and dissemination. The HAN has been involved in developing aging-specific questions for a number of large surveys [18, 20], and has a long history of experience and expertise in this area. It should be noted that the CDC Healthy Aging Program (funder of the HAN) developed a 10-question Behavioral Risk Factor Surveillance System (BRFSS) module on Perceived Cognitive Impairment. Twenty-two states included the module on their state BRFSS in 2011; an additional 16 states are including the module in 2012 (total 38 states, including the District of Columbia). The CDC Healthy Aging Program is working with partners, including the states, to expand the module in 2013 to all 50 states.

In summary, to achieve the goals of NAPA, collaboration with and among public health researchers across the nation is needed. The HAN is an example of a successful and productive collaborative effort, and we look forward to helping move the science forward to address this important public health issue.

References:

  1. U.S. Centers for Disease Control and Prevention, Alzheimer's Association. The Healthy Brain Initiative: A National Public Health Road Map to Maintaining Cognitive Health. Chicago, IL: Alzheimer's Association, 2007.
  2. Laditka JN, Beard RL, Bryant LL, et al. Promoting cognitive health: A formative research collaboration of the Healthy Aging Research Network. Gerontologist. 2009;49(Suppl 1):S12-S17.
  3. Bryant LL, Laditka JN, Laditka SB, Mathews AE. Characteristics of the Healthy Brain sample: Representing diversity among older Americans. Gerontologist. 2009;49(Suppl 1):S23-S29.
  4. Laditka SB, Corwin SJ, Laditka JN, et al. Methods and management of the Healthy Brain study, a large multi-Site qualitative research project. Gerontologist. 2009;49(Suppl 1):S18-S22.
  5. Laditka SB, Corwin SJ, Laditka JN, et al. Attitudes about aging well among a diverse group of older Americans: implications for promoting cognitive health. Gerontologist. 2009;49(Suppl 1):S30-S39.
  6. Wilcox S, Sharkey JR, Mathews AE, et al. Perceptions and beliefs about the role of physical activity and nutrition on brain health in older adults. Gerontologist. 2009;49(Suppl 1):S61-S71.
  7. Friedman DB, Laditka JN, Hunter R, et al. Getting the message out about brain health: A cross cultural comparison of older adults' media awareness and communication needs on how to maintain a healthy brain. Gerontologist. 2009;49(Suppl 1):S50-S60.
  8. Belza B, Snyder S, Thompson M, LoGerfo J. From research to practice: EnhanceFitness ®, an innovative community-based senior exercise program. Top Geriatr Rehabil. 2010;26(4):299-309.
  9. Belza B, Shumway-Cook A, Phelan E, et al. The effects of a community-based exercise program on function and health in older adults: The EnhanceFitness Program. J Applied Gerontol. 2006; 25(4):291-306.
  10. Hughes SL, Seymour RB, Campbell RT, et al. Long term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006; 46(6):801-814.
  11. Hughes, S.L., Seymour RB, Campbell RT, et al. Fit and Strong!: Bolstering maintenance to physical activity among older adults with lower-extremity osteoarthritis. Am J Health Behav. 2010;34(6):750-763.
  12. Smith ML, Ory MG, Belza B, Altpeter M. Personal and delivery site characteristics associated with intervention dosage in and evidence-based fall risk reduction program for older adults. Translational Behavioral Medicine: Practice, Policy and Research, in press 2012.
  13. Smith ML, Jiang L, Ory M G. Falls efficacy among older adults enrolled in an evidence-based program to reduce fall-related risk: Sustainability of individual benefits over time. Family and Community Health, in press 2012;35(2).
  14. Smith ML, Ahn S, Sharkey JR, et al. Successful falls prevention programming for older adults in Texas: Rural-urban variations. J Applied Gerontol. 2011; DOI:10.1177/0733464810378407
  15. Hughes SL, Leith KH, Marquez DX, et al. Physical activity and older adults: expert consensus for a new research agenda. Gerontologist. 2011;51(6):822-832.
  16. Daviglus ML, Bell CC, Berrettini W, et al. National Institutes of Health State-of-the-Science conference statement on preventing Alzheimer's disease and cognitive decline. NIH Consensus Science Statements. April 26-28, 2010; 27(4):1-27.
  17. Hochhalter, AK, Bryant, LL, Hunter R, et al. Primary care providers' perceptions about cognitive health: A qualitative study. AcademyHealth Annual Research Meeting, Seattle, WA, June 12-14, 2011.
  18. Day KL, Friedman DB, Laditka JN, et al. Perceptions and practices on prevention of cognitive impairment: A survey of U.S. physicians. J Applied Gerontol. 2011; DOI: 10.1177/0733464811401354.
  19. Teri L, McKenzie G, Logsdon RG, et al. Translation of two evidence-based programs for training families to improve care of persons with dementia. Gerontologist. 2012 Jan 12. PMID: 22247431.
  20. Friedman DB, Hunter R, Bryant LL, et al. Beliefs and practices for reducing risk of cognitive impairment among physicians and other adults. Society for Public Health Education Midyear Scientific Conference, Nashville, TN, April 11-14, 2012.

ATTACHMENT:

Response to Draft National Plan to Address Alzheimer's Disease
HAN Recommendations

Submitted on behalf of the Healthy Brain Workgroup of the Centers for Disease Control and Prevention-funded Healthy Aging Research Network (CDC-HAN)

The Healthy Brain Workgroup of the Centers for Disease Control and Prevention-funded Healthy Aging Research Network (CDC-HAN) strongly supports the vision statement of the National Alzheimer's Project Act (NAPA) presented by President Barack Obama, which aims to alleviate the suffering and burden associated with Alzheimer's disease (AD) and to "confront the challenge it poses to our public health."

The Healthy Aging Research Network (HAN) was formed in 2001 to help develop and implement a national research and dissemination agenda related to the public health aspects of healthy aging. The HAN consists of a coordinating center, seven member and affiliate universities, and representation from and participation by over 10 national agencies with interests in the well-being of older adults, including AARP, the Alzheimer's Association, the American Medical Association, the US Administration on Aging, the National Association of Chronic Disease Directors, the National Council on Aging, and the U.S. Environmental Protection Agency. This network has played a vital role in national initiatives to ensure the inclusion of AD, cognitive impairment, and cognitive health promotion in the Healthy People 2020 Older Adult objectives. The network has also worked successfully to inform the National Public Health Road Map to Maintaining Cognitive Health, released in June 2007 by the CDC and the Alzheimer's Association [1].

Between 2005 and 2009, the HAN conducted community-based research with over 600 diverse older adults, caregivers, and healthcare providers. Interviews and focus groups were conducted in English, Spanish, Mandarin, Cantonese, and Vietnamese, with representation from African American, American Indian, Asian American, Hispanic, and Non-Hispanic White communities, in urban and rural locations across nine states. [2-4]. These older adults and those who care for older adults represent the stakeholders to whom NAPA is targeted. Findings from this large-scale, multi-site initiative (published in The Gerontologist, volume 49, supplement 1, June 2009) indicated that older adults, regardless of gender, race, ethnicity, language, or geographic region, agree that cognitive health is essential to healthy aging [5, 6]. Older adults also stated that existing media messages about cognitive health and its association with lifestyle factors can be conflicting and confusing [7]. It is imperative that researchers, educators, and policymakers continue to examine communication strategies to better inform the public about the evolving science of maintaining cognitive health and reducing the risk of cognitive impairment. Based on its strong track record, the HAN is well positioned to participate in such efforts.

As currently written, the NAPA does not explicitly state the impact of AD and other dementias on public health or the role that public health can play in this important area. We therefore strongly recommend the explicit inclusion of HAN expertise in public health research and practice in addressing each of the goals outlined in the NAPA. This document provides recommendations for roles that the HAN might fill in implementing the Plan.

1. Prevent and Effectively Treat Alzheimer's Disease by 2025

Public health has a long history of fielding prevention research and educational efforts in multiple chronic diseases such as heart disease, musculoskeletal disease, and cancer. HAN member centers have helped develop, evaluate, and implement successful health promotion programs in primary care, senior centers, and other community-based organizations. HAN researchers, in partnership with community collaborators, have developed and tested effective, evidence-based, and widely-used older adult exercise programs, including EnhanceFitness [8-9], Fit and Strong! [10, 11], and A Matter of Balance [12-14] and have demonstrated chronic illness risk reduction and improved health outcomes in these investigations. Although research is still needed about the impact of such lifestyle changes on AD [15], epidemiological and early randomized clinical trials (RCTs) show promise [16]. A cadre of experts within the HAN can help advance this work, both by conducting focused reviews of existing literature and large datasets, and by planning and implementing large scale lifestyle-enhancing initiatives. In addition, as noted above, the HAN has a proven track record in partnering with diverse groups who represent the growing numbers of racial and ethnic minorities in the US and recruiting them to participate in research and the implementation and dissemination of evidence-based findings.

2. Optimize Care Quality and Efficiency

Initiatives focused on expanding dementia-specific capabilities in primary care settings are already underway within the HAN. HAN centers have examined primary care providers' perceptions and practices regarding AD and cognitive impairment [17, 18]. A current CDC-funded Special Interest Project (SIP 10-37; PI: M. Snowden) is reviewing the scientific literature to determine the impact of cognitive impairment on co-occurring chronic illnesses, including morbidity, mortality, and how AD and dementias influence the medical care that an individual receives. The project will also identify and catalogue the elements of existing research databases for use in future studies to better understand the relationship between dementia and chronic conditions. The HAN member centers' established associations with racial and ethnic minority, low income, and rural populations provide resources and expertise for assessing and addressing the complications and obstacles faced by these groups who are at high risk for inadequate health care.

3. Expand Supports for People with Alzheimer's Disease and Their Families

There is a need for more broadly distributed evidence-based services through involvement of a variety of service providers, including State Health Departments, Area Agencies on Aging, non-profit organizations, faith-based organizations, and other facilities within local communities. Public health has a long history of working within these organizations, and can help mobilize communities to meet these challenges. HAN members and affiliates are actively engaged in working with the Administration on Aging (AoA) in this effort (e.g., University of Washington HAN investigators are currently working with the states of Washington, Oregon, and Ohio on translating evidence-based interventions for individuals with dementia and their family caregivers into existing community health systems [19]).

4. Enhance Public Awareness and Engagement

The Department of Health and Human Services should take advantage of the formative investigation already conducted by the HAN that was cited earlier [2-7]. This investigation found low health literacy and lack of access to culturally relevant information about cognitive health across all ethnic and language groups, and in both rural and urban environments. Older adults often reported that recommendations that they heard were ambiguous, contradictory, or impossible to comply with, and recommendations from health providers were often vague and lacked specific planning processes [7]. Thus, there is an urgent need for culturally and educationally appropriate materials and resources for individuals with cognitive impairment, individuals at risk for dementia, caregivers, and providers. The HAN comprehensive data set can provide guidance about messages and media that will be most effective in disseminating this information. The HAN has tremendous reach for public health and aging focused message testing and awareness campaign development, implementation, and evaluation.

In addition, each HAN site has worked for over 10 years with community advisory groups to facilitate communication between and among state and local government agencies, nonprofit partners, racial and ethnic minority service providers, and academic public health researchers. These partnerships have actively developed and disseminated healthy aging programs, and can be leveraged to promote dementia-prevention education and intervention programs.

5. Track Progress and Drive Improvement

Public health researchers have long been instrumental in evaluating large-scale programs to promote health in older adults, including both lifestyle (e.g., exercise, nutrition) and primary prevention (e.g., immunization) interventions. Any effort to measure and evaluate the impact of NAPA on health outcomes for older adults and caregivers and on policy change must be informed by public health, taking advantage of existing expertise in population-level evaluation planning, data collection, analysis, interpretation, and dissemination. The HAN has been involved in developing aging-specific questions for a number of large surveys [18, 20], and has a long history of experience and expertise in this area. It should be noted that the CDC Healthy Aging Program (funder of the HAN) developed a 10-question Behavioral Risk Factor Surveillance System (BRFSS) module on Perceived Cognitive Impairment. Twenty-two states included the module on their state BRFSS in 2011; an additional 16 states are including the module in 2012 (total 38 states, including the District of Columbia). The CDC Healthy Aging Program is working with partners, including the states, to expand the module in 2013 to all 50 states.

In summary, to achieve the goals of NAPA, collaboration with and among public health researchers across the nation is needed. The HAN is an example of a successful and productive collaborative effort, and we look forward to helping move the science forward to address this important public health issue.

References:

  1. U.S. Centers for Disease Control and Prevention, Alzheimer's Association. The Healthy Brain Initiative: A National Public Health Road Map to Maintaining Cognitive Health. Chicago, IL: Alzheimer's Association, 2007.
  2. Laditka JN, Beard RL, Bryant LL, et al. Promoting cognitive health: A formative research collaboration of the Healthy Aging Research Network. Gerontologist. 2009;49(Suppl 1):S12-S17.
  3. Bryant LL, Laditka JN, Laditka SB, Mathews AE. Characteristics of the Healthy Brain sample: Representing diversity among older Americans. Gerontologist. 2009;49(Suppl 1):S23-S29.
  4. Laditka SB, Corwin SJ, Laditka JN, et al. Methods and management of the Healthy Brain study, a large multi-Site qualitative research project. Gerontologist. 2009;49(Suppl 1):S18-S22.
  5. Laditka SB, Corwin SJ, Laditka JN, et al. Attitudes about aging well among a diverse group of older Americans: implications for promoting cognitive health. Gerontologist. 2009;49(Suppl 1):S30-S39.
  6. Wilcox S, Sharkey JR, Mathews AE, et al. Perceptions and beliefs about the role of physical activity and nutrition on brain health in older adults. Gerontologist. 2009;49(Suppl 1):S61-S71.
  7. Friedman DB, Laditka JN, Hunter R, et al. Getting the message out about brain health: A cross cultural comparison of older adults' media awareness and communication needs on how to maintain a healthy brain. Gerontologist. 2009;49(Suppl 1):S50-S60.
  8. Belza B, Snyder S, Thompson M, LoGerfo J. From research to practice: EnhanceFitness ®, an innovative community-based senior exercise program. Top Geriatr Rehabil. 2010;26 (4):299-309.
  9. Belza B, Shumway-Cook A, Phelan E, et al. The effects of a community-based exercise program on function and health in older adults: The EnhanceFitness Program. J Applied Gerontol. 2006; 25(4):291-306.
  10. Hughes SL, Seymour RB, Campbell RT, et al. Long term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006; 46(6):801-814.
  11. Hughes, S.L., Seymour RB, Campbell RT, et al. Fit and Strong!: Bolstering maintenance to physical activity among older adults with lower-extremity osteoarthritis. Am J Health Behav. 2010;34(6):750-763.
  12. Smith ML, Ory MG, Belza B, Altpeter M. Personal and delivery site characteristics associated with intervention dosage in and evidence-based fall risk reduction program for older adults. Translational Behavioral Medicine: Practice, Policy and Research, in press 2012.
  13. Smith ML, Jiang L, Ory M G. Falls efficacy among older adults enrolled in an evidence-based program to reduce fall-related risk: Sustainability of individual benefits over time. Family and Community Health, in press 2012;35(2).
  14. Smith ML, Ahn S, Sharkey JR, et al. Successful falls prevention programming for older adults in Texas: Rural-urban variations. J Applied Gerontol. 2011; DOI:10.1177/0733464810378407
  15. Hughes SL, Leith KH, Marquez DX, et al. Physical activity and older adults: expert consensus for a new research agenda. Gerontologist. 2011;51(6):822-832.
  16. Daviglus ML, Bell CC, Berrettini W, et al. National Institutes of Health State-of-the-Science conference statement on preventing Alzheimer's disease and cognitive decline. NIH Consensus Science Statements. April 26-28, 2010; 27(4):1-27.
  17. Hochhalter, AK, Bryant, LL, Hunter R, et al. Primary care providers' perceptions about cognitive health: A qualitative study. AcademyHealth Annual Research Meeting, Seattle, WA, June 12-14, 2011.
  18. Day KL, Friedman DB, Laditka JN, et al. Perceptions and practices on prevention of cognitive impairment: A survey of U.S. physicians. J Applied Gerontol. 2011; DOI: 10.1177/0733464811401354.
  19. Teri L, McKenzie G, Logsdon RG, et al. Translation of two evidence-based programs for training families to improve care of persons with dementia. Gerontologist. 2012 Jan 12. PMID: 22247431.
  20. Friedman DB, Hunter R, Bryant LL, et al. Beliefs and practices for reducing risk of cognitive impairment among physicians and other adults. Society for Public Health Education Midyear Scientific Conference, Nashville, TN, April 11-14, 2012.

 

S. Tucker  |  03-29-2012

These are thoughts and quotes from people with early dementia that are actively involved as a Early Stage Advisory member at the Minnesota-North Dakota chapter. I feel it would be helpful and important to include the voice of someone with the disease.

Advocacy:

"Advocacy is important because you know that you are not alone in this disease." Bob PWED

"Early dementia is a total change in my life-loss of independence in the way I have lived my life. It is like standing on a high mountain and not knowing if I will be able to get down safely. Being an advocate for this disease gives me empowerment over this disease and hopefully others are empowered too." Julie PWED

"Alzheimer's is a quiet disease,people who have it often don't want to talk about it. Stating the disease can often take the shame out of the shadow and it can develop connections." Dick PWED

"It is important for us to be verbal about what we are experiencing. There are times of loneliness and sadness. We need the support of care partners and others. By support I mean a genuine concern and willingness to care. "Jim, PWED

Education:

"Education helps me know what is happening to me, helps me navigate and understand this disease." Bob PWED

"This diagnosis hits you in the gut. Life stops for a time until someone comes my way, to help me learn a whole new life." Julie PWED

"More people understand the disease more clearly when it is spoken openly" Dick PWED

Support Groups:

"Support groups are helpful in learning and supporting one another." Bob PWED

"We need a time and place to learn from each other, to support each other, to learn to live again knowing that we will each hold the other up." Julie PWED

"Getting together with others and speaking openly about the disease opens up discussion that can be very helpful and connects us with others." Dick PWED

Early Stage Advisory Quotes

"It's bad enough being diagnosed," Julie said, "it feels like no one wants you anymore. I chose to get involved because I want a purpose; I want to be engaged and for my life to have meaning. I want to help others who are just like me and use the brain power I do have, for something that is good." Julie PWED

"You have to understand, life doesn't stop with diagnosis," Jim said. "This group is a testament to what it's like to live with this disease." He smiled. "And right now, this is the best period of my life. I'm going to enjoy it." Jim, PWED

"We can change the world." Mike said. "My goal is to eradicate this disease so my children never have to deal with it again." Jim, Dick and Julie all nod in agreement. Mike, PWED

"We're the new faces of Alzheimer's," Dick said. "And we're choosing to make a difference." Dick, PWED

"We don't just have a disease," Dick said, the newest member of the Minnesota-North Dakota Early Stage Advisory Group. "We live the disease. And while I've accepted that this is a part of me, I'm not going to let it define who I am."

"We're the same people we were yesterday," Julie said. "We haven't changed and it's important others know."


 

A. Mendrys  |  03-29-2012

Attached please find a letter from the National Academy of Neuropsychology (NAN) regarding the Draft HHS National Plan to Address Alzheimer's Disease. Please let me know if you have any questions.

ATTACHMENT:

Draft HHS National Plan to Address Alzheimer's Disease. Comments from the Professional Affairs & Information Committee, National Academy of Neuropsychology

We are writing on behalf of the National Academy of Neuropsychology (NAN), a professional association with 3,500 members dedicated to the advancement of neuropsychology as a science and health profession for the benefit of the culturally diverse patients and caregivers that we serve.

Clinical neuropsychologists are licensed, independent doctoral level practitioners with special expertise in the applied science of brain-behavior relationships. We provide neurocognitive assessment, diagnosis, treatment, and integrated support of culturally diverse patients (and their caregivers) suffering from a variety of neurological, medical, neurodevelopmental, and psychiatric conditions, including neurodegenerative diseases such as Alzheimer's disease (AD; cf. Goals 2, 3 & 4 of the Draft HHS Plan). Our patients are referred by a variety of medical specialties. Neuropsychological assessment measures brain functioning with standardized, well-researched tests of attention, processing, memory, language, spatial, motor, sensory, and executive functions as well as social-emotional aspects of behavior and mood (cf. NINCDS-ADRDA, Goal 1 of the Draft HHS Plan). This information aids diagnosis, medical management, placement, and practical life-related patient and caregiver decisions and can stage disease progression and recovery (consequent to future biological interventions). Neuropsychologists are most often located in metropolitan areas, but many have developed part time rural practices to serve outlying communities, and consult with general clinical psychologists and primary care physicians in rural areas.

We thank you for the opportunity to submit comments on the Draft HHS National Plan to Address Alzheimer's disease. We appreciate the effort and diligence of the HHS staff and of the National Advisory Council on Alzheimer's Research, Care, and Services in guiding the agenda for AD research and services which will positively impact the lives of the patients and caregivers that all of us serve. We would also like to thank you for including Psychology in your revised document, given the role that many psychologists play in service to AD patients and caregivers via research, education, and direct services. While neuropsychologists and psychologists share many things in common, neuropsychologists are more specialized in their knowledge of brain-behavior relationships, neuroanatomy, biological bases of cognition and behavior, standardized neurocognitive assessment, and management of neurodegenerative diseases (such as AD). Neuropsychologists frequently consult with their clinical/counseling psychologist colleagues and provide additional highly specialized diagnostic and intervention planning services for the benefit of AD patients and their caregivers. Below we will provide information regarding the critical role that neuropsychological/neurocognitive assessment plays in AD diagnosis, treatment, education, and research, specifically with regard to linking biomarkers to neurobehavioral phenotypes and clinical presentation. Currently neuropsychology and neurocognitive assessment are not acknowledged in the draft HHS plan. We hope to persuade you to redress this omission.

We want to highlight that neuropsychologists already play an active and instrumental role in AD research (e.g., via understanding the neurocognitive and behavioral profile of the disease, determining early clinical signs and symptoms of the disease, and providing the neurocognitive clinical correlates needed for biomarker research). Neuropsychology also plays a key role in education (e.g., to other medical professionals, to patients and caregivers) and direct care of AD patients and their caregivers (e.g., innovative quality of life programs). Your acknowledgement of neuropsychology's role in the future direction of care and research in AD will help to perpetuate neuropsychology's involvement in research and innovative service programs of importance to the Alzheimer's community. Conversely, exclusion of neuropsychologists from the Draft HHS Plan may limit opportunities for neuropsychologists to remain active in AD research, education, and clinical service, and this could seriously disadvantage AD patients and caregivers who are amidst the AD experience.

Specifically, we seek to have neuropsychology included in (1) Strategy 1.C, Action 1.C.1: Identify imaging and biomarkers to monitor disease progression, which stresses the importance of the use of biological markers in the diagnosis of AD. Currently, this section of the document fails to recognize the importance of neuropsychological/neurocognitive markers of the AD phenotype that are currently the gold standard for determining the presence and progression of AD. Additionally, (2) inclusion of neuropsychologists as direct service providers (Strategy 2.A., below) is also critical to AD patients and caregivers needing this help.

1. Strategy 1.C, Action 1.C.1: Identify imaging and biomarkers to monitor disease progression

Regarding Strategy 1.C, Action 1.C.1: Identify imaging and biomarkers to monitor disease progression, we offer the following wording suggestions for your consideration (italics ours):

Under Strategy 1.C: "Significant advances in the use of imaging and biomarkers in brain, blood, and spinal fluids in relation to neuropsychological manifestations have made it possible to detect the onset of Alzheimer's disease, ..."

and/or

Action 1.C.1: "Identify imaging and biomarkers in relation to sensitive neuropsychological measures to monitor disease progression."

In support of these suggestions we offer the following information and references:

Neurocognitive decline is the hallmark of AD, and according to the NIH neurocognitive assessment is essential to the diagnosis of Alzheimer disease, along with clinical history (symptoms and their course), medical tests (such as blood work), and neuroimaging (http://www.nia.nih.gov/alzheimers/topics/diagnosis). Also, While the National Institute on Aging-Alzheimer's Association workgroup on diagnostic guidelines for AD has recommended continued research on biological markers, they continue to consider AD to be a clinical diagnosis based on neurocognitive and functional data,1,2 which are hallmarks of neuropsychological evaluation at very sensitive and detailed levels.

In general, the cognitive screening tests used in the medical context lack sensitivity to early cognitive decline3, and this is further complicated when assessing premorbidly intellectually bright or well-educated patients. Neuropsychological assessment, using standardized and demographically normed tests of cognition, is known to be more sensitive to early cognitive decline.4 Further, neuropsychologists are listed by the NIH along with Geriatricians, Geriatric Psychiatrists, and Neurologists, as specialists in assessment who can provide detailed diagnosis of AD(http://www.nia.nih.gov/alzheimers/topics/diagnosis). In fact, clinical neuropsychologists often field referrals from the other three specialties mentioned by the NIH to provide very detailed assessments to assist in their patient evaluations, and often refer to the other specialists for the benefit of AD patients.

Neuropsychology has significantly advanced the research exploring biological markers of Alzheimer disease through the development of very sensitive neurocognitive tests; tests that are critical to early identification of neurocognitive decline (complementing Strategy 1:C of the HHS draft document).5 In fact, it is not uncommon for a detailed neuropsychological evaluation to detect progressive neurocognitive decline before pathology is observed on neuroimaging such as brain MRI. Such work has assisted countless AD patients and their caregivers to enhance what time they have left, and is now being effectively used by physicians to initiate and monitor the effects of dementia delaying medications (such as cholinesterase inhibitors).

In the final analysis, however, there is still much that needs to be learned of the relationship between AD biomarkers and neurocognitive/functional (neuropsychological) symptoms and outcomes. As Jeffrey Cummings, M.D., noted expert on dementing conditions, has written:

The predictive relationship between biomarker changes and clinical outcomes is critical to their successful utilization in AD drug development programs. This is not known for any AD-related biomarker. Preliminary correlations have been established for some clinical outcomes and some biomarkers; it is unknown if changes in a biomarker (such as reduced MRI ventricular enlargement with treatment) will correlate with reduced decline in cognition or function following treatment (p.1482).6

Dr. Cummings' insightful comments lead to at least three conclusions based on the totality of biomarker research to date. First, more work needs to be done, including continued development of very sensitive standardized neuropsychological measures in relation to biomarkers for earlier identification of AD (as a clinical syndrome). Second, while there may be a correlation between biomarkers and clinical manifestations, the correlation is not perfect. Consequently, AD remains a clinical diagnosis at present, and the measurement of neurocognitive decline or enhancement (based on biological intervention) still requires detailed standardized neuropsychological assessment results (i.e., standardized and objective clinical correlates) to help press forward in biomarker research and to benefit AD sufferers. Third, neuropsychological measures are needed within the research itself as the best current means of characterizing the disease for which biomarkers are sought (i.e., neuropsychological markers remain the gold standard for biomarker research).

2. Strategy 2.A: Build a workforce with the skills to provide high-quality care

Regarding the inclusion of neuropsychologists as direct care providers: While clinical neuropsychology and clinical psychology are related, and often work together in a complementary manner in the community for the benefit of AD patients and caregivers, they are not the same specialty. Consequently, we suggest that you consider including "neuropsychologists" (along with "psychologists") as distinct additional providers within "The workforce that cares for people with Alzheimer's disease..." (Strategy 2.A.), and also in receiving HHS information regarding "...dementia curricula and practice recommendations..." (Action 2.A.3).

In closing, NAN again applauds your efforts to aggressively address AD, and we offer our support and services as researchers and clinicians in this endeavor. Thank you for your time in reviewing our comments. Please direct any comments, questions, or concerns to us via the NAN central office.

References and Annotations:

  1. McKhann, G.M., Knopman, D.S., Chertkow, H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimer's & Dementia, 2011; 7(3):263-269. (From the abstract: "The core clinical criteria for AD dementia will continue to be the cornerstone of the diagnosis in clinical practice, but biomarker evidence is expected to enhance the pathophysiological specificity of the diagnosis of AD dementia.")
  2. Jack, C.R. Jr, Albert, M.S., Knopman, D.S., et al. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimer's & Dementia, 2011; 7(3):257-262. (From the Biomarkers of AD section of the article: "Progression of clinical symptoms closely parallels progressive worsening of neurodegenerative biomarkers," and "In the symptomatic predementia, MCI, phase biomarkers are used to establish the underlying etiology responsible for the clinical deficit." Both of these statements, and others in the article, emphasize the importance and effectiveness of neuropsychological/neurocognitive measures in the identification and tracking of clinical symptoms of AD.)
  3. Stephan, B. C., Kurth, T., Matthews, F. E., Brayne, C., & Dufouil, C. (2010). Dementia risk prediction in the population: are screening models accurate? Nature Reviews, Neurology, 6, 318-26.
  4. Smith, G. E., Ivnik, R. J., & Lucas, J. A. (2008). Assessment techniques: Tests, test batteries, norms, and methodological approaches. In: Textbook of Clinical Neuropsychology. J Morgan and J Ricker (Eds.). New York: Taylor & Francis.
  5. Petersen, R.C., Gill, D.P., Phillips, L.E., & Aisen, P. Early MCI as an imaging target: Data from the National Alzheimer's Coordinating Center. Alzheimer's & Dementia; 6(4): S58.
  6. Cummings, J.L. Integrating ADNI results into Alzheimer's disease drug development programs. Neurobiology of Aging, 2010; 31(8): 1481-1492. (This article includes ample neuropsychological test data.)

Notes:

Special thanks to J.D. Ball, Ph.D., for his editorial comments in the preparation of this document. Submitted electronically by NAN on March 29, 2012.


 

R. Ellis  |  03-29-2012

Attached are my comments. By way of background I am a caregiver for my wife who has dementia. I am also a volunteer Ambassador for the Northern AZ Region of the Desert SW Chapter of the Alzheimer's Association.

ATTACHMENT:

Comments on the Draft National Plan to Address Alzheimer's Disease
Robert Ellis
March 2012

Thank you for the opportunity to comment. The document represents an excellent start. Never the less, improvements can be made.

p.3 - Alzheimer's Disease: There is growing evidence that traumatic or incremental brain injuries can lead to dementia later in life. Perhaps this should this be included as a dementia.

p.12 - .E.3 Educate the public ... Here and elsewhere the word "educate" could be interpreted by by some as having a condescending and/or coercive effect. "Inform" or "Provide educational materials" might be better alternatives.

p.13 - Goal 2: Assisted living facilities should be added to the list of settings; it is often a transition from home care to nursing home.

p.13 - Strategy 2.A: "Unique challenges" are also faced by family caregivers. There is a separate section for caregivers but it deserves to be mentioned in many places.

p.18 - Strategy 2.F: Families also experience difficulty when the AD patient is transferred between care settings and systems.

p.22 - Strategy 3.A: "Caregivers report that they feel unprepared for some of the challenges of caring for ..." is a drastic understatement. Overwhelmed is more likely.

p.23 - Strategy 3.B: The availability of affordable facilities, such as adult day services, is vitally important to family caregivers health and well-being.

p.25 - Strategy 3.C.1: Long term care awareness: Issues of cost, hope, complexity, drastic interventions are all reasons for lack of planning for long term care needs.


 

S. Peschin  |  03-29-2012

Attached are the Alliance for Aging Research's comments on the draft National Plan to Address Alzheimer's Disease.

Thank you for the opportunity to comment.

ATTACHMENT:

On behalf of the Alliance for Aging Research, we thank you for the opportunity to comment on the draft National Plan to Address Alzheimer's Disease. The Alliance for Aging Research, http://www.agingresearch.org, is a leading nonprofit organization dedicated to accelerating the pace of medical discoveries to improve the universal experience of aging and health. Our work in Alzheimer's disease includes chairing the Accelerate Cure/Treatments for Alzheimer's Disease (ACT-AD) Coalition that brings together stakeholders to accelerate development of new treatments; and as an active member of the Leaders Engaged in Alzheimer's Disease (LEAD) coalition, serving as co-chair of its research and drug development workgroup.

Thank You and Introduction

We would like to first thank and praise the Administration and U.S. Department of Health and Human Services (HHS) for its swift implementation of the National Alzheimer's Project Act (NAPA). In only 14 months since President Obama signed the legislation into law, HHS has appointed the Advisory Council on Alzheimer's Research, Care, and Services, convened the council three times, and developed both a draft framework and draft national plan.

Perhaps most important, we would like to thank you for the Obama Administration's commitment of a $50 million boost in immediate funding for Alzheimer's disease research at the National Institutes of Health (NIH) in 2012 and for the $80 million increase in the President's fiscal 2013 budget. The announcement about the availability of these funds marks a historic moment for the country. No previous administration has proposed a research increase specific to this dreaded disease. In addition, the initiative also includes a much-needed increase of $26 million for FY 2013 to enhance support for people with Alzheimer's disease and their family caregivers as well as education for providers and the general public.

We praise HHS for recognizing the importance of the larger demographic shift in the U.S. aging population as a motivator for success of the National Plan, which states:

NAPA offers a historic opportunity to address the many challenges facing people with Alzheimer's disease and their families. Given the great demographic shifts that will occur over the next 30 years, including the doubling of the population of older adults, the success of this effort is of great importance to people with AD and their family members, public policy makers, and health and social service providers.

The Alliance believes that increased investment in preventing, treating or curing chronic diseases of the aging, such as Alzheimer's disease, is perhaps the single most effective strategy in reducing national spending on healthcare. As you are aware, eighty percent of seniors have at least one major chronic condition and half have two or more. Chronic diseases associated with aging account for more than 75 percent of Medicare and other federal health expenditures. Unprecedented increases in age-related diseases as the population ages are one reason the Congressional Budget Office projects that total spending on healthcare will rise to 25 percent of the U.S. gross domestic product by 2025 from 17 percent today. Simply put, our nation does not have the luxury of time to address the health research needs of this population.

