Public Comment Index for the National Alzheimer's Project Act . 2017 Comments

11/20/2017

2017 Public Comments

 


 

NOVEMBER 2017 COMMENTS

K. Kero  |  11-10-2017

I'm writing bring a broken link to your attention. On the Agency Reports page at: https://aspe.hhs.gov/agency-reports none of the AoA website links connect to any reports. It looks like they would be a good source of information, I hope they are repaired soon!

ANSWER:

Thanks for letting us know about the broken links. Most of the information on that page is sent to us by other agencies/organizations, and they do not always alert us when a report has been removed or the link changed. If the new URLs can be located for these reports, we change them on the page.

UPDATE (January 2018): The list of Administration for Community Living and Administration on Aging reports has been updated at https://aspe.hhs.gov/agency-reports#ACL.


 

J. Denosky  |  11-08-2017

I took a look at your summary "research recommendations" document (https://aspe.hhs.gov/system/files/pdf/258446/Mtg26-Slides4.pdf). I must admit to being surprised that I could not find one concrete suggestion to help caretakers of Dementia patients. The level of abstraction of the suggestions in extraordinary.

No direct mention of mobility, transfer, ADLs, nursing care issues in lock-up dementia wards, Hospice and Dementia, Dementia-related medical conditions, financial issues of Dementia, low CNA pay, caregiver isolation and depression, nursing home costs, Medicaid costs and spend-down, .... I could go on.

I respect researchers, epidemiological studies, the need for standards, and I understand the need for best practices, etc. But ALL my suggestions were apparently completely ignored. If you have nurse-advocate stakeholders present, they must have been very quiet.

As a former nurse of Dementia patients, I am forced to conclude based on your summary recommendations that your conference is of little direct value to caregivers or patients, and too distant from the actual problems posed by Dementia patients to do much good. I find this very disappointing. I hope you and colleagues will some day actually spend time with patients so you can understand the range of issues a conference on Dementia and caretakers should cover. Your focus is far too narrow.

ANSWER:

The Summit recommendations were summarized at the October 27 NAPA Advisory Council meeting. That presentation, both in slides and video, is available on the Summit website at https://aspe.hhs.gov/national-research-summit-care-services-and-supports-persons-dementia-and-their-caregivers-recommendations. The Summit chairs are currently organizing the recommendations into groups, and they will soon be available at that same link. If you are on the NAPA Listserv, you will be alerted when that information is online.

The recommendations that the chairs are organizing ARE in material available on the Summit website. You would, however, need to glean them from looking on the following pages:


 

L. Gerdner  |  11-03-2017

I am the author of the book, "Musical Memories." I would like to notify your group about the recent publication of this book by donating a copy for your review.

Description:

Gabrielle loves ballet. When her grandmother presents her with tickets to Cinderella, she can hardly wait. But outside the theater after the magical performance, Gabrielle is frightened and confused by Grandmother's strange behavior. Gabrielle's mother explains that Grandmother has Alzheimer's disease. Alzheimer's disease sometimes makes Grandmother forgetful, anxious, and agitated, but Gabrielle soon discovers that through music, she and Grandmother can share memories and make new ones. One night, Grandmother wakes the house in fear of an intruder, and cannot be calmed. But Gabrielle remembers a way to break through Grandmother's fear and help her relax again.

I have attached a journal article that describes the background information that served as the impetus for "Musical Memories.".

I am also providing you with the link for a website devoted to "Musical Memories." The sited includes free downloadable resources for Health Care Professions, Family Caregivers / Teachers, and Kids; to enhance the learning experience of the book. Resources for caregivers includes a 50-based evidence-based protocol for the use of individualized music that is currently in its 5th edition and was originally published in the early 1990s

https://gerdnerlinda.wixsite.com/musicalmemories

Please provide the name of the person I should direct the mailing to, along with the address. I want to make sure it gets routed to the correct person.

Thank you for your time and consideration regarding this request.

ATTACHMENT:

Musical Memories: Translating Evidence-Based Gerontological Nursing Into a Children's Picture Book, Journal of Gerontological Nursing, Vol. 39, No. 1, 2013 [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-musical-memories]


 

K. Jameson  |  11-02-2017

Thank you for your ongoing emails to us, they are much appreciated.

I am a bit curious, because not all dementias have a pathology related to AD...

Can you tell me, is there any movement afoot among the NAPA participants to change the phrase most commonly used, "Alzheimer's and related dementias," to a more accurate all-inclusive and shorter single word, such as "Dementias," which obviously includes forms such as AD as well as many others.

Or, maybe to a little less-better version, but still more correct: "Alzheimer's and other Dementias"? Note, just the single word swap.

A simple change would mean a great deal to those living with non-AD dementia.

Your thoughts and insights would be welcome. Thank you again.


 

OCTOBER 2017 COMMENTS

J. Imm  |  10-26-2017

Today is October 26, I am reaching out to you again to give Mr. Ellenbogen an opportunity to speak at the NAPA October 27 conference. Will you provide him with such an opportunity via conference call?

==========

From: J. Imm

[Link to comments -- J. Imm]


 

M. Hogan  |  10-23-2017

Thank you for the opportunity to once again address the Advisory Council. In 2007 my brother was diagnosed with AD. He also had Down syndrome. He died in 2010 of complications of aspiration pneumonia at the age of 49. Since that time I have been dedicated to assuring that folks with these co-occurring conditions receive the care and attention that they require and deserve and that family members and care partners have the opportunity to access the support required to maintain quality of life for their family member. I have been a presence at the Advisory Council meetings since 2011, am a member of the NTG and have worked closely with the NDSS on their projects on DS, aging, and AD. I have continued to develop close working relationships with both national and state Alzheimer's Associations and have benefitted from their training, collaboration with the NTG as well as their extensive family resources.

I would like to welcome Dr. Gitlan and the other new members to the Council. In the past we have shared a positive working relationship with Council members and I look forward to continuing this relationship in the days ahead. I wish you well in your new role.

Last week I was one of three trainers who presented the NTG Dementia Capable Care Curriculum at a three-day workshop in Lincoln, RI. Our audience included an OT, Psychologist, Nurses, Social Workers, Agency and Direct Care Professionals and Family Members. They were most receptive to the information presented and left feeling informed and empowered. We have made a commitment to continued support of all trainees as they return to their work settings and attempt to change the culture surrounding dementia care in their communities.

I agreed to bring to your attention one of the challenges and other concerns that many of these individuals expressed. They noted in particular the concept of active treatment. Given the nature of ADRD there is a mismatch between active treatment requirements for funding and the decline of their community members. They look to CMS and ACL for guidance in this arena and are hopeful that you will offer direction in the very near future. Many expressed concern about the inconsistent translation of Federal directives at the state and local levels and the lack of availability of support and services from state to state. How can care be more consistently organized across our communities nationally and Medicaid dollars shared more equally? What will happen if budgets cuts occur in the near future and care of individuals is reduced or eliminated? Hopefully you can help address these questions for dedicated caregivers across the nation.

I once again wish to request that a morning Council Meeting session be dedicated to both the accomplishments that have taken place in the ID community since the inception of the National Plan to address Alzheimer's disease along with the many challenges that remain. It seems that the time is right with the transition of Council leadership and members. Such a discussion will enable the new members to understand the challenges faced by this special population, some of whom are at increased risk for the onset of AD at an early age.

I also wish to continue my appeal to include those with ID in regional projects that explore the improvement of diagnosis, care coordination and support services. As noted previously, separate does not always translate to equal. Disparities continue to exist and creative opportunities not always inclusive. Leadership is required in order to further facilitate communication, collaboration and inclusion.

For the past 4 years I have talked of the crises faced by aging caregivers and have shared the story of Betty, age 88, Frank, age 93 and their son Richard, age 51. This family has represented the challenges faced by life longcaregivers who have had limited access to support services and a work force that lacked appropriate knowledge and training in day programs. They were faced with few options when Richard was no longer safe in their family home. Betty and Frank have remained dedicated to and advocated for Richard as AD has progressed. I am deeply saddened to report that Richard died of complications of aspiration pneumonia on August 31, 2017. He was 51 years old.

Photo of Richard (last name unknown).
Richard Date of Death: 8/31/17 Age: 51

Richard led a rich and active life prior to the onset and decline associated with AD. He loved to work, bowl, compete in the Special Olympics, watch football and cheer for his favorite college team. He loved to be out and about in the communities in which they lived and was a garrulous fellow who thrived on social interaction. Betty and Frank are experiencing a profound sense of loss as are Richard's peers, one of whom recently comforted them with these profound words, "I cry for you." At Richard's burial with family members adorned in their red shirts, each was awarded a Special Olympic medal as they quietly sang the team's fight song.

So fight we must to eradicate this disease in those with Down syndrome as well as those in the general population who face this great battle. I am hopeful that you will be champions for a group of people who know how to love, show empathy and compassion, have great value in their communities and help to give meaning to life.

Betty and Frank have spent countless hours being comforted by photos and newspaper clippings that have included milestones that Richard marked. The most profound milestone came from an aging article in a now defunct local paper that included a photo of a 5 year-old boy with the byline "Retarded Youth Needs a Home". 45 years later Betty and Frank celebrate the gift of Richard's life, as they grieve his recent passage. He did indeed find home.


 

A. Helsing  |  10-20-2017

I am excited to be here at the Advisory Council October Meeting with you all today. Thank you so much for having me. The National Down Syndrome Society, the leading human rights organization for all individuals with Down syndrome, is excited to announce the publication of our newest resource for the Down syndrome community! During the first week of November in honor of National Family Caregivers Month, NDSS will introduce "Alzheimer's Disease & Down Syndrome: a Practical Guidebook for Caregivers"! This booklet was written to help empower caregivers and families with knowledge and guidance about the connection between Down syndrome and Alzheimer's disease, how to carefully and thoughtfully evaluate changes that may be observed with aging and how to adapt and thrive within an ever-changing caregiving role when a diagnosis is made. People with Down syndrome are now going to college, getting competitive jobs, getting married and living full lives and we know this guide will be an amazing resource for the caregivers of those with Down syndrome as they age.

For more information, please visit http://www.ndss.org/.


 

M. Sharp  |  10-20-2017

On behalf of AFTD I want to welcome the new council members and thank you all for giving your, time, experience and passion to help NAPA achieve its goal of ending dementia. I am the Program Manager for The Association for Frontotemporal Degeneration and have been attending these quarterly meetings since 2012 to represent the related dementia -- FTD.

I also want to comment on the research recommendations from the Care and Services Summit at NIH last week. I remain in awe of how well the summit accomplished the herculean task of compiling an enormous amount of information on existing dementia care and services and condensing it all into a comprehensive set of recommendations that will move the field forward if given the appropriate support. Identifying critical themes and issues that cut across all the topic areas was key to organizing the vast amount of information on dementia care and services that already exists. All the sessions addressed the cross-cutting themes to some degree but whether and when the word dementia applied to the full range of clinical presentations depended largely on the expertise of the presenters. That is not surprising and it is certainly appropriate that care and services match the demand, which by and large means Alzheimer's disease. However, if this natural tendency toward serving the largest common denominator is not consciously resisted nothing much will change for those coping with FTD or any other non-Alzheimer's dementia who will continue to struggle to find the care or services they need.

This issue was partially addressed by the cross-cutting theme of etiology and disease stage but those terms do not address the entire problem. A more comprehensive theme is clinical heterogeneity. Clinical heterogeneity includes etiology and disease stage but also encompasses age of onset, abilities and level of functioning prior to onset and other factors that affect symptomatology and disease trajectory. Simply put, clinical heterogeneity describes the person with dementia and not just their disease, and without explicit attention to the individual differences of the person with dementia, care and services will naturally revert to a one size fits all model that doesn't actually fit everyone.

I strongly suggest that the cross-cutting theme "etiology and disease-stage" be replaced with "clinical heterogeneity" as that term will more effectively guide the development of dementia care and services that address the full range of dementia symptoms.


 

I. Kremer  |  10-20-2017

This is a day for thanks and a day to look ahead.

We are thankful for those who have served the Advisory Council so ably over the past six years, and for those who bring new perspectives to Advisory Council as their terms begin.

We are thankful to those who contributed to the successful first National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers, including summit co-chairs L. Gitlin and K. Maslow; the federal agencies and non-governmental partners; the presenters, attendees and others who contributed content and generated research recommendations; and we are especially thankful for the people living with dementia and the carerswho shaped the summit through service on the steering committee and advisory groups, and through decades of participation in research and testimony about their experiences, expectations, wants, needs, a human rights. [https://aspe.hhs.gov/national-research-summit-care-services-and-supports-persons-dementia-and-their-caregivers]

We are thankful for the NIH's 2019 Bypass Budget continuing to set an ambitious course grounded in solid science toward our national goal of preventing and effectively treating dementia by 2025.

We are thankful for elected leaders who have responded with resources to fuel the science roadmap forward.

We are thankful for ACL, CDC, CMS, FDA, HRSA, VA and other federal agencies that push to innovate and deliver improvements in quality of life.

We are thankful for ASPE and all who others who ensure not only that the National Plan says the right things, but that it drives both sustained progress and meaningful accountability inside and outside government.

All which makes us thankful also makes us understand that far more remains to be done, that we can and must act with even more urgency for more rapid, more enduring, more inclusive and more transformative progress. With this in mind, I would urge the NAPA Advisory Council to act swiftly to:

  • Adopt a national quality of life goal, comparable to the 2025 goal for prevention and effective treatment in its capacity to galvanize national attention and resources behind rapid, enduring, inclusive and transformational progress.
  • Establish an interagency working group with significant non-governmental expert representation to develop a formal research, policy and practice road map -- with milestones and metrics -- toward achieving that quality of life goal. The working group should begin with (but not be limited to) a re-examination of the thoughtful, remarkable, and important work presented by M. Baumgart at the January 25, 2016 Advisory Council meeting: Milestones for Goals 2 and 3 of the National Alzheimer's Plan. [https://aspe.hhs.gov/advisory-council-january-2016-meeting-presentation-goal-milestones]
  • Charge the Dementia Care Summit steering committee with developing a series of sequenced post-summit activities to carry forward the work begun in the pre-summits and the summit itself. Among other priorities, this should include completing work -- before the NAPA Advisory Council finalizes its 2018 National Plan recommendations -- on the summit's second formal anticipated outcome: "Identification of evidence-based programs, strategies, and approaches that can be used now to improve care and services."
  • Update the position, adopted by the non-federal members of the Advisory Council a number of years ago, regarding the annual amount of NIH research funding needed to achieve the 2025 goal for prevention and effective treatment.

     

In closing, I offer my thanks to others making public comments today and my appreciation to Advisory Council members and staff who give of their minds and hearts beyond what words can express. I offer my hope to all those living with dementia and their loved ones that they will be heard, heeded, and healed through the work we all do together.


 

M. Janicki  |  10-18-2017

I and Dr. S. Keller are the co-chairs of the National Task Group on Intellectual Disabilities and Dementia Practices (NTG), a group formed in 2010 with a mission to advocate for people with intellectual disability and their families and other caregivers when an adult with intellectual disability is affected by dementia (http://www.aadmd.org/ntg). The NTG is an affiliate of the American Academy of Developmental Medicine and Dentistry and is associated with the Rehabilitation Research and Training Center on Developmental Disabilities and Health at the University of Illinois at Chicago.

We wish to use this opportunity to congratulate and welcome Dr. Gitlin as the incoming Chair of the NAPA Advisory Council on Alzheimer's Research, Care and Services. We look forward to her two-year term and contributions to the welfare of people affected by dementia.

We also wish to commend the Council on the 2017 Plan Update and its depth and breadth, as well as thoughtful recommendations. The discussion of the partner provisions, as well as the federal contributions, is making this effort truly a national plan. It was good to see the efforts being undertaken to expand the capacity of the nation's workforce to address Alzheimer's diseases and other conditions contributing to the occurrence of dementia. In that vein, we would to note the contributions of the National Task Group to the education efforts being undertaken. One of our aims when we were formed was to help inform and educate all components of the provider community delivering services to people with intellectual disability, as well as their caregivers. To this end, we developed a national curriculum on dementia and Intellectual disability composed of 20 distinct content modules. I am pleased to report that since 2015 to the present, the NTG has drawn from this curriculum to provide over 30 two-day workshops on dementia and intellectual disability across the US. All told some 1300 persons were trained, including some 790 professionals who also provide some form of training at their agencies or in their communities and attended our 'third-day trainer day'. Attendees have included direct support workers, clinicians, administrators, family caregivers, and a range of professionals. The workshops were held in 17 states with an average site registration of about 50 persons. Post-workshop evaluations have been positive and encouraging -- most attendees noted that the found that workshops highly beneficial and would recommend the training to others. Currently, we have about a dozen additional workshops in the pipeline into early 2018. I am also pleased to report that we are having discussions with HRSA over inclusion of a module on intellectual disability within the GWEPs national training activities on workforce enhancement.

At the last two Council meetings, we reported on the International Summit on Intellectual Disability and Dementia that was held in October 2016 in Scotland, and which came about from a partnership between the NTG, the University of Illinois at Chicago, and the University of Stirling(in Scotland). We are pleased to report that since the last meeting, an additional number of papers have been published.

  • One of the papers, Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to Nomenclature, has appeared in the October 2017 issue of the American Association on Intellectual and Developmental Disabilities' journal, Intellectual and Developmental Disabilities.
  • Another, the Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to End-of-life Care in Advanced Dementia, has appeared in the most recent issue of the Journal of Applied Research in Intellectual Disability.

     

Also, several other papers have been accepted for publication.

  • One, Defining Advanced Dementia in People with Down Syndrome and Other Intellectual Disabilities: Consensus Statement of the International Summit on Intellectual Disability and Dementia, has been accepted for publication in the Journal of Palliative Medicine.
  • Another, a Summative Report of the International Summit on Intellectual Disability and Dementia, has been accepted for publication by The Gerontologist.
  • Lastly, a Consensus Statement of the International Summit on Intellectual Disability and Dementia on Valuing the Perspectives of Persons with Intellectual Disability, has been accepted for publication by the Journal of Intellectual Disabilities.

     

Each of these papers contains a series of recommendations that would address issues raised in the papers. It is our hope that the Council will consider the substance and recommendations of these reports and papers at future meetings and when constructing next year's update of the National Plan to Address Alzheimer's Disease.

These reports and publications are available from us and posted on the NTG website -- http://www.aadmd.org/ntg.


 

J. Ransdell  |  10-18-2017

Thank you for the opportunity to address the Council. I am the mother of a 43-year-old gentleman who has Down syndrome, Autism and Alzheimer's. It is because of him that I stand before you today. My son is one of more than 250,000 people with Down syndrome living in the United States. As they age, many like him,are susceptible to Alzheimer's. Families caring for and supporting people with Down syndrome and Alzheimer's need the Council's recognition and support and must be given due consideration in the National Plan.

Photo of Matt Ransdell.
M. Ransdell, 43-year-old gentleman from Florida who has Down syndrome, Autism and Alzheimer's.

We first suspected that he was developing Alzheimer's approximately three years ago. He exhibited some signs that could have been attributed to premature aging that is often seen in people with Down syndrome. Unfortunately, he continued to have symptoms that ultimately led his health-care providers to diagnose Alzheimer's. At first, I didn't know what to do; I didn't know where to turn for information and didn't know which of his doctors could best advise me.

I eventually connected with the National Task Group on Intellectual Disabilities and Dementia Practices (NTG) and will forever be grateful for what I have learned to help me better support him on this journey. As we moved forward I recalled how alone I felt when he was born and we were told he had Down syndrome. Those memories got me thinking about other families who were getting Alzheimer's diagnoses and were experiencing those same feelings of isolation. Because of the opportunity I was given through the NTG, I dusted off my advocacy hat, and went to work to connect families around the country on this same journey.

Because of the dedication of the NTG volunteers, my co-chair, M. Hogan and I have been able to reach out and support numerous families around our great nation. The stories they share are all different, but similar in various ways. We, too often, listen as families express frustration that they can't find doctors or other service providers who are knowledgeable of aging with Down syndrome or the connection of Down syndrome with Alzheimer's. We have been able to offer them opportunities to learn more about this disease so that they can educate the health-care providers working with their loved ones.

As we have provided this support and connection for families we have learned:

  • Although Alzheimer's in the general population can be like Alzheimer's in a person with Down syndrome, there are some unique differences.
  • There is a critical need for information to be readily available to families on all aspects of Alzheimer's and Down syndrome.
  • Families want to connect with other families who are navigating the Down syndrome and Alzheimer's journey.
  • There is a need for more support opportunities for families - we receive inquiries and referrals every week and sometimes are overwhelmed by the volume of the need.

     

I am pleased to say that in the past 18 months, through the NTG we have supported many families with our monthly national online support group and ongoing individual connections, and we have reached hundreds, perhaps thousands of families and professionals with our bi-monthly Caregiver Newsletter. And, I'm pleased to announce that next April, in partnership with the National Down Syndrome Society and the National Alliance for Caregiving we are hosting a Down syndrome Adult Summit in which we will offer sessions related to aging with Down syndrome, as well as Down syndrome and Alzheimer's.

Thank you for the opportunity to speak with you today and for including people with intellectual disabilities (and especially those with Down syndrome) in the National Plan. I encourage you:

  • In the next plan update:
    • To advocate the inclusion of people with Down syndrome and Alzheimer's in all research projects focused on Dementia care, services and support;
    • To advocate for state Developmental Disability programs to recognize the changes that occur, and the additional supports that are necessary when a person has an intellectual disability and Alzheimer's; and
    • To recognize more fully, the contributions that voluntary groups, such as the NTG, provide to help achieve the goals in accordance with the national plan. Such recognition will truly reflect your work to produce and uphold a national plan that is inclusive and acknowledges the efforts of non-governmental groups;
  • To continue a dialogue with volunteers, such as those within the NTG, who support people with Down syndrome and Alzheimer's so that we can provide the best possible care to this special population.

 

J. Imm  |  10-17-2017

I am with Responsible for Equality And Liberty (R.E.A.L.).

Since there was no conference call availability for Alzheimer's Disease activist M. Ellenbogen to speak on the October 16/17 Dementia Care Summit, would NAPA be willing to provide him conference call ability to speak at the October 27 Advisory Council Meeting #26? https://aspe.hhs.gov/advisory-council-alzheimers-research-care-and-services-meetings#Oct2017

R.E.A.L. believes that NAPA has the capability and technological resources to accept comments from speakers with Alzheimer's Disease and dementia via conference call. R.E.A.L. urges NAPA to make such flexibility to accommodate these voices that need to be heard.

Specifically, R.E.A.L. calls for NAPA to permit M. Ellenbogen, a long time activist for those with Alzheimer's Disease to speak, as his own Alzheimer's Disease and physical limitations make such in-person travel to the Dementia Care Summit impossible.

Please give him this opportunity.


 

J. Imm  |  10-17-2017

I am, with volunteer human rights activists, Responsible for Equality And Liberty (R.E.A.L.).

R.E.A.L. believes that NAPA has the capability and technological resources to accept comments from speakers with Alzheimer's Disease and dementia via conference call. R.E.A.L. urges NAPA to make such flexibility to accommodate these voices that need to be heard.

Specifically, R.E.A.L. calls for NAPA to permit M. Ellenbogen, a long time activist for those with Alzheimer's Disease to speak, as his own Alzheimer's Disease and physical limitations make such in-person travel to the Dementia Care Summit impossible.

Please give him this opportunity.


 

AUGUST 2017 COMMENTS

J. Koehler  |  08-24-2017

I am looking for NAPA council meeting dates, could you please send me the link to future meetings?

ANSWER

Information on future meetings is available at https://aspe.hhs.gov/advisory-council-alzheimers-research-care-and-services#NextMtg.


 

A. Harvey  |  08-22-2017

I have been doing homehealth for 17 yrs And I love my job!!!! Any info would be highly appreciated!!! please thank u.


 

JULY 2017 COMMENTS

M. Ellenbogen  |  07-28-2017

Good to see you at NAPA by video. Can they find another way to say demented? I really hate it when I hear that word and so do most of us with AD. It's okay if one doctor talks to another but not in public. Thanks


 

S. Blumrosen  |  07-27-2017

My father had a stroke in 2011, experienced a sharp decline in 2013, and passed away July 23, 2015. His death certificate lists Alzheimer's Disease (AD) as a cause of death, although there was no brain autopsy to make that determination.

I am not an officer or director of any organization focused on matters concerning AD. While taking care of my father, I did found a company to promote a product I, and other caregivers, found useful. The website is still available at http://www.247caregivingproducts.com.

My father, A.W. Blumrosen, the Thomas A. Cowan Distinguished Professor of Law, taught at Rutgers School of Law -- Newark for 46 years, 1955-2002.

He met and married my mother, R.G. Blumrosen, when they were students at the University of Michigan School of Law. She was one of five women students in their class, one of ten women students in the law school.

They graduated in 1953 and practiced law in the same office where S. Blumrosen, my father's father, had practiced. He graduated from the University of Michigan Law School in 1913.

Following is a brief chronology to inform you about his life and work. Since my father and mother worked on many projects together, I will use their first names (Al and/or Ruth) for clarity:

1960 (approx.), Al was granted tenure and became a full professor.

1961, Al was a visiting professor at LSU, in Baton Rouge, Louisiana.

1963 (approx.), at the request of S. Reitman, a Newark attorney appointed to the NJ Civil Rights Commission, Al's class studied and made recommendations concerning that agency.

1965, June (approx.), Al and Ruth were each early hires at the Equal Employment Opportunity Commission (EEOC). Eventually, Al became the EEOC's first Director of Federal State Relations and first Chief of Conciliations, for purposes of conciliating cases in which the Commission found reasonable cause to believe several employers in Alabama had violated Title VII, he was based in the Federal Building in Birmingham; Ruth was Acting Chief for Advice and Analysis and Acting Director of Compliance at the EEOC, and became Lecturer of Law and Assistant to the Dean of Howard University School of Law, C. Ferguson.