The Alliance recognizes that fiscal restraints are required in the current economic climate, and that the Administration has already extended itself to support Alzheimer's disease funding in the National Plan. However, one of our overall comments is that funding lines must be developed and additional resources provided to adequately meet the goals of an otherwise ambitious plan. The National Institute on Aging (NIA) specifically, and NIH in general, will need a funding commitment in the billion dollar range to meet the defined 2025 goal to "prevent and effectively treat Alzheimer's disease"; FDA will need an increase of hundreds of millions to accelerate the regulatory process and promote innovation in the development of Alzheimer's disease treatments; and other agencies from AoA to CMS and HRSA will need additional resources to meet Alzheimer's-specific objectives identified in the plan that are expected to occur in conjunction with implementation of Affordable Care Act programs. The Alliance suggests that HHS create a detailed chart of current (within the next fiscal year) expected federal/private investment in each area and costs associated with meeting each goal and strategy within the plan. Otherwise, a majority of these activities look to be unfunded mandates for federal programs with already limited resources.

Second, the Alliance is pleased that HHS has recognized the data gaps that exist for Alzheimer's disease and has additionally committed $1.3 million for FY 2013 to address them. HHS' use of NIA-generated, peer-reviewed, figures for Alzheimer's disease prevalence is monumental. While seemingly academic, the identification and development of reliable data is the necessary starting point for accurate needs assessment and programmatic response. Data development is a cornerstone of the plan that the Alliance believes should be integrated throughout each goal as well as remain its own goal.

Last, the Alliance was disappointed that this draft plan did not include the inventory conducted by the federal interagency working group. It is challenging to comment on the goals and strategies of the draft plan when the rationale behind them is not included as a resource. We understand that this was the first inventory conducted and that certain federal regulations must be met before presenting it in a clear format for the public. However, we wanted to note the issue and strongly recommend that future draft plans include the inventory to allow for more informed public comment.

The comments below are organized by the goals and strategies identified in the plan in specific areas where we felt the Alliance had expertise and that were not already being addressed in comments submitted by the research and drug development workgroup that the Alliance co-chairs through LEAD.

Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025

The Alliance praises HHS for setting a goal of 2025 to "develop effective prevention and treatment modalities." We believe that setting this goal makes sense for a number of reasons, including the fact that the NAPA legislation expires in 2025. Goal setting is valuable for mobilizing policymakers and the advocacy community, motivating researchers and industry, and galvanizing public attention and awareness of the issue. The Alliance feels strongly that HHS and NIH should be clear with the public in particular about the state of Alzheimer's disease research to manage expectations. We hope that the upcoming May Alzheimer's Research Summit will include an explanation of this goal that will be captured by the press.

Action 1.E.1: Identify ways to compress the time between target identification and release of pharmacological treatments

The Alliance is very supportive of this particular action to "examine ways to speed up the processes for bringing pharmacological treatments to market, including: identifying and validating therapeutic targets; developing new interventions: testing efficacy and safety; and regulatory approval." In fact, the Alliance spearheaded a coalition effort, Accelerate Cure/Treatments for Alzheimer's Disease (ACT-AD) Coalition, http://www.act-ad.org, in 2006 to accomplish similar goals. HHS should consult with ACT-AD as it moves ahead with this action.

ACT-AD is a coalition of nearly 50 national non-profit health professional, patient, health provider and consumer organizations seeking to accelerate development of potential cures and treatments for Alzheimer's disease. ACT-AD's mission is to support accelerating research for transformational therapies to potentially slow, halt or reverse the progression of Alzheimer's disease.

Until the formation of the ACT-AD Coalition, there was no point of advocacy combining the perspectives and commitment of respected advocates for women's health, consumer interests, caregiver support groups and aging interested organizations. ACT-AD is strengthened by the diversity and credibility of those voices and is bringing that strength to bear on critical issues concerning the development, review and approval of a new generation of disease-modifying therapies for Alzheimer's disease.

Under the current regulatory environment, research being performed today cannot reach patients in time to avert this disaster. CNS drugs take, on average, 13 years from initial animal studies of a drug candidate to approval. A delay of one year negatively impacts the lives of nearly 333,000 patients and their families. While these figures underscore the urgency of seeking more effective therapeutic interventions for patients with Alzheimer's disease, there are promising treatments being tested that may slow, halt or reverse Alzheimer's disease.

The ACT-AD Coalition works with urgency to accelerate development of potential cures and treatments for Alzheimer's disease. The methods the Coalition uses to conduct its important work include:

  • Educating healthcare professionals, providers and other key constituencies about ways to focus the attention of Food and Drug Administration (FDA) officials and other decision makers about the need to expedite Alzheimer's disease treatments in the crowded landscape of those vying for consideration and action.
  • Advancing ACT-AD's profile with the Food and Drug Administration officials and other key influencers and audiences as an organization that has critical mass and strategic focus to sustain a long-term commitment to improving the regulatory review of Alzheimer's disease drugs.
  • Initiating efforts to build support for FDA reform among key Congressional leaders who influence appropriations necessary for Agency reform.
  • Developing needed research and link Alzheimer's disease expertise to the Food and Drug Administration in order to support their efforts to prioritize drug review with a comprehensive, multidisciplinary base of facts.
  • Mobilizing support and pressure upon the Food and Drug Administration from outside the agency, especially through ACT-AD member organizations and collaborations with other third-party organizations.
  • Engaging the caregiver population that continues to be overburdened and unfocused on the need for political and regulatory reform.

The ACT-AD Coalition holds periodic meetings with its members and representatives of the Food and Drug Administration. Scientific workshop topics have included clinical meaningfulness and Phase II trial issues--and the focus is always on areas relating to an open dialogue between the Food and Drug Administration and Alzheimer's disease community to advance efforts to combat the illness.

Goal 2: Enhance Care Quality and Efficiency

Our nation faces an impending healthcare crisis as the number of older individuals with Alzheimer's disease and other complex health needs increasingly outpaces the number of healthcare providers with the knowledge and skills to adequately care for them. If current workforce trends do not change, we will continue to fail to ensure that every older American is able to receive high-quality care. The Institute of Medicine's (IOM) April 2008 report, "Retooling for an Aging America: Building the Health Care Workforce," calls for immediate investments in enhancing the geriatric competencies of the entire workforce, increasing the recruitment and retention of geriatric specialists and caregivers, and improving the way that care for older adults is delivered.1

Strategy 2.A: Build a workforce with the skills to provide high-quality care

First, direct-care workers provide critical support to older adults in need of long-term care, providing eight out of every ten hours of paid service delivered.2 This field, which is increasing at three times the rate of other jobs within the United States economy, provides the best opportunity for caring individuals to obtain vital employment positions.3 There is also a significant shortage of health professionals and direct-care workers with specialized training in geriatrics and an even greater shortage of the geriatrics faculty needed to train the entire workforce. Title VII Geriatrics Health Professions programs are the only federal programs that increase the number of faculty with geriatrics expertise in a variety of disciplines and offer critically important geriatrics training to the entire healthcare workforce. Title VIII Geriatrics Nursing Workforce Development Programs are the primary source of federal funding for advanced education nursing, workforce diversity, nursing faculty loan programs, nurse education, practice and retention, comprehensive geriatric education, loan repayment, and scholarship.

The $6 million investment by the Administration for "provider education and outreach" will barely scratch the surface in addressing shortages in geriatric workforce and training outlined in actions under Strategy 2.A. Much more substantial investment is needed to fund the recommendations by IOM and we suggest that HHS revisit that report and the three others that came before it.

Even if more students enter geriatrics training, incentivizing them to stay will require loan forgiveness options. Senator Barbara Boxer (D-CA) introduced S. 1095, the "Caring for an Aging America Act" that would amend the National Health Service Corps (NHSC) requirements to add geriatrics and gerontology to the permanent eligibility. This small change in the language governing eligibility for NHSC loans would mean that geriatrics and gerontology specialists would always be eligible for NHSC loans as opposed to the current situation which is that these geriatrics and gerontology specialists can only participate in the program if the HHS Secretary so designates it. An additional advantage is that the loan forgiveness would be fully funded through the NHSC.

By 2030, our nation will require 3.5 million additional healthcare professionals and direct-care workers to fulfill the growing demand for care. The National Health Care Workforce Commission, established by the Affordable Care Act, will play a central role in formulating a national strategy for bolstering the healthcare workforce in order to meet the needs of the escalating number of older Americans. There is no mention of the commission in Strategy 2A.

Action 2.B.1: Link the public to diagnostic and treatment services

We are concerned that the use of warning signs to promote early detection by providers and patients may create confusion in the public. Warning signs for Alzheimer's disease have not been validated and are not promoted as screening instruments; however, concern has been raised that individuals experiencing cognitive deficits and their families may treat warning sign lists as a screening tool.4Although warning signs are publicized by several national organizations for educational purposes, they are not a substitute for a structured screening or consultation with a primary care provider. Further, the utility of these warning signs is questionable since the individuals in whom these problems are first noticed are frequently well into a dementia course. In addition:

  • Most of the warning signs may be indicative of a number of other health issues, including everything from depression (changes in mood/personality) to transient ischemic attack (problems with language/disorientation). There is often no mention that these warning signs may indicate other conditions.
  • By the time any one or more of the warning signs presents the individual may be in the early moderate/moderate stage at best so "early detection" is a misnomer.
  • Warning signs may be useful in raising public awareness about Alzheimer's disease. However, elevating warning signs to an early detection tool and then placing the onus of recognition on those with the illness and their loved ones is not sound policy--especially given that anosognosia (unawareness of a problem of cognition in oneself, usually to the point of vigorously denying the problem) is a common symptom for individuals with the disease.
  • Moreover, promoting the use of warning signs among individuals and family caregivers may serve as a disincentive to providers to learn more about proper, proactive detection methods.

Action 3.D.2: Monitor, report and reduce inappropriate use of anti-psychotics in nursing homes

Behavioral issues are a main reason that psychoactive medications are administered in long-term care settings, which may result in increased falls, increased mortality and increased confusion. There has been increased focus on the use of "atypical" antipsychotic medications in particular, after FDA introduced its black box warning in 2005 and for "conventional" antipsychotics in 2008 for patients with dementia.5

In May 2011 the HHS Office of the Inspector General released a report Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents," which found that over a six month period from January-June 2007, 51 percent of Medicare claims for atypical antipsychotic drugs were erroneous, amounting to $116 million.6 The report found that over 726,000 of the 1.4 million atypical antipsychotic drug claims for elderly nursing home residents did not comply with Medicare reimbursement criteria. The claimed drugs were either not used for medically accepted indications as supported by the compendia or not documented as having been administered to the elderly nursing home residents. The OIG report concludes "We suggest that CMS either use its existing authority or seek new statutory authority to prevent payment [emphasis added] and hold nursing homes responsible for submitting claims for drugs that are not administered according to CMS's standards regarding unnecessary drug use in nursing homes."

The two main reasons for overuse of antipsychotics in nursing home residents with dementia are 1) understaffing and 2) lack of training. Required staff ratios have been suggested for years by nursing home advocates but Congress is reluctant to touch the issue. Training was somewhat addressed in the Affordable Care Act as part of the Nursing Home Transparency provisions, but the training section only applies to nursing assistants--not supervisors. Dementia training for nursing home staff should apply to nursing supervisors as well as assistants.

What makes the issue even more complicated is that there is valid use for antipsychotics in the treatment of dementia-related psychosis. A September 2011 report, a comparative effectiveness review prepared for AHRQ's Effective Health Care Program by the Southern California Evidence-based Practice Center, based at the RAND Corporation, found statistically significant evidence for risperidone, olanzapine, and quetiapine, for the off-label indications of dementia.7

There are provisions in the Nursing Home Reform Law, enacted in 1987, that clearly define appropriate use of psychoactive drugs, circumstances when antipsychotic drugs should be limited and provides for review of a patients drug regimen. CMS guidance to surveyors in the State Operations Manual8also encourages facilities to use non-pharmacological alternatives, identifies situations where antipsychotic medications are not indicated,9 and provides an investigative protocol for unnecessary drugs, including antipsychotic drugs. Despite these strong provisions antipsychotic drug use remains a serious concern, in part because the law, regulations, and surveyor guidance are inadequately and ineffectively enforced. Stronger enforcement of these standards would make an enormous difference.

Conclusion

As HHS considers ways to strengthen its National Plan to Address Alzheimer's Disease, the Alliance looks forward to working with you. Thank you for considering our views, and please do not hesitate to contact Alliance for Aging Research Director of Public Policy if you have any questions or would like additional information.

  1. http://www.iom.edu/Reports/2008/Retooling-for-an-Aging-America-Building-the-Health-Care-Workforce.aspx
  2. C.A. McDonald, "Recruitment, Retention and Recognition of Frontline Workers in Long-Term Care," Generations: Journal of the American Society on Aging (Fall1994), Vol. XVIII. No 3.
  3. Paraprofessional Healthcare Institute, Direct-care Health Workers: The Unnecessary Crisis in Long-Term. The Aspen Institute, January 2001.
  4. Solomon PR, Murphy CA. Should we screen for Alzheimer's disease? A review of the evidence for and against screening for Alzheimer's disease in primary care practice. Geriatrics. 2005, 60(Nov): 26-31.
  5. http://www.webmd.com/alzheimers/news/20080616/antipsychotics-for-dementia-up-death-risk
  6. http://oig.hhs.gov/oei/reports/oei-07-08-00150.asp.
  7. http://www.effectivehealthcare.ahrq.gov/ehc/products/150/786/CER43_Off-LabelAntipsychotics_execsumm_20110928.pdf.
  8. State Operations Manual, Appendix PP,https://cms.gov/manuals/Downloads/som107ap_pp_guidelines_ltcf.pdf (scroll down to page 344 for the beginning of guidance for §483.25(l).
  9. Id. 386 ("1) wandering; 2) poor self-care; 3)restlessness; 4) impaired memory; 5) mild anxiety; 6) insomnia; 7) unsociability; 8) inattention or indifference to surroundings; 9) fidgeting; 10) nervousness; 11) uncooperativeness; or 12) verbal expressions or behavior that are not due to the conditions listed under 'indications' and do not represent a danger to the resident or others").

 

R. Frank  |  03-29-2012

In accordance with the solicitation in the Federal Register on 2/24/2012, please find embedded a letter of input from GE Healthcare regarding the National Plan to Address AlzheimersDisease.

A hardcopy has been sent also by courier to your attention for receipt by the deadline of March 30. Thank you for this opportunity to contribute.

ATTACHMENT:

Public Input on the Draft National Plan to Address Alzheimer's Disease

GE Healthcare appreciates this opportunity to provide input and comments on the draft National Plan to Address Alzheimer's Disease. Our comments focus on the use of diagnostics to help physicians diagnose and treat disease and to reduce the burden of Alzheimer's Disease (AD) and related dementias on patients and their caregivers.

GE Healthcare, a division of the General Electric Company, has decades of expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceuticals manufacturing technologies. GE Healthcare's broad range of products and services enables healthcare providers to offer patients earlier and better diagnosis and treatment of cancer, heart disease, neurological diseases, and other conditions that threaten the quality and length of life. Worldwide, GE Healthcare employs more than 53,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

Overview of Comments

Our comments and recommendations focus on the following issues:

Diagnosis, Monitor, Treatment and Prevention: The magnitude of Alzheimer's disease and related dementia in the US is overwhelming; Alzheimer's disease affects 1 in every 8 older Americans and nearly half of those ages 85 and older. As the number of people with Alzheimer's disease and other dementias grows in the future, aggregate payments for their care will increase dramatically from $183 billion in 2011 to an estimated staggering $1.1 trillion by 2050.

While an estimated 5.4 million Americans have Alzheimer's disease, the Alzheimer's Association reports that half of them lack a specific diagnosis. This represents a fundamental gap that is identified in the Draft National Plan. To address this gap, the Plan calls for increased efforts to identify disease, diagnose AD and monitor disease progression.

New diagnostic technologies suggest benefits in early screening and utility in determining treatment pathways. Specific diagnostic tests including brain imaging may aid practitioners and caregivers to implement care plans early in the disease process.

For treatment decisions, new diagnostic imaging technologies may help inform and guide healthcare providers when making decisions ranging from pharmacologic choices to duration of therapy. In addition, technological advancements in diagnostics using brain imaging may serve useful in drug development as they allow researchers to stratify patient populations according to the extent and anatomic distribution of pathophysiology and then to measure the effect of tehapeutic intervention.

For non-medical purposes, diagnostic tests offer patients and caregivers information that may enable the initiation of preventive measures like exercise (both cognitive and physical), time to make life planning decisions and understanding of the course of the disease.

Because AD progresses in the brain for as long as a decade before classic signs and symptoms become clear to diagnosticians, early detection of the pathophysiology is crucial to effective intervention and better health for those affected.

GE Healthcare's Effort To Address Alzheimer's Disease and Related Dementia (ADRD): For decades, GE Healthcare has invested heavily in R&D to bring to market an increasing number of molecular medical diagnostic products; companies like GE Healthcare translate scientific and medical discoveries into innovative products and services that add objectivity to clinical trials and every day practice of medicine to help physicians prescribe the right drug at a dose which is right for their patients.

By example, these advances have begun to change the paradigm for treatment of diseases such as cancer.

Access To New Technologies: While predictive testing and risk assessment have evolved rapidly over the past decade, the adoption of new diagnostic imaging procedures comes with challenges. GE Healthcare is pleased that cognitive testing has been added to the routine physical exam in Medicare as a screening tool. Nevertheless, the benefits of new brain imaging or molecular imaging diagnostic tests have not been widely recognized by payers that see limited value in early diagnosis when treatment choices are limited. We support the many action items included in the draft plan that will accelerate the development and adoption of important diagnostic imaging tools.

Recommendation: We encourage the inclusion of action items in the Plan that stress the need for Medicare to provide access to the health benefits of diagnostic imaging technologies, as well as other innovative technologies while under a doctor's care within the practice of medicine.

GE Healthcare also supports the draft Plan's focus on accelerating research aimed at preventing, diagnosing and treating this debilitating disease, and strengthening care quality and efficiency of care both before and after new treatments become available. Patients and their caregivers deserve no less.

GE Healthcare very much appreciates the opportunity to submit comments on these important issues and looks forward to HHS and the Advisory Council's final recommendations in the National Plan to Address Alzheimer's Disease. If you have any questions on our comments, please do not hesitate to contact me.


 

D. Hearn  |  03-29-2012

The University of Virginia's Office of Continuing Medical Education (CME) is working in collaboration with the Institute on Aging at the University of Virginia and the Alzheimer's Association, Central and Western Virginia Chapter and other partners to advance Goal 1, Strategy 1.E, to facilitate translation of research findings into medical practice, and Goal 2, Strategy 2.A and 2B, to build a workforce with the skills to provide high-quality care. We have developed an authoritative website for Alzheimer's education for physicians, nurses, and other healthcare professionals, to facilitate dissemination, translation, and implementation of the latest research findings and treatments. Called MemoryCommons:

http://www.memorycommons.org/

this web-based portal serves as a single point of access for on-line CME and training programming related to prevention, diagnosis, treatment, and public health challenges of Alzheimer's disease and related conditions, including the cognitive changes in aging and clinical differentiation of illnesses causing memory loss and dementia. Overall, MemoryCommonsserves as a national resource where physicians, physicians in training, and other healthcare professionals can easily participate in educational activities and self-assessment; find tools that can support their clinical care of the aging patient; and apply the latest medical advances to their practices. We would be pleased to continue development of this tool as an existing resource upon which additional efforts can be built.


 

A. Stewart  |  03-29-2012

Attached please find Merck's comments regarding the Draft National Plan to Address Alzheimer's Disease.

If you have any questions, please let us know.

ATTACHMENT:

Comments on Draft National Plan to Address Alzheimer's Disease

Merck & Company, Inc. appreciates the opportunity to comment on the Draft National Plan to Address Alzheimer's Disease. Merck is an innovative, global health care leader that is committed to preserving and improving human life. We continue to focus our research on conditions that affect millions of people around the world.

We commend you and the Advisory Council on the first Draft of the National Plan. The plan is comprehensive in scope and addresses many of the most significant challenges to changing the course of Alzheimer's disease in the US and globally. As indicated in the Draft Plan, we encourage you to make subsequent iterations of the Plan far more specific, and to give a practical sense of what can be accomplished not only through government action but by bringing government, industry, and academia together to align and build on each other's already substantial activities on Alzheimer's disease. We applaud the government's leadership in organizing and hosting the Alzheimer's Disease Research Summit in May to bring a wide array of stakeholders to the table, and we look forward to participating in this meeting.

The Importance of Goal I

We are particularly pleased with the first Goal of the Draft Plan: to prevent and effectively treat Alzheimer's disease by 2025. Only by setting such a challenging goal and by allocating sufficient resources and aligning critical partners can we hope to achieve such an important global public health outcome.

Broad Collaboration Needed

This is not a goal the US federal government can accomplish solely through its own actions or by directing the actions of others, particularly in light of the limited resources currently at its disposal. Rather this is a goal that all of us committed to a breakthrough in Alzheimer's disease must chare; and must, indeed, share with our colleagues around the world. It will take a true partnership of research, business, advocates, health care and government and the combined resources of all parties to develop and apply the needed therapeutics at the rate required to attain this goal.

Leadership is critical, and the government, through this Plan and its funding and convening powers, can to do much to provide that leadership. Achieving key milestones in advancing therapeutics will require a collaboration of government, academia, and industry.

Industry Partnership Is Essential

In Streamlining Regulatory Pathways

While the Draft Plan proposes a number of areas in which greater collaboration with industry can be productive, there are a number of proposed actions where more constructive engagement of industry could be helpful. Specifically, Action 1.E.1 to identify ways to accelerate time to market, should engage industry as a full partner in identifying ways to simplify the approval process, provide greater clarity and predictability in validation and application of diagnostics and biomarkers and in the selection of endpoints.

In Establishing New Approval Standards

Currently, efficacy can only be established in large and lengthy clinical trials. Advances in knowledge of disease pathophysiology, risk factores, and disease biomarkers through academic, government and industry sponsored research is critical to develop more efficient new approaches for clinical trials. Industry should be directly involved in an ongoing dialogue with the FDA on how to translate the rapidly evolving science of Alzheimer's disease into standards for establishing safety and efficacy of treatments. Developing new approaches that can be used to shorten this timeline and remove risk earlier will require the combined efforts of industry and the FDA. Collaboration with the EMA and other major regulatory bodies will be essential as well to ensure global consistency in the translation of science into regulatory pathways to get therapeutics to patients.

In Accounting for Different Disease Segments

Imaging and biomarker development in Strategy 1 C should contribute to clear differentiation by the FDA of segments of disease -- prevention, early treatment and later treatment -- which have different issues and may have different pathways for approval. For each segment, the FDA will need to provide guidance on acceptable diagnostic criteria and clinical end-points needed to prove efficacy.

In Designing and Conducting Clinical Trials

Clinical trial design and conduct is another area where much can be gained from a true partnership with academia and industry. Action 1.B.5 proposes that HHS, VA, and NIA develop and fund clinical trials on the most promising therapeutics. This Action does not account for the amount of time and effort, and the amount of uncertainty that is involved in finding safe therapeutic candidates and testing these mechanisms in trials. Nor does it acknowledge the existence of the substantial infrastructure that exists in industry for discovering promising new agents for trials and the relationships that already exist with regulators to ensure that medicines are approved. This is an infrastructure today fully engaged in developing the more than 100 Alzheimer's disease candidates currently in the pipeline.

Efficiency Needed in Research

It is important in Strategy 1 B in expanding the research aimed at preventing and treating Alzheimer's disease, to ensure the most efficient use of all partners and resources, and make the best use of the limited number of patients that will be available for clinical trials. Studies need to be adequately powered, with agents that effectively test mechanisms and produce evidence of brain target engagement to avoid studies that confuse the field and do not advance the state of knowledge, in order to make the best use of patients that enter clinical trials.

Again, we commend you on the progress to date on this important project. We appreciate the opportunity to provide comments on the Draft National Plan to Address Alzheimer's Disease. We look forward to the opportunity to remain fully engaged in this important mission of developing an effective prevention and treatment for Alzheimer's disease by 2025.


 

J. Case  |  03-29-2012

Thank you for the opportunity to submit written comments for the draft National Plan to Address Alzheimer's Disease as part of the National Alzheimer's Project Act.

In Oklahoma, our aging network formed an interagency workgroup to discuss the draft and make recommendations. The following agencies and their representatives were asked for their input:

Aging Services Division (ASD) Division Director
ASD Aging and Disability Resource Center (ADRC) Project Director
ASD Policy and Strategic Planning Supervisor
Oklahoma Health Care Authority representative (the state Medicaid agency)
ASD Home and Community-Based Services Program Administrator
Adult Protective Services Program Administrator
OKDHS Developmental Disabilities Division Director
ASD Older Americans Act Program Administrator
Oklahoma Mental Health Advocacy Coalition Director
ASD Legal Services Developer
ASD State Long Term Care Ombudsman

Many of these individuals also served on Oklahoma's task force to study and make recommendations regarding the effect of Alzheimer's Disease in our state. This task force, co-chaired by Senator Tom Ivester and Representative David Dank, met over a year and filed a final report which can be found here: http://www.oksenate.gov/publications/issue_papers/health_social_services/effect_of_alzheimers_task_force_final_report.pdf

Our group focused on Goals 2, 3, and 4 of the national draft plan.

General Thoughts:

Our group felt inclusion of the existing aging network is necessary for the success of the national plan. The aging network, through the above listed agencies and programs, already works with family caregivers, documents existing service gaps, and disseminates information statewide. Our statewide ADRC program already works to help families and caregivers to meet current needs and plan for future ones. Our Older Americans Act services specially target those individuals and their families who are facing an Alzheimer's diagnosis through the National Family Caregiver Support Program. Including the aging network would help to optimize existing resources and coordinate implementation of the plan's objectives. Our overarching concern is the aging network and its involvement in the rollout of this plan.

Specific Comments:

  1. The draft plan references a Research Summit in May 2012 (pg. 7). We were curious if that has been scheduled, who will be participating, what will come out of that summit that could be used and in what way, etc. Likewise, the Federal Interagency Working Group referenced in the plan could be heavily leveraged to support change needed at the state level. Have the members of that group been chosen? What are differences between that group and the to-be-assembled leadership team referenced on pg. 29?

  2. We really liked the references in both plans for 1) veterans 2) private sector. The private sector piece has limitless opportunity. Finally, we think for anything meaningful to happen -- either at the national or state level -- you must see legislative involvement and support.

  3. In Oklahoma we have recognized the importance of providing case management to inform and coordinate services available to caregivers and their families and would like to see it as a cornerstone of services under this plan.

  4. Oklahoma's Aging Services Division works with the Oklahoma Department of Corrections and would like to see the unique needs of older prisoners addressed: (1) For those who are incarcerated, we would like to see specialized training in dementia information for prison personnel and comparative treatment options and (2) For those who have been released, more "safety net" provisions since these individuals are less likely to have a family/friend support network.

  5. We would like the plan to include the following action items under a new Strategy 3.F:

    Strategy 3.F. Provide leadership in understanding legal issues, including legal opportunities and obstacles faced by persons with Alzheimer's Disease, their family members and caregivers. Legal issues of persons with Alzheimer's Disease emerge as the progression of the disease continues. Prompt and early legal intervention, prior to the onset of incapacity, can relieve stress on family members and caregivers who must deal with the consequences of lack of legal planning as capacity continues to diminish. AOA's Legal Services Developers in each state address the development of local legal services and ensure that education is available to inform persons with Alzheimer's Disease, their family members and caregivers about legal options.

    Action 3F.1. Provide information to caregivers and family members regarding legal issues during life of the person with Alzheimer's Disease as capacity diminishes. HHS will prioritize the dissemination of legal information to caregivers and family members regarding legal issues during life of the person with Alzheimer's Disease. HHS will encourage state and local entities to work with local attorneys and legal providers to offer information related to the issues of capacity for decision making along the continuum of the progression of the disease; the uses and abuses of powers of attorney for finances and health care; the execution of advance directives, including living wills, do not resuscitate consent forms and the appointment of health care proxies; the process of legal guardianship that enables caregivers or family members to make decisions regarding the care of the person and/or the finances of the person Alzheimer's disease, and the appropriate use of "least restrictive" means to preserve the dignity of the person with Alzheimer's Disease.

    Action 3.F.2. Provide information to caregivers and family members regarding legal issues upon the death of the person with Alzheimer's Disease. HHS also recognizes that the need for quality information regarding legal issues upon the death of the person with Alzheimer's Disease is paramount. HHS will work with states to engage local attorneys and legal providers in providing information related to estate planning documents and techniques including the execution of a will and the process of probate that addresses the need to name an executor and beneficiaries; estate planning techniques that may be available in states to avoid probate including living trusts; transfer on death and payable on death documents and deeds; and the use and abuse of joint tenancy as an estate planning tool with finances and real property.


 

M. Harpold  |  03-29-2012

I am uncertain whether my comments on the Draft National Plan to Address Alzheimer's Disease (see attached) are most appropriate to be sent to you, as liaison with the Advisory Council, and/or napa@hhs.gov (representing address for public comments), as I am unclear whether there is a distinction. I believe my comments may be most appropriate and relevant for the Advisory Council and their considerations, and therefore sending to you. Please let me know if I should also send directly to napa@hhs.gov.

I appreciate the opportunity to participate in the March 14 Advisory Council teleconference as well as the opportunity to submit my comments on the Draft National Plan to Address Alzheimer's Disease and its importance for the more than 400,000 individuals with Down syndrome in the US and their families and caregivers as well as associated stakeholders. More explicit inclusion of Down syndrome as integral to the Plan, particular concerning fundamental, translational and clinical research, will be important for accelerating progress and success not only for individuals with Down syndrome, and associated very high Alzheimer's disease neuropathology and dementia, but also for the entire population that will develop or currently have Alzheimer's disease.

Should you have any additional questions etc., please do not hesitate to contact me.

ATTACHMENT:

Comments Regarding Draft National Plan To Address Alzheimer's Disease
March, 2012

Thank you for the development of the Draft National Plan to Address Alzheimer's Disease, and for the opportunity to submit comments.

The Down Syndrome Research and Treatment Foundation is a national/international 501(c)(3) nonprofit organization with the mission to stimulate and support biomedical research that will accelerate development of treatments to significantly improve cognition, including memory, learning and speech, for children and adults with Down syndrome. The major objectives include creating new opportunities for all Individuals with Down Syndrome to: 1) Lead more independent lives; 2) Participate more successfully in schools & employment; and 3) Prevent additional early cognitive decline with aging & Alzheimer's disease. Since its founding in 2004, DSRTF, through its novel research strategy and grants program, has identified and substantively supported much of the research that has led to the recent rapid and unprecedented advances in Down syndrome cognition research and the first clinical trial with a novel drug candidate to focus on as a primary indication and specifically address overcoming cognitive and behavioral impairments in individuals with Down syndrome by a major international pharmaceutical company, Roche.

We acknowledge and appreciate the explicit recognition, inclusion and designation of attention to intellectual disabilities populations as unequally burdened by Alzheimer's disease within Strategy 2.H: Improve care for populations disproportionally affected by Alzheimer's disease and for populations facing care challenges. However, this is far too limited within the overall plan; it is more than just initiatives addressing only care. As discussed further below, there is a very strong rationale to explicitly include Down syndrome in each of the strategies, and designated strategic sub-actions, comprising the National Alzheimer's Plan and resulting initiatives, and Strategy 1 involving fundamental, translational and clinical research in particular.

As research has documented, virtually all individuals with Down syndrome, now numbering more than 400,000 individuals in the US, develop the characteristic neuropathology associated with Alzheimer's disease by age 40. Research has also shown that, very conservatively, at least 25% increasing to 75% or more of the individuals with Down syndrome between the ages of 40-60 develop the signs and symptoms of Alzheimer's-type dementia and the percentage increases with age. These facts underscore the very significant and important relevance of this population as a key and explicit element to be included not only in the National Alzheimer's Plan but also in the development and implementation of all aspects of the Plan, including research (fundamental, translational, and clinical) to effectively prevent and treat Alzheimer's disease, enhancing care quality and delivery, and expanding supports for people with Alzheimer's disease and their families. Given these facts, explicit and integral inclusion and consideration of Down syndrome in the Plan and associated initiatives can not only significantly address the significant number of individuals with Down syndrome but also the larger non-Down syndrome population developing or with Alzheimer's disease. This requires significant increases in awareness and rational considerations among researchers and clinicians, which can be partly addressed through explicitly including Down syndrome more prominently in the Plan as well as in resulting initiatives and increased proportional funding.

Given the significant size of the Down syndrome population (>400,000 in the US, and up to 10-times that number worldwide) and the virtual certainty that the individuals will develop the characteristic neuropathology of Alzheimer's disease and ultimately the associated dementia further compromising their cognition and life, inclusion of Down syndrome, particularly in the research initiatives (fundamental, translational, and clinical) would significantly contribute important novelty, unavailable otherwise, to as well as enhance and accelerate essentially all aspects of the major objectives specified under Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025 as well as Goal 2. NIH grants and funding for all of Down syndrome research have remained disproportionately very low, e.g. $20M in FY 2011. This includes a much smaller and too limited subset of research grants investigating the aspects of Alzheimer's disease associated with Down syndrome. As only one contrasting example, explicit and significant attention and funding by NIH and its Alzheimer's disease research initiatives, both basic and translational, have been targeted to so-called dominantly inherited Alzheimer's disease, both basic and translational (see e.g., the DIAN initiative) that is much more rare and with a much smaller population. In both Down syndrome and dominantly inherited Alzheimer's disease myriad research has confirmed the significant involvement of the same gene, APP, and its products (The APP gene is located on human chromosome 21, the chromosome trisomic in Down syndrome, as are a number of additional genes demonstrated to be involved in mechanisms associated with Alzheimer's disease.). Through more detailed and sufficient investigations in the Down syndrome population, researchers can obtain invaluable insight into how and why Alzheimer's disease develops, and can compare and extend their findings to the much more common late-onset sporadic Alzheimer's disease as well as enhance and accelerate development of new therapeutics. The relevant trajectory to Alzheimer's disease and size of the Down syndrome population provides a strong rationale for greater recognition and explicit inclusion in the National Alzheimer's Disease Plan and resulting Alzheimer's disease fundamental, translational and clinical research initiatives.