1968, Al was Special Attorney in the Civil Rights Division of the U.S. Department of Justice.

1969-71, Al was a Consultant to Assistant Secretary of Labor for Employment Standards, A. Fletcher, where he advised on regulations and procedures including OFCCP-Order No. 4 and a national program concerning the construction trades, the Philadelphia Plan.

1970, Al and Ruth were each a participant in the first International Labor Organization (ILO) conference behind the Iron Curtain, the 5th International Conference of Labor Law and Social Security. By that time, the ILO was part of the United Nations.

1970, Al published "Administrative Creativity: The First Year of the Equal Employment Opportunity Commission" in the George Washington Law Review.

1971, Al published Black Employment and the Law (Rutgers University Press).

1972-73, Al was Acting Director of the Michigan Department of Civil Rights.

1972, Al published "Strangers in Paradise: Griggs v. Duke Power Co. and the Concept of Employment Discrimination" in the Michigan Law Review. This article was cited in a U.S. Supreme Court decision handed down June 25, 2015, Texas Department of Housing and Community Affairs, et al. v. Inclusive Communities Project, Inc., et al (https://www.supremecourt.gov/opinions/14pdf/13-1371_m64o.pdf).

1977-79, Al was Consultant to EEOC Chair E.H. Norton in connection with EEOC Reorganization, Uniform Guidelines on Employee Selection Procedures, Affirmative Action Guidelines, and procedures for processing individual and systemic cases. He resigned so Ruth could be Consultant to EEOC Chair E.H. Norton on issues raised by workforce reductions and gender-based income inequality.

At that time, Al and Ruth started thinking about why R.H. Lee and T. Jefferson would want to revolt against Great Britain and began research on a book that was published 25 years later, Slave Nation: How Slavery United the Colonies and Sparked the American Revolution (Sourcebooks, 2005). The first chapter is about J. Somerset and the Somerset Case.

1979-1982, Al was Of Counsel to the New York law firm, Kaye, Scholer, Fierman, Hays & Handler advising employers on equal opportunity matters; 1980-81, Ruth was Consultant on Equal Employment Opportunity, here at the Department of Health and Human Services.

1982, Al and Ruth were Counsel to mainly white female employees challenging a discriminatory layoff in Chrapliwy v. Uniroyal, 670 F.2d 760 (7th Cir. 1982) cert. denied, 103 S. Ct.2428 (1983).

1983, Al wrote "Six Conditions for Meaningful Self-Regulation" which won the Ross Essay Prize awarded by the American Bar Association. Later, Al learned that the judge of the competition was Judge Higginbotham.

1985, Al was Counsel to the NAACP in NAACP v. Meese, 615 F. Supp. 200 (D.D.C) seeking an injunction against rescission of consent decrees involving affirmative action.

1986, Al published "Some Thoughts on Affirmative Action Here and in India: Galanter's Competing Equalities," Industrial Relations Law Journal, U.C. Berkeley Law School.

1989, Al was Counsel to the NAACP in Wards Cove Packing Co. v. Atonio, 109 S.Ct. 2115 (D.D.C) concerning the interpretation of Title VII of the Civil Rights Act.

1989, Al and Ruth were Counsel to the mainly white male employees seeking equal pay in Klask v. Northwest Airlines, 57 FEP Cases 1147, 1152 (D. Minn. 1989, 91).

1993, Al and Ruth were each Fulbright Scholars at Stellenbosch University in South Africa where they examined the usefulness of the U.S. experience with equal employment opportunity law in the post-apartheid period and, with L. Human, published "An Affirmative Action Statute for Employment and Contracting: Some Proposals" in the South Africa industrial Law Journal (1994).

1995, Al was Advisor to the U.S. Department of Labor, which resulted in "How the Courts are Handling Reverse Discrimination Claims," Bureau of National Affairs, Daily Labor Report, March 23.

1995, Al and Ruth were each Resident Scholars at the Rockefeller Institute Conference and Study Center in Bellagio, Italy.

1998: Al and Ruth published "Downsizing and Employee Rights," 50 Rutgers Law Review 943.

1998-2004: Al and Ruth, with the benefit of a Ford Foundation grant administered by Rutgers, published "The Realities of Intentional Job Discrimination in Metropolitan America, 1999." 40 state reports and a national report compare, with statistical precision, the standard deviations of the workforce of each employer-establishment, by occupation, with the workforces of similar establishments in the same Metropolitan Statistical Area and industry, by occupation. Statisticians D. and S. Dale worked on the reports. Available at http://www.eeo1.com. My brother, Alex, and I worked with Al and Ruth on this project.

2004, Ruth died suddenly and unexpectedly in an auto accident.

2005, Slave Nation: How Slavery United the Colonies and Sparked the American Revolution was published by Sourcebooks. Alex and I worked with Al and Ruth on this project.

2005, Al and Alex published "Using Statistics to Measure Diversity Compliance by Establishing Deviations from Labor Market Practices -- A Model for Effective and Economic Regulation in the Global Computer Age."

2011, Al and I published "Restoring the Congressional Duty to Declare War," Rutgers Law Review.

2011, Al had a stroke which left him with "expressive aphasia," which meant that, as intellectual and articulate as he used to be, with great dedication to speech, physical and occupational therapy, he was unable to find all the words he wanted, when he wanted to use them. He could take in information through his senses and process that new information with his mind, but he could no longer express himself as fluently as before.

Even so, we began work on our next project, a book about E. Coles. We wrote about Coles in one of the last chapters of Slave Nation, because it is noted by many historians that he challenged then former-President Jefferson to free their slaves together. Jefferson refused. Coles proceeded with his plan of emancipation and may have been the first plantation owner to free his slaves while he could have profited from them. We were into the fourth volume of R. Caro's biography of LBJ when my father was no longer able to concentrate enough on the material to communicate, in any way, about it.

That project was shelved and I focused on being my father's 24/7 caregiver. I got to be so good at taking vitals, giving meds, and keeping my patient safe, germ and rash-free that the home health care professionals suggested I challenge the CNA exam.

Since my father passed away, I have been administering his estate and developing a plan to outline our book about E. Coles. Recently, I found your website (https://aspe.hhs.gov/national-alzheimers-project-act) and found out about your quarterly meetings.

I am grateful that our nation is taking a comprehensive interest in all of the elements concerning issues related to Alzheimer's Disease and I am especially appreciative of your concern for the needs of caregivers, whether professional or family-volunteer.

Thank you for letting me "pay it forward" by sharing the following top-of-mind comments. Perhaps they will be useful to you and others who are working to efficiently marshal and focus our limited resources on matters concerning AD.

My father chose to "age-in-place" and asked me to take care of him at home in Bonita Springs, Lee County, Florida, as long as I was able. I agreed.

Home Health Care

The greatest help to me, and to my father, were the home health-care workers -- nurses, CNAs and therapists (speech, occupational, and physical).

Under Medicare, they were available only after a hospital stay of at least three days, and only as long as there was opportunity for improvement. I hope this national effort will spend some time and expend some resources:

  1. Figuring out ways to provide the connection and services of home health care -- without the pre-requisite of a hospital stay and, in appropriate situations, without the requirement that there be room for improvement, perhaps with the removal of speech, physical and occupational therapy and the retention of nursing and CNA services, and
  2. Improving and standardizing the best practices of professionals providing home health care. In our experience, some excelled -- both at the technical aspects of their job and also in approaching people with Alzheimer's Disease -- and some did not do their jobs well. Medicare pays the same to the home health care agencies (I think) but it matters who comes to the house. Therapists, CNAs and nurses are not, yet, fungible in the basic performance of their duties.

     

Brain Autopsies

During my father's last days, many people spoke with us -- hospice, doctors, etc. No one said anything about brain autopsies.

I would like to suggest that someone specific in the health care setting be tasked with informing the health care proxy about the availability of brain autopsies.

I have since learned that Medicare considers the payment for brain autopsies to be included in the cost of a hospital stay, and some hospitals disagree. I hope this has been, or will be, clarified.

I know, for my own peace of mind, I would have liked a definitive diagnosis of AD, which -- at that time -- could only be done with a brain autopsy that revealed whether there were plaques and tangles, or there was something else that mimicked the symptoms of AD.

Based on conversations with Dr. F. Schaerf in Ft. Myers, principal investigator and founder of the Neuropsychiatric Research Center of Southwest Florida, I assume that it would be helpful to the medical community to have many more brain autopsies that could provide more data-points about the plaque and tangles, amyloid and tau proteins, in the brain.

I would suggest some consideration of ways to ease the flow of information to health care proxies about brain autopsies, as well as clarification to hospitals that they are expected to perform brain autopsies at no additional cost to the family, the caregiver or the taxpayers.

Perhaps hospitals could be required to submit a small portion of their per diem to a national trust which would save and combine such deposits for the designated purpose of performing brain autopsies. This way, the full cost of a brain autopsy would not have to be borne by the last hospital where a decedent happened to be an in-patient. The cost would be spread over every hospital that charged Medicare for treating a patient with AD.

Research

Shortly before my father passed away, I learned there is research being done on the use of sonogram technology to "cure" Alzheimers. See, for example, http://www.sciencealert.com/new-alzheimer-s-treatment-fully-restores-memory-function.

As you know, sonograms and ultra-sound have been approved for other uses in the United States, for many years and, I have been told, that the technology could be used for this purpose if a doctor was courageous enough. Perhaps such courage could be strengthened with laws protecting doctors from liability for the creative use of current technology (1) with patients who are certified to be in the last stages of life and (2) with the health proxy's consent.

My father could not be more dead than he is now, if a doctor had tried a new use of an approved technology on him. And, he would have made one last contribution to society. I am proud of him for the work he did while active, for his courage in fighting to re-learn skills we took for granted like talking, and for his fight for life. He was reaching for his last gasp of air in the hands of an ambulance attendant and did not go gently into the night. It would have extended my reasons to be proud if we could have furthered Alzheimer's research by trying non-invasive non-pharmaceutical ways to deal with his challenges and our situation.

Alternatives or Supplements to Pharmaceuticals

One time my father was in a small well-respected rehabilitation facility after a hospitalization in Naples, Florida. Rehab, there, is short-term and intense. It requires a certain amount of concentration during the day. My father would get anxious at night and receive medication to calm him. But, that resulted in his being sleepy the next day, which interfered with his therapies.

I suggested that the facility try what they talk about in their beautiful four-color brochure and take an alternative holistic approach by using aromatherapy. When I arrived for visiting hours that evening, they had sprayed his pillow with lavender. He slept well that night, needed less attention from the nursing staff, and was more awake the next day.

I wonder whether non-pharmaceutical solutions (which, I imagine are typically lower cost) are receiving attention equal to pharmaceutical solutions.

AD Mimics

After the experience with my advocacy for my father, one of the head nurses talked with me. There was an article in the April 2014 AARP Bulletin by M.D. Rosen, "Am I Losing My Mind: Conditions that Mimic Dementia," that says over 100 disorders can mimic AD. The article highlights:

  • Normal pressure encephalitis (NPE),
  • Medications,
  • Depression or another mental health disorder,
  • Urinary tract infection (UTI), and
  • Thyroid.

     

The nurse explained that there can be difficulties in determining exactly what is producing the symptoms of Alzheimer's.

Perhaps there could be further study and the development of programming, best practices and information for the public, including untrained and unlicensed family caregivers, about ways to filter out symptoms that mimic AD.

I showed the article to my father's neurologist, a dedicated doctor. He set up an appointment with someone who gives tests. I, as someone who was not going to be the subject of the test and was the subject's health proxy, inquired about the nature of the test. The tester was opaque; she would tell me nothing more than the doctor would be able to make a definitive diagnosis of AD, which every article I read said was impossible without a brain autopsy.

I suggest that "experts" be trained and required to explain what they are about to do, in plain language that the health care proxy can understand, so the health care proxy can make an informed decision.

Alzheimer's Village

The nurse at the rehab center also told me she had heard on Facebook about an "Alzheimer's Village." I found there is one. It is called Hogewey, a small village in Weesp, the Netherlands, where every resident has severe dementia (https://www.youtube.com/watch?v=LwiOBlyWpko). Hogewey is specially built, with the intention of maintaining strong connections with the interests and thought patterns of people who show symptoms of AD, while providing a safe and supportive place to live.

It is called a village because it has different areas for different interests. Recognizing that people develop circles of friends with similar interests, Hogewey connects someone with a strong interest in sports, for example, with other people who are interested in sports.

In our experience, living in a place that was familiar to my father and focusing on the work of writing about E. Coles probably kept my father engaged much longer than if he were in an institution with few touchstones to his personal experience and memories, and little intellectual stimulation.

I saw support for this when my father was in another well-respected rehab facility. They sat people with similar interests or backgrounds at the same table for dinner. Our dinner companions were more engaged in conversation and aware of their circumstances than those in facilities where I would have dinner with my father and the dining room staff was not purposeful and intentional about putting people together who had things to talk about.