Although by no means an attempt to thoroughly include detailed or exhaustive rationale and recommendations in these comments here, in addition to the suggestions and requests above with respect to more prominent and explicit integral recognition and inclusion of Down syndrome in the ultimate version of the National Alzheimer's plan, I submit the following recommendations for further consideration:

  • Explicitly recognize and include discussion and components specifically involving Down syndrome in Goal 1 as well as each of the proposed "Actions" under Strategy 1A, including Actions 1.A.1-5.
  • Explicitly recognize and include discussion and components specifically involving Down syndrome in Strategy 1.B. including Actions 1.B.1-6. This would include not only research in animal models of Down syndrome, but with respect to human clinical studies explicit designation and inclusion of relevant and appropriate cohorts of individuals with Down syndrome, together with and/or in parallel/addition to those clinical studies initiatives involving non-Down syndrome cohorts. The results would be expected to be mutually informative and beneficial.
  • Explicitly recognize and include discussion and components specifically involving Down syndrome in Strategy 1.C. including Actions 1.C.1-2. Again, given that essentially every individual with Down syndrome develops the characteristic neuropathology associated with Alzheimer's disease by age 40 with a significant proportion also developing the signs and symptoms of Alzheimer's-type dementia and further increases with age earlier, inclusion of relevant and appropriate cohorts of individuals with Down syndrome, together with and/or in parallel/addition to these research initiatives involving non-Down syndrome cohorts would uniquely provide important relevant and additional information, insights, direction and acceleration of success.
  • As is true for Alzheimer's disease research and development, relevant Down syndrome research is ongoing, and increasing, internationally. It will be important to coordinate with and expand relevant Down syndrome research internationally and collaboratively. Therefore, explicitly recognize and include discussion and components specifically involving Down syndrome in Strategy 1.D. including Actions 1.D.1-2.
  • Explicitly recognize and include discussion and components specifically involving Down syndrome in Strategy 1.E. including Actions 1.E.1-3. With respect to Action 1.E.1., again, given that essentially every individual with Down syndrome develops the characteristic neuropathology associated with Alzheimer's disease by age 40 with a significant proportion also developing the signs and symptoms of Alzheimer's-type dementia and further increases with age earlier, inclusion of relevant and appropriate cohorts of individuals with Down syndrome, together with and/or in parallel/addition to these research initiatives involving non-Down syndrome cohorts would uniquely provide important relevant and additional information, insights, direction and acceleration of success. With respect to Action 1.E.2., inclusion of private-public collaborations and partnerships between Federal entities such as NIH and non-governmental nonprofit organizations such as DSRTF with its focus on Down syndrome cognition research will enhance productivity, accelerate significant progress and success as well as minimize duplications of efforts and resources. With respect to Action 1.E.3., the critical importance of the increasing development and very significant impact of Alzheimer's disease on individual with Down syndrome and their families and care givers underscores the importance of involvement and communication with this community and associated stakeholders.
  • As indicated above, given the particular and significant relevance and importance of and impact of Alzheimer's disease on the relatively large population of individuals with Down syndrome, their families and caregivers as well as the healthcare system, it is not sufficient to generally designate "intellectual disabilities" in only Strategy 2.H. "Down syndrome" should be explicitly included in proposed Strategies 2.A.-H., 3.A.-E., 4.A.-B. and each of the Actions included under those strategies. Therefore, explicitly recognize and include discussion and components specifically involving Down syndrome in Strategies 2.A.-H., 3.A.-E., 4.A.-B. and each of the Actions included under those strategies.
  • Finally, based on the comments, rationale and recommendations outlined above, we would encourage and recommend that a representative from the Down syndrome community be added to the National Alzheimer's Project Act (NAPA) Advisory Council, as the important deliberations, priorities and implementation will have mutual benefits to science/research, clinical care, and long term care not just additionally for individuals with Down syndrome and associated Alzheimer's disease but also for the broader population and research efforts involving Alzheimer's disease.

I would be very pleased to further discuss, as may be helpful and informative, any aspects of the above concerning the importance of explicit inclusion and considerations of Down syndrome relating to Alzheimer's disease in further detail with those involved in developing the National Plan, including members of the Advisory Committee. I have registered for and plan to attend the upcoming May 14-15 NAPA/NIH Alzheimer's Disease Research Summit in Bethesda, and look forward to the opportunity for further discussion of the importance and relevance of Down syndrome for the Plan and its successful implementation as outlined above.


 

R. Baier  |  03-29-2012

Thanks for writing earlier this week to clarify your group's upcoming deadlines regarding the draft National Plan to Address Alzheimer's Disease. I'm attaching written comments from my organization, Healthcentric Advisors, and the leadership team on our Medicare-funded Safe Transitions Project. After our project's Advisory Board meets next week, we'll also share a summary of the group's discussion about the draft plan.

We appreciate the opportunity to review and comment on this document--and wish you the best of luck as you finalize it!

ATTACHMENT:

We are writing to commend you and the Department of Health and Human Services for including care transitions in the National Alzheimer's Project Act's (NAPA's) draft National Plan to Address Alzheimer's Disease.

At Healthcentric Advisors, Rhode Island's Medicare Quality Improvement Organization (QIO), we are currently in our 4th year working with local providers and stakeholders to improve the safety of patient care transitions. Our Medicarefunded Safe Transitions Project aims to implement sustainable systems change that improves patients' experiences and outcomes as they transition between care settings. In 2011, we published the results of a patient coaching intervention that we implemented in six Rhode Island hospitals, which reduced the odds of 30-day hospital readmission 34% among coached patients vs. those who were eligible, but not approached for coaching (Voss et al., Archives of Internal Medicine).

Regrettably, there is little evidence or expert consensus about how to include patients with cognitive impairment, such as Alzheimer's disease, in interventions to improve transition quality. Our project's multi-stakeholder Advisory Board includes consumers, providers and payors from a variety of inpatient and outpatient settings, including Rhode Island's free-standing psychiatric hospital, and has recently begun discussion of ways to target and tailor post-hospital coaching and other interventions to these patients and/or their caregivers. We believe that NAPA's inclusion of care transitions in the draft National Plan will inform efforts across the country, helping us collectively provide better care for these vulnerable patients.

Our next Advisory Board meeting, scheduled for Thursday, April 5, 2012, includes discussion of the draft National Plan. We plan to follow-up with you later that week to share the results of our group's discussion, in hopes that additional input will be helpful as you and your colleagues continue to refine your draft.

With questions, please contact me.


 

B. Schwartz  |  03-29-2012

Attached please find written comments from Dr. J.K. Holton, Director of the Illinois Department on Aging, supporting the role of the Aging Network in the National Alzheimer's Plan and the importance of addressing the needs of caregivers of persons with dementia.

Please contact me should you have any questions.

ATTACHMENT:

National Alzheimer's Plan

As Director of the Illinois Department on Aging, I am writing in support of the proposed National Plan for Alzheimer's and Related Disorders (ADRD) that would promote an earlier diagnosis of the disease, improve strategies for long term services and supports, and accelerate the search for a cure.

The Illinois Department on Aging was created by the State Legislature in 1973 for the purpose of improving the quality of life for Illinois' senior citizens by coordinating programs and services enabling older persons to preserve their independence as long as possible. It is the single State agency authorized to receive and dispense Federal Older Americans Act funds and is mandated to provide a comprehensive coordinated service system for the State's 2.2 million older persons, giving high priority to those in greatest need. I appreciate the opportunity to comment on the proposed goals, strategies and actions that directly affect the Aging Network, caregivers and persons with Alzheimer's and related dementia.

According to the Illinois Department of Public Health, an estimated 222,300 individuals in Illinois are living with Alzhiemer's disease with a direct and indirect financial toll of $5.2 billion. More than 70% of those suffering from Alzheimer's disease are living at home.

Caregivers of persons with Alzheimer's disease are more likely to assist care recipients with Activities of Dailiy Living (ADLs) than caregivers to other persons.(1) Caregivers often help to manage other serious medical conditions in addition to Alzheimer's, and because Alzheimer's and other dementia usually progress slowly, most caregivers spend many years in the caregiving role.(2) In 2006 the Family Caregiver Alliance and National Family Caregiver Association reported an estimated 1.2 million family caregivers in Illinois were providing 1.3 million hours of care to family members. As the baby boom generation enters the age of greatest risk for Alzheimer's, by 2025 their number in Illinois is expected to increase to over 239,000.

Thirteen Area Agencies on Aging and statewide service providers comprise the Aging Network in Illinois, which effectively links older persons with needed services. The National Family Caregiver Support Program (NFCSP), implemented through the Aging Nework, provides five basic service categories to family caregivers including: information about services; assistance in accessing services; counseling; support groups and trianing/education; respite care; and, supplemental services.

In FY 2011, 66,132 Illinoisans received assistance through services of the NFCSP. Additionally, 493,313 individuals received assistance through supportive and nutrition services of the Older Americans Act.

The proposed National Plan for Alzheimer's and Related Disorders contains thoughtful recommendations which address the immediate and long-term needs of caregivers, providers and individuals affected by Alzheimer's disease. The Aging Network in Illinois is committed to providing services to Alzheimer patients, their families and caregivers through a number of programs which support the five goals of the National Plan.

  • Public Education and Outreach: Through Title III-B efforts under the Older Americans Act and Title III-E programs of the National Family Caregiver Support Program the Aging Network provided education and outreach on aging issues and available resources to 6,429 individuals in FY 2011. Additionally, the Department collaborates with many professional organizations to provide education and training opportunities. Examples include the Annual Elder Rights Conference; Senior Expos; Area Agencies on Aging sponsored Lunch and Learn/Brown Bag events; Caregiver Conferences; AIRS (Alliance of Information and Referral Systems) training; the Illinois Department of Children and Family Services Older Caregiver Training.
  • Outreach to healthcare providers: Home and community-based resources are critical to ensure that persons living with Alzheimer's disease are adequately and safely cared for in their homes as long as possible and contain the cost of health care. The Illinois Department on Aging sponsors many conferences and workshops for professionals including the Community Care Program/Case Coordination Unit Annual Supervisor Conference convening supervisors from case coordination units and home care agencies; the Annual Governor's Conference on Aging and Illinois TRAID comprised of state and local law enforcement agencies and other professional organizations. The Department also promotes the use of the Administration on Aging's National Alzheimer's Call Center by caregivers and encourages referrals by AAAs and providers.
  • Expanded support for people with Alzheimer's disease and caregivers in the community: The Department has aggressively pursued funding to expand and enhance services for caregivers. In 2009 the Administration on Aging awarded the Department a three year Lifespan Respite grant which has enhanced access to and improved awareness of respite services. The Department has established a statewide Caregiver Advisory Committee which convenes regularly to discuss caregiver issues, share resources and best practices and review caregiver programs and is establishing protocol to implement and effective service delivery system through Aging and Disability Resource Centers/Coordinated Points of Entry.
  • Improved data collection and analysis: The Department works closely with the thirteen Area Agencies on Aging to collect data for NAPIS reporting as well as reviewing current caregiver assessment tools.

In 2009, the Illinois Department of Public Health published the "Alzheimer's Disease and Other Related Dementia State Plan - Senate Joint Resolution 43 - Report to the Governor and General Assembly." Recommendations in this report are reflected in the National Plan and include:

  • Establishing adequate staffing levels and funding
  • Establishing basic and specialized education and training for persons when responsibilities make it likely they will come into contact with persons with AD and related dementias and their caregivers
  • Facilitate planning, treatment and research
  • Provide assistance to unpaid caregivers of persons with AD
  • Determine an effective system to collect data

We must continue to examine our current capability to meet the Alzheimer's crisis and propose action to prepare for and respond to these challenges which include the development of a standardized caregiver assessment; establishment of the ADRC service delivery model; continue collaborative efforts of the Lifespan Respite Program; continue to incorporate consumer directed care service models through the National Family Caregiver Support Program; continue to collaborate with the Alzheimer's Association in Illinois; utilize Area Agencies on Aging and service providers to disseminate information and provide culturally sensitive training and materials to providers and caregivers; assist families and individuals in planning for future needs and provide updates to families, caregivers and providers regarding the latest clinical guidelines and information on how to work with people with AD; examine the capacity of public safety and law enforcement to respond to person's with Alzheimer's; examination of trends in the Alzheimer's population and needs, including assistance to persons with early stage and early on-set Alzheimer's and persons with Alzheimer's and developmental disabilities.

The Illinois Department on Aging and the Aging Network is committed to continue to respond in the most appropriate and effective way to this growing health problem and meet the challenge of providing service to Alzheimer's patients, their families and caregivers. The proposed National Plan is sensitive to local efforts to support caregivers and direct-care workers and offers viable proposals to support, educate and train the direct-care workforce and state aging workforces. Thank you for this opportunity to provide comments.

  1. 2009 National Alliance for Caregiving/AARP Study
  2. National Alliance for Caregiving

 

E. Sokol  |  03-29-2012

Attached please find the Alzheimer's Foundation of America's (AFA's) report, "The Time Is Now," which serves as AFA's comments to the draft national plan to address Alzheimer's disease which was released February, 2012.

As always, please let me know if you have any questions or require further information.

ATTACHMENT:

The Time to Act Is Now: Action Steps and Recommendations to the Draft National Plan to Address Alzheimer's Disease [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-time-act-now]


 

F. White-Chu  |  03-29-2012

I was quite pleased to read about the National Plan to Address Alzheimer's Disease. As a geriatrician and wound care physician, the majority of my patients are in some form of this devastating illness.

I was dismayed, however, to see absolutely no mention of the fact that currently Alzheimer's Disease is a terminal disease. In reviewing the following statement, one must get to the root cause as to how more healthcare resources are spent on these individuals:

"Caring for people with Alzheimer's disease also strains the health and long-term care systems. Individuals with Alzheimer's disease use a disproportionate amount of healthcare resources; for instance, they are hospitalized 2-3 times as often as people the same age who do not have the disease.9"

Many family members and caregivers do not understand that the natural progression of Alzheimer's Disease results in total dependency, resulting in aspiration pneumonias because of swallowing dysfunction, urosepsis and failing to thrive - despite 1:1 care by family members or caregivers.

The Institute for Aging Research at Hebrew SeniorLife has recently published "Advanced Dementia: A Guide for Families". This guide informs family members that Alzheimer's, and other forms of dementia, are terminal and that decisions can be made to enhance the quality of life rather than the quantity.

Until we find a cure for Alzheimer's, it will continue to be a terminal illness. Efforts must be made to educate the masses on the progression of this disease so that appropriate choices are made in the best interest of these patients and their families.


 

C. Nadeau  |  03-29-2012

Attached please find New York Memory Centers NAPA comments for the record. Please confirm receipt of this e-mail. Thank you.

ATTACHMENT:

New York Memory Center comments on the Draft Framework for the National Plan to Address Alzheimer's Disease

Thank you for inviting the public to comment on the U.S. Department of Health and Human Services "Draft Framework for the National Plan to Address Alzheimer's Disease." For over two decades New York Memory Center has been on the front-lines of Alzheimer's community-based care. As a pioneer in Social Adult Day programming and Caregiver Supportive Services we welcome the opportunity to provide recommendations for your consideration.

We believe that the five goals outlined in the plan which form the foundation of the National Plan are ambitious, courageous, and seek to offer a comprehensive and multi-faceted approach. In comparing the National Plan to the most recent work of the three Sub-Committees, we felt the need to underscore a few key recommendations.

While our ultimate goal is a world without Alzheimer's, we recognize the very real possibility that even with increased financial support to drive a targeted research agenda, we may not put an end to this horrible disease by 2025. Moreover, those living with the disease today and tomorrow deserve the best possible care we can offer. We need better care now. We are concerned that the ultimate research agenda will be too narrow in scope and leave research relative to care practices as a back-burner issue, instead of integrated as a significant component.

In innovative Alzheimer's Adult Day Centers around the country, various non-pharmacological approaches to care such as arts-based programming; cognitive stimulation; exercise and movement training; meditation; learning methods; sensory therapy, cognitive training; tailored diets; communication techniques for managing behavioral symptoms; early stage education designed to maximize independence and efforts to reduce excess disability; and caregiver education, coaching, and counseling are practiced with evident increases in quality of life, and evident reductions in challenging behaviors; and with some interventions, short term improvements in cognition, language and learning. These interventions must be recognized as active treatment for Alzheimer's disease and reimbursed by Medicare.

Although these practices emerged as grassroots movements, we now have significant studies that support many of these interventions as evidence-based or evidence informed practices in the care of individuals with dementia and their caregivers. Any plan to invest in research should substantially include non-pharmacological care-based research. Much more research is needed in these areas as positive outcomes are consistently identified by care providers and clinicians as superior to other conventional approaches. We must address the clinical significance of these various approaches to treatment. The small size of most studies, and variability in quality in these areas limits generalization of the results, and discourages widespread practice changes in care settings. What is needed is funding for large, well designed, robust studies in order to influence practice changes nationally.

Today, approximately $30 million dollars of the $479 million dollars devoted to Alzheimer's disease research is earmarked for clinical research in Alzheimer's disease care, support and education. We recommend a substantial increase in this area relative to the overall annual research budget. Research based, non-pharmacological, active treatment needs to be implemented as standard practice. Research must seek to understand what care works, why, and to ensure that the best care is widely practiced nationwide.

One agency missing from the list of participating inter-agency departments and government agencies tasked to help support the development of the national plan is the National Endowment for the Arts. We strongly recommend that this agency have an opportunity to weigh in and support efforts in creating this national plan. Recently, this agency partnered with the U.S. Department of Health and Human Services in creating a white paper framing a national research agenda for the arts, health and well-being.

We believe that HHS should provide federal funds to support a state lead entity in every state--- determined by each Governor for the purpose of developing a state Alzheimer's Strategic Plan. We recommend that this lead agency Chair a state inter-agency committee comprised of other departments in state government which impact the Alzheimer's community, labor, other stakeholders, community service providers, caregivers and at least one resident living in the state with capacity who is living with memory loss to serve on this committee. We believe this committee should be tasked to provide annual updates which compare results to planned goals, and made publicly available to the citizens of each state.

We strongly recommend that the plan encourage the development of statewide plans for a full assessment of each state's current service delivery system, and outline a strategic plan for caring for individuals living with Alzheimer's and related dementias now and in the future. The national plan should weigh in on these efforts and seek to reward states for creating and implementing innovative cost savings while improving care outcomes.

We also believe that Administration on Aging Title IIIE Caregiver Support Service Programs can be an effective resource in meeting the needs of the Alzheimer's and related dementia community. With increased funding to the States, these programs could provide memory screenings and referrals to local diagnostic centers in order to receive a full differential diagnosis. Moreover, these programs could take a lead role in case management and care coordination, and in helping families with advanced care planning. We recommend that the plan include increased new funding to states within IIIE that stipulates services for individuals with Alzheimer's disease and their caregivers.

Medicare must provide an Adult Day Services benefit for persons with dementia. Adult Day Care Services provides active treatment for the person with dementia and support for their caregivers. This is particularly vital for the person with the disease that lives alone and/or has no caregiver. Medicaid should include Adult Day Services as a state option. Simply put, public policy discriminates individuals with a dementing disease. Medicare and Medicaid provide coverage for active treatment of medical and functional needs related to disease processes but does not include active treatment for individuals with dementia. These services allow adults with memory loss to be safe, socially connected, and therapeutically supported in order to maintain functional abilities as long as possible and avoid premature institutionalization. Moreover, this provides caregivers needed respite in order to extend their ability to care for their loved ones at home.

The cost savings to our long-term-care system would be tremendous relative to the over usage of home care, and nursing homes. In New York State the average cost for Adult Day Services is approximately $80 per day--- compared to $144 a day for home care, and between $253-376 a day for nursing home care. We must ask ourselves--- why are we--- over-medicalizing long term care services when they are often inappropriate. Adult Day Services provides care in the lease restrictive setting and offers a therapeutic oasis where those living with Alzheimer's disease and related dementias can continue to actively participate in the life of a community.

Thank you for the opportunity to share our thoughts and recommendations.


 

J. Thomas  |  03-29-2012

Caregiver support: comment/recommendations for a caregiver "proxy" for specific recurring elements/items to obtain AZ care and/or documentation of services. For example, there is a service here in Maryland (maybe all states - but I never utilized it until I moved here). For a fee (that is well worth it) the service is automobile title/tax documentation and filing. This title service obtains the necessary information from the owner of the vehicle and then completes the necessary processes at the title/courthouse to research title, complete documents and file the title.

Something similar could/should be offered to caregivers. They lose many hours from their own work/family/life spending hours dealing with the mandatory documentation/filing/provider visits - Insurance, Medicare, SSI, finances.

Improvements could be gained through informatics and digitalization of records and bioscreen/markers. Obtain information from AZ healthcare proxy/financial proxy caregivers to write a book on a step wise process of what is required by caregivers to file Medicare, SSI, etc. and suggestions on how a business "proxy" service could do this work. And/or how to automate the procedures through functionalities through a software application and with secure/encryption.

Home/housing models: I hear repeatedly that it is cheaper for an AZ patient to live at home (if home is available) than in an institutional setting. That is not true in the current environment. The cost of maintaining 24h/7d care in an AZ patient home is more expensive that placing the AZ patient in an institution. For example, the cost of care in Alabama, is primarily due to in-house sitter/aide - minimum $12-15/hour, is the equivalent of $264-$360/day, equivalent to up to $10,000/month. This does not include cost of housing overhead, food, medications, transportation, clothing, toiletries, taxes. The cost of AZ/dementia care in an assisted living facility is about 50% of that cost (includes housing, utilities, and food). Either cost is excessive and any personal savings are rapidly consumed and then insurance (if coverage purchased), then Medicaid pays.

The only way to reduce or minimize in home care is for volunteer services and/or family live in care. Churches may be a "mission" service and should consider the care/education/services for elderly adultsequivalent to the resources they invest in children services. With improvement of technology, monitoring/tracking devices, virtual monitoring, the care in house may be drastically reduced until the AZ patient is incapable of or has severe reductions in ADLs.


 

J. Zeisel  |  03-28-2012

I hope the attached serves as a useful mechanism for bringing nonpharmacological issues to the fore in the final draft of the National Alzheimer's Plan.

ATTACHMENT:

Thank you for the opportunity to comment on the draft National Alzheimer's Plan.

While the Draft National Alzheimer's Plan mentions nonpharmacological treatments and initiatives for dementia, it does so in a way that enables these important initiatives to be easily sidelined through lack of funding, lack of understanding and inappropriate research.

We the undersigned believe that the unique and positive alternative paradigm of nonpharmacological interventions in Alzheimer's must be recognized. This paradigm has several key dimensions that the National Alzheimer's Plan must recognize as a legitimate treatment modality for Alzheimer's and related dementias that can significantly improve the lives of those with these conditions and can significantly reduce costs in the care and treatment of those with Alzheimer's and other dementias.

The following must be recognized and included in the plan if these significant care options are to be valued as they clearly need to be so the many millions of people with Alzheimer's and other dementias today and tomorrow receive the quality of life and human rights they deserve.

  1. A DIFFERENT PARADIGM
    Nonpharmacological interventions represent a global paradigm of Alzheimer's treatment; much more than just individual actions such as chocolate, dolls, and environmental design. This paradigm, based on neuroscience theory, applied research, and clinical practice, has been developed by many experts over decades. If this powerful approach to dealing with dementia and reducing symptoms is to be taken seriously, the particulars, no matter how exceptional (such as museum programs for people with Alzheimer's, providing improvisational theatre, or giving chocolate), need to be taken as examplars of a larger way of thinking about Alzheimer's and dementia--a new paradigm--not as ends in themselves.

  2. EVIDENCE-BASED PRACTICE
    There is a huge cache of evidence-based knowledge demonstrating how non-pharmacological interventions reduce symptoms and improve daily lives of people living with dementia and their care partners. This research is often discounted and rejected because although it is meaningful and fits the needs of the evaluation being conducted, it does not fit a particular research model--the double blind randomized controlled trial. It is important to assess these data carefully to calculate the statistical effect sizes they represent and thus their impact on people's lives.

  3. METHODOLOGY AND METHODS
    Much existing research is discounted by policymakers, researchers, and others because they are convinced that the only evidence worth counting is generated by double-blind randomized controlled trials (RCTs). RCTs represent one important way to generate knowledge; but only one way. Other methodologies contribute substantially to our knowledge of nonpharmacological interventions and need to be taken seriously. It makes little sense to discredit a large body of knowledge that could immensely help policy and decision-making. The following summarizes two alternative ways to think about research methodology.

    The RCT gold standard assumes that 1. It is the highest level of proof, no matter what the research question, 2. It is at the top of a hierarchy of methods where other methodologies are "lower" on the continuum, and 3. That statistical significance is a measure of meaningfulness of a finding.

    The alternative gold standard for nonpharmacological and other research assumes that 1. The best methodology for any research question is the methodology that fits the question best--not any particular one, 2. There is no single continuum of methodology and no absolute hierarchy, and. 3. That effect measures are an important addition to statistical significance as a measure of a finding's "meaningfulness."

  4. HUMAN RIGHTS
    Freedom to choose, getting what you want, being part of the larger society and taking part in cultural activities are human rights everyone deserves--including those living with Alzheimer's and other dementias. We ought to be shocked at the limits to human rights being imposed daily on those with dementia (no chocolate and no visits to museums) rather than amazed that human rights are being respected in a few places--Arizona, or New York, or Massachusetts or wherever.

    The World Health Organization defines the rights of all people as dignity, independence, self-fulfillment, participation and care. Respecting these for people living with Alzheimer's could well be a rallying cry for those who care about people living with this condition.

  5. THE WAY OUT OF THE ETHICAL DILEMMA OF EARLY DIAGNOSIS
    In the name of science and further research, there is a movement taking place to diagnose Alzheimer's disease long before those being diagnosed show any cognitive or behavioral symptoms. Although these tests are presented as limited to research purposes, they are highly likely to be employed in everyday practice. For the millions who will receive this early diagnosis tomorrow and the millions living with this dementia diagnosis today, early diagnosis presents a major ethical dilemma: What to do with a diagnosis if no medications are available that stop the progress of the disease? The nonpharmacological paradigm and its associated interventions represent an ethical way to respond to the call for early Alzheimer's diagnosis since they offer a clear solution to improve the quality of life of people living with dementia.

For these reasons, we urge that an expert and champion of nonpharmacological approaches and treatments for dementia be appointed to generate research, direct information gathering and otherwise serve the needs of those with dementia today employing nonpharmacological approaches.

We also urge the Federal Advisory Panel and others administering research programs for dementia to include on an equal basis in all research, both nonpharmacological treatments and pharmacological ones. By nonpharmacological "treatments" we mean all health related activities that research has demonstrated have positive behavioral and health outcomes. These include, among others: engaging activity, exercise, targeted nutrition, music, visual arts, film, drama, museums, an appropriately designed and stimulating environment, memory books, high-touch end of life care, external written cueing, information technology, training family and formal caregivers, counseling, meditation, yoga, tai chi, exercise, poetry, storytelling, pets, and even chocolate.

We also urge the Federal Advisory Panel and those administering Alzheimer's-focused research programs and Alzheimer's-focused intervention strategies to develop and make explicit key performance indicators suited to nonpharmacological interventions. We also urge them to include in research protocols all evaluation methods and methodologies suited to studying the effects of real-world applications of nonpharmacological treatments. We urge that all research involving treatment of dementia, both pharmacological and nonpharmacological interventions, include reporting the clinical significance of effects produced by treatments, as well as statistical significance.


 

J. Levis  |  03-28-2012

I am the Early Stage Clinical Manager for the Alzheimer's Association Greater San Fernando Valley Service Center.

We offer care consultation and early stage support groups for both the person with the memory problems and their care partners. I asked my early stage support group participants to provide suggestions for the NAPA Plan and here they are for your consideration:

  • Education:
    • More emphasis on community education for people recently diagnosed
    • Opportunity to remain educationally integrated in society (taking classes to build cognitive reserve, educational institutions for cognitive impaired, etc.)
  • Peer support
    • Develop support networks for early stage individuals (support groups, social clubs, etc.)
  • Research
    • Greater emphasis on ES intervention- preventative treatment (what to do to avoid disease progression)
  • Media
    • More AD exposure in the media to assist people in recognizing the early signs

 

D. DiGilio  |  03-28-2012

Attached please find the American Psychological Association's comments on the Draft National Plan to Address Alzheimer's Disease.

As noted in the attached, APA is eager to collaborate with the Advisory Council on Alzheimer's Research, Care, and Services, federal agencies, and other organizations in the continued planning and implementation of the National Plan.

Thank you for the opportunity to provide these comments.

ATTACHMENT:

On behalf of the American Psychological Association (APA), I would like to commend the Department of Health and Human Services, the Advisory Council on Alzheimer's Research, Care, and Services, and the Interagency Group on Alzheimer's Research, Care, and Services for your efforts to develop and refine the National Plan to Address Alzheimer's Disease.

Enclosed are our APA comments in response to the draft plan released on February 22, 2012. APA is a scientific and professional organization representing psychology in the United States, with 154,000 members and affiliates. APA's mission is to advance the creation, communication, and application of psychological knowledge to benefit society and improve people's lives.

APA is eager to collaborate with the Advisory Council, federal agencies, and other organizations in the continued planning and implementation of the National Plan. We will continue to promote the involvement of our members in this important effort and stand ready to recommend psychologists (including researchers, clinicians, and educators) with expertise in a wide array of areas that are critical to the plan's success. These areas include: cognitive aging; neuropsychological and capacity assessment; evidence-based interventions for individuals with Alzheimer's disease and their caregivers; implementation research, public education and social marketing; palliative care; designing culturally appropriate programs and materials; health provider education and training; integrated health and care coordination models; and dementia guideline development.

Please direct any questions, comments, or concerns to Director of APA's Office on Aging.

American Psychological Association Comments on Draft National Plan

The American Psychological Association (APA) appreciates that the Draft National Plan is responsive to some of the concerns that we raised in January. In particular, we are pleased to see greater attention to clinical trials to test lifestyle interventions, including exercise and cognitive training. These interventions show promise as ways to improve cognitive health, and may in time be shown to prevent or slow the progression of Alzheimer's disease (AD). The second draft's emphasis on recruiting diverse participants to clinical trials is also important.

The ability to image biomarkers has significantly advanced the study of Alzheimer's. What continues to be missing in the current draft is an acknowledgement of the critical role of neuropsychological testing and assessment to measure changes in cognitive performance. Real clinical benefits for those with AD depend on fully understanding how biomarkers relate to cognition and behavior. It is fundamentally important to understand why people with similar amounts of beta amyloid may have very different cognitive profiles. The National Institute on Aging and its funding partners are urged to support additional research that links the presence of biomarkers with changes in cognition and functional behavior.

Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025

Strategy 1A: Identify research priorities and milestones

APA supports the convening of a summit to help set research priorities to reach the goals articulated in the National Plan, and the additional strategies to receive broad input and refine and update research goals and priorities as the Plan is put into effect. APA also supports the convening of a workshop on non-Alzheimer's dementias, and offers assistance for this project.

In order to clarify the types of research being discussed, APA suggests the following wording changes - with underlined text to be added and struck-through text to be deleted:

Strategy 1B: Expand research aimed at preventing and treating Alzheimer's disease

"HHS and its federal partners will expand clinical trials on pharmacologic and [REMOVE non-pharmacologic] [ADD behavioral] ways to prevent Alzheimer's disease and manage and treat its symptoms."

Rationale: APA prefers that behavioral studies be given their own name, and that they not be defined only by whether they include a pharmaceutical.

"Action 1.B.1: Expand research to identify the molecular, cellular, [ADD and cognitive] mechanisms underlying Alzheimer's disease, and translate this information into potential targets for intervention. "

Rationale: Certainly molecular and cellular work is vitally important. However, an 'integrated interdisciplinary basic science agenda' for Alzheimer's must also include basic cognitive and behavioral research.

Strategy 1.C: Accelerate efforts to identify early and presymptomatic stages of Alzheimer's disease

"Identifying [ADD and linking] [REMOVE imaging] biomarkers [ADD and behavioral/cognitive markers] in presymptomatic people will facilitate earlier diagnoses in clinical settings, as well as aid in the development of more efficient interventions to slow or delay progression."

Rationale: Biomarker research is tremendously important, but it is neuropsychological and cognitive measures that enable scientists to link biomarkers to observable clinical symptoms. Biomarker research advances are leading to the ability to diagnose and track AD, but findings cannot be considered complete in the absence of behavioral data. Therefore, the two areas of research should be linked in the plan's language.

Current research demonstrates that neuropsychological measures function well as diagnostic, prognostic, and disease progression indicators (Blacker et al., 2007; Gomar et al., 2011; Jacobs et al., 1995; Tabert et al., 2006). Cognitive measures are critical in the practical and operational (not theoretical) level within all three recognized stages of AD -- pre-clinical, mild cognitive impairment (MCI), and AD dementia -- in recently updated diagnostic guidelines by the NIA-Alzheimer's Association. Therefore, cognitive measures hold the promise of identifying people at the highest risk of developing AD up to 20 years or more before the disease is diagnosed, and are the best measures of potential impact of interventions on disease progression. Particularly as treatments are worked into preclinical phases of AD, improvements in the sensitivity of the cognitive measures to reliable change over time is critically important.

Recent studies in 2010 and 2011, many using ADNI data, have shown that neuropsychological measures are more accurate, earlier predictors of progression to AD when compared to MRI, FDG-PET, and amyloid imaging (Gomar et al., 2011). There is considerable promise in broadening and improving the measurement of cognitive markers of AD. Every piece of the expansion and improvement of AD research will require good (and better) cognitive assessments.

Goal 2: Enhance Care Quality and Efficiency

Strategy 2.A: Build a workforce with the skills to provide high-quality care

"The workforce that cares for people with Alzheimer's disease includes healthcare and long-term services and supports providers such as primary care physicians; specialists such as neurologists, [ADD neuropsychologists], geriatricians, and psychiatrists; registered nurses and advanced practice nurses; community health workers; social workers; psychologists; pharmacists; dentists; allied health professionals; and direct-care workers like home health aides and certified nursing assistants, who provide care at home or in long-term care facilities. These providers need accurate information about caring for someone with Alzheimer's disease including the benefits of early diagnosis and how to assist caregivers. Physicians need information on how to implement the "detection of any cognitive impairment" requirement in the Medicare Annual Wellness Visit included in the Affordable Care Act. Major efforts by both VA and the Health Resources and Services Administration (HRSA), including expanded training opportunities created in the Affordable Care Act, support geriatric training for physicians, nurses, [REMOVE and other health workers."] [ADD social workers, psychologists, dentists, pharmacists, counselors, and allied health professionals].

Rationale: We believe it is important as this plan will direct future efforts and funding in this area, that all geriatric disciplines be explicitly mentioned. Psychologists, social workers, and other health care providers play an integral role in VA interdisciplinary teams to meet the needs of individuals with dementia and their caregivers. Accordingly, they are included in the ACA expanded training provisions, and are listed on the BHPR website.

Action 2.B.2: Identify and disseminate appropriate assessment tools

"The Affordable Care Act created the Medicare Annual Wellness Visit. 'Detection of any cognitive impairment' must be included as part of the wellness visit. HHS is using research findings to identify the most appropriate assessment tools that can be used in a variety of outpatient clinical settings to assess cognition. The recommended tools will be distributed to practitioners to aid in identification and evaluation of cognitive impairment and risk for dementia," [ADD and to determine the need for referral for a comprehensive neuropsychological evaluation].

Rationale: Neuropsychological evaluation remains a critical component of differential diagnostic methods in discriminating neurodegenerative changes from normal age-related cognitive decline, cognitive difficulties that are related to psychiatric conditions or medical morbidities, and other related disorders. Neuropsychological measures are accurate, early predictors of progression to AD and provide useful information to individuals with dementia and their families regarding the functional capacities of the individual and potential impact of interventions on disease progression.

Goal 4: Enhance Public Awareness and Engagement

"Most of the public is aware of Alzheimer's disease; more than 85 percent of people surveyed can identify the disease and its symptoms. Alzheimer's disease is also one of the most-feared health conditions. Yet there are widespread and significant public misperceptions about the [ADD prevention], diagnosis, [ADD disease management], and treatment." [ADD In addition, there is a lack of public understanding of the differences between normal age-related cognitive change and pathological change].

[ADD These misperceptions can lead both to delayed diagnosis when family members falsely attribute behavioral and memory issues to normal aging and to faulty diagnosis and harmful avoidance behaviors when families become paralyzed with concern about the stigma and decline associated with Alzheimer's disease. Both misconceptions can prevent families from obtaining needed and appropriate supports. They can also lead to inaction in adopting health promoting behaviors such as physical activity, maintaining a healthy weight, and refraining from smoking, which may prevent or slow any disease process]. "Enhancing public awareness and engagement is an essential goal because it forms the basis for advancing the subsequent goals of the National Plan. A better understanding of Alzheimer's disease will help engage stakeholders who can help address the challenges faced by people with the disease and their families."

Rationale: Two top tier messages of this campaign should be: 1) AD is not a normal part of cognitive aging; and 2) there are modifiable risk factors for AD (including diabetes, midlife hypertension, midlife obesity, smoking, depression, cognitive inactivity or low educational attainment, and physical inactivity) AND actions individuals can take now to reduce their risks. A recent study (Barnes et al, 2011), notes that up to half of AD cases worldwide are attributable to seven potentially modifiable risk factors -- and that a 10-25% reduction in all seven risk factors could potentially prevent as many as 1.1-3.0 million AD cases worldwide.

4.A: Educate the public about [ADD normal cognitive aging and] Alzheimer's disease

"Greater public awareness of [ADD normal cognitive aging and] Alzheimer's disease can [ADD encourage individuals and] families to [ADD participate in cognitive health promoting behaviors and] seek assessment, reduce isolation and misunderstanding felt by caregivers, and help link people in need to accurate information, resources and services," [ADD when needed].

References

Barnes, D.E., & Yaffe, K. (2011). The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurology, 10, 819-828.

Blacker, D., Lee, H., Muzikansky, A., Martin E., Tanzi, R., McArdle, J., Moss, M., & Albert, M. (2007). Neuropsychological measures in normal individuals that predict subsequent cognitive decline. Archives of Neurology, 64, 862-871.

Gomar J. J., Bobes-Bascaran, M. T., Conejero-Goldberg, C., Davies, P., & Goldberg, T. E. & Alzheimer's Disease Neuroimaging Initiative (2011). Utility of combinations of biomarkers, cognitive markers, and risk factors to predict conversion from mild cognitive impairment to Alzheimer disease in patients in the Alzheimer's disease neuroimaging initiative. Archives of General Psychiatry, 68, 961-969.

Jacobs, D.M., Sano, M., Dooneief, G., Marder, K., Bell, K. L., & Stern Y. (1995) Neuropsychological detection and characterization of preclinical Alzheimer's disease. Neurology, 45, 957-962.

Tabert, M.H., Manly, J.J., Liu, X., Pelton, G. H., Rosenblum, S., Jacobs, M., Zamora, D., Goodkind, M., Bell, K.,Stern, Y., & Devanand, D. P. (2006). Neuropsychological prediction of conversion to Alzheimer's disease in patients with mild cognitive impairment. Archives of General Psychiatry, 63, 916-922.


 

L. Levine Madori  |  03-28-2012

Please accept my letter regarding the National Plan to Address Alzheimer's Disease.

ATTACHMENT:

Professor, Researcher and Author comments on the Draft Framework for the National Plan to Address Alzheimer's Disease

Thank you for inviting the public to comment on the U.S. Department of Health and Human Services "Draft Framework for the National Plan to Address Alzheimer's Disease." For over three decades I have worked as an educator at the University level, and therapist with individuals who have either been just diagnosed with early on-set of Alzheimer's Disease, mild- to moderate stages of the disease as well as late stage Alzheimer's disease. In addition, I have taught at Colleges and Universities across the United States as well as in many countries internationally. Being a two time Fulbright Scholar in Global Health Studies, I have dedicated my academic career to both teaching, researching and authoring creative and innovative approaches on how to best provide programming to those afflicted with this disease. I welcome the opportunity to provide recommendations for your consideration.

In recent years, various non-pharmacological approaches to care such as creative arts-based programming; cognitive stimulation; exercise and movement programming; meditation; learning methods; sensory therapy, and cognitive training are recognized in small scale studies and are the basis of research information taught and practiced at the University level in career areas such as Therapeutic Recreation, Creative Arts Therapies, Movement and Dance Therapy and Art Therapy. These non-pharmacological approaches have emerged as a grassroots movement responding to an evolution of evidence, put into research and implemented in Social Adult Day Programs, Assisted living Facilities, and Long Term Nursing Facilities.

However small these studies, research is continuing to suggest that some individuals will slow the progression of dementia and have the potential to improve or revert back to normal memory with early interventions due to structured cognitive stimulation (Pressley, J., Trott, C. & Tang, M., 2003; Chertkow, H., et al., 2001). Additionally, there is evidence to suggest that activities in the mental, physical and social domains have protective effects against cognitive decline and dementia (Flatiglioni, et al. 2004; Gilley, W., Wilson, L., Bienias, L., Bennett, A. & Evans, A., 2004; Claire, L., Wilson, B., Carter, G., Roth, I. & Hodges, J.,2004; Davie, J., et al., 2004). More specifically, continued active participation in life through social involvements and activities that are individualized and person centered to each individuals needs and skills have been documented to enhance feelings of self esteem, self worth and directly impact overall quality of life (Pruessner, J., Lord, C., Meaney, M. & Lupien, S., 2004; Manly, J., et al., 2005; Kumara, R., et al., 2005). A National study of all research related to early stage dementia indicated that the need for psychosocial support for persons newly diagnosed should take place soon after receiving the diagnosis to prevent dropping social support networks, cognitive decline and leading to increased institutionalization rates (Brodaty, H., Gresham, M., & Luscombe, G., 1997; Fernandez-Ballesteros et al., 2003). In a review of the literature regarding early stage AD it has been documented that multi-modal approaches have the most significant outcomes (Burgener, S., et al., 2007). The TTAP Method, a multi-modal approach has been documented in a pilot study (Alders, A. & Levine Madori, L., 2010) to improve cognition in Hispanic elderly in a Social Adult Community Day Center in Buffalo, New York and in a research study with Rehabilitation Patients at Helen Hayes Hospital the method proved to increase overall feelings of self control and pain management (Levine-Madori, L., 2009).

Research in the area of non-pharmacological approaches to Alzheimer's care is still being ignored, and yet it continues to remain the most economically sound approach. In a data collection in 2010 on a Gero- psychiatric unit at Lyndon Oaks at Edward Hospital located in Naperville, Illinois, staff was trained in The TTAP Method. Pre- training data collection documented the unit had an average of 90 hours of aggressive interventions a month. These interventions were carried out by a Nursing Supervisor. Six months into staff implementing of thematic person-centered creative arts programming the aggressive behaviors went down to an average of 4.6 Nursing Interventions. Falls went from an average of 5 per month to 3, this statistics validate a direct healthcare savings of over $80,000.00 in just a six moth period. http://www.levinemadoriphd.com/content/site/educational-courses.php .

A world without Alzheimer's, might very well be a real possibility in the future. However, the current 5.4 million people who currently have the disease and the estimated 10,000 people daily diagnosed each and every day will still need daily non-pharmaceutical innovative programming, treatment and care. As an Art Therapist, Recreation Therapist and Ph.D. it is my belief that the current research agenda is narrow in scope and leaves research in the non-pharmaceutical -creative arts completely out of the discussion. For decades we as a society have poured millions of dollars into pharmaceutical research, which to date has yet to make an impact. It is my belief that it is crucial at this point in time, just as the baby boomers are starting dramatically impact the "graying of America". As you probably are aware, it is estimated by the National Association on Alzheimer 's disease, in 2011, that one of every 8 baby-boomers are predicted to have some form of cognitive impairment in their lifetime.

The time for researching the non-pharmaceutical approaches and putting research into practice is now! Those who have dedicated their lives to people afflicted by this disease process understand that these individuals LIVE with the disease for many years. The average person diagnosed with Alzheimer's Disease now lives 15 years and must be given meaningful and person-centered daily therapeutic interventions. Without research we cannot move forward in the healthcare areas such as Art Therapy, Recreation Therapy, Music Therapy, etc. to provide research based, best practice approaches. Please know that these healthcare fields in the Creative Art Therapies, Therapeutic Recreation, and Music Therapy are in fact where daily treatment and ongoing cognitive, social, emotional and physical stimulation comes from. Research money is needed to be earmarked for these healthcare professionals and the research that they do in non- pharmacological approaches to Alzheimer's care.

Thank you for the opportunity to share thoughts and suggestions with you.


 

S. Fitzler  |  03-28-2012

See attached for the comments submitted by AHCA.

ATTACHMENT:

The American Health Care Association (AHCA) appreciates the opportunity to comment on the Draft Plan to Address Alzheimer's Disease published in Federal Register Volume 77, Number 37, pages 11116 - 11117 (February 24, 2012).

AHCA represents nearly 11,000 non-profit and proprietary facilities dedicated to continuous improvement in the delivery of professional and compassionate care provided daily by millions of caring employees to 1.5 million of our nation's frail, elderly and disabled citizens who live in long term and post-acute care facilities. We are most interested in this plan since we care for many people with Alzheimer's disease and related dementias. According to the AHCA Nursing Facility Patient Characteristics Report, March 2012, almost 48% of all nursing facility residents across the U.S. are identified as having some form of dementia, while the March 2012 AHCA Nursing Facility Operational Characteristics Report indicates that 71% of all special care beds in nursing facilities today are dedicated to care for persons with Alzheimer's Disease and related dementias.

AHCA supports the national plan's guiding principles, goals, strategies and actions and believes the plan is timely, and when executed, will produce a better understanding of the disease and the prevention strategies, care and resources that will be required to care for people living with dementia. Since we are in agreement with the national plan and find it to be comprehensive, we offer only a few comments for your consideration.

The plan identifies that it is often difficult to distinguish between Alzheimer's disease and other dementias in terms of clinical presentation and diagnosis. AHCA would like to see this statement expanded to also include the importance of distinguishing undiagnosed psychiatric disease and characteristics, like behavioral symptoms, from Alzheimer's disease.

According to the National Alliance on Mental Health (NAMI), the nation's largest mental health organization formed in 1979, the nation's mental health system has been and continues to be in crisis. NAMI grades states in their provision of mental illness (MI) services and rates the nation as a "D" (an average of all the states). Services found lacking include the number of psychiatrists, treatment services, and community-based supports -http://www.nami.org/gtsTemplate09.cfm?Section=Grading_the_States_2009.

In 2010, David Grabowski, PhD from Harvard Medical School looked at MI and Dementia in nursing homes. Grabowski found that between 1960 and 1970, states closed and downsized psychiatric hospitals. As a result, many states were ill equipped to provide community service alternatives and nursing homes became the "de facto" treatment destination for people with MI. Grabowski cites findings indicating that in 2005, 12% of persons newly admitted to nursing homes had dementia, 19% had MI and 6% had both MI and dementia and the Pre-Admission Screening and Resident Review (PASRR) process, instituted in nursing homes with OBRA in 1987, was not effective at ensuring appropriate placement and treatment of persons with MI - http://www.pasrrassist.org/sites/default/files/Grabowski_Mental_Illness_in_Nursing_Homes_Dec2010.pdf.

The NAMI and Grabowski findings are concerning in that nursing home providers often admit individuals with undiagnosed MIs due to the lack of state MI services. These individuals may present with behavior problems that are often mischaracterized as symptoms of Alzheimer's disease and in some cases, represent both dementia and MI and raise important care issues that need to be addressed. Considering this, AHCA recommends that the national Alzheimer's plan, particularly Goal 1, Strategy 1.A related to research priorities, address the prevalence of undiagnosed MI in nursing homes, ways to distinguish undiagnosed MI from Alzheimer's, and best practices for treating individuals living with both dementia and MI.

Finally, the national plan identifies the need to monitor the use of antipsychotics in nursing homes (Goal 2, Strategy 3.D). AHCA is in agreement with the strategy's focus. One of our four priority goals as part of our Quality Initiative is for our members to safely decrease the off-label use of antipsychotics by 15% by the end of 2012. Given that many individuals admitted to nursing facilities are already on these drugs, reduction in off-label use of antipsychotics in nursing facilities will be more successful if attention is also given to reducing off-label prescribing in the hospital and in the community. It is important for all settings of care that provide services to the elderly to monitor and report their rates of off-label use of antipsychotic drugs. Expanding the scope of monitoring will help to more consistently and effectively detect and eliminate inappropriate uses of these drugs and help reduce antipsychotic drug prevalence in nursing facilities. AHCA recommends that the national plan, Action 3.D.2, be expanded to all healthcare settings.

AHCA welcomes the opportunity to work with HHS on future discussions and planning related to addressing Alzheimer's disease and on any further development and refinement of strategies and actions to improve and monitor care. We thank you for the opportunity to offer these comments.


 

A. Allison  |  03-27-2012

The Down Syndrome Guild of Greater Kansas City represents 1200 families in 37 counties in Kansas and Missouri who are all caring for a loved one with Down syndrome. Many of our parents are gravely concerned about their child, teen or adult's future and the strong likelihood that they will develop dementia and Alzheimer's Disease.

I am writing to urge the Advisory Council to ensure that the population of people with Down syndrome (Ds) is specifically identified in the Draft National Plan to Address Alzheimer's Disease. Currently, this group of individuals, known to be at high risk of developing Alzheimer's and dementia, is given a fleeting reference in the Draft Plan. This omission must be rectified. We are aware that there is a lot of corollary research going on between Alzheimer's and Down syndrome and feel that more attention should be paid to this to ensure a bright future for both populations of people.

In order to better understand the Alzheimer disease process and develop early identification and other practices to treat this devastating disease which often affects individuals with DS early, research is urgently needed. Research of this type will benefit the general population as well as individuals with Down syndrome and those thousands with DS at risk for developing dementia. In addition, as a parent or family member, I am aware of the need to provide special supports for caregivers, often siblings or aging parents, who assume responsibilities for the care needs for individuals with intellectual disabilities and dementia.

It is also case that these individuals have special needs that may differ and require different supports than those provided to individuals in the general population. These needs have been identified by the National Task Group and Intellectual Disabilities and Dementia Practices in an action plan it issued as part of its report: My Thinker's Not Working: A National Strategy for Enabling Adults with Intellectual Disabilities Affected by Dementia to Remain in Their Community and Receive Quality Supports",which has been submitted to the Council.

Individuals with Down syndrome and their families deserve to have research and population specific clinical trials identified clearly as necessary actions in the final National Plan to Address Alzheimer's Disease. They face many challenges that require increased awareness, early recognition and supports. The National Plan to Address Alzheimer's Disease is not complete unless it fully addresses the Down syndrome population as well.

Thank you for your consideration of this request!


 

M. Fitzgerald  |  03-27-2012

Attached are comments submitted by The Arc concerning the Draft National Alzheimer's Plan.

ATTACHMENT:

The Arc is a membership organization of over 700 state and local chapters made up of people with intellectual, developmental and other disabilities, their families, friends, interested citizens and professionals. The Arc has represented individuals with the most significant disabilities for over 60 years.

The Arc is particularly interested in the Council's Draft National Plan to Address Alzheimer's Disease since the disease has special significance for individuals with intellectual and developmental disabilities. The Arc was pleased that the draft plan made reference to people with intellectual disabilities (ID) in Strategy 2.H. However, we believe that the interests of people with ID should be infused throughout the plan rather than addressed in just two bullet points.

The Arc endorses the comments submitted to the Council by the National Task Group on Intellectual Disabilities and Dementia Practices (ntg). Each of the numerous immediate, near-term, and long-term recommendations for priority actions outlined in the draft plan pertains to individuals with (ID). The needs of people with ID apply to all areas addressed in the draft plan - research, early identification, training of practitioners, support for family caregivers, community-based supports and services, and data collection and analysis.

People with ID are living longer and the number of individuals who have Alzheimer's disease and ID likely will increase. It is incumbent on the Advisory Council to ensure that our nation's public health system is prepared.

Thank you for considering our input. Please contact The Arc if we may provide additional information.


 

C. Moseley  |  03-27-2012

Please find attached comments from the National Association of State Directors of Developmental Disabilities Services to the Advisory Council on Alzheimer's Research, Care, and Services regarding the Draft National Plan To Address Alzheimer's Disease.

ATTACHMENT:

The National Association of State Directors of Developmental Disabilities Services (NASDDDS) is a professional organization comprising the directors of state agencies serving individuals with intellectual and developmental disabilities (IDD) in all 50 states plus the District of Columbia. The Association assists state IDD agency officials respond to emerging state and federal policy issues that that affect their efforts to ensure the delivery of services and supports to individuals with IDD in their respective states and jurisdictions. Association staff provide member state agencies with extensive technical assistance on a wide range of system and program related issues, in-depth analyses of Medicaid and other federal statutory and regulatory policies affecting people with IDD, and cutting edge information on state-of-the-art programs and service delivery practices. NASDDDS collaborates closely with the American Academy of Developmental Medicine and Dentistry (AADMD) and the National Task Group on Intellectual Disabilities and Dementia Practices (NTG) to improve health and healthcare of people with IDD nationwide.

State IDD service delivery systems are large with total annual state and federal expenditures in excess of $53 billion. Data reported by the University of Minnesota Research and Training Center on Community Living reveal that over 1,000,000 individuals with intellectual and developmental disabilities, including autism, cerebral palsy and related conditions received publicly financed residential supports through Medicaid and other state/federally funded programs. The majority of these individuals, approximately 57% live with their families, receiving the supports that they need at home, at work and in a variety of in day programs in the community. Of the approximately 440,000 remaining individuals, about 72% live in local group homes or other neighborhood settings of less than 6 persons. Fewer than 28% reside in large state and privately operated institutions.

The purpose of this correspondence is to provide feedback to the Advisory Council on Alzheimer's Research, Care, and Services regarding the Draft National Plan To Address Alzheimer's Disease. We are pleased that the Draft Plan specifically identifies people with intellectual disabilities in Strategy 2.H as a group of Americans who are at exceptionally high risk for contracting Alzheimer's disease. Including people with IDD in the report recognizes their particular vulnerability to these conditions and suggests the challenges that publicly financed systems of support will need to meet in the very near future. We believe, however, that the report does not go far enough in addressing the specific issues identified by NASDDDS member state agencies and articulated by a national report prepared by NTG entitled, My Thinker's Not Working: A National Strategy for Enabling Adults with Intellectual Disabilities Affected by Dementia to Remain in Their Community and Receive Quality Supports, and the related National Dementia and Intellectual Disabilities Action Plan. Our specific concerns and suggestions include the following:

Issue 1. The relationship between the presence of Down Syndrome and the risk of Alzheimer's disease is not given proper focus in research and practice recommendations.

Goal 1 of the Draft Plan highlights research but does not reference the need for targeted examination and analysis of the etiology and course of dementia for people with Down syndrome, a group of individuals expressing a particular high risk for Alzheimer's disease. Sustained research in this area is clearly warranted to better understand the course and treatment of the disease and to inform and hopefully improve public policy in this area. We believe that continued support of research concerning and involving people with Down syndrome will not only potentially benefit the general population, but will also benefit the thousands of adults aging with Down syndrome and who are at high risk for and are affected by early onset dementia. Like individuals with genetic mutations resulting in early onset Alzheimer's disease, people with Down syndrome demonstrate early onset of symptoms and more research into this phenomenon is necessary. It should be emphasized that focused research into a relatively homogeneous population such as individuals with Down syndrome and Alzheimer's dementia can provide important clues when generalizing to the larger population of people with Alzheimer's but absent Down syndrome.

Recommendation. NASDDDS strongly recommends that Goal 1 of the Draft Plan emphasize the need for focused basic and treatment research addressing the conditions and support needs of people with Down syndrome at high risk of Alzheimer's disease.

Issue 2. Addressing the specialized programmatic and care challenges faced by people with intellectual disabilities in Goal 2.

NASDDDS agrees with the observations and recommendations of the NTG that the Council revise the Draft Plan to recognize the importance of the special programmatic and care challenges faced by people with intellectual disabilities in Goal 2, under Strategy 2.H (Action 2.H.1). And that the discussion of the special circumstances of adults with Down syndrome and other intellectual disabilities be mentioned earlier on in this section to make it clear that the strategies included under Goal 2 apply equally to this population. It is important that the Draft Plan recognize that Alzheimer's disease impacts adults with lifelong intellectual disabilities in the same manner as it does other people, but sometimes has a more profound effect due to particular risk factors - including genetics, neurological injury, and deprivation. Furthermore, we believe that it is important that any NAPA-related task forces created (as cited in the Draft Plan) not only address improvements of care for this specific population, but also, are designed to increase awareness, improve screening and early recognition, and conduct population specific clinical trials involving adults with intellectual disabilities.

Recommendations. NASDDDS recommends that:

  • The Draft Plan and any resulting guidelines produced include reference to the special circumstances and challenges involved in assessing and determining the presence of dementia in adults with Down syndrome and other intellectual disabilities, and that this acknowledgement be placed earlier in the second section so that it is clear that the Strategies included under Goal 2 apply equally to this population.
  • The Draft Plan reference under Strategy 2.B the need for specialized screening instruments that are designed and normed for use with adults with intellectual disabilities. The administrative screening tool currently under development by the NTG will have specific application to people with intellectual disabilities who otherwise may not be adequately or successfully screened by tools in existence and applicable to the general population that are not normed for use by people with cognitive disabilities.
  • The Draft Plan reference under Strategy 2.E the need for long-term 'dementia capable' services and supports to be offered in small community settings rather than institutional facilities, consistent with the 2002 Madrid International Plan of Action on Ageing. Research in the intellectual disabilities services area has shown this small group home model to be particularly effective in providing quality care for those adults with intellectual disabilities affected by dementia.

Issue 3. Need to address the special support needs of aging caregivers providing long-term in-home care of adults with intellectual disabilities.

As noted above, the majority, over 57%, of all people with IDD receiving publicly financed support reside in the home of a family member. The age of family caregivers, like the average age of the U.S. population in general is growing older however, and these caregivers are now themselves needing support. Tragically, the availability of services has not kept pace with the demand for support. Plummeting state budgets and reductions in Medicaid and state-funded supports have expanded waiting lists and placed a greater burden on families with relatives in need of personal care and assistance. The ability to provide quality care to people with IDD who are aging both now and in the future depends on the ability of state and federal service delivery systems to support the capacity of families to furnish needed long term assistance.

The majority of adults with Down Syndrome and other intellectual disabilities need assistance in decision making and consent. Adults with intellectual disabilities are not the ones planning for their own long-term care needs and consideration must be given to enabling parents or other family members, providing primary care, to undertake productive long-term care planning.

Recommendations. NASDDDS strongly recommends that the Draft Plan address the special challenges faced by life-long caregivers of some persons with intellectual disabilities, (see Strategy 3.C.1)

Issue 4. Need to expand public education activities to include individuals with IDD and their families.

NASDDDS believes that Goal 4 be expanded to ensure that the needs of family caregivers and people with intellectual disabilities are specifically addressed by public education campaigns and to improve coordination efforts by government and the voluntary sector. State IDD agencies are instrumental in organizing, managing and delivering services and supports to people with intellectual and developmental disabilities and their families. It is essential that these state agencies be included in public education efforts and that education and training for health professions with respect to aging individuals with dementia -- especially of the Alzheimer's type -- should be included as part of primary health care education. Aggressive education campaigns addressing the nature of intellectual disabilities and the needs of individuals with IDD should be targeted to universities, hospitals, emergency rooms and general medical specialists.

Recommendation. NASDDDS recommends that the Draft Plan include consideration of additional and targeted efforts related to public and medical education so that these efforts have a functional effect on helping people with intellectual disabilities affected by dementia.

NASDDDS member state agencies furnish a wide array of publicly financed services and supports to people with intellectual and developmental disabilities. As the age of the population increases, state service delivery systems are working to develop effective strategies for meeting the needs of people with IDD in a way that allows them to age in place and remain a part of their families and communities. The National Plan to Address Alzheimer's is an important step forward. We appreciate the work and recommendations of the Advisory Council, not only for the population in general, but particularly for persons with intellectual and developmental disabilities who are especially vulnerable to this condition. NASDDDS gratefully acknowledges the work on this issue by the National Task Group on Intellectual Disabilities and Dementia Practices and their assistance in forming the recommendations of this Association.


 

C. Lingo  |  03-27-2012

Please include individuals with Down syndrome in the National Plan for Alzheimer's disease and related dementias. This group if individuals is underrepresented and under funded.

Your attention is appreciated.


 

M. Rosenblut  |  03-26-2012

The Alzheimer Center at the Parker Jewish Institute for Health Care and Rehabilitation, located in New Hyde Park, New York, vigorously supports the draft National Plan to Address Alzheimer's disease. We are particularly supportive of the Plan's objectives to increase funding for Alzheimer's disease research and training initiatives, as well as development of state plans.

Parker is a highly acclaimed non-profit that offers inpatient short term rehabilitation, sub-acute care and nursing home care, as well as a comprehensive network of community health care services, inclusive of adult day health care, home health care, hospice care, on-site dialysis, medical transportation -and a unique Alzheimer Center that accepts participants at all stages of dementia. In 2011 alone, the Alzheimer Center at Parker served 1,085 participants. The Institute is also among the leaders in teaching and research.

Should you need additional testimony with regard to the plan, or are considering sites for pilot programs, please feel free to call upon us.


 

D. Harvey  |  03-26-2012

The Iowa Department on Aging is encouraged by the initiation of a national plan to address Alzheimer's disease and related disorders. A diagnosis of, or in many cases just a discussion about Alzheimer's disease or related dementia can trigger a sense of fear, foreboding and uncertainty.

The National Alzheimer's plan has the potential to greatly improve and enhance the current system and help improve the quality of life and quality of care for both people diagnosed and their caregivers. But without adequate funding attached to the proposed goals, we are concerned that systems change is not possible.

  1. To effectively create a system to enhance quality care and efficiency we believe the Plan should dictate minimum standards including, but not limited to the following:
    • An increased number of hours of education and training required for health care professionals and other disciplines who come in contact with people diagnosed with dementia.
    • Physician training programs that stress the importance of early detection and diagnosis.
    • Create and implement dementia unit requirements that include specially trained activity personnel, increased daily programming and adequate social work staff to meet the needs of people living in long-term care facilities.
    • Dementia care offered in hospitals must include staff with dementia training and enough staff to properly care for patients with a dementia diagnosis.
  2. Expand patient and family support by enhancing existing systems.
    • Strengthen the National Family Caregiver Program to ensure that specialists are dementia capable and can provide education, referral and resource information and support to family caregivers who are caring for a person with dementia.
    • Strengthen the Lifespan Respite Program by providing adequate funds for respite care for people with dementia. Statistics show that access to respite care has a definite impact on the length of time a person can be cared for at home.
    • Provide access to evidence based programs that demonstrate effective support to all caregivers of people experiencing dementia
    • Increase psychosocial interventions for the caregiver and care receiver that offer support and assistance for people in home and community based programs.
  3. Enhance public awareness and engagement through an organized, funded campaign to assist the general public in:
    • Understanding the importance of early detection, diagnosis and treatment.
    • Understanding the importance of future planning
    • Becoming knowledgeable about long term living and community support services that are available in local communities

       

The Iowa Department on Aging believes that a nationally funded and coordinated effort is needed to enhance care, expand caregiver support and increase awareness and we support the National Alzheimer's Plan.


 

M. Ducker  |  03-26-2012

The U.S. Department of Health and Human Services (HHS) should have Address the Mental Health Needs of People with Dementia and their caregivers in its ambitious plan to address Alzheimer's disease.

Unfortunately, the draft plan does not provide adequate attention to mental disorders commonly experienced by people with dementia and their caregivers.

Dementia frequently co-occurs with mental health conditions such as depression and anxiety disorders. In addition, family caregivers are at high risk for mental and physical health problems. Recognizing and treating these conditions plays a vital role in improving patients' cognitive functioning as well as the quality of life of people with dementia and their caregivers.


 

J. Patterson  |  03-26-2012

As younger populations become increasingly urban and concentrated, persons more likely to have Alzheimer's or related dementia, become stranded in rural communities without adequate resources or family to assist them as the disease progresses. As jobs become scarce in rural communities, children of the baby boomers have moved where there are better job prospects leaving their parents alone. The community supports simply are not adequate in rural communities to address the specific needs of persons with dementia who have no informal primary caregiver's. Many of these people will end up in nursing facilities, that are ill-equipped to handle the specific care needs of an Alzheimer's patient. Nursing homes are for skilled care; however, Alzheimer's patients frequently do not need skilled care (for much of the disease progression), they simply need supervision, social stimulation, and help with minimal ADL's and IADL's. Nursing facilities have problems handling the behavior of Alzheimer's patients, because they are frequently mobile and cause disturbances with other patients. As a result nursing facilities are reluctant to accept patients with Alzheimer's disease early in disease progression. The addition of Alzheimer's dementia specific units to nursing facilities, especially in rural communities, would alleviate some of this problem. The staffing would be smaller, and the cost per day to medicare/Medicaid could be reduced as a result.

Additionally, for informal caregivers that do live in rural communities, support groups, educational opportunities, and training are absent. In addition, broadband internet is also difficult to obtain do inadequate infrastructure, leaving the caregiver unable to obtain information. The stress of caregiving combined with isolation shortens the amount of time an informal caregiver can increase the chance the persons are placed in nursing facilities for lack of another option. Providing community training through religious institutions, civic organizations, and other groups would allow for wide dispersal of accurate information, as well as the infrastructure in rural communities, improving early diagnosis and extending the amount of time a person can stay at home with a caregiver by reducing their stress through knowledge and resources. One way of accomplishing this is to certify persons at the AAAs or County Health Departments to recruit and train volunteers to provide outreach and educational events in their communities.

Another component of stress reduction is respite support. Caregiver's of persons with Alzheimer's or related diseases care for their loved ones for long periods of time. The time spent away from work, church, and family can become taxing and frequent breaks are needed. As there is increased demand for respite, and in the absence of increased funding for flexible respite support one of two options is available: 1) reduce the amount of respite per caregiver or 2) maintain lengthy waiting lists. Both options fail. At some point, respite is ineffective if it is infrequent and for very brief periods of time. If the caregiver waits too long without a break on a waiting list for respite, the caregiver will give up before the programs can provide assistance. The solution is to increase funding for respite supports through the AAAs, V.A., as well as introduce a income needs based component to respite support programs eligibility requirements. People that are wealthy ought to pay for their respite, or prove they have paid x amount before they can gain access to subsidized respite support each year. The reach of the programs would extend to those least likely to take a break, because they are unable to afford it.