The rehab nurse thought there could be room on or near the NCH campus for such a village. Perhaps, nationally, there could be incentives for the study and development of such people-oriented living situations that adjust to activities a patient prefers in their daily life rather than expecting a patient to fit into an institution's routine and "blaming" the patient for not carrying on a pre-determined set of activities in their daily life.

Finally, modern technology and last stages of life.

To return to my anecdote about the use of sonogram technology, according to news releases the principal investigators are at the University of Queensland in Brisbane, Australia. They work with several labs in other places of the world. I tried to email with them, but there was not enough time.

Apparently, the work of the researchers continues, using focused ultra-sound in combination with "microbubbles" to temporarily open the blood brain barrier and enhance delivery of anti-amyloidal antibodies directly to the brain (See, http://www.sciencealert.com/ultrasound-with-immunotherapy-could-be-used-to treat-alzheimer-s and http://www.fusfoundation.org).

This year, this technique has been used on humans. Research is progressing quickly. (http://www.medpagetoday.com/neurology/alzheimersdisease/64114).

It would be nice if there were:

  1. A central place where untrained family caregivers could find verified information about the progress of research that is not tied to gatekeepers for the research studies. Perhaps the NIH website could be a source of information that has no interest in any particular path of research.
  2. Consideration of conducting experimental research on people with less to lose, who are certifiably near the end of their lives. Families would more fully appreciate the miracle. And, if it doesn't work, the researchers will not unduly hasten the demise of the patient.

 

M. Hogan  |  07-23-2017

Thank you for the opportunity to once again address the Council.

For the past 6 years I have attempted to have a presence at and bring a voice to this forum as a representative of individuals with intellectual disabilities and dementia and their families. I have been driven to do so because of my late brother Bill who had DS, developed AD in his mid 40's and died in 2010 of aspiration pneumonia at age 49. Since his death I have remained determined to improve the quality of life for the ID population with AD and for their caregivers.

For 6 years I have been witness to topic specific NAPA Council agendas and detailed testimony from various arenas about the work that has been done to improve quality of life for those in the general population with ADRD and for their caregivers. I continue to request a quarterly session dedicated to the needs of the ID population who were originally included in Section 2H, populations disproportionately affected by AD. Such a session would be most advantageous as you look forward to a transition period and the arrival of a newly selected Advisory Council Leadership and Team who may bring to the table little or no background information about this special population.

In the course of the last seven years I believe that there has been increased awareness of issues related to those with ID and Dementia, especially those with DS and AD. More recently additional research dollars have been earmarked for research on the correlation of these two diseases with a focus on biomarkers that might help the general population as well.

There has been additional material made available for families on aging, ID/DS and dementia, generated by the NTG and NDSS along with the inclusion of info on the Alzheimer's Association website. A companion publication on DS and AD will soon be released by the NDSS. This work has been the result of a collaboration involving the NDSS, the Alzheimer's Association and the NTG. It is a long awaited and much needed resource. The ACL has identified and funded pilot programs in selected communities across the US. These have been designed to increase the knowledge base of agencies, care providers and family members.

Despite these efforts, individuals with ID experiencing further cognitive decline and their families and care providers face continued serious obstacles. These obstacles are voiced from all regions of the country in a monthly online support group for family members hosted by the NTG. These are the same obstacles repeatedly mentioned in public testimony at NAPA Council meetings over the course of the past 6 years.

They include:

  • Limited awareness of or misunderstood risk factors for AD in the ID population
  • Difficulty obtaining a differential diagnosis or accessing Physicians familiar with the ID population
  • Limited access to Agencies with Skilled Direct Support Professionals familiar with ID and ADRD
  • Trouble identifying and accessing resources in ID and Aging networks
  • Underdeveloped resources that focus on quality of life for a person with ID and ADRD
  • Lifelong caregivers who are aging and facing physical decline as family member needs increase
  • Sibling/Compound caregivers, caring for parent, spouse or other family member simultaneously
  • Decreased support networks as disability increases, especially in small communities and rural areas
  • Limited residential alternatives when caregiving resources are depleted
  • Lack of coordination of care
  • Limited access to palliative and hospice care

As you look ahead to the Research Summit in October of 2017, I am hopeful that you will consider many of the afore-mentioned challenges faced by families.

However, as a lay person, my greatest fear is that there will be added lag time as areas of research are identified, studies conducted and the findings translated into actions that may possibly improve the quality of life for all people with ADRD and their caregivers.

Change cannot come soon enough for individuals with ID and ADRD and their families scattered around the US in both rural and urban settings. Each month when we meet on line or share an email, I hear in their many voices the same sense of desperation that I experienced more the 10 years ago. Their voiced desperation reinforces the fact that we have not come far enough, fast enough and need to be more action oriented in the immediate future. This is a population of individuals and most often lifetime caregivers that cannot be forgotten.

Thank you for the opportunity to address the Council today.


 

S. Fournier  |  07-22-2017

Seven Hills RI and the Project Partners involved with our project funded through would like to express appreciation to the Administration for Community Living or for the funding opportunity that Seven Hills RI received to address efforts to create a more dementia capable system of care for individuals with intellectual and developmental disabilities and dementia. We would also like to express our appreciation for the support of E. Long and S. Shuman, and to make available the newly published document Intellectual Disability and Dementia: A Caregiver's Resource Guide for Rhode Islanders.

Seven Hills also extends thanks to the collaborative partners of the National Task Group on Intellectual Disabilities and Dementia Practices (NTG), Alzheimer's Association of Rhode Island (AARI), Lt. Governor McKee and his staff, the RI Geriatric Education Center (RIGEC) at the University of RI (URI), and the families and agency personnel who served as focus group members and who provided their comments prior to the Resource Guide's publication. Without the help of each of these groups, this guide, and its dissemination, would not have been possible.

Our hope is that this Resource Guide will provide the foundation that caregivers need to begin the conversation in planning supports for the individuals you support. Additionally, we hope this Resource Guide will serve as a reference tool for other states to develop their state specific Guides and include them in their state plans that address Alzheimer's Disease and related dementias.

ATTACHMENT:

Intellectual Disability and Dementia: A Caregiver's Resource Guide for Rhode Islanders [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-ri-caregivers-resource-guide]


 

J. Dorey  |  07-21-2017

I am submitting herewith as a public comment to be read at the next meeting of the "Advisory Council on Alzheimer's Research, Care and Services" a manuscript entitled "Alzheimer's Hypothesis" as copied below and also attached hereto in pdf format.

The manuscript outlines a pathological hypothesis which offers a complete explanation for the development of Alzheimer's disease, compressed into a one page submission that can be read at the meeting within the allotted two minute limit for such public comments.

I have also attached two other items as supporting documentation which will allow you to better evaluate the validity of the hypothesis. in accordance with your procedure for public submissions this supporting documentation is not intended to be considered as a submission to the meeting.

I do not propose to attend the meeting, please confirm my understanding that the submission can be read to the meeting in my absence.

I am a retired professional engineer and have no organizational affiliation. On reading the submission you will realize that the pathology for Alzheimer's disease bears a resemblance to an engineered system and my hypothesis was developed on the basis of a system engineering study that correlated apparently unrelated findings in numerous published manuscripts.

ATTACHMENT #1:

Alzheimer's Hypothesis

This presentation offers a complete explanation for the development of Alzheimer's disease and identifies a possible way to reduce the incidence of Alzheimer's disease in future.

In a catechol-o-methyl transferase reaction norepinephrine released in the cortex of the brain breaks down elastic polymers in the walls of the arteries resulting in a gradual build-up of atherosclerosis in those arteries. The extent of atherosclerosis that has built up over many years significantly restricts the flow of blood through the arteries causing Alzheimer's brains shrink from a lack of nourishment in support of neuron activity and the beta amyloid deposits that form in Alzheimer's brains are the misfolded protein remnants of broken down polymers from the walls of the damaged arteries. Mental, physical and chemical types of stress all tend to promote the release of norepinephrine thus accelerating the build up of atherosclerosis for an increased risk of developing Alzheimer's disease during a person's lifetime.

Cerebrospinal fluid (CSF) is pumped through aquaporins wound in a covering spiral over the arteries in the brain and the pulsating elastic expansion and contraction of healthy arteries pressing against the covering of aquaporinins provides the pumping mechanism for the flow of CSF through the aquaporins and its circulation throughout the individual areas of the brain served by each artery. As atherosclerosis builds up in the arteries their walls harden and cause the pumping action for circulation of CSF to become reduced due to a loss of pulsating arterial expansion and contraction. The build-up of beta amyloid deposits in the brain also tends to obstruct the circulation of CSF; therefore, the circulation of CSF becomes compromised both by the build-up of beta amyloid deposits and by a steadily decreasing pumped volume of CSF through the aquaporins.

At the start of each activity cycle, neurons in the brain emit a K+ ion and thus acquire an internal negative electrical charge. During recovery from activation a neuron which still retains its negative internal electrical charge before achieving electrical equilibrium will undergo a seizure and be destroyed if it happens to capture a nearby K+ ion which has not been washed far enough away by the circulation of CSF. The circulation of CSF in healthy brains establishes a virtually negligible probability for the capture of K+ ions but the statistical probability for capture of K+ ions during recovery from activation increases exponentially in areas of the brain where the circulation of CSF becomes compromised. A compromised inadequate circulation of cerebrospinal fluid and the resulting destruction of neurons is the direct cause of Alzheimer's disease. The tau tangles that form in Alzheimer's brains are the remnants of destroyed neurons.

Brain plasticity is so effective in programming repairs which bypass destroyed neurons that the first symptoms of cognitive impairment only become apparent after too much extensive vascular damage and resulting neuron destruction has already taken place, making it impossible to effect a cure for the disease. However, the incidence of Alzheimer's disease could be greatly reduced in future by the development of a daily prophylactic therapy which would restrict the release of norepinephrine in the brain and slow down the build up of atherosclerosis in the intracranial arteries. Ideally, such a therapy should be commenced at an early age, typically before age 30. A small daily dosage of alpha blocker medication with supplements of vitamins D, B6, B12 and folic acid might possibly serve as such a prophylactic therapy. (Adding a beta blocker could possibly extend scope of the therapy to also reduce the incidence of type 2 diabetes and vascular disease.)

The level of plasma total homocysteine in the blood and of normetanephrine in the urine are biomarkers for the release of norepinephrine and also for a resulting increased risk of developing Alzheimer's disease in future. The development of a reasonably priced capability for monitoring such a biomarker would allow people to assess the effectiveness of the prophylactic therapy and to adjust their diet, lifestyle and medication etc to minimize the risk of developing Alzheimer's disease in future.

There are medications which promote the release of norepinephrine that should be identified and either shown on the label to have an associated Alzheimer's risk or removed from the market if their benefit does not justify the risk.

ATTACHMENT #2:

Pumping of CSF Through Aquaporins of the Brain

A study contribution by J.D. Dorey

Results of a study by M. Nedergaard and J. Iliff as outlined in the following two pages describe the glyampic system of aquaporins that delivers cerebrospinal fluid (CSF) which circulates throughout the brain. The additional information provided below describes the pumping mechanism which promotes the flow of CSF through the aquaporins and how that pumping mechanism and the circulation of CSF becomes inhibited in areas of the brain where atherosclerosis develops in the walls of the intracranial arteries.

The CSF circulating to the brain is delivered through aquaporin pipes which form a sheath over the outer surface of the intracranial arteries that distribute blood within the brain. In healthy brains the arteries have elastic walls and are continuously undergoing cycles of expansion and contraction as spurts of blood pass through them under pressure from the pulsating pumping action of the heart and when the arteries expand they compress against the surrounding aquaporin pipes forcing spurts of the contained CSF to flow through the aquaporin pipes ahead of the advancing spurts of blood in the arteries, much like the process of squeezing toothpaste out of a tube. This mechanism is what circulates CSF throughout the brain.

Atherosclerosis is a condition where the walls of the intracranial arteries gradually harden and lose their elasticity and ability to expand and contract as necessary to circulate CSF through the brain. One purpose of CFS circulation is to cleanse waste matter from the brain however the absolutely vital purpose is that a good flow of CFS is required to maintain the statistical probability for excitotoxic destruction of neurons as a negligibly rare occurrence that the brain's plasticity can work around.

The study referenced below in bold type indicates that the statistical probability of excitotoxic neuron destruction increases enormously in areas of the brain where the circulation of CSF is significantly reduced. This would explain why atherosclerosis from damage to arteries by dopamine produced in the substantia nigra area of the brain results in Parkinson's disease and from damage to arteries by norepinephrine produced in the cortex of the brain results in Alzheimer's disease or dementia.

Delayed K+clearance associated with aquaporin-4 mislocation:
Phenotypic defects in brains of á-syntrophin-null mice.
Nov 11, 2003 - by Mahmood Amiry-Moghaddam, Professor of Medicine, University of Oslo
Proceedings of the National Academy of Sciences Vol. 100 No. 23

(The text of this study can be viewed on the Internet.)

Two possible secondary consequences of atherosclerosis in the intracranial arteries are:

The flow of blood through healthy arteries is facilitated by their elastic expansion and contraction and when the walls of the intracranial arteries lose their elasticity the flow of blood to provide oxygen and glucose in support of neuron activity becomes significantly reduced.

A healthy human brain continually produces about 20 Watts of heat within the close confines of the skull and the circulation of blood and CSF throughout the brain provides liquid cooling that removes heat from inside the skull and ensures that all parts of the brain are maintained at about the same ideal operating temperature. When the circulation of blood and CSF is curtailed there is a possibility of impaired operation if part of the brain is not maintained at its optimum operating temperature.

ATTACHMENT #3:

Scientists Discover Previously Unknown Cleansing System in Brain -- The Glymphatic System

Wednesday, August 15, 2012

A previously unrecognized system that drains waste from the brain at a rapid clip has been discovered by neuroscientists at the University of Rochester Medical Center. The findings were published online August 15 in Science Translational Medicine [http://stm.sciencemag.org/lookup/doi/10.1126/scitranslmed.3003748].

The highly organized system acts like a series of pipes that piggyback on the brain's blood vessels, sort of a shadow plumbing system that seems to serve much the same function in the brain as the lymph system does in the rest of the body -- to drain away waste products.

"Waste clearance is of central importance to every organ, and there have been long-standing questions about how the brain gets rid of its waste," said M. Nedergaard, M.D., D.M.Sc. [http://www.urmc.rochester.edu/people/23788299-maiken-nedergaard], senior author of the paper and codirector of the University's Center for Translational Neuromedicine [http://www.urmc.rochester.edu/ctn/]. "This work shows that the brain is cleansing itself in a more organized way and on a much larger scale than has been realized previously.

"We're hopeful that these findings have implications for many conditions that involve the brain, such as traumatic brain injury, Alzheimer's disease, stroke, and Parkinson's disease," she added.

Nedergaard's team has dubbed the new system "the glymphatic system," since it acts much like the lymphatic system but is managed by brain cells known as glial cells. The team made the findings in mice, whose brains are remarkably similar to the human brain.

Scientists have known that cerebrospinal fluid or CSF plays an important role cleansing brain tissue, carrying away waste products and carrying nutrients to brain tissue through a process known as diffusion. The newly discovered system circulates CSF to every corner of the brain much more efficiently, through what scientists call bulk flow or convection.

"It's as if the brain has two garbage haulers -- a slow one that we've known about, and a fast one that we've just met," said Nedergaard. "Given the high rate of metabolism in the brain, and its exquisite sensitivity, it's not surprising that its mechanisms to rid itself of waste are more specialized and extensive than previously realized."

While the previously discovered system works more like a trickle, percolating CSF through brain tissue, the new system is under pressure, pushing large volumes of CSF through the brain each day to carry waste away more forcefully.

The glymphatic system is like a layer of piping that surrounds the brain's existing blood vessels. The team found that glial cells called astrocytes use projections known as "end feet" to form a network of conduits around the outsides of arteries and veins inside the brain -- similar to the way a canopy of tree branches along a well-wooded street might create a sort of channel above the roadway. Those end feet are filled with structures known as water channels or aquaporins, which move CSF through the brain. The team found that CSF is pumped into the brain along the channels that surround arteries, then washes through brain tissue before collecting in channels around veins and draining from the brain.

How has this system eluded the notice of scientists up to now?

The scientists say the system operates only when it's intact and operating in the living brain, making it very difficult to study for earlier scientists who could not directly visualize CSF flow in a live animal, and often had to study sections of brain tissue that had already died. To study the living, whole brain, the team used a technology known as two-photon microscopy, which allows scientists to look at the flow of blood, CSF and other substances in the brain of a living animal.

While a few scientists two or three decades ago hypothesized that CSF flow in the brain is more extensive than has been realized, they were unable to prove it because the technology to look at the system in a living animal did not exist at that time. "It's a hydraulic system," said Nedergaard. "Once you open it, you break the connections, and it cannot be studied. We are lucky enough to have technology now that allows us to study the system intact, to see it in operation."

First author J. Iliff, Ph.D. [http://www.linkedin.com/pub/jeffrey-iliff/47/856/a52], a research assistant professor in the Nedergaard lab, took an in-depth look at amyloid beta, the protein that accumulates in the brain of patients with Alzheimer's disease. He found that more than half the amyloid removed from the brain of a mouse under normal conditions is removed via the glymphatic system.

"Understanding how the brain copes with waste is critical. In every organ, waste clearance is as basic an issue as how nutrients are delivered. In the brain, it's an especially interesting subject, because in essentially all neurodegenerative diseases, including Alzheimer's disease, protein waste accumulates and eventually suffocates and kills the neuronal network of the brain," said Iliff.

"If the glymphatic system fails to cleanse the brain as it is meant to, either as a consequence of normal aging, or in response to brain injury, waste may begin to accumulate in the brain. This may be what is happening with amyloid deposits in Alzheimer's disease," said Iliff. "Perhaps increasing the activity of the glymphatic system might help prevent amyloid deposition from building up or could offer a new way to clean out buildups of the material in established Alzheimer's disease," he added.

In addition to Iliff and Nedergaard, other authors from Rochester include M. Wang, Y. Liao, B. Plogg, W. Peng, E. Vates, R. Deane, and S. Goldman. Also contributing were E. Nagelhus and G. Gundersen of the University of Oslo, and H. Benveniste of the Health Science Center at Stony Brook University.

The work was funded by the National Institutes of Health (grant numbers R01NS078304 and R01NS078167), the U.S. Department of Defense, and the Harold and Leila Y. Mathers Charitable Foundation.

ATTACHMENT #4:

How to optimise your brain's waste disposal system

Aug 22, 2015

New research suggests that body posture during sleep may affect the efficiency of the brain's self-cleaning process

The human brain can be compared to something like a big, bustling city. It has workers, the neurons and glial cells which co-operate with each other to process information; it has offices, the clusters of cells that work together to achieve specific tasks; it has highways, the fibre bundles that transfer information across long distances; and it has centralised hubs, the densely interconnected nodes that integrate information from its distributed networks. Like any big city, the brain also produces large amounts of waste products, which have to be cleared away so that they do not clog up its delicate moving parts. Until very recently, though, we knew very little about how this happens. The brain's waste disposal system has now been identified. We now know that it operates while we sleep at night, just like the waste collectors in most big cities, and the latest research suggests that certain sleeping positions might make it more efficient.

Waste from the rest of the body is cleared away by the lymphatic system [http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer], which makes and transports a fluid called lymph. The lymphatic system is an important component of the immune system. Lymph contains white blood cells that can kill microbes and mop up their remains and other cellular debris. It is carried in branching vessels to every organ and body part, and passes through them, via the spaces between their cells, picking up waste materials. It is then drained, filtered, and recirculated.

The brain was thought to lack lymphatic vessels altogether, and so its waste disposal system proved to be far more elusive. Several years ago, however, M. Nedergaard [https://www.urmc.rochester.edu/labs/nedergaard-lab/] of the University of Rochester Medical Center and colleagues identified a system of hydraulic "pipes" [https://www.newscientist.com/article/dn22183-waste-disposal-network-discovered-in-the-brain/] running alongside blood vessels in the mouse brain. Using in vivo two-photon imaging to trace the movements of fluorescent markers, they showed that these vessels carry cerebrospinal fluid around the brain, and that the fluid enters inter-cellular spaces in the brain tissue, picking up waste [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3551275/] on its way.

Nedergaard and her colleagues also discovered that proper function of these vessels depends on movements of water around the brain, which are carried out by glial cells called astrocytes, [https://www.theguardian.com/science/neurophilosophy/2013/mar/07/human-brain-cells-boost-mouse-memory] and therefore named them the glymphatic system. They went on to show that inter-cellular spaces expand by up to 60% in the brains of naturally sleeping and anaesthetised mice, and that this expansion drives the clearance of waste from the brain [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880190/] by facilitating the movements of lymph and water.

Last month, researchers from the University of Virginia reported the identification of lymphatic vessels in the central nervous system [https://www.nature.com/articles/nature14432.epdf?referrer_access_token= 73VNMajh-YctNTGco_XUj9RgN0jAjWel9jnR3ZoTv0PP9svrp_06Oir1YyDWe7ejvVLL2VbrH_EwNtYJfrQFs0e9-52wHfwKPwFmFnLP6V31OlM0nnYEmBXU_cERvmChguYSd02A9zDIMThkJLhI_iVl4f1FJO IZ7PnYDwSJ0ANlqQQ0LnUd3e_CFRU0mcDKYsPUDBoHrQFYKAyuXzHBsJfzRxH0ZsJuk50cmJ-Z0S2GOBquBoA09XaF-yZQO-PmnSWBFlT7TBPGHTyzhkDq_w==&tracking_referrer=www.theguardian.com]. They demonstrated that the lymphatic system extends into the dura mater, the thickest and outer-most of the three meningeal membranes that envelope the brain and spinal cord. These vessels run parallel to the major veins and arteries, and split to send branches deep into the brain's crevices. The researchers believe that they could be linked to the glymphatic system, and may be the second stage of the disposal mechanism, which would transport waste out of the brain and spinal cord altogether.

The latest study from Nedergaard's group, published [http://www.jneurosci.org/content/35/31/11034] in the Journal of Neuroscience earlier this month, shows that body posture affects the efficiency of the glymphatic system's waste clearance. Using fluorescence microscopy and radioactive tracing once again, they showed that drainage of the cerebrospinal fluid worked best in mice lying on their sides [http://www.jneurosci.org/content/35/31/11034] compared to those lying on their back or standing up.

The function of sleep was once deeply mysterious, but there's plenty of evidence that it is critical for memory consolidation, [https://www.theguardian.com/science/neurophilosophy/2014/jun/09/sleep-dendritic-spines-memory] and it would now seem to be required for the effective removal of waste from the brain, too. Although these studies were performed in mice, preliminary results suggest that lymphatic vessels are also present in the human brain and spinal cord, but further research will be needed to confirm that they actually constitute a working waste disposal system.

Eventually, the link to sleep could have important implications for the treatment of neurodegenerative diseases such as Alzheimer's and Parkinson's, all of which involve the build-up of misfolded proteins within and around nerve cells, because of a defective waste disposal system. Indeed, it is now seems clear that good sleep hygiene has a neuroprotective effect [https://www.theguardian.com/science/neurophilosophy/2014/sep/22/the-neuroprotective-lifestyle] and, in line with this, other research shows that sleep disturbances predict the onset of neurodegeneration. [https://www.theguardian.com/science/neurophilosophy/2013/may/22/dreaming-of-animals-and-other-warning-signs-of-neurodegeneration]

Sleeping on the side just happens to be the most popular sleeping posture for both mice and humans, and so this preference may have evolved to optimise the waste disposal system and thus ensure that the metropolis of the brain runs as effectively as possible.

References

Lee, H. et al. (2015). The Effect of Body Posture on Brain Glymphatic Transport. J. Neurosci, 35: 11034-44. DOI: 10.1523/JNEUROSCI.1625-15.2015. [http://www.jneurosci.org/content/35/31/11034]

Louveau, A., et al. (2015). Structural and functional features of central nervous system lymphatic vessels. Nature, 523: 337-41. DOI: 10.1038/nature14432. [https://www.nature.com/nature/journal/v523/n7560/full/nature14432.html]

Xu, L., et al. (2014). Sleep Drives Metabolite Clearance from the Adult Brain. Science, 342: 373-7. DOI: 10.1126/science.1241224. [Full text http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880190/]

Iliff, J., et al. (2013). A Paravascular Pathway Facilitates CSF Flow Through the Brain Parenchyma and the Clearance of Interstitial Solutes, Including Amyloid ß. Sci. Trans. Med., 4: 147ra111. DOI: 10.1126/scitranslmed.3003748. [Full text http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3551275/]

ATTACHMENT #5:

Delayed K+ clearance associated with aquaporin-4 mislocalization: Phenotypic defects in brains of a-syntrophin-null mice, PNAS, 2003, Vol. 100, No. 23, pg 13615-13620 [Available as a separate link: https://aspe.hhs.gov/pdf-document/napa-public-comment-attachment-delayed-k-clearance]


 

I. Kremer  |  07-21-2017

In today's meeting, the Advisory Council is focusing on research gaps and dementia prevention strategies. So it is particularly fitting that NIH will present its FY 2019 Bypass Budget for Alzheimer's Disease and Related Dementias. We remain optimistic that NIH laying out an ambitious research agenda and supporting highly meritorious science will continue to inspire bold funding support from Congress -- as has been the pattern in recent years. Our confidence was bolstered earlier this month when the House Appropriations Committee approved the draft FY 2018 Labor, Health and Human Services, and Education (LHHS) bill, which included a $400 million increase for NIA dementia research. As the Advisory Council knows, there has been significant progress in both NIH's bypass budget and its actual grant allocations to better support both social science and bench science so that we improve quality of life for people facing dementia now while seeking breakthroughs to prevent, modify or cure these diseases and disorders.