 

S. Terman  |  03-26-2012

This letter is very similar to my oral testimony (a few corrected typos and better words)--except for my adding a new paragraph at the beginning--to respond more fully to a public comment that preceded mine:

A person (M. Ellenbogen?) who currently suffers from mild Alzheimer's dementia concluded his comments by recommending the Advisory Council on Alzheimer's Research, Care, and Services consider the "right-to-die" option. He thus implied that Physician-Assisted Dying could be an option for patients who suffer from dementia. Because of time limitations, I could only disagree briefly by saying that Physician-Assisted Dying will neither help nor is needed. I now explain more: (1) Why would Physician-Assisted Dying NOT help? Where Physician-Assisted Dying is legal, the law requires patients be of "sound mind" when they ask their physician to write a prescription for a lethal dose of medication. Yet dementia patients lose the mental capacity to make medical decisions early in the course of this progressive disease. Thus for dementia patients, Physician-Assisted Dying would compound their tragedy with premature dying. This is because dementia patients can have much good life after they lose capacity--and they can expect more, with further research--so I and many others consider premature dying an act that violates the principle that life is precious. (2) Why is Physician-Assisted Dying NOT needed? Because Living Will forms and the discussions they provoke can be both moral and effective. Combined with other clinical and strategic forms, diligent Advance Care Planning can give people peace of mind, whether they are still well or in the early stage of dementia. They need not worry about being forced to linger for months to years by enduring the huge burdens and suffering that characterize Advanced Dementia. Instead, they can feel confident that others will honor their Known Wishes after they lose the ability to speak for themselves.

Here is my original comment:

For patients who will someday suffer from Alzheimer's and related dementias, Advance Care Planning is most urgent, most important, and most challenging. The process of expressing one's end-of-life wishes in advance warrants both 1) the development of innovative planning tools that are easy, effective, and acceptable to both patients and physicians, and 2) sufficient effort to train professionals to honor Advance Directives and to recommend that their patients/clients complete them.

Why is Advance Care Planning most urgent? Unlike most diseases, patients who have dementia typically lose mental capacity to make end-of-life medical decisions early in the course of the disease. Once their window of opportunity to make decisions closes, they will not be able to participate in their own end-of-life planning. The reality of the huge, increasing epidemic of patients whose lives will end as they suffer from Alzheimer's disease makes Advance Care Planning even more urgent on a societal level.

Why is Advance Care Planning most important? Because patients can linger in the terminal stage of Alzheimer's Dementia for several years. The relentless course of their disease may frustrate the best efforts of their clinicians, their caregivers and their loved ones. The multiple burdens on others are well known. For example, more than one-third of Alzheimer's caregivers are depressed. Yet the suffering patients themselves experience is under-appreciated. For too many who have lost the ability to complain and whose behavior may be atypical, pain and suffering may go unrecognized and therefore under-treated for months, or even years

Why is Advance Care Planning most challenging? Unlike other terminal illnesses, often there are no life-sustaining treatments that physicians can withhold or withdraw. Typically, a strong body houses a feeble brain. Many who feel the pang of the "Dementia Fear" consider "premature dying." They may believe: "If I don't kill myself now, I won't be able to kill myself later. Then, I'll be trapped in a condition I loathe so much that I'd rather be dead." Those who act on this fear only compound the tragedy of their disease. We must offer patients effective advance care planning so they can feel confident they can choose to avoid a prolonged dying of months to years with suffering and burdens. Then, many will ironically choose to live as long and as well as possible--and benefit from improvements in the medical and non-medical management of their disease.

Advance Care Planning for Advanced Dementia needs research funding to develop and to implement--even if other researchers discover new drugs that delay the onset of symptoms or slow down their progression. We know that changes in the brains of dementia patients begin one or more decades before clinical symptoms emerge. We also know it takes many years to prove the safety and efficacy of new drugs and to adopt a policy to implement widespread treatment. Realistically, most of the 76 million baby boomers predicted to get dementia are still likely to become demented. Even if a new drug were available today, patients afflicted with Alzheimer's disease who do not die of another cause will eventually reach the stage of Advanced Dementia. Most importantly, when they do reach the advanced stage of dementia, these patients will then have only their Advance Directives on which they can rely, to control how long, and how much, they must sufferbefore they die.

To reduce end-of-life suffering of millions of victims of Alzheimer's disease and their loved ones, we must thus fund research programs that will: 1) develop new Advance Directives that are easy, effective, and acceptable to both patients and physicians, and 2) train professionals to honor Advance Directives and to recommend their clients and patients have the discussions and complete the forms...now, while they still can.


 

O. Molinari  |  03-26-2012

My father is the third person I know to be diagnosed with Alzheimer's disease. First was my uncle who passed away in 2005 and then my aunt or father's sister who, although 6 years younger has had it for over two years now.

The impact of this illness on the family is devastating. There is no one place to go for help or all the information you need. It takes a village to handle an aggressive, geriatric Alzheimer's family member. As a caregiver one needs to find out as much as possible as quickly as possible to get the help needed for a loved one. Nobody tells you all the challenges you will have and the financial impact it has on the family as well.

My father was normally an intelligent man, very good with mathematics, science and spoke English, Spanish, Italian and Portuguese. Now we see him unable to handle his finances, becoming increasingly aggressive, suffering from delusions and hallucinations regarding our mother who he has been married to for 62 years.

Due to the fact that a mental healthcare power of attorney was not signed since the lawyers don't mention that when you go to get your will and other papers in order, we had to apply for emergency guardianship to get my father admitted to a level one psychiatric facility. After he is there for three weeks and thoroughly evaluated we are told he cannot come home due to delusions regarding our mother. Now we have to find someplace for him and try to find resources to help us. Unfortunately we end up putting him in a group home which we think is the right thing since it is similar to his home and the advice we get from social workers as well as companies such as Care Patrol, that have familiarity with this illness. Since we have no experience we follow the guidance of these "professionals." Unfortunately in our case perhaps also due to the stressfulness of the situation we did not make the right decision. The home was nice but the caregiver, although a nurse, was not there most of the time, and the other caregivers were Pilipino and did not understand English very well.

The situation gets worse when my brother goes to visit my father and he is in bed at 7:30 since the caregivers don't seem to want to be bothered with the patients. When he arrives my father gets up from bed and falls and the door is locked and the caregivers can't seem to figure out how to get the door opened. My brother finally does and dad is on the floor. The caregivers just leave the area and my brother and his son help my father get back into the bed. My father seems to be in a drug stupor and his eyes roll back in his head. I get a frantic call from my brother and call the hospice since he was on palliative care and ask them to send a nurse immediately since the nurse who owns the group home is not there. I also leave an urgent message for her, which is never returned. I wait and then call for the nurse at the hospice that is on call to find out that she was denied entry into the home by the caregivers who told her he was sleeping and to come back the next day. When I confront the owner of the home the following morning she insists that she called me even though there is no record on my answering machine or caller id on the home or cell phones. Then she also indicates that her mother told her that nobody came to the door from the hospice, which was an outright lie. I immediately started looking for another facility but it was difficult since they are all extremely expensive and my mother is alive and living with physical disabilities at home and all of my father's social security, pension and VA benefits (which I applied for since he was a WWII veteran) have to go in their entirety to his care and we still fall short.

During the time I looked for a facility I asked the group home owner not to transport my father anywhere since there was an issue when we brought him home for lunch prior to that. I had met him at a follow-up appointment with his neurologist and she said we could try to bring him home to see how it went. The first time we tried it he seemed ok but it was after an appointment for a vision test and he refused to get in the car unless we took him home. On that occasion, he managed to get his checkbook which we later found out about since we could not locate it to pay the bills.

The following week he had a dentist appointment due to periodontal disease which we needed to attend to. After that appointment , when we brought him home, he became very agitated and pulled a knife out of a drawer, which usually had only papers(so we can only imagine he had placed it there the week before, since we did not). He sat down and said he was not going back to the group home or as he called it, a jail. Then he said he would kill my husband if he ever saw him again since he was the one who, with my sister, brought him to the hospital. I asked him to return the knife and he took it and put it under some papers behind him. This wasn't a small knife it was a large carving knife. I asked for it back but he refused and then went out back and started cutting plants with it and ended up coming in the house without it. He had hidden it. I sent my sister out to retrieve it and she found it in a bucket outside. I took that knife and the rest that were in the house and put them in the trunk of my car. While I did that he went in the back yard and left from the gate on the side and was halfway down the block on foot. I ran to catch up with him and my sister called the police since we were very concerned and needed to get him back to the group home. When the police came he told them he would go back with us and when they left and we were a few blocks away he lunged over the back seat and grabbed my steering wheel and tried ripping the keys out of my ignition and then grabbed the gear shifter to get the car out of gear. I immediately jammed on the breaks and told my sister, who was sitting next to me, to call 911 and that is when he tried to grab the phone from her. I told him I would go back to the house and proceeded slowly to give the policemen a chance to get there. I went past the house and he became agitated and tried getting out of the car but could not since the child locks were on the doors. Unfortunately I forgot the window locks and he was able to open the window and got his body out up to his hips. I had to stop the car and get his feet back in. This is 5'8" man who weighs 158 lbs. I am only 5'3" and weigh 130. This time four police cars came and the officer ended up having to put my father in his squad car and take him back to the home.

Despite the incident that happened and the fact that the group home owner knew about what happened and was told not to take him out, her husband took my father to the bank a couple of weeks later and the bank rep called my mother and then me since my father was requesting his social security number to take out money.

When I finally found a decent place for my father that specializes in Alzheimer's and dementia care, the group home was very rude and unprofessional with the nurse who came to assess him and asked them in front of my father if they were going to take him to a psychiatric facility. So in addition to all the stress now we had to deal with a group home that was manipulating him so he would not leave. He was also writing them checks, which I got back, but we closed the account to keep anyone from taking advantage of him. He had promised money to them, wrote checks to his attorney who was appointed by the court and was promising thousands to the staff and doctors in the hospital where he was assessed.

On top of everything we ended up getting calls from Elder abuse since the owner of the home was apparently upset that we were taking him out and kept arguing that he wasn't ill despite the medical records from a neurologist and psychiatrist.

Our family has been going through hell. On top of all this there was a tremendous amount of paperwork to get VA benefits, get medications and other medical issues taken care of and the legal expenses for guardianship are bleeding my parent's dry. The emotional impact on our mother and the rest of us has been awful as well.

I tell you all this so you can see what it is like since none of us ever imagined how awful this would be. I don't think anyone knows what it is like until they experience it firsthand.

Waiting until 2025 is too late. In my visits to many facilities I have seen people in their 40's and 50's with the disease and it will only get worse as the baby boomers age. With twice as many of them as their parent's generation we are in for a healthcare meltdown if something isn't put in place soon. We need to do something now. I am sure we are not the only family going through this.

There should be more research into different modalities (allopathic, homeopathic, naturopathic, etc.) to address this illness. I have read that there are studies being done regarding a cancer medication that is on the market that reduces the amyloid plaque in the brain. This is the website: http://www.case.edu/think/breakingnews/breakthrough.html.

I have also read about a possible treatment or preventative in raw coconut oil by a doctor who used it on her spouse: http://www.coconutketones.com/whatifcure.pdf. Perhaps the cure or prevention lies in a combination of different modalities and all should be considered.

Families need more financial assistance and better resources where they can find all or most of the information needed with respect to legal, medical and assisted living resources as well as support groups to help families get the assistance they need as quickly as possible. Most of what is out there now is just "you are on your own" looking though websites in the midst of a crisis trying to find the help and guidance you need or other families at support groups trying to help each other. When a family is in constant crisis they need as much assistance/guidance as quickly as possible to help them navigate the system of care so they can make the right decisions for their loved one.

I agree with all of the findings but it must also be noted that some co-occurring chronic conditions such as sleep apnea (http://www.newschief.com/article/20111229/news/112295021) hearing loss (http://www.hopkinsmedicine.org/news/media/releases/hearing_loss_and_dementia_linked_in_study) and periodontal disease (http://www.breathproblems.com/link-between-periodontal-disease-and-dementia.html)should also be included in annual geriatric screenings since they can be directly linked to causing dementia and may be overlooked. In addition something should be put in place regarding hearing loss and the prohibitive cost of hearing aids. Perhaps insurance companies can increase fees by a few dollars a month on their premiums to include some coverage for hearing aids. Everyone is impacted by hearing loss of a senior citizen: family, motorists who drive on the roads along with them, and anyone who the hearing impaired interact with. Since hearing loss can be linked to dementia making hearing aids more affordable through some sort of coverage could help in part, to address this issue.

Anyone directly related to the care of a patient with dementia or Alzheimer's and affiliated with a medical facility, assisted living, or group home should need to be certified to care for a patient with this illness and display that certification where it is visible to family who are looking for care for their family member. There are people who claim to know how to handle patient s with this illness, yet do not, and tend to take advantage of the family as well as the person with the illness.

There should be clear guidelines in place as to what the group homes can and cannot do such as taking a dementia patient to the bank to take out money. I bring this up since this happened with my father.

Medical assessments in the home would help greatly as well since it can be impossible to get a dementia patient to the doctor or hospital unless you have a mental health care power of attorney. If a patient is hospitalized and determined to have dementia, a mental health care power of attorney should automatically be granted without the family having to dish out thousands of dollars to an attorney when the person has received a neurological and psychological evaluation by qualified physicians. This would save the families of these patients thousands of dollars which can be used for their care. A regular health care power of attorney is insufficient since we were told that Alzheimer's and dementia are considered physical illnesses with psychological manifestations. Without a mental health care power of attorney the family has to file for emergency guardianship and then permanent guardianship which can cost upwards of $20,000. This is a progressive disease with no known cure at this point. It is ridiculous to penalize an already suffering family to have to deplete their savings when their loved one is only going to progress in mental deterioration and obviously needs a guardian. Many times they feel that they are not ill and will continue to fight and deplete their funds further until they end up on ACCHHS (Medicaid), which in turn just depletes the government's funds further. If this is a necessity perhaps some cost containment should be put in place so families aren't hurt financially by exorbitant legal fees.

Another issue is medication. The VA indicates it can help with the cost of medication but you have to bring the patient into their facility. Once they are in a memory care facility they are not always amenable to being transported so it would be of great help to have a VA rep come to the patient facility to assess them for the medication benefits or just to have the paperwork from the doctor diagnoses serve as proof that the person needs the medication and provide it and delivery at no cost to the veteran.

The facility that my father is currently in provides dental care via mobile dentistry. It would also be beneficial to have the same with respect to mobile hearing units to help many of the residents in these facilities to get the hearing assessments and hearing aid cleaning, hearing aids, wax removal, etc. to ensure that they can hear effectively. Mobile vision care would also be a plus to ensure that the patients are seeing well or are not developing illnesses of the eye.

Finally decent memory care facilities are very expensive (the one our father is now at costs $4,338/mo.) and that it would help greatly to have some sort of coverage to help as the only thing available is long term care insurance which many people do not have and once you are diagnosed with Alzheimer's, is no longer an option.

I hope you will take these suggestions into consideration in your National Plan. After going through all of this first hand I can tell you that these changes are greatly needed and would help all the families out there who are going through all of these challenges.

Thank you for your time and consideration.


 

M. Zuccaro  |  03-26-2012

Thank you for the opportunity to offer public comment on this important and much needed national plan.

From my experience as a nurse working with several community hospices over the past 15 years, it's often a struggle to utilize antipsychotics (i.e. Haldol) in skilled nursing facility setting. Nursing facilities have many regulations which are well-intentioned to provide safe care for residents.

However, I would just like to offer that haloperidol is often preferred over lorazepam for agitation, terminal restlessness for many patients, especially Veterans with a history of PTSD. We have found that these patients may benefit from a medication that may help them to think more clearly, so that they feel less vulnerable by feeling more in control.


 

C. Clemente  |  03-26-2012

This is to request that the Committee address the mental health concerns of persons with dementia and their caregivers.


 

S. Griffith  |  03-26-2012

Working with individuals with dimensia requires services that are unique and tailored to address those needs which in our mental health facilities they are address all in the same, and they are not.


 

K. Shepard  |  03-26-2012

Please accept the attached comment letter from the American Academy of Neurology (AAN) on the recently released National Alzheimer's Project Act (NAPA) Draft National Plan To Address Alzheimer's Disease. The AAN is proud to support the overall Plan and fully supports the vision of a nation free of Alzheimer's disease.

The AAN stands ready to assist in these important efforts and remains committed to partnering with other organizations to prevent and reduce the burdens of this devastating disease.

ATTACHMENT:

AAN Comments on Draft National Plan to Address Alzheimer's Disease

On behalf of the American Academy of Neurology, I would like to commend the Department of Health and Human Services and its federal partners, the Interagency Group on Alzheimer's Disease and Related Dementias, and the Advisory Council on Alzheimer's Research, Care, and Services for your efforts to develop the highly comprehensive and needed National Plan to Address Alzheimer's Disease (Plan).

The American Academy of Neurology (AAN) is the largest scientific and professional organization for neurology in the United States. Representing more than 25,000 neurologists and neuroscience professionals, the AAN strives to promote the highest quality patient centered neurologic care. The AAN is proud to support the overall Plan and fully supports the vision of a nation free of Alzheimer's disease. The AAN is further pleased that a neurologist, Dr. Ron Petersen, was named as chairman of the Advisory Council.

The AAN is committed to playing an active role in supporting the objectives of the Plan. Our feedback in the following areas is provided for your consideration as you refine the Plan framework:

  • Neurologists' Role in Alzheimer's Diagnosis and Treatment
  • Strategy 1.A: Identify Research Priorities and Milestones
  • Strategy 2.A: Build a Workforce with the Skills to Provide High-Quality Care
  • Quality Measurement Considerations
  • Current AAN Dementia-related Resources
  • Submission to the CMI on Alzheimer's Care Delivery
  • Concluding Remarks

Neurologists' Role in Alzheimer's Diagnosis and Treatment
The science and practice of neurology are integral to efforts to prevent Alzheimer's disease (AD), diagnose it, treat it, and slow its progression, as well as, provide support for patients suffering from the disease and their caregivers. Neurologists are specifically trained to manage AD and other chronic disorders of the brain and central nervous system.

Neurologists:

  • Conduct basic and translational AD research
  • Provide a comprehensive assessment including clinical diagnostic evaluation and evaluation of cognitive deterioration over time
  • Make decisions regarding treatment for patients with AD " Engage in follow-up visits every three to six months for patients with AD
  • Provide patients and caregivers with decision aids, such as comprehensive end-of-life counseling and advance care planning

Independently, and as a part of multidisciplinary teams, neurologists have been at the forefront of research and treatment of AD. The role of the neurologist in the care continuum of AD is critical.

Many factors contribute to the current variations in care that patients with AD receive in the US. The AAN believes that improving care coordination among health care providers, strengthening education and support for AD caregivers, and increasing rates of early diagnosis would have a significant impact.

Strategy 1.A.: Identify Research Priorities and Milestones
The AAN strongly supports increased investment in AD research. Current funding levels are vastly disproportionate to impact of the disease now, and will be greatly exacerbated as prevalence increases in the future as the US population ages if funding trends remain unaltered. In addition, there is a tremendous gap between the research budgets for AD and dementia (approximately $450 million) and the research budgets for other diseases like HIV/AIDs (approximately $3 billion). The AAN believes in the need to raise the profile of AD research to bring it in line with its present and expected impact to the country.

Strategy 2.A: Build a Workforce with the Skills to Provide High-Quality Care
Expanded educational efforts are important in reducing care variations and preparing the health care work force for an aging population. However, the AAN would note further support for expanding the supply of well-trained specialists is critical as more complex diagnostic tests and AD therapies become available.

The AAN agrees that a sufficient workforce is necessary to have high quality health care. Though reimbursement issues are not directly addressed in the Plan, they undoubtedly shape care delivery. Spending needed time face-to-face with patients diagnosing and coordinating care for complex neurologic diseases such as AD is undervalued in the current fee-for-service payment model. A lack of proper payment threatens the future supply of individuals trained specifically in neurology, which is of particular concern since neurologists are key to a timely diagnosis.

There is a large role for case managers to handle some of the social aspects of AD care, including the provision of support or information about next steps to caregivers, so that physician can focus on medical issues.

Quality Measurement Considerations
Since there is still limited evidence and effective treatments for AD, it is intrinsically difficult to develop high standard quality measures. However, the AAN agrees that care quality should be measured to the extent possible, and has developed a quality measure set for dementia that was recently approved by the American Medical Association (AMA) Physician Consortium for Performance Improvement (PCPI).

Current AAN Dementia-related Resources
AAN evidence-based guideline documents related to dementia:

  • Update: Evaluation and Management of Driving Risk in Dementia
  • Detection of Dementia and Mild Cognitive Impairment (currently under update)
  • Diagnosis of Dementia (currently under update)
  • Management of Dementia

View the guideline documents here: http://www.aan.com/practice/guideline/index.cfm?fuseaction=home.welcome&Topics=15&keywords=&Submit=Search+Guidelines

AAN quality measures related to dementia:

  • Caregiver Education and Support
  • Cognitive Assessment
  • Counseling Regarding Risks of Driving
  • Counseling Regarding Safety Concerns
  • Functional Status Assessment
  • Management of Neuropsychiatric Symptoms
  • Neuropsychiatric Symptom Assessment
  • Palliative Care Counseling and Advance Care Planning
  • Screening for Depressive Symptoms
  • Staging of Dementia

View the quality measures here (must download after clicking on the link): http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit=PCPI

Submission to the CMI on Alzheimer's Care Delivery
The AAN met with the Center for Medicare and Medicaid Innovation in early 2012 to discuss a suggested concept for modernizing the way care is delivered to patients with AD through a cooperative care team including neurologists, geriatricians/primary care physicians, geriatric psychologists, neuropsychologists, case managers, social workers, nurses, dietitians, and pharmacists. The concept goes on to address a major problem in the current delivery system for AD care: the misalignment of financial incentives that are causing monetary constraints to providing coordinated care.

View AAN's suggested concept here: http://www.aan.com/globals/axon/assets/9408.pdf

Concluding Remarks
Broad collaborations with private and non-profit entities should be encouraged and incentivized at the grassroots level to accomplish many of the goals outlined in the Plan, especially those involving caregiver support and quality of life interventions for patients. The AAN stands ready to assist by recommending content experts (including researchers, clinicians, educators, and specialists), publicizing the Advisory Council's efforts, and reviewing and dissemination of its work. The AAN remains committed to partnering with other organizations to prevent and reduce the burdens of this devastating disease. We appreciate your consideration of our comments. Please direct any questions, requests for clarification, or dialogue regarding our comments to us.


 

M. Schwinder  |  03-26-2012

Please make sure that the U.S. Department of Health and Human Services addresses the mental health needs of people with dementia and their caregivers in its final plan.


 

J. Pinkowitz  |  03-26-2012

There are numerous improvements in the draft national plan to address Alzheimer's disease from the initial framework plan. Additional areas of the plan still need strengthening and improvement. CCAL appreciates the opportunity to submit comments to help strengthen the draft plan. The comments follow.

General

  • CCAL suggests that the plan include the words "other dementias" and be known as the National Plan to Address Alzheimer's Disease and Other Dementias. The terms "Alzheimer's" and "dementia" are often used interchangeably. Many internists and family practice physicians (among others in the health care field), for example, are still not well educated about assessing and diagnosing Alzheimer's disease and use the general term "dementia" to explain cognitive decline to patients and their families. The addition of the terminology "other dementia" is more inclusionary and desirable.
  • Person-centered care is the widely recognized gold standard of services and supports for people living with Alzheimer's disease and related dementias (PWD) (Alzheimer's Association, 2006; Edvardsson, et al, 2010). It is a foundational aspect of the Affordable Care Act of 2010. The draft plan is silent about person-centered care. CCAL suggests that the plan integrate the philosophy and orientation to person-centered care throughout the plan.

The Challenges Section (page 4)

  • Notably missing as a national challenge is the over prescription and utilization of antipsychotic medications as a first line of management for behavioral challenges experienced by PWDs. The medical community as well as the formal and informal caregiver communities need to be educated about non-pharmacologic approaches to such behavioral challenges as agitation. Medications should be used only if and when non-pharmacologic approaches have not been effective. There is currently a dearth of readily accessible information about recommended non-pharmacologic approaches and practices.
  • Also missing as a national challenge is recognition that the quality of programs and services for PWDs who reside in residential long-term care (assisted living, nursing homes) across the nation continues to be uneven and often less than optimal. There is no national focus on or effort to address quality for these long-term care programs and services despite the fact that the number of people living with dementia will increase over fifty percent by 2030.

Plan's Three Guiding Principles (page 5)

  • CCAL applauds the second Guiding Principle that supports public-private partnerships. We recommend that the detail for this principle be expanded to specifically include dementia experts who represent the practice, policy, and research sectors. All too often senior executives are included on advisory panels solely because of their positions. Unfortunately they often lack actual dementia expertise and experience. It is vitally important that the national plan be developed, planned, and implemented by a diverse group of dementia experts who can provide "face validity" both to the plan and the process of its development and implementation.

References

  • Alzheimer's Association, 2006. Dementia Care Practice Recommendations for Assisted Living Residences and Nursing Homes.
  • Edvardsson, D., Fetherstonhaugh, D., Nay, R. 2010. Promoting a continuation of self and normality: person-centered care as described by people with dementia, their family members and aged care staff. Journal of Clinical Nursing, 111/j.1365-2702.

Thank you for the opportunity to submit comments on the draft national plan to address Alzheimer's disease.


 

T. Goldberg  |  03-25-2012

I have just two comments on the National Alzheimer's Plan which is mostly nice sounding rhetoric that I hope helps with this devastating disease.

First, Goal 1 (an effective treatment by 2025) just seems to me arbitrary and unrealistically optimistic. Of course that would be wonderful but as a physician specializing in geriatrics and Alzheimer's I see little hope of this being accomplished in the foreseeable future or perhaps ever. How will this be done by 2025 when there are no significantly effective drugs on the market at this time -- this is only 13 years away and the drug development/approval process takes many years. Hopefully the research summits proposed will help. $50-80 million in new funding seems a pittance that can't possibly make a significant difference. We have had a "war on cancer" with much higher rates of funding for about 40-50 years now with some modest positive results but certainly no cure for cancer.

Second, in my opinion, Action 3.D.2: Monitor, report and reduce inappropriate use of anti-psychotics in nursing homes, has no place in this report. Most of the other items in this report are positive, optimistic goals. This is a narrow and arguable negative. In my opinion again as an experienced geriatrician and long term care physician, I feel the issue of antipsychotics in nursing homes is overblown and not significant enough to be a major national priority. Inappropriate use of medications is one thing that of course must be minimized, though what is appropriate is highly individualized and subjective. However the "off-label" use being considered inherently inappropriate or fraudulent is completely wrong. Physicians and nursing homes are already extensively educated and regulated on this issue. All drugs are commonly and legally used for many "off-label" scenarios and there is nothing wrong with that if the medical judgement is reasonable and the patient benefits. Unfortunately Alzheimer's patients often have uncontrollable anxiety and agitation and until a better therapy comes along, antipsychotics are often the only answer. "Conflicts of interest" among pharmacists and physicians have NOTHING to do with this issue. Clinicians simply often have no better solution for dementia related psychosis and agitation at this time. I am an active member of the American Medical Directors Association and vehemently disagree with their their "politically correct" approach to this difficult issue (they have gone along with government suggestions to more vigorously educate and crack down on physicians and nursing homes).

Perhaps a brief mention of better treatments for behavioral and psychological symptoms as well as cognitive symptoms and "cure" would be appropriate under goal 1. Otherwise I think this entire paragraph 3D2 is inappropriate in this report and should be completely deleted.

==========

From: H. Matheny

For your information, attached is the first draft of the National Plan to Address Alzheimer's Disease. As a non federal member of the national Alzheimer's Disease Advisory Council I encourage each of you to review the draft and provide comments. Your perspective as a physician is critically important. HHS is seeking input on the draft National Plan through March 30, 2012. Please send your comments to napa@hhs.gov. Also, please feel free to copy me. I serve on the Council's Clinical Care Subcommittee and would greatly value your suggestions. I expect the second draft of the plan to be available mid-April.

I look forward to hearing from you.


 

J. Cohen  |  03-25-2012

The suffering of people with Alzheimer's Disease and their family caregivers is invariably compounded by depression and anxiety. These are among the most devastating daily effects of the disease, undermining the quality of life of both caregivers and patients and limiting their ability to contribute to society in a meaningful and economically viable way. Any effort to improve the management of the disease should therefore include a program of psychological intervention as well as medical research and therapy.


 

D. Metzel  |  03-25-2012

My sister died from Alzheimer's Disease on Oct. 5, 2011. My sister had Down syndrome.

The proposed plan fleetingly mentions "intellectual disabilities," which is woefully inadequate to address that fact that people with Down syndrome have a higher incidence of Alzheimer's Disease than the general population.

"Intellectual disabilities" must be replaced with Down Syndrome since it is these people who experience it at such a high rate at this time. "Down syndrome and other Intellectual disabilities" would be an acceptable term.


 

M. Willis  |  03-24-2012

The Developmental Disabilities Nurses Association supports the specific inclusion of persons with intellectual and developmental disabilities in the National Alzheimer's Project Act (NAPA) as requested by the National Task Group on Intellectual Disabilities and Dementia Practices (NTG). In most cases, nurses assess individuals with IDD on a more frequent basis than primary health care providers, and thus may note signs and symptoms indicative of early stages of dementia in the settings in which individuals reside or spend their days. This increases the likelihood of prompt referral for diagnosis and treatment.

We sincerely hope that this medically underserved population, some of whom by the very nature of their developmental disability are at increased risk for Alzheimer's disease, are considered by the NAPA council for inclusion in its proposal.


 

Z. Mann  |  03-23-2012

People diagnosed with dementia frequently have mental health conditions such as depression and anxiety disorders.

In addition, their family caregivers are at high risk for mental and physical health problems.

There is a great need to recognize and treat these conditions, so that patients' cognitive functioning and quality of life is improved( or at least maintained).

Families of people with dementia have the regular challenges of us all; in addition family caregivers have the responsibility of caring for an adult whose behavior can be quite erratic. The unpredictability of their loved ones' behavior can lead to anxiety and depression.

Please apply the power of your position to bring relief to these families.


 

K. Cross  |  03-23-2012

Attached, please find C-Path's letter of support.

ATTACHMENT:

Making the case for Public Private Partnerships for NAPA

The Problem
A crisis in medicine today is that there are increasing investments in biomedical research but decreasing numbers of new medical products, especially drugs, that obtain FDA approval and are available to patients.1,2 In order to respond to this crisis, the field of drug development is undergoing transformational changes.

Taking a basic scientific discovery through development and regulatory approval of a medical product that finally reaches patients faces overwhelming challenges including the long length of research, high rate of failures of potential candidates and enormous costs. This research and development process is so difficult it is called the "Valley of Death." As many as 80-95% of promising drug candidates fail.3,4 Drug companies will spend tens of thousands to perform research on millions of compounds and spend in excess of a billion dollars over a 10- to 20-year period just ot have one drug reach patients.5 A pressing example is Alzheimer's Disease (AD) for which diagnosis is difficult and there are only a few FDA approved treatments to temporarily slow the disease but no cure, at a time when this debilitating disease is exploding in the aging population. In fact, the pace for development and FDA approval of Central Nervous System (CNS) drugs is even longer than other drug classes.6

These challenges mean that companies have to be smarter and more efficient in managing drug discovery and development. Innovation is needed to create greater efficiencies to help move therapies through development, review and approval for patient use. John Castellani, President PhRMA, stated that "The regulatory process is a strategic priority that if done right can reduce time, cost and uncertainty in drug development."4

The Solution: Increasingly, public private partnerships (PPP) are presenting an opportunity to meeting these challenges. Partnerships between the private sector, regulatory and other government agencies, academic institutions, nonprofit organizations, and patient groups represent a new model offering innovation and efficiencies in drug development. Innovation comes from focusing on science that can improve the process of drug development and be applied to regulatory decisions. Efficiences come from building collaborations and sharing.

The flagship success of PPPs in AD is the Alzheimer's Disease Neuroimaging Initiative 1 (ADNI1), a $60 million, 5-year study to test whether imaging and biological markers, and clinical and neuropsychological assessments could measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). Begun by the National Institute on Aging (NIA) and supported by other federal agencies, private-sector companies and organizations, the ADNI1 investment would have been prohibitive for a single stokeholder. However, ADNI1 has transformed the understanding of the pathophysiology of AD. Additionally, many other PPPs are having an impact in AD, some of which are described below:

  • ADNI2: Approximately 1,000 people aged 55 to 90 will be followed with imaging and biomarker measures to identify who is at risk for AD, track progression, and devise tests to measure the effectiveness of potential interventions. This ~ $60 million study is funded by NIH and companies.
  • FNIH Biomakers Consortium: One project is the first part of a multi-phased effort to utilize ADNI samples to construct multiplex panels in plasma and CSF to diagnose patients with AD and monitor disease progression.
  • Alliance for Aging Research: The Alliance initiated Accelerate Cure/Treatment forAlzheimer's Disease, a coalition of national organizations representing patients, providers, caregivers, consumers, older Americans, researchers, employers, and health care industries seeking to accelerate development of potential cures and treatments for AD.
  • Alzheimer's Association Global Standardization: This organization is leading global efforts to standardize Alzheimer's biomarkers with the World Wide AD Neuroimaging Initiative (WW-ADNI) and the Alzheimer's Association Cerebrospinal Fluid (CSF) Quality Control Program.
  • Alzheimer's Association Research Roundtable: Members facilitate the development and implementation of new treatments for Alzheimer's disease by collectively addressing obstacles to research and development, clinical care and public health education.
  • Critical Path Institute's Coalition Against Major Diseases (CAMD): CAMD accelerates the development of therapies for AD by advancing drug development tools for regulatory approval. CAMD developed AD data standards with CDISC, a pooled clinical trial database with 6,000 patients, and a clinical disease progression model. CAMD obtained regulatory approval for imaging biomarkers from the EMA and is collaborating with the FDA on CSF and imaging biomarkers.
  • Critical Path Institute's Patient Reported Outcome (PRO) Consortium: A workgroup is developing and evaluating a PRO instrument on MCI for use in clinical trials designed to evaluate the safety and efficacy of new AD drugs.
  • IMI PharmaCog: The five-year €20M PharmaCog project, funded under the European Innovative Medicine Initiative (IMI), will provide tools to define the potential of a drug candidate, reduce the development time of new drugs and thus accelerate the approvals of promising new medicines.