In the spirit of identifying research gaps, thank you again to the Advisory Council for your deep engagement in, and strong support for, the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers [https://aspe.hhs.gov/national-research-summit-care-services-and-supports-persons-dementia-and-their-caregivers]. I serve on the summit steering committee and we look forward to delivering findings and recommendations that will inform your next National Plan Update, and help both the public and private sectors improve research, and ultimately deliver tangible, transformative results for tens of millions people across this country.

I also would offer congratulations to all those who made possible the 2018 Alzheimer's Association International Conference. Each year, AAIC is a crown jewel in advancing both science and the understanding of science by the broader public. This year was no exception. We look forward to a time when science liberates us all from the shadows of dementia.

And to the entire Advisory Council, thank you for your leadership toward the 2017 National Plan Update. We look forward to its publication and welcome the opportunity to participate in its implementation.


 

C. Laxton  |  07-21-2017

I'm a former college professor and have been living with dementia since 2005. I'm sorry not to be here today to deliver these remarks in person, but the date conflicted with another commitment. Since this is the last NAPA Advisory Council meeting before the National Research Summit in October, I appreciate the opportunity to provide comments.

Having conducted, taught, analyzed, and participated research studies for the past 30 years, I value the convening of a Research Summit. As a person living with dementia (PWD), based upon reading the Background Papers and other pre-Summit materials available online, I am, however, alarmed about the context and direction of this Summit whose focus is on the service, support and care needs of people like me and our care partners. The first Background Paper, "Research on Care Needs and Supportive Approaches for Persons with Dementia," starts with, "As the disease progresses, individuals with dementia become more dependent on others for assistance with daily activities. Ultimately, in advanced dementia, people with the disease need assistance with basic tasks, such as eating. Dementia reduces a person's cognitive function and ability to perform routine activities; it also is often associated with challenging behaviors. The psychosocial aspects of dementia often include depression, anxiety, and strain on family relationships."

Framing dementia in this context reduces the humanity of people with dementia to mere bodily functions and emotional difficulties. Stripped away are many vital and fundamental aspects of being human, including the need to be connected to others, feeling productive and having purpose, doing activities that bring satisfaction and joy, and maintaining self-sufficiency. Without understanding that these are vital aspects of living, is there any wonder emotional outcomes include depression, anxiety and strain on family relationships?

A stated goal of the National Research Summit is to identify what is known and what needs to be known about care, services and support for PWDs and CPs. What needs to be known is to expand the boundaries and horizons of the deficit-oriented, capacity-defined, negative attributes mindset. The barriers to well-being that lie outside these parameters, including the origins and effects of pervasive stigma, misperceptions and low expectations for people living with dementia, and mistaking dementia as one, homogenous condition need exploration. There are many types of dementia, so symptoms vary significantly from person to person, as does the progression. Yet we are not recognized as individuals with unique needs different from those of others.

In the 1960's, there was a major breakthrough in psychology with the Rosenthal and Jacobson study. The results of the study, commonly known as the Pgymalion Effect, found that reality can be positively or negatively influenced by the expectations and perspectives of others. Thus, if the focus is on functional deficits and negative attributes of people with dementia, that's what will be found. As an example of such negative perceptions of people with dementia, one of the six Summit sessions is titled, "Challenges in Involving Persons with Dementia as Study Participants." A positive perception would be "What Do Researchers Need to Know about Involving Persons with Dementia as Study Participants?" Such adjustments would go far in alleviating the misunderstandings and social stigma attached to people with dementia.

As a former Board member of the Dementia Alliance International, I have had the opportunity to speak with many PWDs and CPs all over the world, and to speak at the United Nations on the importance of including people with dementia in the conduct of research and policy. We universally need you to enable, rather than further disable, us. That is, we need to be included as equals to learn what is needed to be supported and accommodated.

Like you, I am a complex human being with feelings and emotions, ideas and opinions, social and spiritual needs, and even a sense of humor. These aspects of my life are not irrelevant or secondary to my physical capacity, but are indeed central to who I am. Marcel Proust famously said, "The real voyage of discovery consists not in seeking new landscapes, but in having new eyes." People living with dementia sorely need you to have new eyes and see a wider perspective on what is needed to support, accommodate and enable people living with the many forms of dementia!


 

M. Janicki  |  07-19-2017

I and Dr. S. Keller are the co-chairs of the National Task Group on Intellectual Disabilities and Dementia Practices (NTG), a group formed in 2010 with a mission to advocate for people with intellectual disability and their families and other caregivers when an adult with intellectual disability is affected by dementia (http://www.aadmd.org/ntg). The NTG is an affiliate of the American Academy of Developmental Medicine and Dentistry and is associated with the Rehabilitation Research and Training Center on Developmental Disabilities and Health at the University of Illinois at Chicago.

NTG Activities on Information Development and Dissemination

What we wish to raise today concerns our efforts to create and disseminate information related to dementia and intellectual disabilities. We recognize, as does the Council, that much of the general public, health care professionals, and even workers in the field of intellectual disability, are relatively uninformed about the nuances of dementia and how it affects adults with intellectual disability, as well as their spouses, friends, and caregivers. In concert with colleagues within the Alzheimer's and other dementias, intellectual disability, and university educational community, the NTG continues to develop materials in various media to inform and disseminate such information.

The basis for this is that many families have experienced in obtaining reliable information on recognizing dementia and how to best provide care and supports, in particular when their relative with intellectual disability is in the late or advanced stage of dementia and needing end-of-life specialized care. Further, we recognize that there are many nuanced issues that at times mirror those affecting adults with dementia in general, but also differ due to factors posed by lifelong intellectual disability. These differences can pose barriers to acceptance into generic services or add to confusion about how to provide specialized services. It is our hope at the NTG, as it is among our international colleagues in the intellectual disability and aging community, that any information produced will provide a basis for increased understanding of how dementia affects people with intellectual disability (as it might among other recognized 'special populations') and constructively influence and affect state and local planning, public policies, and clinical and service practices.

NTG Related Publications

Last February we reported on the International Summit on Intellectual Disability and Dementia that was held in October 2016 in Scotland, which came about from a partnership between the NTG and the University of Stirling. We noted that the participants came from numerous countries within Europe and from the USA and Canada. We also noted that subsequent to that meeting the NTG has spearheaded the development of a series of reports, many of which were pending publication in professional journals. These reports covered select issues and contain recommendations that can help expand knowledge, influence policy, and enhance services affecting adults with dementia and intellectual disability.

Thus, we are pleased to report that since February, a number of these papers have been published. One of the papers, Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to Nomenclature, will appear in the October issue of the American Association on Intellectual and Developmental Disabilities' journal, Intellectual and Developmental Disabilities. Another, Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to End-of-life Care in Advanced Dementia, has been published in the Journal of Applied Research in Intellectual Disability. A third, International Summit Consensus Statement: Intellectual Disability Inclusion in National Dementia Plans, has been published by the American Journal of Alzheimer's Disease and Other Dementias. A fourth, Dying Well with an Intellectual Disability and Dementia, has just been published in the Journal of Dementia Care.

Several other papers are under consideration by various journals. One, Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to Post-Diagnostic Support, is with the journal, Aging & Mental Health, and another, Quality Care for People with Intellectual Disability and Advanced Dementia: Guidance on Service Provision, is with BMJ Supportive & Palliative Care. A paper titled, Consensus Statement of the International Summit on Intellectual Disability and Dementia on Valuing the Perspectives of Persons with Intellectual Disability, is under consideration by the Journal of Intellectual Disabilities, and the paper, a Summative Report of the International Summit on Intellectual Disability and Dementia, is under consideration by The Gerontologist.

Another reports and papers are in various states of preparation. These will address a variety of additional topics, including the needs of family caregivers, quality of life and dementia, and dementia-capable services design for providers. Each of these papers contains a series of recommendations that would address issues raised in the papers. These reports and publications are posted on the NTG website -- http://www.aadmd.org/ntg.

NIH Research Summit on Dementia Care: Building Evidence for Services and Supports

We are pleased to report that the NTG commissioned pre-Summit activity has produced a report titled, "Caregiving and Intellectual Disabilities and Dementia: Report of the Pre-Summit Workgroup on Caregiving and Intellectual and Developmental Disabilities". The members of the workgroup, led by Professor Tamar Heller, the chair of the Department on Human Development and Disability at the University of Illinois at Chicago, have completed their discussions and have provided us with a report with recommendations which will be submitted shortly to the Planning Group for the Summit. Copies will be available on the websites of the NTG (http://www.aadmd.org/ntg), the University, and the Summit.

Caregiver Resource Guide

We are also pleased to report that the NTG has completed the booklet and website media, "Intellectual Disability and Dementia: A Caregiver's Resource Guide for Rhode Islanders." This resource was commissioned by the Foundation for Seven Hills Rhode Island and was designed to provide valuable background information for caregivers, including a listing of relevant Rhode Island resources for helping caregivers. Seven Hills Rhode Island is one of the Administration on Community Living's Alzheimer's Disease Initiative grantees and its project work in currently in its second year. The Guide will be on the agency's website and print copies distributed throughout Rhode Island.

Closing

It is our hope that the Council will give due consideration to the substance and recommendations embedded in these various articles and reports, as well as the resource guide, at future meetings and when constructing next year's update of the National Plan to Address Alzheimer's Disease.


 

JUNE 2017 COMMENTS

N. Satyadev  |  06-27-2017

I would like to please submit the attached video for public comment during the next NAPA Advisory Council Meeting.

(video file) [Available as a separate link: https://drive.google.com/file/d/0BzBVXUmxGCMYd1Jrd0c0VUVWdVE/view]


 

C. Schelhorn  |  06-26-2017

Do you happen to know when the next NAPA Advisory Council meeting will be held? Is there a schedule for 2017-2018? We're working on our planning calendar and want to be aware of the dates.

ANSWER

Information on future meetings is available at https://aspe.hhs.gov/advisory-council-alzheimers-research-care-and-services#NextMtg.


 

H. Fillit  |  06-13-2017

Definitely speaks to the need for new therapeutics for Alzheimer's

==========

From: R. Louie

[Link to comments -- R. Louie]


 

R. Louie  |  06-13-2017

You may have seen the NEJM review last month by B. Ramsey, a noted cystic fibrosis investigator, and colleagues, about developing therapies when there are relatively few patients. The editors at NEJM were considering my AD related comment for a Letter, but it appears as an online comment.

http://www.nejm.org/doi/full/10.1056/NEJMra1612575#t=comments

Text:

An ironic counter-example: dementia
Ramsey, Nepom and Lonial describe how therapeutic success can be achieved despite daunting and frustrating barriers, even in the "orphan drugs" arena. The authors are modest about their own roles in these projects, and don't detail the leadership necessary to synergize collaborations between disparate, "siloed" organizations. An ironic counter-example, Alzheimer's Disease (AD) / dementia, is said to have five million patients. There is no disease modifying therapy, despite the enormous market, but the field seems to lack the clinical focus and collaboration discussed in the review. The NIH 2018 Bypass Budget for AD research calls for $1.4B, mainly for research that is not directly therapeutic. The Alzheimer's Association is active in research, one of several foundations for the disease. Pharmaceutical companies are heavily involved, but these elements are evidently not enough: over the last five years, only one new agent has been FDA approved, a capsule combining two older agents. Let's hope that AD and other patients awaiting therapy can benefit from the strategies, collaborations and implied leadership reported by these authors.


 

APRIL 2017 COMMENTS

R. Louie  |  04-270-2017

This is the same theme. I'm not that creative, but this version may be more accessible to a lay audience, I hope. They were able to publish it earlier online than expected.

http://www.baltimoresun.com/news/opinion/oped/bs-ed-alzheimer-progress-20170426-story.html

My original title was "The Emperor's New Clothes: A Ped Oncologist looks for Progress in AD", but the editors took a more direct approach. They also removed a light-hearted reference to the "New Clothes" fairy tale.


 

B. Hallberg  |  04-19-2017

At the suggestion of Dr. Peterson, I am making inquiry as to the application for membership procedure of the Advisory Council. Would you be so kind as to direct me to the appropriate link to gain information as to how best make membership application.

ANSWER:

Information on becoming a member can be found at https://aspe.hhs.gov/advisory-council-alzheimers-research-care-and-services#FAQ.


 

A. Bell  |  04-19-2017

I'm looking at this document: https://aspe.hhs.gov/advisory-council-april-2017-meeting-presentation-ltss-subcommittee-recommendations

How did the panel votedon the LTSS recommendations?

Thank you for your help.

ANSWER:

The final version of the Recommendations is available at https://aspe.hhs.gov/advisory-council-recommendations.


 

M. Sharp  |  04-12-2017

Hello and thank you for another opportunity to provide input from the perspective of FTD -- one of the "related disorders". In addition to input on the recommendations voted on this morning I would like to reiterate the need for a clear and consistent terminology on dementia and emphasize the potential benefits that could come from a working group on dementia nomenclature as recommended by the research sub-committee.

But first, I would like to follow-up on the topic of the February's council meeting and announce that the FTD Disorders Registry was launched on [Date] and that within [x days] of it going live, [x#] of people registered, which exceeded expectations by far. The creation of the FTD Disorders Registry was a joint effort between The Association for Frontotemporal Degeneration (AFTD) and The Bluefield Project to cure Frontotemporal Dementia. Registry data will be used by advocacy groups, scientists, and clinicians to support research studies and clinical trials. It is both a Contact Registry and a Research Registry and will become a powerful new tool to help develop therapies and treatments for FTD. I urge you all to look up the registry online and please do not hesitate to contact me or AFTD for more information.

As the Program Manager at The Association for Frontotemporal Degeneration I speak to a lot of people coping with one of the various clinical diagnoses that fall under the umbrella of FTD. One of the most common complaints I hear is how frustrating and exhausting it is to repeatedly have to say "no, my spouse is not too young to have dementia" or "no it doesn't affect memory" and "yes FTD is a form of dementia but it's not the same as Alzheimer's". On top of everything else people coping with FTD will often have to educate others about the disease, including the medical professionals and healthcare providers they turn to for help. For them, the need for clearer and more consistent terms is painfully clear and even small improvement could help ease their burden.

We realize there are many reasons why developing a uniform nomenclature is a challenge. Not the least of which is the fact that we still do not fully understand the pathologies underlying the different causes of dementia. The NAPA council has already done a lot to promote a better understanding of different types of dementia. But as discoveries and breakthroughs are made, clear and accurate language will be needed to share the news and make the importance of dementia research clear to all the potential supporters and stakeholders. It would be unrealistic to expect a working group to unravel all the linguistic knots around dementia, but how we talk about it will guide what we do about it. I encourage the council to see the working group on nomenclature as both an opportunity for continued success in increasing awareness and understanding of dementia and necessary to gain the support required to accomplish the goals of the National Plan.


 

S. DeSanti  |  04-12-2017

Good afternoon. I am the Vice President of Medical Affairs, North America and Asia Pacific, for Piramal Imaging. I want to thank the council for the opportunity to make comments during this very important meeting.

Piramal Imaging markets Neuraceq™, a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.1

Today, AD is usually diagnosed after an already symptomatic patient with a cognitive impairment undergoes an extensive clinical diagnostic workup. This workup typically includes family and medical history, physical and neurological examinations, psychiatric screen, laboratory tests (i.e. folate, B12 and thyroid blood tests) and imaging procedures such as computed tomography (CT) or magnetic resonance imaging (MRI) scans.

However, despite having acess to these mainstream diagnostic workups, it is clear that we are still far way from being able to early and accurately asses and characterize the cause of disease. A definitive diagnosis of AD can only be made post-mortum by histopathology which can reveal the presence of beta-amyloid plaques and neurofibrillary tangles. Recent post-mortem studies looking for AD pathology have shown that 10 to 30 percent of diagnoses based on clinical examinations alone are incorrect -- thus missing an opprtunity to better manage and provide care for patients who are suffering with the uncertainty of their cognitive decline.2

Our company is working to improve the diagnostic accuracy of patients by detecting the underlying pathologies causing the cognitive impairment. Combined with current diagnostic tests a PET scan with Neuraceq holds the promise to detect or rule out, with a high degree of sensitvity and specificity, the presence of beta-amyloid plaques in the brains of living patients. Studies have shown that diagnostic accuracy, physician confidence, and changes to patient management are seen when the results of the PET procedure, such as amyloid imaging are included as part of the diagnostic workup.3

Currently, beta-amyloid PET imaging is not covered by the Centers for Medicare and Medicaid Services (CMS) except for a limited number of scans performed under an approved Coverage with Evidence Development (CED) program. Per CMS program requirements, Medicare beneficiaries are eligible for one beta-amyloid PET imaging scan per lifetime, as long as the beneficiary is enrolled in a CMS-approved clinical trial.4

Since finalizing the CED decision in September 2013, CMS has approved four clinical trials of which three are actively enrolling with a total estimated beneficiary enrollment of 18,788. The bulk of patient enrollment is expected to occur through the Imaging Dementia -- Evidence for Amyloid Scanning (IDEAS) Study, which anticipates Medicare beneficiary enrollment of 18,488.5

Enrollment is expected to end in less than 1 year. Of the 46 million medicare beneficiaries over the age of 65, 15-20% are estimated to suffer from Mild Cognitive Impairment (MCI), a condition that increases the possibility of developing Alzheimer's or other dementias.6 However, fewer than 19,000 Medicare beneficiaries have access to beta-amyloid PET imaging as a covered Medicare benefit, due to the lack of clinical trial approvals by CMS. This means that less than 1% of the estimated 8 million to 11 million Medicare beneficiaries with MCI have access to beta-amyloid PET imaging.

This coverage ratio is lower than other Medicare CED programs, such as the National Oncologic PET Registry (NOPR), which enrolled over 100,000 Medicare beneficiaries7 and the Transcatheter Aortic Valve Replacement (TAVR) registry, which had registered almost 55,000 procedures by the end of 2015.8

While we recognize that CMS has the authority to institute CED decisions, Medicare is an entitlement program. All beneficiaries are supposed to have access to covered services and benefits. CMS is limiting coverage by not approving additional clinical trials under the beta-amyloid PET imaging CED. This is blocking beneficiary access to this important diagnostic tool, a benefit to which the beneficiaries are entitled. Furthermore, we are concerned that CMS has not approved clinical trials that will generate enough evidence to determine whether or not beta-amyloid PET imaging meets Medicare's "reasonable and necessary" standards for coverage.

We request that this Advisory Council ask CMS to explain how the current trials that have been approved under the existing CED will generate the evidence the agency needs to reconsider the PET coverage determination and efforts by the agency to develop or recruit investigators to develop new clinical trials that will generate other evidence necessary to reconsider the coverage determination.

Such an update provided in a public forum will inform stakeholders as to the current status of the CED determination, as well as publicize the types of research that the agency would like to see proposed in the near future.

We appreciate the opportunity to provide these comments, and we look forward to working with the Advisory Council to change the trajectory of Alzheimer's disease and related dementias. Piramal Imaging has also submitted written comments in advance of this meeting. Thank you.

NOTES:

  1. Full Neuraceq Prescribing information is available online: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf.
  2. Beach TG, Monsell SE, Phillips LE, Kukull W. J. Accuracy of the clinical diagnosis of Alzheimer disease at National Institute on Aging Alzheimer Disease Centers, 2005-2010. Neuropathol Exp Neurol. 2012 Apr;71(4):266-73.
  3. Boccardi M, et al. Jama Neurology, 2016
  4. Additional details on CMS' coverage requirements are available online: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Amyloid-PET.html.
  5. IDEAS Study. ClinicalTrials.gov NCT 02420756: https://clinicaltrials.gov/ct2/show/NCT02420756.
  6. Alzheimer's Association. 2017 Alzheimer's Disease Facts and Figures. https://www.alz.org/documents_custom/2017-facts-and-figures.pdf.
  7. CMS. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/NaF-18-PET-for-Bone-Metastasis.html.
  8. Grover F et al. 2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Jour of Am Coll Cardiology (December 9, 2016). http://www.onlinejacc.org/content/early/2016/12/02/j.jacc.2016.11.033?_ga=1.92519133.1911975317.1484767598.

 

MARCH 2017 COMMENTS

J. Webster  |  03-02-2017

With the future of our nation's health care reform and the repeal and replacement of Obamacare still unclear, Dr. E.F. Group III is reaching out to Health and Human Services Secretary Price in an open letter encouraging him to assemble a Health and Wellness Advisory Committee to focus on the root cause of our nation's healthcare problems including prevention and the implementation of proven natural remedies.

The open letter is online at http://www.globalhealingcenter.com/natural-health/open-letter-to-secretary-tom-price/.

Price has the responsibility to advise the President on matters of health, welfare, and income security programs across America. The open letter urges Price to assemble a team of scientists, experts, and independent researchers who have no ties to the pharmaceutical, food, or chemical industries. Their job will be to evaluate the safety and effectiveness of all artificial ingredients, genetically modified foods, colors, dyes, fluoride, herbicides, pesticides, phthalates, refined sugars, preservatives, and other toxic compounds added to or used in food and beverage production. These have been linked to the cause of many degenerative diseases.

"Our existing allopathic model treats the symptoms of disease, not the root cause. It does not encourage wellness or disease prevention," said Dr. Group, CEO of Global Healing Center. "The root cause of disease is the accumulation and exposure to toxins that pollute our air, food, and water. We know they damage our health, make us sick, and harm the earth."

Dr. Group and his team of healthcare practitioners are willing to volunteer their time, effort, and expertise to begin this conversation and work towards healing America. America can't be great again until we make America healthy again.

Dr. E.F. Group III founded Global Healing Center in 1998 with the goal of providing the highest quality natural health information and products. He is world-renowned for his research on the root cause of disease. Under his leadership, Global Healing Center earned recognition as one of the largest natural and organic health resources in the world. Dr. Group is a veteran of the United States Army and has attended both Harvard and MIT business schools. He is a best-selling author and a frequent guest on radio and television programs, documentary films, and is quoted in major publications.


 

JANUARY 2017 COMMENTS

 

S. Peschin  |  01-31-2017

Good afternoon. I serve as President and CEO of the Alliance for Aging Research. Thank you for the opportunity to provide a public comment.

I have a few thoughts for the council to please consider today:

  1. As I mentioned at the October council, we would still like to see Dr. Hodes include data on clinical trial recruitment and participation numbers for each NIH- funded AD trial in his federal updates moving forward. While it is interesting for Dr. Ryan to provide overall numbers of 150+ trials seeking 70,000+ volunteers, it would be more helpful to see if some trials have more luck with recruitment than others, and then to explore why. These reports would ideally include progress on recruitment of minority populations.
  2. The council should consider exploring the creation of a Medicare reimbursement for healthcare providers to cover their time counseling patients about clinical trials. Such a reimbursement may serve as an incentive for them to better identify cases. There is also concern by some docs that they may "lose" patients to trials, which means a loss in their business, so it's important to address this issue as well. These are issues that CMS or perhaps MedPAC could explore. A great deal of time was spent by HHS' Healthcare Payment Learning and Action Network to identify approaches for patient attribution that would be acceptable to providers. Perhaps this could be a starting point for alleviating these concerns.
  3. As far as I can tell, outreach efforts on AD clinical trial recruitment have been relatively limited to within the ADRD community. There may be a lot more opportunities for clinical trial education if these efforts expanded out to the aging network, such as senior centers and state health insurance programs (SHIPs). The Alliance is partnering with PhRMA to develop a short "pocket film" to educate older adults about clinical trials, and we hope all of you will use this free tool when it's done later this year.
  4. One more idea: would HHS be able to ask each of its agencies to include a "Find out about research opportunities" banner with the clinicaltrials.gov button on the front page of their websites?

     

Last, I have one more comment. To the federal members and staff that serve this counsel, and to your thousands of colleagues back at your agencies: The Alliance for Aging Research believes that the work you do is important, and worth defending. We have hope that this new Administration and Congress will share our sentiment on several of the research funding, clinical development, and healthcare issues that matter to us, and we look forward to working with them on those issues. They may also disagree with us on other issues. But, nothing will prevent us from speaking out and standing up for what we know is right.

Thank you for the work you do, and please know that we support you.

Thank you for the opportunity to comment!


 

V. Helmly  |  01-30-2017

Hi, I am looking to connect with someone who may be able to assist me in addressing challenges to the structure and processes of implementing our state plan. I am currently working as the Georgia Alzheimer's Disease & Related Dementias State Plan Coordinator and we are working on improving the processes and procedures of the implementation of our state plan and I would love to speak with someone on the federal level about advice or best practices. Would you be able to direct me to the best contact for this?

Thank you so much!


 

M. Sterling  |  01-29-2017

It's increasingly difficult for many families, struggling to care for someone with dementia, to focus. The first week of the new administration has left us wondering what an uncertain future will bring. As I'm writing this, the Affordable Care Act is in serious jeopardy.

When you ask most Americans, "what impact will the repeal of the Affordable Care Act have on people with dementia and their families?", most have never even considered that it WOULD have an impact. People need to know.

My colleagues at the LEAD Coalition did a wonderful job of outlining the "actual facts" in a concise, must-read issue brief. We have copies for each of you. This is important information because repeal of the ACA could very well impact the goals and recommendations of this Council for years to come.