While the impact of these PPPs is extensive, there are still significant challenges and opportunities for preventing and treating AD. One challenge is in the regulatory arena. For approval of a new drug, a pharmaceutical company engages exclusively with the regulatory agency and all information within the drug approval process is proprietary. Lessons learned from one AD drug trial are not shared, so any insights on why drugs fail or how particular biomarkers track with disease progression are lost. However, in recognizing the need for change, the FDA established an innovative approach in the Critical Path Initiative. The FDA formalized a process for submitting tools as biomarkers and clinical outcome assessments to be "qualified" for specific uses in supporting drug development.7 Tools that receive a designation of "fit for use" from the FDA's qualification process8 can then be widely shared.

Recommendations
Providing the extensive evidence needed for qualification of tools by regulatory authorities can optimally be carried out through public-private partnerships. PPPs can support publicly accessible clinical trial databases that can be mined for information on biomarkers and disease progression. Drug companies can contribute data and conduct prospective trials that may be required to provide the regulatory levels of evidence to assure qualification of new drug tools. Academics can also provide clinical data and analysis to identify optimal biomarkers for qualification.

The challenge then becomes funding PPPs that move products toward regulatory approval. The cost of qualification for a single biomarker is several million dollars over a time frame of up to 5 years. Such costs require significant investment by both public and private sectors and in-kind contributions in order to be successful. However, the end product is a tool that FDA can have confidence in to produce better data and be used by all drug companies in clinical trials. The result benefits all stakeholders, including patients.

Since not all PPPs conduct research as ADNI does, there needs to be new models of PPP funding, within or possibly outside of NIH, especially for non-profit organizations and those working toward improving the process of drug development and regulatory review. Infrastructure support for such an AD PPP could be provided through HHS or other governmental agency appropriations. Because PPPs rely upon multi-stakeholder collaborations, it is critical that oversight be provided by a multi-stakeholder board to represent the broad spectrum of the various entities (industry, regulatory agencies, government funding, non-profits, academic experts, and patients).

Reference List

  1. Moses H, III, Dorsey ER, Matheson DH, Thier SO. Financial anatomy of biomedical research. JAMA 2005;294(11):1333-1342.
  2. Booth B, Zemmel R. Prospects for productivity. Nat Rev Drug Discov 2004;3(5):451-456.
  3. National Institutes of Health. NIH Announces New Program to Develop Therapeutics for Rare and Neglected Diseases. 2009. Ref Type: Online Source
  4. Pharmaceutical Research and Manufacturers of America (PhRMA). Profile 2008. 2008. Washington DC, PhRMA. Ref Type: Online Source
  5. Moos W. SRI . 2010. Ref Type: Online Source
  6. Impact Report: Pace of CNS drug development and FDA approvals lags other drug classes. Tufts Center for the Study of Drug Development, 201214(2).)
  7. Guidance for Industry: Qualification Process for Drug Development Tools. FDA . 2012. Ref Type: Online Source
  8. Barratt RA, Bowens SL, McCune SK, Johannessen JN, Buckman SY. The critical path initiative: leveraging collaborations to enhance regulatory science. Clin Pharmacol Ther 2012;91(3):380-383.

 

D. Kaplan  |  03-23-2012

Please see below for my feedback on the National Plan to Address Alzheimer's Disease. I am a gerontological clinical social worker with over ten years experience in the field of dementia care. I was formerly the Director of Social Services at the Alzheimer's Foundation of America, and now I am a doctoral candidate who teaches and conducts research on dementia care at Columbia University School of Social Work.

Congratulations on creating such a progressive plan of action. I hope that my feedback is of value. I would be delighted to get involved in any of the efforts related to finalizing this national plan or taking action on any of the activities outlined within the plan. Please contact me with any questions, comments, or concerns.

Positive Feedback:

  • The plan is overwhelmingly comprehensive in breadth of scope and depth of detail.
  • The lists of challenges and guiding principles for the national plan are thoughtfully crafted and easily justified.
  • This plan looks to make substantial achievements toward fulfilling the objectives of NAPA with both immediate and long-range potential benefits to our citizens.
  • The inclusion of diverse stakeholders' input, as well as plans to coordinate efforts across federal agencies, shows dedication to setting realistic priorities and working toward meaningful outcomes.

Constructive Criticism:

Action 2.A.2: Encourage providers to pursue careers in geriatric specialties

  • The professions identified in this Action Statement are surely appropriate targets of the relevant activities, but the exclusion of the social work profession is a major oversight. This oversight is not repeated in Action 2.A.3 on dementia-specific guidelines and curricula, which shows some acknowledgement on the part of NAPA representatives of the value of a competent social work workforce. Social workers are integral members of the professional care teams in every setting and program of health, mental health, and aging services. They perform essential roles which are crucial to the successful delivery of those services, and this is especially true in the context of the multidimensional, bio-psycho-social domains of need in dementia care. Look to the work of the John A. Hartford Foundation's Geriatric Social Work Initiative for information on the importance of shoring up for a gerontologically-competent social work workforce, as well as for models of successful workforce development.

Action 2.A.3: Collect and disseminate dementia-specific guidelines and curricula for all provider groups across the care spectrum

  • The Action Statement suggests a plan for HHS to seek input from public and private entities to complete this activity, but it does not detail a process for identifying or selecting providers of such input. With regard to collecting social work guidelines and curricula, I gladly offer my assistance. There are few such guidelines on social work practice in dementia care, and even fewer curricula. However, this is truly my area of expertise, I have lists of the few resources available, I have developed a graduate social work course exclusively on dementia, and I know of several other experts who would also be willing to assist in this effort.

Action 2.A.4: Strengthen the direct-care workforce

  • The direct-care workforce includes both those who work in private homes and those who work in facilities, yet this Action Statement is focused exclusively on nursing home personnel. Failure to include home health and home care personnel in this effort would be a tremendous oversight. The preferred location of care for nearly all citizens is their own home, the quality of home care services is known to be inadequate for the general population, and to date there are no research studies which have attempted to examine appropriate home care service models, training protocols, patient and family outcomes, and worker outcomes related to dementia care in the home environment. The home health care and home care industries must be strengthened if we are to avoid a crisis in care. Federal money and coordinated efforts among federal and state agencies, and private industry stakeholders, must be dedicated to addressing improvements in the quality of home care services for individuals living with dementia.

Action 3.D.1: Educate legal professionals about working with people with Alzheimer's disease

  • The importance of reducing the abuse, neglect and exploitation of individuals with dementia cannot be overstated. Toward this end, the Action Statement should be revised to call specific attention to the need to educate District Attorneys and Assistant District Attorneys about responding to charges brought against alleged perpetrators as a result of police and Protective Services investigations. This is particularly important for victims with dementia who lack the capacity, and often the availability of capable advocates, necessary for seeking justice and protection. For example, financial exploitation charges filed by Protective Service agents are rarely addressed by District Attorneys, and, as a result, the perpetrators are not brought to justice and the elders' funds are not restored.
  • Adult Protective Service programs are generally overwhelmed and understaffed. Certain states have taken the lead in developing more highly effective programs for dealing with elder mistreatment, such as the Massachusetts Executive Office of Elder Affairs which supports programs for Elder Protective Services and Elders at Risk. These elder-specific programs should be required in each state. In addition, all Protective Services agents should have access to dementia-specific education. When the victims of elder abuse are individuals with dementia, their vulnerabilities are unique, the investigations are additionally complex, and the intervention options are distinct.

Action 3.E.2: Examine patterns of housing and services

  • Efforts to understand professional care services must now look beyond simple profiles of service availability and use in order to study the effectiveness and efficiency of the services. Access and use of a service are important issues to measure, but the quality of care provided by these formal service systems (most of which are regulated at the state level) needs to be studied as well. Anecdotal and research-based evidence continually suggests that consumers do not receive adequate care, families are not relieved of their burdens by using formal care services, and community-based services do not effectively postpone nursing home placement. Investments in improved quality of care would likely result in significant long-range savings due to reduced worker turnover, delayed family burnout, delayed nursing home placements, reduced hospitalizations for avoidable medical and behavioral complications, and fewer transitions between care settings.
  • This Action Statement calls for an in-depth analysis of the National Survey of Residential Care Facilities, but should also include the further development and analysis of the National Home and Hospice Care Survey.

General concern-

  • This plan does not provide adequate attention to mental disorders commonly experienced by people with dementia and their caregivers. Dementia frequently co-occurs with mental health conditions such as depression and anxiety disorders. In addition, family caregivers are at high risk for mental and physical health problems. Recognizing and treating these conditions plays a vital role in improving patients' cognitive functioning as well as the quality of life of people with dementia and their caregivers.

 

E. Vogt  |  03-23-2012

Please include the mental health needs of people with dementia and their caregivers in your final plan.


 

C. Knowlton  |  03-23-2012

Please become more informed about the vital and large voting population who have a loved one with dementia or depression or anxiety. The Baby Boomers are one of the largest groups around and have the most voting power as well as the needs for supportive services to keep their loved ones at home. It seems when it comes to home care, respite services and other supportive case management services and counseling are the first ones to be cut. We once had an older adult program here in Illinois and that was cut (temporarily once and completely the 2nd time around). The message you are sending the public is that our government does not value the family as a place for care recipients to grow older (it is a proven statistic that family members experience less depression in the family home than in a nursing home facility). Older Adults deserve our respect and they deserve to continue to have quality care. Please do not let our government succumb to the prejudice of ageism. All people have value especially the old--who have much to still teach us.

ATTACHMENT:

Offering Quality Care to our Seniors Brochure [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-offering-quality-care-our-seniors]


 

C. Davis  |  03-23-2012

I work with many clients with dementia and their caregivers. I am also a caregiver of a parent, my Father, with Lewy Body Dementia. I see first- hand the mental health issues that occur with dementia. My Masters' degree is in Health Sciences and I still get overwhelmed at times with things that my father experience. Please do not take this lightly, address the mental health needs of people with dementia and their caregivers in your final plan. Thank you.


 

various  |  03-23-2012

Great letter. Send it.

==========

From: M. Gardner

THIS MESSAGE WAS FORWARDED BY THE FOLLOWING PEOPLE DURING THE MONTH OF MARCH 2012:

  • J. Ryan (submitted March 23)
  • C. Jackson Kelartinian (submitted March 23)
  • A. Cedro-Hament (submitted March 23)
  • C. Lee (submitted March 23)

[Link to comments -- M. Gardner]


 

M. Gardner  |  03-23-2012

Please see attached document, thanks.

ATTACHMENT:

The California Mental Health Planning Council (CMHPC) is mandated by federal and state statute to advocate for children with serious emotional disturbances and adults and older adults with serious mental illness, to provide oversight and accountability for the public mental health system, to advise the Administration and the Legislature on priority issues, and to participate in statewide planning. With passage of the Mental Health Services Act, the Planning Council also has responsibilities related to workforce development.

One of the Systems of Care Committees that support the Planning Council is the Older Adult Committee (OAC). At our quarterly meeting that took place in San Diego, CA January 18-20, 2012, the OAC discussed the problems counties are experiencing in regard to providing older adults who have mental health diagnosis integrated care when they begin to display cognitive problems associated with the onset of dementia/Alzheimer's disease. We are concerned that as their cognitive abilities decline, their level of care will suffer. Full integration of care is what we feel they deserve. Older adults with mental illness dealing with yet another serious health issue deserve our support.

The OAC strongly believes that the Department of Health and Human Services (HHS) must address the mental health needs of people with dementia/Alzheimer's disease. As the final plan is completed, we urge you to address the mental health needs of people with dementia/Alzheimer's disease and other cognitive issues as well as their caregivers who also deserve our attention. By recognizing and treating all these conditions we will improve the functioning of our patients as well as improving the quality of life for them and their caregivers.


 

J. Slane  |  03-23-2012

I understand that the present draft legislation in HHS needs to further address the MH needs of people with dementia and their care givers.

Dementia can frequently co-occur with mental conditions such as depression and anxiety disorders. Additionally family care givers carry an increased risk for mental and physical health problems. Please consider including these aspects of care for those with dementia in the current legislation.


 

M. Rich  |  03-23-2012

Please address the mental health issues to go along with Alzheimer's Disease. My mother-in-law currently has this disease and suffers from depression and anxiety due to the frustrations that she feels in not remembering things. It is only getting worse as the disease progresses. This is a common issue. Currently she is in a skilled nursing facility because her husband passed away several years ago. He had been her caretaker. This disease takes a great toll on anyone who keeps their loved ones in their home, because constant vigilance is needed on a regular basis. This isolates the caregiver as well as the one suffering from Alzheimer's. This can lead to depression for the caregiver. Please address the mental health aspects that accompany this disease in developing your plan regarding Alzheimer's.


 

M. Friedman  |  03-23-2012

Yesterday I sent you a letter regarding the draft National Alzheimer's Plan from a group of national experts on dementia and behavioral health.

Today I am sending a personal letter that is much more detailed. In it I provide comments and suggestions section by section. I hope that you will find it useful in identifying parts of the plan that need to be modified so as to reflect the behavioral health needs and opportunities of people with dementia and their families.

I would be happy to help to redraft the plan in detail.

ATTACHMENT:

COMMENTS ON THE DRAFT NATIONAL ALZHEIMER'S PLAN

Thank you for the opportunity to comment on the draft National Alzheimer's Plan. I am, of course, very pleased that the federal government is developing plans to address the needs of people with dementia and their families, a population that will grow substantially over the next quarter century because of the elder boom and because of increased life expectancy.

I believe, however, that, as drafted, the plan will fail to meet the needs--and to improve the quality of life--of millions of people who currently have dementia and their families as well as millions more who will develop dementia over the next decade and more.

In these comments I will address two major concerns: (1) unbalanced distribution of new funding and (2) the failure to address the behavioral health dimensions of Alzheimer's and other dementias.

Funding: Although the draft plan does not specify future funding, it does provide information about funding that has been committed prior to the finalization of the plan. Altogether $156 million will be added over the next two years. It will be distributed as follows:

Goals Amount %
Research $130.0 million 83.3%
Expanded/Improved Support and Care $10.5 million 6.7%
Enhanced Public Awareness and Engagement $8.2 million 5.4%
Enhanced Provider Knowledge $6.0 million 3.8%
Improved Data Collection and Analysis $1.3 million .8%
Total $156.0 million 100%

If this reflects how funds will be distributed going forward, it is clear that research is the only priority of the Plan; its other four goals are of very limited importance.

Let me be clear. I do not oppose increased spending on research seeking a cure, preventive interventions, or a way to substantially slow the growth of disability due to dementia. But expecting to achieve this by 2025 is wildly optimistic given the current state of research. And while we are waiting, 10's of millions of people with dementia and their families will not get the care and support that they need and deserve, resulting in avoidable suffering and missed opportunities for improved quality of life.

This plan appears to write off a generation or more of people with dementia and their families.

I suppose those who want research to be the virtually exclusive priority of our nation's efforts regarding Alzheimer's and other dementias could argue that funding for services is available elsewhere. But this is at best a partial truth. Medicare mostly does not cover long-term care or family support; and Medicaid is supposed to be for people with very limited means. Indeed, long-term care is one of the targets for cost cutting in Medicaid, and one of the proposals to cut Medicaid that resurfaces routinely is reducing the ability of people who are not extremely poor to become eligible for coverage of long-term care services.

I strongly urge HHS to revisit the question of how new funds should be spent and to place much greater emphasis on improving care now and for the foreseeable future than this draft plan does.

Neglect of Behavioral Health

The summary of facts about dementia given near the beginning of the plan notes (1) that people with dementia experience "behavioral and psychiatric disorders", (2) that "personality and behavior changes may also occur", and (3) that family caregivers experience tremendous stress and "report symptoms of depression and anxiety and poorer health outcomes." But these very important facts are barely mentioned in the rest of the plan and, with the possible exception of family caregivers, are not addressed in any meaningful way.

This omission will result in certain failure to meet behavioral health needs that are common among people with dementia and their families.

Here are the sections of the plan that should reflect behavioral health needs.

  • Framework and guiding principles: This section lists service systems that are important to people with dementia and their families, mentioning health care, long-term care, home care, legal services, and social services. Mental health and substance abuse (behavioral health) systems are not mentioned.

  • Strategy 1.B: Expand research aimed at preventing and treating Alzheimer's disease: This section mentions both pharmacological and non-pharmacological interventions, but

    • The clear priority is bio-medical research seeking pharmacological treatments. There is also a great need for research regarding non-pharmacological, psycho-social interventions, which hold great promise for improving the quality of life of people with dementia and their caregivers virtually immediately.
    • In addition, there is a great need for research regarding preventing and/or treating co-occurring mental or substance use disorders or the neuro-psychiatric symptoms that affect virtually all people with dementia.
  • Strategies 1.B. 3, 5, and 6: Expand clinical trials: These sections fail to mention clinical trials of anti-psychotic and anti-depressant medications. It is true that these medications are over-used for people with dementia and can be dangerous. Fortunately, it is also true that non-pharmacological, psychosocial interventions can be enormously helpful to people with dementia and co-occurring psychiatric disorders. But it would be useful to develop medications that are safe and effective.

  • Strategy 1.E: Facilitate translation of findings into medical practice and public health programs: This section lists fields and settings where findings of research should be disseminated so as to improve practice. Behavioral health settings are not mentioned.

  • Action 1.E.2, 3: These sections mention a number of federal agencies that need to be involved. SAMHSA, NIMH, NIDA, and NIAAA are not mentioned.

  • Strategy 2.A: Build a workforce with skills to provide high-quality care: This section notes, "Physicians need information on how to implement the new requirement regarding "detection of any cognitive impairment." They, and other health providers, also need information about how to detect co-occurring mental or substance use disorders and to distinguish their effects from those of dementia.

  • Strategy 2.B: Ensure timely and accurate diagnosis: As noted, accurate diagnosis requires a very difficult differential diagnosis to distinguish between dementia, depression, and other psychiatric disorders.

  • Strategy 2.B.1: Link the public to diagnostic and treatment services: This section notes opportunities to provide information and referral through NIA and AoA. It does not mention the National Suicide Prevention Lifeline, which is funded by SAMHSA, and which provides a national I&R network for help with any mental health issue--not just suicide. There are also local I&R systems focused on mental health and/or substance abuse, which are not mentioned in the draft plan.

  • Strategy 2.D: Identify high-quality dementia care guidelines and measures across care settings: This section mentions "home, physician's office, and long-term care facility." It does not mention mental health settings such as clinics, day programs, inpatient units, psychiatric rehabilitation, crisis services, and case management programs. People with dementia and/or their family members are often served in these settings. And when people with AD in crisis, it is usually the mental health system that is turned to for help.

  • Strategy 2.E: Explore the effectiveness of new models: This section mentions "medical homes", which are required to integrate physical and behavioral health care, but there is no mention in the plan about this fact. The plan also does not note the emphasis in the Affordable Care Act on developing "health homes", for which many people with dementia will probably be eligible because they have multiple chronic conditions.

  • Strategy 2.F: Ensure that people with AD experience safe and effective transitions between care settings and systems: Despite the fact that settings and systems officially charged with caring for people with dementia frequently turn to the mental health system when there are behavioral problems, there is no mention of how profoundly flawed transitions between the mental health and the long-term settings and systems are.

  • Strategy 2.F. 1: Identify and disseminate models of hospital safety for people with AD: Despite the fact that many people with AD--with and without psychiatric disorders-end up in psychiatric inpatient units of hospitals due to behavioral problems, there is no mention of the need to address psychiatric hospitalization specifically.

  • Strategy 2.G: Advance coordinated and integrated health and long-term services: This section and its subsections do not mention the need to coordinate physical and behavioral health services, which is particularly surprising since integration of this kind is a major goal of health care reform.

  • Strategy 2.H: Improve care for populations disproportionally affected by AD and for populations facing care challenges: This section appropriately identifies "people with intellectual disabilities" as disproportionately affected by AD, but it fails to mention people with psychiatric disabilities, who often develop dementia as they age, compounding causes of cognitive impairment and complicating care and treatment.

  • Goal 3: Expand Supports for People with AD and The Families: This section does mention the mental health needs of family and other informal caregivers. They could get more attention than is in the plan, but it's there to some extent. However, this section vastly neglects the mental health needs of people with dementia.

  • Action 3.A.2: Distribute materials to caregivers: This section calls for "dissemination through the Aging Network, state public health departments, and public websites." There is no mention of the mental health system, to which people with AD and their families frequently go for help.

    In addition, there is no mention of dissemination to people with dementia, most of whom can read and process information in the early and mid-phases of dementia. They, as well as caregivers, can benefit from informational material.

  • Action 3.B.2: Identify and disseminate best practices for caregiver assessment and referral through the long-term care services and supports system: Again, the plan fails to recognize the frequent use of the mental health system by people with AD and their families.

  • Action 3.B.5: Provide effective caregiver interventions through AD-capable systems: This section says "AoA will expand efforts to develop more AD-capable long-term services and supports [for] AD caregivers." Although the section mentions the need for interventions regarding depression, it fails to mention anxiety disorders--which are very common. In addition it fails to mention the need for "AD-capable" behavioral health services.

  • Action 3.B.7: Support caregivers in crisis and emergency situations: This section notes the importance of call centers, but does not reflect awareness of the National Suicide Prevention Lifeline, which could be an important resource during a crisis. This section also does not reflect the fact that, it is usually the psychiatric services in local hospitals or psychiatric mobile crisis teams that are called on to deal with a behavioral crisis.

  • Action 3.D: Maintain the dignity, safety and rights of people with AD: This section appropriately notes the fact that people with dementia are vulnerable in many ways and that many need more protection than they get. (The inadequacy of many Adult Protective Services programs is particularly important to address.) However, there is nothing here to suggest that people with dementia need anything other than protection. Treating people still capable of some degree of self-care and of being helpful to others, solely as people in need of protection, diminishes them and deprives them of the dignity and rights that this section is supposed to address. There needs to be a strengths-based model for dementia as increasingly there is for people with psychiatric and other disabilities.

  • Action 3.D.2: Monitor, report, and reduce inappropriate use of anti-psychotics in nursing homes: This is clearly important to do, but it is also important to address the use of anti-psychotics in other formal care settings such as assisted living facilities, senior housing, adult day care, etc. It is also important to address the likely overuse of anti-psychotics for people with dementia who live in their own homes or with family caregivers.

    In addition, it is very important to address the inappropriate use of anti-depressants because recent studies suggest that anti-depressants have high risks and virtually no benefits for people with dementia and should be used only after non-pharmacological interventions have been tried.

  • Strategy 3.E: Assess and address the housing needs of people with AD: Stable housing, as the plan says, is a critical need for people with dementia. But the plan seems to have a remarkably limited view of the kinds of stable housing that can be helpful, failing to mention assisted living, continuing care communities, senior housing, supportive housing, housing for people with developmental disabilities, and housing for people with serious mental illness.

    The draft plan also fails to note that people with serious mental illness are frequently dumped out of housing they have had within the mental health system for many years and are sent to nursing homes when their dementia or physical disorders make them too difficult for the mental health system--as it is currently organized--to care for. It should be possible for people with serious mental illness to stay in their own homes or in the housing that has become their home rather than to be shunted off to a long-term care system that has very limited capacity to care for them.

    In addition, even though reducing the unnecessary use of nursing homes for people with dementia is a clear goal of this plan, there is no mention of the fact that there are now more people admitted to nursing homes with mental illness other than dementia than with dementia alone. Frequently they are people with co-occurring dementia and psychiatric disorders. Housing designed for this population is needed to help them avert admission to nursing homes.

  • Goal 4: Enhance Public Awareness and Engagement: Public education should include information about the frequent overlap of mental disorders and dementia.

  • Goal 5: Improve Data To Track Progress: Because this plan does not seem to reflect awareness of the important role the mental health system plays in helping people with dementia and their families, it seems likely that plans for improved data collection will overlook data related to psychiatric disorders and mental health settings. It is important to track progress regarding the behavioral health of people with dementia and their families.

I hope that you will find these comments on specific sections of the draft plan helpful in identifying what to include in the final plan regarding the behavioral health needs of people with dementia and their families. Let me add that behavioral health services are not only important for those who are experiencing mental or substance use disorders. In addition, care informed by understanding the psychological potential of people with dementia could result in vastly improved quality of life for them.

We do not have to wait for a cure to make life better for people with dementia and their families, and we should not devote virtually all new resources to seeking an ultimate solution when so much could be accomplished with better care and support.

I would be happy to help the group developing the plan to flesh out any of the suggestions included in this letter.


 

J. Morris  |  03-22-2012

Thank you for your efforts to develop a national plan to address the growing crisis of Alzheimer's Disease. As an elder law attorney who has worked for many years with low income caregiving families in diverse ethnic communities, I understand the urgency of your work. I applaud your efforts to be both comprehensive and realistic in the development of this plan. My own work with Alzheimer's families began through a program called El Portal -- a Latino Alzheimer's project that was funded through the Alzheimer's DiseaseSupportive Services Program (ADSSP), once called the Alzheimer's Federal-State Matching Grant Program. Later I worked with Asian caregivers through another ADSSP-funded program, the API Dementia Care Network. Like many other elder care professionals in this community, this grant brought me into the Alzheimer's cause where I have worked for over 20 years.

As I look over the plan, I am concerned that I do not see any reference to this program. I believe it is the only federally-funded program that uniquely targets dementia patients and their families with support and education services. Specifically, this is a program that could help to fund the part of the plan devoted to populations disproportionately affected by AD and populations facing care challenges, such as racial and ethnic minorities (Strategy 2H). It could also be referenced in section 2.C.2 as it definitely enhances assistance to people with AD and their caregivers. This program supports and educates people with the disease and caregivers, a significant concern addressed in the plan.

I have heard that there is a possibility that funding for the worthy program may be eliminated and that it has already been reduced. I urge you to use the NAPA planning process to assure that this program remains in place and continues to help develop services for under-served, at-risk populations. It may not be a perfect program but it is the ONLY federal program supporting this work for patients with AD and their families.

Thank you for attending to my feedback. I hope it will strengthen our plan to prepare for the public health crisis that is Alzheimer's Disease.


 

B. Lerner  |  03-22-2012

As the baby boomers age we need to address the issues that will arise when some of them will suffer from dementia. Please include that in your bill.


 

M. Haynes  |  03-22-2012

As you revise your policy on Alzheimer's it should also address Dementia which is the onset of this disease. Its inhumane to address one without including this illness.


 

D. Cassel  |  03-22-2012

Please give more attention to mental health of patients with depression and other problems. There are problems that our elderly have and their family that can be helped with education, direction and other resources that the mental health has available. I am a RN and have seen the work the Mental Health Dept. is capable of giving. So please fund the necessary areas with necessary staff and information.


 

T. Monti  |  03-22-2012

I applaud your efforts to address such a significant issue as Alzheimer's Disease. I am a licensed social worker who provides services to older adults in Westchester County full-time. Unfortunately, I am highly concerned about the lack of support for those individuals with Dementia and other co-occurring disorders to increase as more baby boomers turn 65.

Please consider revising your ambitious draft plan to incorporate those in need of assistance due to Dementia and other co-occurring disorders.


 

A. Stern  |  03-22-2012

This is my professional world, and the co-morbidity of depression, anxiety, delusional disorders, etc. runs high with dementia. Please do not ignore the needs of this sadly ever growing population.


 

S. Keller  |  03-22-2012

We, Drs. M.P. Janicki and S.M. Keller, are the co-chairs of the National Task Group on Intellectual Disabilities and Dementia Practices. On behalf of the National Task Group, we wish to make our thoughts and recommendations available to the Advisory Council with respect to the Draft National Plan to Address Alzheimer's Disease. To complement the National Alzheimer's Plan Act process, the National Task Group was convened and produced a report titled, "My Thinker's Not Working: A National Strategy for Enabling Adults with Intellectual Disabilities Affected by Dementia to Remain in Their Community and Receive Quality Supports", which was designed, in part, to develop and enhance community care options for aging adults with intellectual and developmental disabilities. The National Task Group also issued the "National Dementia and Intellectual Disabilities Action Plan" as part of this report. The National Task Group issued this Action Plan in January 2012 in the hopes that it would promote better understanding of how adults with intellectual and developmental disabilities age and how dementia, in particular, affects them.

We note that the issues we identified in the National Task Group's report, which was submitted to the Advisory Council at its January 17th meeting, has many parallels with those raised in the Draft Plan. Our report summarized and addressed some of the challenges facing the nation due to the increasing rate of dementia found in older people with Down syndrome and other intellectual disabilities. Our report also noted that older adults with intellectual and developmental disabilities have special needs that at times require different actions than those provided for people in the general population. Alzheimer's disease affects everyone; but not everyone can be treated the same way when they are affected by this disease.

We have submitted these comments in order to clarify and provide feedback to the Advisory Council regarding its Draft Plan. First, we would like to note that the National Task Group is pleased that the Draft Plan contains mention of intellectual disabilities (in Strategy 2.H) as this group of Americans is composed of a significant number of individuals who are at exceptionally high risk for Alzheimer's disease. We also would like the Draft Plan to contain at least mention of some general issues that we have raised in our Report and also have more elaboration on some key specific issues affecting people with intellectual disabilities.

Given this, we'd like to offer the following comments:

  1. Missing mention of the significance of Down syndrome in Alzheimer's research

    We are concerned that the text under Goal 1, neglects mention of the research with respect to the needs of people with Down syndrome, a group of individuals expressing a particular high risk for Alzheimer's disease. Certainly sustained research is warranted to better understand the etiology and course of dementia in this group of individuals. Additionally, notwithstanding the competing beliefs of whether research involving people with Down syndrome will benefit general research into the nature and cause of Alzheimer's disease, we feel that continued support of research concerning and involving people with Down syndrome will not only potentially benefit the general population, but will certainly benefit the thousands of adults aging with Down syndrome and who are at high risk for and are affected by early onset dementia. Like individuals with genetic mutations resulting in early onset Alzheimer's disease, individuals with Down syndrome also demonstrate early onset of symptoms and more research into this phenomenon is necessary. We would like to emphasize that focused research into a relatively homogeneous population such as individuals with Down syndrome and Alzheimer's dementia can provide important clues when generalizing to the larger population of people with Alzheimer's but absent Down syndrome.

    Thus, we strongly recommend that the Draft Plan include mention that given the high risk of Alzheimer's disease among adults with Down syndrome, there is the continued need for focused basic and treatment research involving people with Down syndrome -- and this should be included under Goal 1.

  2. Mention of the special programmatic and care challenges faced by people with intellectual disabilities

    We note with satisfaction that the Advisory Council's Draft Plan recognized the importance of the special programmatic and care challenges faced by people with intellectual disabilities and included mention of this in Goal 2, under Strategy 2.H (Action 2.H.1). However, we would like to recommend that mention of the special circumstances of adults with Down syndrome and other intellectual disabilities receive mention earlier in this section, so that it is clear that the Strategies included under Goal 2 apply equally to this population. We would like to see the Draft Plan recognize that Alzheimer's disease mostly impacts adults with lifelong intellectual disabilities in the same ways as it does other people, but sometimes has a more profound effect due to particular risk factors - including genetics, neurological injury, and deprivation. Further, under the Strategies noted under Goal 2, it is important to propose that any NAPA-related task forces created (as cited in the Draft Plan) not only look into improvements of care for this specific population, but also, and perhaps more importantly, increase awareness, improve screening and early recognition, and conduct population specific clinical trials involving adults with intellectual disabilities.

    Thus, we strongly recommend that the Draft Plan include mention of the special circumstances of adults with Down syndrome and other intellectual disabilities earlier in the second section, so that it is clear that the Strategies included under Goal 2 apply equally to this population.

    Under Strategy 2.B, we would also like to recommend that mention be made of the challenges of carrying out effective screening and diagnoses for dementia among most individuals with intellectual disabilities due to their inherently varying abilities and cognitive functions. When nationally applicable instrumentation is developed or recommended it would be highly beneficial to make mention in the Draft Plan of the need for specialized screening instruments for use with adults with intellectual disabilities. The National Task Group is currently undertaking the development of such an administrative screen, which would have specific application to people with intellectual disabilities who otherwise may not be adequately or successfully screened by tools in existence and applicable to the general population. Recognition of this special need and work by the National Task Group would go far to gain acceptance of a regularized screen applicable to adults with intellectual disabilities.

    We also would recommend -- adding text under Strategy 2.E -- that the notion that community care, as noted in the 2002 Madrid International Plan of Action on Ageing, be the paramount means of long-term 'dementia capable' care delivery. We note specifically the growing evidence-based research that is supporting the inclusion of small group homes -- as a viable assisted living model -- and their role as a potentially powerful alternative care setting for people with dementia, and in particular those with lifelong disabilities. Research in the intellectual disabilities services area has shown this model to be particularly effective in providing quality care for those adults with intellectual disabilities affected by dementia.

    Thus, we strongly recommend that the Draft Plan include consideration of the special challenges in assessing and determining the presence of dementia in adults with certain intellectual disabilities and that any national guidelines produced contain this consideration.

    We also strongly recommend the consideration of the use of small group homes for the community 'dementia capable' care of adults with intellectual disabilities affected by dementia as backed by evidence-based research in the intellectual disabilities field.

  3. Mention of the special support needs of aging caregivers providing long-term in-home care of adults with intellectual disabilities

    As many adults with intellectual disabilities and in particular those with Down syndrome remain in their family homes living with their parents or other family caregivers as they grow older, it is crucial that under Goal 3 inclusion of the challenges faced by these caregivers -- when providing care-at-home to their relatives with intellectual disabilities and dementia -- be given due mention. These 'life-long caregivers' warrant special attention in the Draft Plan as they are providing an important and crucial bulwark against costly institutionalization and oft-times inappropriate admissions to long-term care facilities. They are also often vexed by emerging symptoms of dementia in their adult children who have successfully mastered many general activities of daily living and now are manifesting decline. Special mention to the situations of these lifelong caregivers should be made in the Draft Plan. In this context, the National Task Group also recommends that Strategy 3.C.1. be amended to recognize that in many settings concerned with adults with intellectual disabilities, decisions are often made by proxy (and not by 'middle-aged adults') and that adults with intellectual disabilities are not the ones planning for their own long-term care needs. Thus, consideration should be given to enabling parents or other family members, providing primary care, to undertake productive long-term care planning.

    Thus, we strongly recommend that the Draft Plan include consideration of the special challenges faced by life-long caregivers of some persons with intellectual disabilities.

  4. Mention of the enhanced public education resources related to intellectual disabilities

    Under Goal 4, we strongly recommend including the needs of family caregivers and people with intellectual disabilities under public education campaigns and that the greater coordination efforts by government and the voluntary sector should get mention. As the state developmental disabilities authorities (agencies) are instrumental in helping organize state functions and programs with respect to intellectual and developmental disabilities it would be extremely beneficial to include these entities (and state developmental disabilities planning councils) in any public education efforts at the state level. Also, education and training for health professions with respect to aging individuals with dementia -- especially of the Alzheimer's type -- should be included as part of primary health care education. As there are health care disparities, an aggressive education campaign should involve universities, hospitals, emergency rooms and general medical specialists as it relates to cognitive and functional disability and its detrimental effect on caregivers and quality of life of the individuals with intellectual and developmental disabilities.

    Thus, we strongly recommend that the Draft Plan include consideration of additional and targeted efforts related to public and medical education so that these efforts have a functional effect on helping people with intellectual disabilities affected by dementia.

The National Task Group recognizes that dementia has a devastating impact on all people -- including people with an intellectual disability and their friends, families and the staff who may be involved with them as advocates and caregivers. Given this, we are very pleased that the Advisory Council recognized the import of the special challenges faced by people with intellectual disabilities and included mention of this group in Strategy 2.H. We would hope for those adults with intellectual disabilities currently affected by dementia and those in the next generation who may be affected (as the timeline for the NAPA process encompasses the next 13 years) that the Advisory Council will recognize other areas of inclusion of the specific issues affecting individuals with intellectual disabilities within the Draft Plan and accept our recommendations for additional areas of mention and focus.

We trust the our comments and recommendations will be accepted in the spirit in which they are provided -- as the collective concerns and thoughts of a significant body of professionals, scientists, administrators, family caregivers and advocates, and persons personally affected by dementia -- who are represented by the National Task Group on Intellectual Disabilities and Dementia Practices.


 

K. Smith  |  03-22-2012

Dementia frequently co-occurs with mental health conditions such as depression and anxiety disorders. In addition, family caregivers are at high risk for mental and physical health problems. Recognizing and treating these conditions plays a vital role in improving patients' cognitive functioning as well as the quality of life of people with dementia and their caregivers.

Please provide access to mental health treatment for people with dementia and their caregivers in your final HHS Alzheimer's Plan.


 

B. Bensadon  |  03-22-2012

I'd like to commend the Department of Health & Human Services for developing an ambitious plan to address Alzheimer's Disease.

I would add, however, some concern about its apparent overemphasis on biology and pharmacology. Based on my own clinicial experience, chats with colleagues, and reading of the related literature, I can confidently state this focus is necessary but not sufficient. The mental health (i.e., depression & anxiety) of patients and unpaid caregivers alike is inextricably linked to this disease and its treatment. Should these psychological components remain unaddressed, the costs (financial & human) will continue to mount. Conversely, adequate support can reduce this burden, both at the individual and societal levels.

Experts estimate it will take decades before "cures" for Alzheimer's are discovered, let alone made available (and affordable) broadly. While this remains an appropriate aspirational goal, behavioral treatment of the millions currently afflicted, and support for those trying to care for them, must not be sacrificed.


 

T. Bledsoe  |  03-22-2012

Please see the attached.

==========

From: J. Morris

[Link to comments -- J. Morris]


 

K. Bachand  |  03-22-2012

Please include the impact Dementia has on caregivers. My father has Dementia and my mom's health has taken a turn for the worst. She has been to the hospital (medical) for heart problems because of the stress of taking care of my father. It is essential that you include in the draft plan attention to mental disorders commonly experienced by people with Dementia and their caregivers.


 

C. Anflick  |  03-22-2012

As a Social Worker addressing the needs of seniors with mental health issues, I see how overwhelming the diagnosis of Dementia can be for patients and the people who care for them.

Many people are in denial over the diagnosis and its consequences, and who can blame them?

There is no cure at this time, and more and more support services have been limited.

Please provide for the mental health needs of patients and their families, as the following are increasingly evident:

Dementia frequently co-occurs with mental health conditions such as depression and anxiety disorders. In addition, family caregivers are at high risk for mental and physical health problems.

Recognizing and treating these conditions plays a vital role in improving patients' cognitive functioning as well as the quality of life of people with dementia and their caregivers.


 

P. Whittingham  |  03-22-2012

Please consider the best treatment practices for people and caregivers who are struggling daily with this illness. It's becoming one of the greatest mental health challenge we must face in the future. A comprehensive approach must be considered in the treatment practices as the myriad of this illness will eventually affect us all in some way or another. The co- occurring mental conditions that are experienced by both the patients and caregivers need to be taken seriously as it greatly affect their quality of life. It is our duty as professionals to ensure that the best is offered at all times to others who rely on our expertise/training. Thank you.


 

C. Ban  |  03-22-2012

I am very heartened to learn that the federal government released a draft of a comprehensive plan to address Alzheimer's disease. I do want to voice my fervent hope that adequate attention is paid to the mental disorders commonly experienced by people with dementia and their caregivers in the government's plan.

I worked as a psychiatric social worker for 17 years on a locked inpatient hospital geriatric unit, where the predominant diagnoses were Alzheimers or Dementia with agitation, depression, delusions and/or hallucinations. I witnessed the range and severity of symptoms that caused elderly people with dementia to neglect themselves, to become violent, refuse help offered to them even by their own loving children, to become paranoid toward loving family members, and the devastating effects this had on families. Without access to mental health treatment provided by knowledgeable geriatric psychiatrists and other practitioners, these individuals suffering from dementia would remain in agony and distress, harmful to themselves and others.

I applaud our government for addressing Alzheimers disease and urge you to carefully consider the mental health needs of this population in planning for the future.


 

L. Schwartz  |  03-22-2012

ADDRESS MENTAL HEALTH ISSUES OF PEOPLE WITH DEMENTIA, AS WELL AS THEIR CAREGIVERS


 

K. Cook  |  03-22-2012

As you draw up plans to address the needs of the growing population of people with Alzheimers Disease and dimentia I ask that you would consider the mental health needs of both the caregivers and the patients.

My mother-in-law has been declining as a result of alzheimers, and as one of a many family member team that takes shifts caring for her I know how rough it is to maintain a positive attitude and stamina as her condition declines from one plateau to another.

If you are developing a comprehensive plan, I would think it would be critical to recognize the challenges of mental health and well-being as part of that overall picture, and include steps in your plan to support a mentally healthy population.

Please do not under estimate this critical aspect. The mental attitude of both the patient and the caregiver(s) can make an enormous difference in whether the patient is happy and the caregiver is attentive and loving.

Thank you for taking the time to read this and consider this aspect. People can be old and *well*.


 

L. Mertz  |  03-22-2012

The federal government has released a draft ambitious plan to address Alzheimer's disease.

Unfortunately, the draft plan does not provide adequate attention to mental disorders commonly experienced by people with dementia and their caregivers.

Dementia frequently co-occurs with mental health conditions such as depression and anxiety disorders. In addition, family caregivers are at high risk for mental and physical health problems. Recognizing and treating these conditions plays a vital role in improving patients' cognitive functioning as well as the quality of life of people with dementia and their caregivers.

Please address the mental health needs of people with dementia and their caregivers in the final plan.


 

B. Meyer-Arnold  |  03-22-2012

I was pleased to be able to respond the the NAPA draft plan as part of the group gathered by

SAMHSA in December of 2011. I support all of the comments gathered by the group and sent to you my Michael Freeman.

I also ask you to consider the additional comments that I've included in my letter, based on my 25 years experience in developing, implementing, researching and administering programs for persons with dementia.

ATTACHMENT:

COMMENTS ON THE DRAFT NATIONAL ALZHEIMER'S PLAN

Thank you for the opportunity to comment on the draft National Alzheimer's Plan. I am, of course, very pleased that the federal government is developing plans to address the needs of people with dementia and their families, a population that will grow substantially over the next quarter century because of the elder boom and because of increased life expectancy. I have signed onto a letter drafted by M. Friedman, MSW and signed on by the vast majority of members of a group of experts assembled in December of 2011, in Washington DC, by SAMHSA, to inform them of the psychosocial, mental health and behavioral issues, concerns and strategies that should be included in the NAPA plan. We are all disappointed that few, if any of our input has been included in the draft plan.

I support everything in the letter from the group but would add the following two comments:

  1. Not only do we need more research on psychosocial interventions, but also on creative engagement interventions. There is an increasing number of successful art and creativity programs (Stagebridge, Kairos Dance, TimeSlips, SPARK, Art Care, Memories in the Making) for persons with dementia, that are making a difference in the quality of life not only for the person, but also for the caregivers. We all know that most aggressive or violent behavior in persons with dementia is behavior that is trying to communicate something else besides aggression; most often pain, boredom, grief, loneliness or urgency of personal body functions. As we develop relationships with people with dementia, we learn their language and can anticipate their unspoken needs by learning what they are communicating to us. Creative engagement and art programs can provide fun and adult-like experience that help us to hear the voices of those with dementia and to avert disaster before it happens.
  2. I would also add that in searching for alternatives to nursing homes for those with Alzheimer's disease, consider the thousands of adult day health care programs that are providing creative and psychosocial interventions, as well as nursing care to over 260,000 participants and family caregivers. ADS have become a preferred platform for chronic disease management with much higher percentages of care provided for hypertension, physical disability, cardiovascular disease, mental illness and developmental disability. (Metlife, 2010). These are all medical issues that compound the care of persons with Alzheimer's disease. According to this national survey, conducted in 2010, by The Ohio State University and funded by MetLife Mature Market Institute, the adult day centers are leaders in community based care for individuals with Alzheimer's disease. (over 75% of centers offer cognitive and memory training programs, and educational programs for Alzheimer's disease).

I hope that you will find these comments helpful in identifying what to include in the final national plan for persons with Alzheimer's in America. We do need research for persons with dementia, but not only for new drug interventions. We need research in these psychological and psychosocial interventions also. We must not ignore the 5.4 million persons living with Alzheimer's disease NOW!


 

G. Burkhart  |  03-22-2012

I would like to submit a few comments regarding the Draft National Plan to Address Alzheimer's Disease. First, NAPA is a wonderful thing and long overdue. Second, thanks to the drafters who clearly state on page 3 that "Alzheimer's disease" as used also includes related dementias. My husband has Dementia with Lewy Bodies (DLB), and when someone refers to Alzheimer's, I am always the little voice that chimes in with, "...and don't forget the related dementias."

I hope that when the "experts" meet to discuss and forge the plans, they will include ideas from caregivers in the process. I've learned a tremendous amount from my experience with my husband's illness over the last several years, and believe I could provide valuable input about what it's like in the trenches.

A few items that I would like to specifically comment on:

page 4, a note that AD patients are hospitalized 2-3 times more than others: Often they are sent to the hospital and shouldn't be. The ER is a terrifying experience for them, and sometimes they are just exhibiting symptoms of their illness and don't even need the repeated MRIs, CT scans, and other tests that come back negative every time.

Throughout the document, references are made to provider education and outreach in various settings. This is my personal goal, as I have found that hospital and other staff, unless specifically trained in dementia diseases, are pretty much clueless as to caring for AD patients. One nurse in an excellent hospital in Las Vegas even told me, after caring for my husband as an inpatient, that he was "very confused." Really?

page 21, Goal 3: What does this mean? I hope the needs of caregivers will be addressed by talking to actual caregivers, and not just health care professionals who don't live this disease on a daily basis. (Also, what are "informatics?")

page 23-24, money issues: Why don't we have long-term care? For the middle class (us), it was not affordable at the time, and now it's impossible. More needs to be done to bring costs down for AD patients - they usually don't need skilled nursing care, just compassionate assistance. Also mentioned on page 25, housing options - I would be interested in participating in this discussion.

page 24, Strategy 3D: I agree that this is very important. However, I have found that sometimes the pendulum swings too far the other way, and I as a long-term spouse am viewed with suspicion. This is another goal of mine - to get government agencies and institutions at all levels to understand the difference between a person caring for their long-term spouse and someone who would exploit or abuse the AD patient.

page 26, Goal 4: Yes, we need to educate the public! But sometimes educational programs and materials are written or presented in a manner that the general public cannot understand. Short and simple is best!

page 28, Goal 5: Data is important - is there a way to also include anecdotal evidence?

Thank you for receiving comments. I guess I could summarize my thoughts by asking that the compilation of the Plan include input from real people who are experiencing the terrors of this disease each day.


 

M. Ellenbogen  |  03-21-2012

Just wanted to pass along the finished article and video that was produced: http://www.foxnews.com/health/2012/03/21/alzheimers-at-39/

Please make sure to add it to twitter, face book and your web pages.


 

M. Ramirez  |  03-20-2012

Thank you for your time in considering this document.

ATTACHMENT:

The Mental Health Association in New York State, Inc., the undersigned, is writing in response to the draft National Alzheimer's Plan recently released for comment by the Department of Health and Human Services.

We are all pleased that a National Alzheimer's Plan is being developed in recognition of the vast growth of the number of people who will have Alzheimer's or other dementias during the elder boom, and we appreciate the opportunity to comment on the draft plan.

However, we all believe that the draft plan is inadequate in several critical ways.

Imbalance of Use of Funding: The draft plan does not specify how much funding will be available to deal with Alzheimer's and other dementias in the future, but it does provide some information about new federal funding that has been committed prior to the completion of the plan. $156 million will be made available for the five major goals of the plan. Of this $130 million (83%) is designated for one goal--research. $26 million is designated for enhanced services and supports, provider education, public education, and improved data collection. Of this, $10.7 million is designated for improved care and treatment of 5.4 million people who currently have dementia and their family caregivers. That's less than $2 per person. This is simply not adequate.

Inadequate Attention to Research About Psychosocial Interventions: The clear tilt of the draft plan is towards research to find a cure for Alzheimer's. It seems to focus heavily on bio-medical research and the development of effective pharmacological treatments. Prevention, cure, or effective slowing of the progression of dementia are, of course, much to be desired. But we do not believe that it is at all likely that this will be achieved by 2025--the goal of this plan--and even if it is, the millions of people who now have or will develop dementia prior to that will not be helped at all.

We know that psychosocial interventions can do much to improve the quality of life of people with dementia and their family caregivers, but we need to know more--to develop truly evidence-based practices. We strongly urge those developing the research plan to pay much more attention to research about psycho-social interventions.

Lack of Attention to Mental Disorders Commonly Experienced by People with Dementia and their Caregivers: People with dementia often have co-occurring mental health conditions such as major depression, anxiety disorders, and psychosis. Almost all exhibit neuro-psychiatric symptoms such as depression, anxiety, apathy, irritability, delusions, hallucinations, agitation, aggression, and sleep disorders. (See Lyketsos, et al) When this happens, those who care for people with dementia turn to mental health providers for help. Yet, the role of the mental health system is barely reflected in the draft plan.

In addition, family caregivers are at high risk for depression, anxiety, and stress related physical disorders. There are evidence-based family support interventions. (See Mittelman). The need for supports for family caregivers is noted in the plan, but briefly and with little substance.

We strongly believe that failure to address issues of mental health will result in continued failure to meet fundamental needs of people with dementia and their families.

Thank you again for the opportunity to comment on the plan. We would be glad to work with HHS to provide the details that are needed to complete a National Alzheimer's Plan that reflects the psychosocial/mental health needs of Americans with dementia and their families as well as their opportunities for improved quality of life.


 

B. Lamb  |  03-20-2012

I would like to thank Mr. Ellenbogen for his supportive remarks regarding my comments on the National Plan to fight Alzheimer's disease. I hope that HHS and the Secretary will consider these comments as they revise the Plan. We are truly at a unique stage in our fight against Alzheimer's that will have implications for years to come. Developing an Office that is singly focused on coordinating and organizing efforts to fight Alzheimer's disease as well as to provide feedback to HHS and the Advisory Council as well as Congress is essential as we move forward. While there is certainly the possibility that this may step on toes within HHS and/or the NIH, it is something we literally cannot afford to do if we are serious in our efforts to fight Alzheimer's disease. Indeed, developing this infrastructure at the beginning of the Plan rather than years later will likely save money and lives into the future.

Thanks for your consideration.

==========

From: M. Ellenbogen

[Link to comments -- M. Ellenbogen]


 

G. Odenheimer  |  03-19-2012

I have reviewed the scientific agenda for the National Initiative on Alzheimer's Disease.

Perhaps there is another document of which I am unaware.

However if this is the gist of the national plan then I would submit with urgency that there are enormous gaps in the plan.

As a Geriatric Neurologist who specializes in diagnosing and managing patients with dementia and caring for their families I see no where in the plan for a mechanism to increase clinical providers.

There is a national urgency to recruit and keep clinicians who care for people with dementia.

Currently, I am one of very few providers in my town of nearly 1million people who will see patients with dementia. I have been told that I spend too much time with them, so I would have to pay the clinic to see these patients.

I WOULD HAVE TO PAY!

I have since spoken with many other providers who have told me that they cannot afford to see these patients.

The Neurology residents at our medical school no longer rotate through our dementia clinics, since they have no intention of taking these patients.

I am constantly asked by the public where to turn for dementia providers. I am at a loss. I have asked Alzheimer's Association representatives for recommendations and they just shake their heads and say they cannot find providers either.

If we are to take important research findings and bring them to the public, we desperately need the providers to be there to deliver this care.

This will require a major shift away from current payment plans that value procedures over time spent with patients.

Please do not neglect this critical area in your plan.

If I can be of further assistance in this, don't hesitate to let me know.


 

R. Berte  |  03-19-2012

I am the primary caregiver for my mom and this disease has shattered our family,

I had a bad experience with a Nursing Home and took my mom home (which was about about 8 months ago); took time off from work...and since she has almost returned to pre-nursing home "state".

But our family needs more help...it's been a stain physically and mentally..and financially; but I am doing all I can as my mom did for my brother and I growing up..

But this disease is like murder, and we need a cure.

Hope all avenues are being taken..


 

A. Wolf  |  03-19-2012

I am a co-author and now facilitator for our state plan, Conquering the Specter of Alzheimer's Disease in South Carolina, which was presented to the State Legislature on March 1, 2009. Needless to say, I have a keen interest in a national strategy to fight this disease. One of the recommendations that came out of South Carolina's task force was the involvement of the work force in supporting and assisting caregivers. Following is one of the recommendations in our plan regarding employers enabling caregivers to remain in the work force. This seems to coincide with the priorities of the national plan and represents an area not specifically addressed through the draft plan.

Recommendation 20. Promote and support private and public sector businesses in addressing the needs of employees who are caregivers to persons with ADRD through the use of on-site respite, support groups, or other initiatives.

Rationale: Seventy percent of people with ADRD are living at home, most of whom receive unpaid help from family members[i]. One study of family and other unpaid caregivers of people with ADRD found that 57% were employed full time or part time. Of those who were employed, two-thirds said they had to go in late, leave early or take time off because of caregiving; 18% had to take a leave of absence; 13% had reduced their hours; and 8% had turned down promotions[ii]. Eight percent of caregivers in the study had quit work entirely because of caregiving. Another study of family and other unpaid caregivers of more than 2,000 older people found that caregivers of people who had Alzheimer's or other dementias without behavioral symptoms were 31% more likely than caregivers of other older people to have reduced their hours or quit work[iii]. Caregivers of people who had Alzheimer's or other dementias with behavioral symptoms were 68% more likely than caregivers of other older people to have reduced their hours or quit work[iv].

Responsible Party: SC Alzheimer's Association, SC Chamber of Commerce, SC Better Business Bureaus, SC Technical College System, SC Manufacturers Association

References

  1. 2008 Alzheimer's Disease Facts and Figures, Alzheimer's Association, p. 24.
  2. Families Care: Alzheimer's Caregiving in the United States. Alzheimer's Association and National Alliance for Caregiving, 2004, Accessible at http://www.alz.org ).
  3. Covinsky, KI; Eng, C; Liu, L-Y; Sands, LP; Sehgal, AR; Walter, LC; et al. Reduced Employment in Caregivers of Frail Elders: Impact of Ethnicity, Patient Clinical Characteristics, and Caregiver Characteristics. Journal of Gerontology: Medical Sciences 2001; 56A (11): M707-713.
  4. 2008 Alzheimer's Disease Facts and Figures, Alzheimer's Association, p. 18.

Thank you for your time and consideration.


 

T. Holmes  |  03-18-2012

I am an Occupational Therapist and specialize in Dementia Care. I have reviewed th National Alzheimer's plan and find the outline to be refreshingly comprehensive. As you and HHS move forward on the plan, please consider the important role of occuaptional therapy and the importance of providing services within a Psychosocial model and NOT a medical model.

I suggest the following beneftis for American seniors, as paid for without raising the debt.

  1. Allow for medicare to reimburse for Outpatient education and training services provided to the caregiver of someone with dementia. This training must be to meet a skilled need and can be provided within context of a small group session (2-3 caregivers). For example, as an OT, I could provide training to 3 caregivers in the bathing of patients in the moderate stages of dementia. This would be an efficient use of resources and time. Medicare must accept the fact that dementia care involves treating the dyad (patient+caregiver), not just the patient.
  2. Allow for coordination of services between organizations without barriers of HIPPA (I would need to call a social worker or case manager at a hospital and freely discuss a patient's case).
  3. Identify Occupational Therapy as a critically needed and stand alone provider of services to dementia patients and their caregivers.

 

M. Ellenbogen  |  03-17-2012

I would like to commend and thank B. Lamb, who is an Alzheimer's researcher and Staff Scientist at Department of Neuroscience, in the Lerner Research Institute at the Cleveland Clinic. He shared his view points on January 13, 2012, under the SUBJECT: Draft Framework for the National Plan to Address Alzheimer's Disease, in the public forum.

I found his view point's very interesting and highly recommend reading if you have not already done so. He also had an attachment that was titled, Right sizing funding for Alzheimer's disease, which was written by Todd E Golde, Bruce T Lamb, and Douglas Galasko and published May 6, 2011.

https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-right-sizing-funding

I really like these paragraphs, which I extracted for your reading.

If one assumes that funding for HIV/AIDS was right sized to enable translation of basic discoveries to successful therapies, then given the lack of effective AD therapies, one possible implication is that funding for AD has been insufficient. A quick comparison of funding levels for HIV/AIDs relative to AD in the United States suggests this may be at least one factor that has hindered the translation of AD discovery to effective therapies. Based on publicly available data, National Institute of Health funding for HIV/AIDS in the United States is currently approximately $3 billion [5]. With approximately 1 million HIV-positive subjects in the United States, this equates to $3,000 of NIH funding per person with HIV/AIDs. In contrast, current NIH funding for AD is at a level of approximately $450 million [5], with perhaps another approximately $100 million to $200 million in NIH funding that might have some relevance to the study of AD (cognitive decline in aging, related neuro degenerative conditions). With a current prevalence of approximately 5 million individuals affected with AD in the United States, this equates to a maximum of $130 of NIH funding per person affected with the disease. So, on a per affected individual basis, NIH funding for HIV/AIDs is 23 times the level of that for AD.

Of course, there are many different ways to evaluate proportional or relative funding. Another one that is quite germane is economic impact. For AD in the United States this is estimated at more than $170 billion per year (and worldwide at $600 billion per year) [6]. Again focusing only on the United States, the yearly funding for research by the NIH represents 0.4% of the yearly costs of the disease in the United States. In other words, for every $2 the disease costs the United States, we spend less than 1 cent on research.

There are many people who believe in reinventing the wheel when undertaking a new project or endeavor. I have always been a firm believer that the people before us have laid the framework need to get started so we are not wasting a lot of time on the basics. The only approach I always followed along with that is, to delete, enhance and critique to make the plan even better. I always did that by asking the previous plan makers what they realized they did wrong and what would they do different. Ninety percent of that frame work would usually come from the best of many minds. I really believe the input and suggestion made by Bruce Lamb, be discussed when building this framework.

One thing that keeps coming to mind is the disparity issue related to AD. Am I the only one that sees this, or do we all just not want to talk about it. For example AD was first identified and named in 1906, while AIDS was identified in 1981. I see us now in the same stages as HIV was in 1988, when a focused effort was begun towards treatment or cure, with the creation of The Office of AIDS Research. It took an additional 5 years to strengthen this OAR (The NIH Revitalization Act), which really made a huge difference. Within three years of that day and by 1996 we started to finally have an impact on AIDS.

Let's not make a similar mistake as we did with HIV. Let's create a diseased focused agency for AD, with all the necessary strength, as of day one. Just think you can make up for the disparity that has been created and just maybe we could have a cure in less than 5 years.

Let me leave you with one last thought that I have not heard or seen anywhere. I think the government should offer a large sum of money to anyone who can come up with the cure for this disease first. While I am not sure what that amount should be it can be in cash and partial tax credits. I think that will drive many more into this arena and more efforts if the pie is big enough. Just think of all the savings insurance companies can benefit, not to mention the government. They may all be willing to help in that funding. Just a though. Sometimes you have to be creative and think outside the box.


 

M. Ellenbogen  |  03-16-2012

I was diagnosed with Alzheimer's at age 49, after struggling to get a diagnoses from age 39. We need to better educate our doctors.

I had the opportunity to read many of the public comments. Many referred Psychologists and Neuropsychologists that may not have been in the plan. While I think they can add a benefit to people with AD, they can also hinder diagnose, as was done to me. In my experience it delayed my diagnoses for about 10 years, not to mention the financial burden it created to our health system. Many need to be better educated on how people with AD react to the test they provide. They also need to put some merit in what their patients and caregivers may share with them. Especially if the caregiver is a RN.

In June 1999, I had my first full Neuropsychological Evaluation conducted by Dr. Lindsey Robinson. The summary and recommendations were: Current level of overall intellectual functioning is in the average range, with verbal and nonverbal cognitive skills relatively evenly developed. Neuropsychological testing revealed moderate to severe impairments in information processing speed and sustained attention, with mild to moderate impairments in verbal learning efficiency. Short-term attention, expressive/receptive language skills, verbal and nonverbal abstract reasoning, and cognitive flexibility were within normal limits for age. There was no evidence of clinically significant depression, anxiety, or other psychological disorder which might account for the patient's cognitive deficits. The etiology of Mr. Ellenbogen's cognitive impairment is unclear as, from a neuropsychological perspective, his symptoms are nonspecific. However, the magnitude of impairment observed on objective testing, in the absence of identifiable affective disorder, does suggest the presence of some form of organic cerebral dysfunction. Further neurological evaluation recommended.

I another appointment with Dr. L. Robinson on February 2001. It was frustrating dealing with these doctors because every time I had to see a new doctor or take a test, my primary doctor needed to okay it. The other frustration was that sometimes I had to wait 5 months for appointments, which was the case with this appointment. The test that I was about to retake was questionable. I was not sure my insurance would cover the procedure, so I had to jump through hoops with the doctor and my insurance company. If the test was not covered, it would cost me about $2,500.00. When you deal with these insurance companies, document the conversation for yourself and ask them to do the same. I cannot tell you how many times they tried to get out of paying, but then they checked their records and saw I had received pre-approval. They kept putting up roadblocks and I had to be in touch with them a lot, when I should have been working. It was bad enough that I had to leave work for appointments, I did not need the added aggravation from the insurance company.

I finally met with Dr. Lindsey Robinson. She had commented on my other doctors findings in the beginning of her report: The etiology of his cognitive symptoms was felt to be multifactorial, including normal aging, alcohol consumption, and anxiety.

I have to tell you that when I saw those comments, I was very angry. She was making up her mind before even administering the test.

Her summary and recommendations were: Current level of overall intellectual functioning is in the average range, with no significant discrepancy between verbal cognitive skills and nonverbal reasoning abilities, There is no significant change in overall intellectual ability in comparison with the evaluation in June of 1999. On neuropsychological testing, Mr. Ellenbogen displays generalized psychomotor slowing and inconsistent impairments in attention, concentration, and memory. In comparison with the previous evaluation, a variable, inconsistent pattern of change was demonstrated, with improvements on some measures and declines on others. This pattern of performance is not suggestive of focal or lateralized organic cerebral dysfunction, and is not consistent with the presence of a progressive cognitive disorder. Rather, Mr. Ellenbogen's neuropsychological test performance suggestive of fluctuating levels of attention, concentration, and performance speed. Objective psychological screening suggest the presence of mild to moderate symptoms of depression and anxiety, and an introspective, perfectionistic personality style. These psychological symptoms are most likely playing a significant role in Mr. Ellenbogen's subjective cognitive dysfunction.

She encouraged me to seek a psychiatric consultation to determine whether a trial of antidepressant or anti-anxiety medication might be helpful in ameliorating my cognitive symptoms. She got me so aggravated, and she would not listen to anything my wife or I tried to tell her. She just did not want to hear it.

I went back to Dr. L.J. Robinson, the Clinical Neuropsychologist, in January 2006. She was going to redo the neuropsychological testing. I thought it would be best to use this doctor again because she had a baseline for me and could compare my new results with the old. It would take months for the results. The other issue was that there were not many doctors, who performed this test, that were covered under my health insurance policy.

In June 2006, just a few weeks after my 48th birthday, Dr. L.J. Robinson finally got back with the results of my testing. Her results for neuropsychological testing were as follows: Background -- Previous neuropsychological evaluation in 1999 and 2001 revealed fluctuating, inconsistent impairments in attention, concentration, and performance speed, and symptoms consistent with anxiety and depression. Summary and recommendations -- Multiple aspects of Mr. Ellenbogen's behavior and test performance suggestive of inconsistent/incomplete effort during the evaluation. Thus, this test results described are not regarded as a valid representation of his optimal cognitive functioning. Mr. Ellenbogen's clinical presentation and test are unchanged in comparison with prior neuropsychological evaluation in 1999 and 2001. There is no evidence of progression of cognitive impairments, and Mr. Ellenbogen's developmental history and current test performance are not consistent with a diagnosis of attention deficit/hyperactivity disorder or any other organically-based cognitive disorder. Mr. Ellenbogen demonstrated an anxious/ obsessive personality style and some symptoms of depression. His cognitive can be most parsimoniously attributed to affective disorder and/or other motivational or psychological factors.

Diagnostic Impression;

R/O Dementia (not in evidence)
R/O Anxiety Disorder, NOS
R/O Personality Disorder, NOS

Her recommendations -- Mr. Ellenbogen should be reassured that thorough medical/neurological evaluation on multiple occasions has revealed no evidence of neurological cause for his cognitive symptoms. A trial of psychotropic medication could be considered to address Mr. Ellenbogen's apparent effective symptoms. He is unlikely to benefit from psychotherapy due to his reluctance to accept a non-medical explanation for his symptoms.

I have to tell you that when I met with her and read this report, I was so upset that I had made the decision to go back to her. First of all, during my testing we were not in a quiet area. Anytime I hear noise, it just throws me off. I have difficulty processing and concentrating when that occurs. There was nothing she could do to make it better. I tried very hard to be accurate during my testing and worked as quickly as I could. I tried to inform her that she was wrong in her findings, but she did not want to hear it.

She was so confident in her failure to diagnose me properly, that when I had reach out to her to make her aware that other Psychologists and Neuropsychologists determined that I did have Alzheimer's. She insisted on writing a letter to tell my primary doctor, that the others were wrong and she felt that her diagnosis was correct. Since that day I tried to reach out to her and gave her the opportunity to see the conclusions that 3 other doctors cane up with, but her office refused. Doctors like this will only hurt people like me. There should be a specific testing they must go through before they can test YOAD patients.

Maybe someone from your office can educate her. [address removed]

As you can see, it requires special doctors with the right training to deal with YOAD. I hope you will insure that happens.


 

M. Ellenbogen  |  03-16-2012

Please check out my new videos. Please make it count and spread the word. Add it to your face book, websites and twitter. Sorry if you are receiving it a second time.

http://youtu.be/viQre91DAL8

http://youtu.be/J7uL6FIyPOs


 

Y. Hayes  |  03-16-2012

I am pleased more money and attention is proposed for the NAPA and that you are asking for comments.

I am a caregiver for my husband, A. Hayes (80 Yrs. old), who has had Dementia for five or more years. He has been diagnosed going int the advance stage; little language skills, completely dependent on me for his personal care and sleeps 15 hours a day. The only outside help (other than family) I get is two afternoons a week when the Santa Fe Senior Services provide Respite Care for three hours, which gives me a chance for free time. I felt very lonely until I took advantage of various Alzheimer's groups, caregivers, Alzheimer Cafe and discussion groups each meeting is only one day a month. There are no day care programs or affordable home care. I am 85 years old and have full 24+7 caretakers responsibility, I can not leave him alone to go shopping. I have had to give up all my interest my involvement with my church and various activities.

I feel more attention should be directed towards caregivers and their needs and their family. My desire is to keep him Home as long as possible but I need more help at home. I am 85 years old and I am concerned about how much longer I can keep up with all the demands of being a caregiver.

The caregiver is like the elephant in the room everyone knows it is there but they keep their blinders on. Caregivers need to be recognized and helped in every way possible.


 

E. Phelan  |  03-15-2012

I believe we met a year or so ago at the CDC's fall prevention expert panel. I hope you are doing well!

I had the opportunity to read the Draft National Plan to Address Alzheimer's Disease and had some thoughts to pass along to you:

  1. It seems like HHS is assigned responsibility frequently throughout. Where translational efforts are mentioned (e.g., p. 12, Action 1.E.2.), I'd suggest specifically calling out partnering with groups like the CDC's Prevention Research Centers Healthy Aging Network (CDC-HAN, http://www.prc-han.org/) and also the Geriatric Education Centers.
  2. There is mention (p. 14, Action 2.A.1.) of training health care providers in how to manage Alzheimer's "in the context of other health conditions." I would assert that there is not sufficient evidence on this topic to date to direct such training, and that some of the funds earmarked for research should go to agencies like AHRQ or the CDC to support external investigators to conduct studies in this area.
  3. Also mentioned in this same section are tools that are being developed to detect cognitive impairment, and (p. 16, Action 2.B.2.) HHS identifying tools for use in outpatient settings to assess cognition. Such tools are in fact already in existence, and in use in clinical practice, and should be cited here. See for example the Mini-Cog (PDF attached).
  4. There is mention (p. 14, Action 2.A.3.) of HHS developing a clearinghouse. CDC-HAN has experience developing and maintaining a clearinghouse (see http://depts.washington.edu/hansite/drupal/); this clearinghouse has won an APEX Award for Excellence in Publication. HHS could consider contracting with CDC-HAN for this activity.
  5. There is mention of the need for measures of quality of care (p. 17, Strategy 2.D.). There is no reference here to the ACOVE work on this topic, and that work should be cited. See Feil DG, MacLean C, Sultzer D. Quality indicators for the care of dementia in vulnerable elders. J Am Geriatr Soc. 2007 Oct;55 Suppl 2:S293-301.
  6. On p. 18, I suggest adding references for the demonstrations mentioned under Action 2.E.1. and 2.E.2. if available, or at least more detail on where these demonstrations are being done, who is funding them, and who the PIs are.
  7. There is emphasis (p. 19, Action 2.F.1.) on hospital safety for persons with AD. However, there is no emphasis on preventing hospitalization in the first place. This is a very realistic and important goal for persons with dementia at all stages of the disease, and I suggest it be added. See a recent publication that I authored examining potentially preventable hospitalizations in persons with dementia compared to a cohort who remained free of dementia: Phelan EA, Borson S, Grothaus L, Balch S, Larson EB. Association of incident dementia with hospitalizations. JAMA. 2012 Jan 11;307(2):165-72.

Thanks for conveying my input into the appropriate channels. As an academic geriatrician with an active clinical geriatrics practice, I applaud this undertaking and will look forward to seeing the final version of the plan!

And please let me know if any questions.


 

J. Painter  |  03-15-2012

I serve on the North Carolina Healthy Aging Coalition and am excited about the proposed national plan addressing Alzheimer's Disease. I have a few comments that may already be inferred in sections of the draft, but did not specifically see the following addressed:

  • On page 14 ,Action 2.A.2 talks about encouraging providers to pursue careers in geriatric specialties and I would like Allied Health professionals added to this section since many of us provide direct care to individuals and their caregivers of those with Alzheimer's Disease.
  • On page 14, Action 2.A.4 talks about strengthening the direct-care workforce. I whole-heartedly agree that this is needed; but also think there needs to be a plan of action to increase the number of cost-effective sites that are designed specifically for those with Alzheimer's Disease. I know later in the Plan, there is discussion about different housing options, but feel that this could be strengthened in the Plan. From my experience, many families do not have the funds to have their loved one cared for in a "Memory Cottage." Along the same lines, perhaps some type of long term health care insurance for dementia could be provided, if it is not currently available.
  • On page 21, Goal 3 indicates $10.5 million dollars will be available in 2013 to support caregivers' needs, but does not indicate how this money will be dispersed and who can apply for the monies.
  • One area I did not seen mentioned in the Plan is research money for prevention strategies, such as fall prevention and home safety. Both of these preventative strategies are crucial in helping the person with Alzheimer's not only remain in their home longer, but also promote their functional performance and integrity.

Thanks for the opportunity to share my thoughts and I look forward to seeing the final Plan,

==========

The Draft National Plan to Address Alzheimer's Disease is available for comment until March 30. This is a very important plan with significant implications for older adults and their caregivers. I encourage you to review the draft and submit any comments to Helen Lamont (helen.lamont@hhs.gov). If there are elements you would like to discuss, given their relevance to North Carolina, please share them via the listserv.

Once the plan is finalized, we will want to consider what we can do to promote implementation in North Carolina. The CDC-Healthy Aging Research Network's Healthy Brain Workgroup will be very engaged, and there will be important roles for geriatric education centers, academic institutions, aging services, public health, mental health, healthcare and indeed, for all of us.

Best to you!

ATTACHMENT:

Draft National Plan To Address Alzheimer's Disease [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-draft-national-plan]


 

B. Hornak  |  03-15-2012

As a Caregiver and Advocate for those affected by Alzheimer's Disease, I am Extremely pleased with the Draft National Plan To Address Alzheimer's Disease.

Given the fact that people are living longer, this Dreadful, Devastating disease is on the Fast track to becoming an Epidemic, which I am confident The National Plan will in deed keep in check and make much more manageable, so long as it is Fully Supported and Enforced.

Below, I wish to offer my input, which comes from Real Life Experience as a Caregiver and Advocate

I sincerely hope that you will find this input most helpful.

With Respect To Diagnosis:

One of the Keys to Success in Keeping Alzheimer's Disease In Check Is Early, Timely Diagnosis.

I have found in my work as a Caregiver and Advocate that Alzheimer's enters the lives of those affected in ways we may classify as minor or may overlook such as; having to write things down more often, patterns of not being able to locate items or patterns of memory lapses, all of which we may joke off as ' Pre- Senior or Senior Moments '.

It is up to All Of Us to Keep An Eye On Each Other and Those Around Us, Should we see these behaviors, we Must Take Them Seriously and Track Them As Such.

Cognitive Testing / Evaluations Must Become Part Of Routine Exams For Everyone ,As We Never Know Where or When This Dreadful Disease May Strike.

With Respect To Testing / Evaluation, It Must Be More than asking a person their name, what day it is, what year it is and who the President is. I Propose we include questioning about work, family, driving skills, life skills, household management, personal care. In addition to Monitoring Personality / Behavioral Status and Changes.

The Key here is Proper Evaluation, Monitoring, Detection of Changes and Knowing When To Red Flag.

Education / Training:

Education and Training are Critically Important and Mandatory in the Diagnosis, Treatment and Care of Those Affected By Alzheimer's Disease, and Must Be An Ongoing Process As The Disease Evolves Over Time.

Through my Exposure and Experience I have seen the Blood Boiling Impact that Those With Poor / Little To No Knowledge, Education and Training can have when it comes to Alzheimer's, from Arguing with Patients , Poor / In-Effective Communication Skills to Leaving Patients Un-Attended. All of which are 100 Percent Un-Acceptable and In-Excusable.

People who are working in Any Capacity With Those Affected By Alzheimer's Must Be The Best Of The Best, The Cream Of The Crop as There Is No Room To Settle For Second Best.

Ill Willed or Under Qualified People Pose A Grave Danger and Threat To Those With Alzheimer's and We Must Ensure, The Best Of The Best Are Ready, Willing and Able To Step Up and Provide The Necessary Care.

Caregivers and Support:

Formal, Thorough, Ongoing Education, Training and Support Are Essential at All levels of the Caregiving Process, and It Must Be Seamless.

There Must Also Be Flexibility Within Medical Coverage Of All Types To Allow For Flexibility and Out of Network / Program Services If These Out Of Network / Program Services Provide A Level of Care / Support Which Standards and Quality Exceed In Network / Program. Why Should Those With Alzheimer's and Their Caregivers Be Backed Into A Corner Which Forces Acceptance Of Sub-Standard Services?

Caregivers at All levels also Need Adequate and Timely Relief To Prevent ' Burnout ' and To Tend To Their Own Personal Health and Affairs.

Caregivers Must Be Educated and Informed Of All Available Support Services, which as a Caregiver , Myself Can Be Overwhelming , In and Of Itself, As Most Are Unsure Of How To Begin The Process Of Locating Services or Lack the Time and Energy To Do So.

Given This, I wish to offer my services, as an official community resource, with respect to assisting Caregivers research, locate, apply for and coordinate support services. I have Professionally and Successfully Linked Caregivers with a myriad of support services ranging from In Home Personal Care Services to Financial and Prescription Support Services.

Closing Thoughts:

In Closing, I Agree That Alzheimer's Is Quickly Approaching Epidemic Levels and If We Fail To Act Now, This Failure Will Prove To Be Devastating To Say The Least.

The National Plan, When Combined With Input, Such As Contained In This Document, Ensure That A Proactive Approach Will Lessen The Burden and Devastation Of Alzheimer's At All Levels.

We Must Also Unite and Advocate Tirelessly To Ensure Every Aspect Of This Plan Does Not Fall Prey To The " Politics ' Of Our Government ,As That Too Will Prove To Be Devastating.

Thank You For The Opportunity To Provide Input On The National Plan, It Has Been An Extreme Honor To Say The Least and I Look Forward To This Being Fully Enacted and Enforced.


 

M. Ellenbogen  |  03-15-2012

This is a follow-up to my speech yesterday with an expanded version. I was concerned in keeping my 3 minute limit, which made me a bit nervous.

First of all, I would like to thank you, the federal and non federal committee members, and all others involved, for what have already been accomplished, but we still have a long way to go. Money is going to be the biggest issue, even though the president recently committed more.

I am a 53 year old, living with Alzheimer's. I was diagnosed at age 49 after struggling for 10 years to get a diagnosis from age 39.

I have a few issues to address. The first one is related to 2025 date which was originally thought of, I have heard many on this committee and others with the dissatisfaction of that date. I strongly recommend that we show urgency and use the 2020date that everyone seems to support. I know it will take some courage on many of you to rethink this date but do it for all of us who have been waiting so long already. Just look back at the momentum and target dates they were trying to shot for HIV and Cancer. They were much more aggressive.

Second issues is the disparity around this disease. While I would like to see more funding dedicated to Alzheimer's, that may not always be possible. Today 18.7 percent of the NIH research budget goes to cancer, 9.9% to HIV, and just 1.4% to Alzheimer's. We need to be more fairly with the designation of those dollar amounts. There are many more people living with Alzheimer's than HIV, yet it receives much less funding. More funding is desperately for Alzheimer. They are all important causes and should be treated fairly. Keep in mind 98 percent of breast cancer patients continue to have a normal life when it its diagnosed early. Yet Alzheimer's patients do not have any chance what so ever. In fact 40% of their last years are so horrific that you would not wish it on your worst enemy, but all of our families have to endure it and become ill in the process..

And last, a subject that no one wants to talk about, but can save millions. The right to die with the help of a doctors. Many of us who have this disease do not want to ride it out to the end. We want to be remembered in a more positive view. We also do not want our families to suffer or have the added financial burden. Please consider the right to die for devastating diseases like this. While I do not like to talk about this, it is important to know how so many of us feel. I have had the opportunity to speak with other like me and they feel the same way. My biggest concern is that I may take my life much earlier than I need to or I may even screw up in the process and great a bigger medical condition because I did it to late and failed. That would not have been an issue a few years ago, when I had guns in the house. I gave the up for the concern for my own family. I did not want to wake up one day and think that they were intruders and shoot them. I would love to opportunity to let someone know what my wishes are based on a number of question answered so they know at what point and time they should acct on my wishes. It can be as simples as a score on the mini mental exam done at two different times. Please don't make me and my family suffer more than I need to. Have some passion. And of course this is based on being able to make these decision when one was still capable to make those decisions with a sound mind, which I still have.

I would also like to volunteer my services to be on your committees to represents others like myself who has this debilitating disease.

I would also like to see an open public input conference line, for all future meetings. I think it's very important for people like me to voice their opinions. What I did not like about the meeting is where many companies are trying to self advertise their special interest for their companies. There is a time for that and it should not take away from the people who are living with the pain. One example was the person representing GE and the petscan. We all know this is great product and all know it's needed, but they should have more brains then that.

Thanks again for hearing my shorten version yesterday and reading my extended version now.


 

M. Hogan  |  03-14-2012

Please submit my attached testimony to the public comment section of the NAPA website.

ATTACHMENT:

Public Testimony
NAPA Advisory Council Teleconference Meeting
March 14, 2012

On January 17, 2012 I addressed the Advisory Council about the need to include people with Down syndrome in all aspects of dementia related research, including clinical trials. I come before you today with great concern that any reference to Down syndrome, a genetic condition known to pose a considerable risk with respect to dementia, has been obviously omitted from the current Draft National Plan, particularly in Goal 1. This group of individuals deserves to be specifically identified in the National Plan. A vague reference to their existence embedded in the 21st page of the current Draft is grossly understated and should be remedied in future Draft National Plans.

Support for research is essential to better understand the disease process, the potential for early identification and the possibility for improved treatment practices. This research may not only benefit individuals with Down syndrome but the general population as well. The Research Summit in May 2012 referred to in the Draft National Plan should be inclusive of those involved in the study of Down syndrome. I strongly urge you to give serious consideration to the letter submitted by the nationally recognized group of researchers and clinicians read today by Dr. Peterson. Inclusion will help to reduce the potential for greater medical disparities so often faced by this group of individuals. I urge you to act responsibly in their regard. Though some members of the Advisory Council may consider Alzheimer's disease within the Down syndrome community as a different disease process, I can assure you, as a family member, that it looks the same, acts the same and has the same tragic ending, more often at a much younger age.

Families of those with Down syndrome and other intellectual disabilities deserve more than inattention by the Advisory Council and the Draft National Plan. Care commitments for adults with late life disability attributed to the onset of dementia can differ from the care commitments required for those with lifelong disabilities who then develop dementia. Certainly, these distinctions warrant mention in the Plan. The plan should include specific reference to the need for special supports for family caregivers now dually challenged by lifetime care sacrifices and the emerging additional needs of an adult child with an intellectual disability affected by dementia. As individuals with intellectual disabilities live longer and may be predisposed to the development of Alzheimer's disease, the role of caregiving is now, more than ever, assumed by siblings of the individual. These family members potentially face the challenges of not only the care needs of their adult sibling with an intellectual disability and dementia but also their parents who may be facing the same issues related to decline. This overwhelming dual role is under recognized and most worthy of notation in the National Plan.

The current draft plan makes no mention of individuals with intellectual disabilities other than the reference in section 2H. Section 2.H.1 recommends the establishment of a future task group to address the issues related to "racial and ethnic minorities and people with intellectual disabilities". It is important to clarify that people with intellectual disabilities tend to develop Alzheimer's disease at the same rate as the general public. People with Down syndrome have a known genetic mutation that results in early onset and a much higher incidence. Reference to the needs of those with Down syndrome should be specifically embedded in all sections of any finalized document, not deferred to some future taskforce.

My great concern is that little or no attention will be paid to the populations disproportionately affected by Alzheimer's disease after the National Plan is finalized and disseminated. The potential for this to occur can easily become reality as the Affordable Care Act is brought into question and the possibility for a change in HSS leadership exists in an election year. I urge both federal and non-federal members of the Advisory Council to do the hard work required to address the needs of all individuals that face the debilitating ravages of Alzheimer's disease. Be thorough and inclusive in your plan and do not yield to the pressure to produce a document that cannot be defined as such.


 

J. Uronis  |  03-14-2012

I am 62 and have recently been diagnosed with AD. Long before my diagnosis, I have been a passionate advocate for those with the diagnosis of Alzheimer's. Since I am no longer able to work, my new full-time career is one of advocacy. I have held executive positions in the healthcare field for over 15 years. My last position was as General Manager of a Hospice where I met with caregivers of persons with AD as well as those with the disease. For some reason I found myself devoted to this population. I also worked as Executive Director of an Assisted Living where I had contact with this special group as well.

My mother had Alzheimer's and died in 2010 at age 92 of the disease. I was her part-time caregiver. I have worked the disease and now am living it. I am a support group facilitator for the Alzheimer's Association and volunteer at an Assisted Living in their Alzheimer's/Dementia care center.

Having worked and experienced the lack of care for those of us with the disease, I am a voice for the voiceless, a voice for those ashamed to speak out and a voice for the issues and concerns that face all of us. Our main concern is one of adequate quality care. Alzheimer's patients require a unique type of care. My observations of the care that is provided to patients in Assisted Livings, Nursing Homes, Hospitals and by some physicians leaves my heart hurting. It leaves me with little hope of what may be in store for me.

My recommendations to give hope to those of us with the disease and to ease the minds of their caregivers are the following:

  • Care given by state certified persons trained in working with those with AD. They need to be required to be recertified to continue to work with this population
  • Physicians trained in Alzheimer's as most have patients with the disease
  • All Medical students should to be trained in Alzheimer's and how to give the respect and dignity that we deserve. We are still human.
  • Nursing schools should also train nurses in the same regard. Being cold and hurried does not ease anxiety and frustration and leads to dehumanization
  • Hospitals need to be particularly aware of those with Alzheimer's and ensure their safety and check on them regularly
  • Emergency Room staff need to be aware of patients admitted with Alzheimer's. This was brought to light by my mother who was taken to the ER from her AL, she was in the late stage of the disease. When I arrived, she was at the edge of the bed with no one in attendance. Being confused I could only image what may have happened if I had not arrived.
  • A place where we can go that is specifically for us, not a part of another facility. This place would have staff that is certified in Alzheimer's care. The ratio of caregivers to patients would be small enough to ensure quality care. This would also ease the minds of caregivers.

These same concerns have been expressed to me by caregivers who have found the same to be true. We all need to be treated with dignity, respect, concern for our safety and given the unique quality of care that we deserve. Alzheimer's care is unique and requires a much better understanding. On behalf of myself and those with the most dreaded disease, I thank you for listening. Our future is in your hands. God bless.


 

L. Sanchez  |  03-14-2012

can you please make sure these comments get added to the public input. thanks.

==========

Here are CSS' comments:

We have no additional comments; however we have identified a few points of interests:

Unless the disease can be effectively treated or prevented, the number of Americans with Alzheimer's disease will increase significantly in the next two decades. Therefore, HHS has included the following five foundational goals:

  1. Prevent and Effectively Treat Alzheimer's Disease by 2025
  2. Optimize Care Quality and Efficiency
  3. Expand Supports for People with Alzheimer's Disease and Their Families
  4. Enhance Public Awareness and Engagement
  5. Track Progress and Drive Improvement

Also, Goals 3 &4 have the most implications to our AAA programs as follows:

Goal 3: Expand Supports for People with Alzheimer's Disease and Their Families

Supporting people with Alzheimer's disease and their families and caregivers requires giving them the tools that they need, helping to plan for future needs, and ensuring that safety and dignity are maintained. To help respond to the challenges faced by families and other caregivers, the Obama Administration's Alzheimer's disease announcement makes a new investment of $10.5 million in fiscal year 2013 to support the needs of caregivers of people with Alzheimer's disease.

Goal 4: Enhance Public Awareness and Engagement

There are widespread and significant public misperceptions about diagnosis and treatment that lead to delayed diagnosis and to people with the disease and their caregivers feeling isolated and stigmatized. Enhancing public awareness and engagement is an essential goal of this project.

Please let us know if you need any additional information.


 

L. Harwood  |  03-13-2012

It is with great hope that I am writing this letter. My mother suffered from this disease for eight years. Not only did she suffer consequences to her health, but the whole family suffered with her. And, other family members in her family had Alzheimers in later years. Our generation is waiting for the disease to strike one of the adult children, with hope that we will not have to deal with this monster. Please, continue the research and give our family and other families hope to live long disease free lives.


 

A. Marschean  |  03-13-2012

Attached please find public comment from the Commonwealth of Virginia Alzheimer's Disease and Related Disorders Commission on the draft National Plan to Address Alzheimer's Disease.

ATTACHMENT:

Having just recently released the Dementia State Plan: Virginia's Response to the Needs of Individuals with Dementia and their Caregivers, the Virginia Alzheimer's Disease and Related Disorders Commission (Commission) welcomes the Draft National Plan to Address Alzheimer's Disease (Draft Plan). The emphasis on promoting research and developing new treatments that prevent and effectively treat the disease, expanding support for people with the disease and their families, and enhancing care quality and coordination are shared goals of both plans and we look forward to working together as state and federal partners in addressing the rapidly mounting Alzheimer's crisis.

Regarding Draft Plan Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025, the Commission promotes research, supports all strategies to facilitate dissemination of research findings into medical practice and public health programs, and would welcome federal funding for provider education and outreach. Under Draft Plan Goal 2: Enhance Care Quality and Efficiency, Virginia's own plan calls for coordinating quality dementia services, integrated systems of care, and development of dementia specific training. The Commission welcomes any federal support of this state plan strategy.

The action items in Draft Plan Goal 3: Expand Supports for People with Alzheimer's Disease and their Families mirror our own state plan recommendation, "In order to survive, families need dementia friendly solutions for their safety, services and behavioral concerns, including: assessment and diagnosis, counseling and support services, care management, respite care, assistive technologies and home modification, transportation, and payment options including long-term care insurance." Additionally, the Commission supports Draft Plan action items for legal services and stable housing for people with the disease. Because of Virginia's large military and veteran population, the Commission advocates for federal and state partnerships to meet the dementia care needs of this population.

As noted in Draft Plan Goal 4: Educate the Public About Alzheimer's Disease, some states and localities "have published plans to address AD that coverage many of the same issues as the National Plan. Leveraging the available resources and programs across these levels of government will aid in the success of these efforts" to advance Alzheimer's Disease awareness and readiness across all levels of government. Finally, both Virginia's plan and the Draft Plan recognize the need to improve data collection to better understand the disease's impact on people with the disease, their families, and the healthcare system and, therefore, Draft Plan Goal 5: Improve Data to Track Progress is also imperative. Specifically, the Commission requests coordination of shared federal and state data and the removal of barriers to sharing of information and best practices.

The Commission looks forward to the final version of the National Plan to Address Alzheimer's Disease this spring as the Commonwealth is just beginning its state plan implementation. Concerted efforts in national and state strategic planning will provide the best chance to overcoming this dreaded disease.


 

K. Summar  |  03-13-2012

I understand that the advisory committee for NAPA will be meeting tomorrow. My boss would like to have the attached letter submitted as part of the record. Is that possible?

ATTACHMENT:

F.S. Collins, MD, PhD

As you mentioned in the Washington Post yesterday, "The science of Alzheimer's disease has reached a very interesting juncture." In that light, I would like to underscore the importance of the relationship between Down syndrome and Alzheimer's disease.

As you know, the pathological findings of Alzheimer's disease have been found in the brains of people with Down syndrome since the late 1800s. You also know that there are 400 genes on the extra chromosome 21 of people with Down syndome. Of these 400 genes, at least 4 candidate genes may play a role in the development of Alzheimer's disease (APP, BACE 2, SOD 1, and RCAN 1). Moreover, Alzheimer's disease attacks adults with Down syndrome at very young age with increased frequency and venom, resulting in tremendous care taker issues for families.

This evidence points to Down syndrome as an important model for Alzheimer's disease. NIH and NICHD, in particular, are building on this significant correlation through cognitive and imaging research. I believe this research will undoubtedly inform treatment strategies for both the cognitive deficits in Down syndrome as well as the cognitive loss associated with Alzheimer's disease.

As the Institute moves forward with crucial Alzheimer's disease research, I encourage you to look closely at the models that have been developed with respect to Down syndrome and the important research being conducted by NICHD.


 

K. Thompson  |  03-13-2012

Per a Twitter Chat on #NAPA (#talkalz) today, please consider the following questions for the upcoming revision of the Act:

  1. What incentives exist for direct care staff to increase education and raise standards of care proposed under NAPA? (As a reminder, their current pay rate is roughly that of a worker at McDonald's while their responsibilities for human health and welfare are exponentially greater.)
  2. Will there be a dedicated funding stream for mandates in the NAPA Act? Without appropriate funding, legislation will force UNFUNDED MANDATES upon the plates of service providers and effectively establish a DIS-incentive to provide Elder Care Services for people with acquired cognitive disabilities like Alzheimer's.
  3. What working models from 10 countries with existing Alzheimer's Planning are being reviewed for successful implementation? If possible, can you please provide a link to those resources?

 

P. McAree  |  03-12-2012

I am the president of EmFinders, the leading national recovery solution for cognitively-impaired individuals who wander off and end up missing. I wanted to reach out to you personally to discuss the benefits of EmFinders for seniors with Alzheimers', their caregivers, and assisted living communities. We at EmFinders are dedicated to helping recover residents who elope as quickly, safely, and affordably as possible.

Our new EmFinders Elopement Risk Program (EERP) features the EmFinders EmSeeQ bracelet worn by residents who have been assessed via the program to be 'at risk'. The unique and patented cellular technology of our device features the smallest personal locator available for nationwide coverage. If a resident leaves their home or community unsupervised for example, the device is activated and notifies the nearest local law enforcement agency via the Emergency 9-1-1 system, and the individual is quickly located by first responders. We have enabled 106 rescues to date, with 100% success rate, and with a median recovery time of 30 minutes..

The EERP and the EmSeeQ device provide the first comprehensive program for caregivers and communities to pro-actively identify and manage elopement risk both for memory care residents as well as the assisted living population at large. By design, this new program should significantly reduce assisted living communities' exposure, while also bringing peace of mind to staff and family members in the event an actual elopement were to occur.

I would be pleased to discuss our solution and your requirements. We have been working with a number of larger Assisted Living providers and we have developed considerable expertise in rolling out and managing our solutions for national caregivers and communities.

I will be attending the upcoming Aging in America event in Washington, D.C. from 26 Mar - 1 April -- we have a booth there and I would be delighted to meet your representatives locally at this event or of course in your office.

Please let me know what would be a good day and time to meet the week of the 26th and I'll be happy to schedule.

I look forward to talking with HHS soon.

ATTACHMENT:

EmFinders Elopement Risk Program for Senior Care Communities: Bringing Peace of Mind to Families, Caregivers and Senior Communities [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-emfinders-elopement-risk-program


 

P. Giannini  |  03-12-2012

Please accept the following comments on the draft National Plan for Alzheimer's and Related Disorders from the State Unit on Aging in Connecticut:

  1. While evidence based research can be a reliable tool, more flexibility should be granted to community providers and researchers to explore innovative and creative non-pharmacological approaches to living with and treating Alzheimer's disease. Our CONNECTIONS grant from AoA and our work in CT with NECC and cognitive training has afforded us with many examples of the positive impacts of this intervention on the quality of life for the caregiver as well as the individual with dementia. Excluding such projects from funding opportunities, further exploration or dismissing them as models because they do not have the full complement of expansive research behind them is short-sighted and limiting to families. Often the most innovative approaches are the ones that afford families a sense of empowerment in combating the disease process.
  2. The strategy area of "maintaining the dignity, safety and rights of people with Alzheimer's Disease" is critical. The perception of this disease and the assumed burden that families incur upon diagnosis often negatively impacts the delivery of care received by those with the diagnosis. Training medical and legal personnel as well as other individuals in the field is an excellent way to begin addressing the stigma associated with the disease and some of the misperceptions and assumptions that are prevalent. Monitoring and reporting the use of anti-psychotics in nursing homes is an excellent proposed action, as is providing awareness training and education for professional caregivers.
  3. It would be beneficial to incorporate hospice options into any training module offered to families as well as facilities working with this population.
  4. The design and implementation of a national education initiative is enthusiastically supported. We are still struggling with the same level of stigma 14 years after implementing our Statewide Respite Care Program (for individuals with Alzheimer's disease) in Connecticut, and many conversations with our local Chapter of the Alzheimer's Association underscore this sentiment.
  5. I strongly encourage the Plan team to conduct a comprehensive needs assessment before new activities are initiated. Since many states and individual organizations may already be implementing aspects of the plan, best practices should be observed to obviate unnecessary and costly duplication or delays.

Please contact me or our Alzheimer's contract specialist should you need more information.


 

D. DiGilio  |  03-12-2012

On behalf of the National Coalition on Mental Health and Aging, I am pleased to submit the attached comments on the Draft National Plan to Address Alzheimer's Disease.

ATTACHMENT:

National Coalition on Mental Health and Aging Comments
on the Draft National Plan to Address Alzheimer's Disease

Thank you for this opportunity to comment on the Draft National Plan. These comments are being submitted by the National Coalition on Mental Health and Aging (NCMHA). NCMHA is comprised of over 80 members representing professional, consumer and government organizations with expertise in mental health and aging issues. The Coalition members represent national organizations as well as many state and local Mental Health and Aging Coalitions. The goal of the Coalition is to work together to improve the availability and quality of mental health preventive and treatment services for older Americans and their families. Information is available at http://www.ncmha.org.

We are delighted that attention is being paid to the significant and growing problem of Alzheimer's Disease (AD) in the United States. However, we hope that the final plan will be more cognizant of the significant mental and behavioral health issues associated with Alzheimer's Disease for which there are effective interventions and supports. Health care teams that include behavioral and mental health professionals create a more effective and comprehensive approach to AD by providing critical evidence-based behavioral health interventions and supportive services for people with AD, their families and caregivers. The inclusion of mental and behavioral health professionals as a part of an interdisciplinary approach to planning, assessment, research, service, training and education is indispensible in efforts to address AD. In that light, we recommend the following for your consideration:

Strategy 1.B: Enhance Scientific Research Aimed at Preventing and Treating Alzheimer's Disease
The draft plan emphasizes the need to expand research on molecular and cellular mechanisms and genetic research to identify risk and protective factors. However, a research agenda that includes critical behavioral and social aspects of AD would be considerably more successful and useful to families and caregivers.

Strategy 1.E: Facilitate Translation of Findings into Medical Practice and Public Health Programs
The world of AD includes much more than medical practice and public health programs. The fact that there is no current cure for AD and that AD presents a complex picture that includes the socio-emotional needs of individuals with AD, their families and caregivers, means that a broader approach should be taken to translational work. Useful findings must be translated into the practices of many health and mental health care providers and in a wide variety of settings.

Strategy 2.A: Build a Workforce with the Skills to Provide High-Quality Care
Given the complexities of AD and the need for a wide variety of service providers to meet the current needs of individuals with AD, their families and caregivers, we urge you to include mental health and behavioral health professionals who offer services for the purpose of improving an individual's psychosocial and mental health or to treat mental illness. The major initiatives to expand geriatric training opportunities at the Department of Veterans Affairs and the Health Resources and Services Administration cited in this section both include mental and behavioral health disciplines.

Strategy 2.D: Identify and Implement High-Quality Dementia Care Guidelines and Measures Across Care Settings
While we agree that guidelines for delivery of care and measures of quality are needed to ensure people with Alzheimer's disease receive high-quality, culturally-competent care in the many different settings where they are treated, we encourage a broader focus that includes behavioral and mental health considerations along with physical care.

Strategy 2.F: Advance Coordinated and Integrated Health and Long-Term Care Services and Supports for Individuals Living with Alzheimer's Disease
Mental and behavioral health services must be included in the wide array of needed health services available to individuals with AD. Mental and behavioral health providers should be represented on interdisciplinary health care teams that work with individuals with AD, their families and caregivers in primary care, long-term care and community and home-based settings. Cognitive impairment alone does not preclude the ability to benefit from various forms of effective behavioral and mental health interventions.

Strategy 3.B: Enable Family Caregivers to Continue to Provide Care While Maintaining Their Own Health and Well-Being
We agree that providing care and supports for families and caregivers can help lessen significant feelings of depression and stress that help delay nursing home placement. We do feel that beginning the description of this strategy with a statement about the eventuality of nursing home placement is not a useful introduction. There are a number of studies and evidence-based interventions that indicate the effectiveness of behavioral interventions for caregivers of individuals with dementia that can significantly delay institutional placement of the care recipient.

Strategy 3.C: Assist Families in Planning for Future Long-Term Care Needs
We strongly agree that educating people about their potential need for long-term services and supports and planning ahead can help ensure that individuals with AD receive care in the setting they prefer and that their dignity is maintained. To accomplish this goal, the centrality of mental health, behavioral health and social services personnel to educate, train and counsel individuals with AD, their families and caregivers is indispensable.

Strategy 3.D: Maintain the Dignity, Safety, and Rights of People with Alzheimer's Disease
Psychosocial interventions are important to preserve the dignity of individuals with AD and enabling family members to accept, support, and engage the person with dementia. It is also critically important that therapeutic goals be discussed directly with the individual who has dementia. In addition, professionals in the fields of mental health and behavioral health are accustomed to recognizing the vulnerability of people with AD to neglect and abuse, including financial abuse, and are able to take a proactive approach to dealing with such issues in a variety of home and community-based settings.

Strategy 3.E: Assess and address the housing needs of people with AD
The need for stable housing is essential to helping people with Alzheimer's disease remain in the community and is a crucial platform for delivering the necessary health and supportive services. To improve health outcomes and housing stability, the promotion of mental health, behavioral health and social work services in the settings where people with Alzheimer's disease live can positively impact services.

Strategy 4.B: Work with state and local governments to improve coordination and identify model initiatives to advance Alzheimer's disease awareness and readiness across the government
As stated throughout these comments, the inclusion of mental and behavioral health professionals as an integral part of an interdisciplinary approach to planning, assessment, research, service, training and education is critically important to advancing services to people with AD, their families and caregivers.


 

H. Reiner  |  03-09-2012

It is essential that when talking about cures for Alzheimers that the mental health problems associated with this disease be addressed as well.

Oth