Here are the important provisions hanging in the balance that EVERYONE needs to be aware of and those that are most important to my family:

  • Medicare annual wellness visit with a cognitive assessment so we can detect issues early, before families are in crisis.
  • Protection for pre-existing conditions, critical for adults with early-onset dementia and their caregivers.
  • Innovative models of care -- so we can find a combination of affordable care and services that WORKS for people with dementia and their caregivers.
  • Medicare-Medicaid care coordination -- critical for families with loved ones in the later stages of dementia.
  • Medicaid expansion -- so those with dementia can remain in the community while preventing the impoverishment of their spouses.
  • Funding for patient-centered research on dementia. As you may remember, I am a Patient Research Partner and Ambassador for PCORI and serve on the advisory council for the National Alzheimer's and Dementia Patient & Caregiver Powered Research Network -- which is doing important clinical research and must continue to do so.
  • New requirements for nursing homes -- aimed at improving the quality of care that we expect for our loved ones.
  • Finally, support for young adult caregivers, so they can remain on their parents' insurance through the age of 26.

     

So in this new era of "alternative facts", let's not leave Alzheimer's families in the dark, only to find the rug has been pulled out from under them and they never saw it coming.


 

F. Li  |  01-27-2017

I am here on behalf of the Physicians Committee for Responsible Medicine, a Washington DC-based nonprofit organization working to advance medical research. Thank you to the NAPA Advisory Council and to all those working tirelessly on the National Alzheimer's Plan to lead the growing efforts to halt the devastating effects of dementia on individuals and our communities.

Although evolution of the Alzheimer's disease and related dementias (AD/ADRD) clinical trials play a central role in achieving the goal of preventing and effectively treating AD/ADRD by 2025, we urge the Council to recognize a number of major caveats and gaps with the current approaches. In particular, there are four major factors in the current drug development pipeline that have and will continue to impede the development of effective disease-modifying treatments:

  1. Preclinical Validity Cannot Hinge on Animal Models: Most current clinical trials initiate from testing drug candidates in genetically-engineered animal models and so do not accurately capture the human disease. In addition, physiological differences between species confound the roles of intrinsic mechanisms essential to the human disease process. Hence, treatments found to be effective in these animal models are often found to be ineffective in human clinical trials. Preclinical research must accelerate emphasis of human-based approaches. (See: http://www.altex.ch/All-issues/Issue.50.html?iid=150&aid=4 ).
  2. Related Conditions Should Not Be Part of Exclusion Criteria: AD/ADRD is often associated with chronic conditions such as cerebrovascular disease, type II diabetes, cardiovascular disease, and hypertension. However, with the exception of studies that explicitly search for links, these important comorbid conditions are too often part of exclusion criteria from many AD/ADRD clinical trials. These exclusions bias our science and miss critical opportunities for important therapeutic approaches that can directly address the chronic factors contributing to sporadic AD (see also #4). And they may preclude effective interventions coming out of clinical trials from being broadly applicable to all AD/ADRD patients.
  3. Reduce Reliance of Familial AD factors to Inform Sporadic AD Therapy: Drug targets for clinical trials are often based on rare genetic defects associated with the inherited form of the disease rather than the chronic form of the disease found in the sporadic AD population commonly associated with lifestyle factors. Moreover, potential drug candidates are often tested in patients with the common form of the disease who may or may not carry the targeted genetic risk factors.
  4. Tackle Lifestyle Factors on Even-Footing with Genetic Risk Factors: Current AD clinical trials primarily aim to modify the pathology associated with AD/ADRD rather than addressing the important underlying lifestyle factors that have effects -- both positive and negative -- on the prevalence and progression of dementias. While beta-amyloid and tau may be important hallmarks of the disease, they may be only pathological consequences and not causes. Hence, targeting these elements often fails to modify the disease or only temporarily ameliorates the symptoms. In contrast, lifestyle factors such as diet, physical activity, exposures to toxins (e.g. tobacco, air pollution), cognitive and social engagement are powerful modifiers (http://thehill.com/blogs/congress-blog/healthcare/311025-ensuring-the-21st-century-curesact-ends-alzheimers). Epidemiological studies have shown that these factors can influence both dementia as well as the chronic diseases associated with and likely contributes to AD/ADRD. A shift to clinical trials with increased focus on prevention and intervention in these realms would forward the science greatly as well as improve and save many lives. (http://www.impactjournals.com/oncotarget/index.php?journal=oncotarget&page=article&op= view&path[]=9175)

     

As the NAPA advisory council works to address the important challenges in clinical trial recruitment, it is essential that the efforts of thousands of patients, caregivers, clinicians and researcher be focused on the most promising targets. Support for future trials based on data derived from humans, preclinical investigation in human-based models, greater prioritization of targeting lifestyle risk factors such as diet will greatly improve our development pipeline for effective interventions to prevent or reverse AD/ADRD in our nation by 2025.


 

I. Kremer  |  01-27-2017

Thank you again to the Advisory Council for your deep engagement in, and strong support for, the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers. We look forward to delivering findings and recommendations that will inform your Nation Plan Update, improve research, and ultimately deliver tangible, transformative results for tens of millions people across this country.

In today's meeting, the Advisory Council is focusing its vision on clinical trials, on how to adopt new and better approaches. That is laudable, appropriate and evidently necessary. I would encourage the Advisory Council also to focus on other assets we have now, assets that work well and hold potential to work even better if properly sustained and strengthened. Two of those assets are dementia-relevant provisions with the Affordable Care Act (ACA) and our federal workforce.

Reasonable people can and do hold a variety of views about the ACA as a whole. But there is widespread agreement that repeal or reform of the ACA would have significant and potentially dangerous implications for people with dementia and their families. The LEAD Coalition recently released an ACA issue brief ( http://bit.ly/LEADCoalitionACA and attached as a PDF) providing an overview of nine elements of the ACA vital to the dementia community. I would encourage the Advisory Council to review the issue brief and to be vocal about the importance of sustaining and strengthening these and other elements of current law that benefit people facing dementia.

I would encourage the Advisory Council also to be vocal about the harmful consequences of a federal hiring freeze or, worse yet, outright reductions in agency bandwidth. It is imperative that the ACL, CMS, CDC, the VA and other agencies are at full capacity to deliver better care, support and quality of life for those facing dementia today. And for all who look forward to a time when science liberates us all from the shadows of dementia, we know it is imperative that the NIH and FDA have the staff necessary to deliver breakthroughs.

Thank you for your leadership.


 

M. Hogan  |  01-27-2017

Once again I appreciate the opportunity to address the Council this morning. In anticipation of the discussion of Clinical Trials, as I write these comments in advance, I am hopeful that issues related to those with Down Syndrome have been included in the morning discussion.

I understand that there are ethical considerations around consent and capacity for those with DS and other intellectual disabilities in regards to participation in clinical trials. However, I am hopeful that participation in the current DS Biomarker research is robust and that the outcome of these studies will provide very useful information for those with DS as well as the general population. I am also hopeful that there will be further efforts to include people with DS in preclinical medication trials in an attempt to delay the onset of AD.

Attached you will find an NIA/NIH document produced by the Alzheimer's Disease Education and Referral Center called: Researchers seek Alzheimer's clues in people with Down Syndrome, dated August 25, 2013 and updated in 2015 [https://www.nia.nih.gov/alzheimers/features/researchers-seek-alzheimers-clues-people-down-syndrome]. This may shed some light on the issue of DS and AD for those on the Council who remain under-informed about this topic.

5 years after the release of the first National Plan we continue to face many challenges for our family members with DS and other forms of ID. These include:

  • Lack of adult clinics that specialize in care of individuals with Downs Syndrome.
  • Lack of training for interns and residents in issues related to ID population at large.
  • Limited proactive planning for those aging with DS/ID.
  • Lack of access to appropriate diagnostic processes across settings and specialties.
  • Potential misdiagnosis or missed diagnosis of AD in individuals with DS (we are now seeing diagnosis of young adults with DS in there mid to late 20's and early 30's which suggests that there is over-diagnosis of AD and missed opportunities to explore and define possible reversible conditions in these younger adults).
  • An untrained work force with very limited information about healthy aging, how to support and care for those with a diagnosis of AD or other dementia and how to interface with other specialties like Palliative Care to insure that there is quality of life until end of life.
  • Lack of attention to side effects of pharmacology, especially in those with Down syndrome who develop seizures concomitant with the onset of dementia. Thus some individuals possibly remain grossly over-medicated and further compromised.
  • Struggling caregivers, across generations, who are dedicated to supporting their family member with DS/ID and AD or other dementia at home or advocating for them in an alternative care setting.
  • A limited voice at this table.

     

In an effort to provide medical information for this population, Dr. S. Keller, NTG Co-Chair and Drs. I. Lott, UC Irvine and Nicole Baumer of Boston Children's Hospital will address an upcoming 2017 Annual Conference for Neurologists on Neurologic Complications in Adults with IDD. Dr. Keller has reached out to Medical Schools to determine the curriculum inclusion for this population. He will also address Neurology Residents at Brigham and Women's Hospital in Boston focusing on the ID population. Additionally, it is his hope to have a round table discussion to address issues related to the needs of adults with DS as they transition to adult Neurology Departments. In the meantime a coterie of trainers from the NTG is providing seminars and webinars to Agencies and Professionals, including Direct Support Professionals, across the US in an effort to expand knowledge, improve care and facilitate further development of local trainers. We are a small group taking on Herculean tasks.

In an effort to provide much needed information to families and other caregivers, including Direct Support Professionals, the National Down Syndrome Society (NDSS), in conjunction with the NTG and Alzheimer's Association, is in the process of preparing a companion document to Aging and DS. This new publication will focus on DS and Alzheimer's disease and will be released at the UN on 3/21, World DS Day.

As Dr. Janicki has noted in his public comments, the NTG and colleagues in US, Canada, UK and Europe are involved in the writing of a number of articles related to ID and Dementia, with the focus on expanding the knowledge base and improving care outcomes for those with ID and Dementia. This effort, resulting from public and private support in Scotland, is to be noted and commended with the sharing of rich ideas and significant efforts across borders.

The NTG has begun a fledging peer support group for Family Caregivers. We are grateful to the NDSS and Cure PSP who assisted us in our efforts. Response to this monthly group has been most positive with a growing number of participants from across the US. Included in this group is a number of parents of young adults facing extraordinary decline in function with no clearly defined cause.

Today we face looming issues with the Federal Budget and changes to the affordable Care Act that could potentially have a disastrous impact on individuals with dementia as well as their caregivers. These concerns will be further noted by I. Kremer, our colleague from the LEAD Coalition, but demand the attention of all of us at this table and well beyond.

These noted activities reflect a dogged commitment to increasing attention to this special population. I assure you we will persist in our tireless effort to see that people with DS and other forms of ID will remain an integral part of the national discussion of Alzheimer's disease and other dementias. We look to you for continued support as we work to expand our public/private efforts.

Thanks, once again, for the opportunity to be here.


 

S. DeSanti  |  01-27-2017

Piramal Imaging is pleased to provide the following comments to the National Advisory Council on Alzheimer's Research, Care, and Services. Piramal Imaging markets Neuraceq™, a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.1

Today, AD is usually diagnosed after a patient with a cognitive impairment undergoes an extensive clinical examination which typically includes family and medical history, physical and neurological examinations, psychiatric screen, laboratory tests (i.e. thyroid blood tests) and imaging procedures such as computed tomography (CT) or magnetic resonance imaging (MRI) scans. However, a definitive diagnosis of AD can be made only after death where an autopsy can reveal the presence of beta-amyloid plaques and neurofibrillary tangles. Post-mortem studies looking for accumulations of neuritic plaque densities and Braak neurofibrillary stages in the brain have shown that 10 to 30 percent of diagnoses based on clinical examinations are incorrect.2 Our company is working to improve the true positive and true negative rates of detection. When used with PET imaging, Neuraceq holds the promise to detect beta-amyloid plaques in live patients.

Neuraceq may be used to assist in the differential diagnosis of Alzheimer's disease or other dementia types. In a pivotal phase 3 clinical trial, Neuraceq was shown to have a high affinity to beta-amyloid plaques in the brain, a hallmark of Alzheimer's disease.3 A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.4

In clinical practice, a patient suffering from cognitive impairment would undergo a clinical assessment by his or her clinician. If after the clinical assessment there is still some uncertainty regarding the cause of cognitive impairment, the clinician will then refer the patient to an imaging center for a beta-amyloid PET scan, using Neuraceq as the diagnostic agent. A radiologist/nuclear medicine specialist reads and interprets the scan and sends a report back to the patient's referring physician. The report includes the reader's findings about the presence of beta-amyloid plaques in the patient's brain. The referring physician can use the clinical findings with the results of the Neuraceq PET scan, including the presence or absence of beta-amyloid plaques, in their differential diagnosis of the patient. Both clinical and Neuraceq findings are important to consider when constructing the patient's treatment plan. Studies have shown that physician confidence in diagnosis is increased when results from betaamyloid scans are used.5

Currently, beta-amyloid PET imaging is covered under Medicare's Coverage with Evidence Development (CED) program. Per program requirements, Medicare beneficiaries are eligible for one beta-amyloid PET imaging scan per lifetime, as long as the beneficiary is enrolled in a CMS-approved clinical trial.6 Since finalizing the CED decision in September 2013, CMS has approved only three clinical trials with a total estimated beneficiary enrollment of 18,788. The bulk of patient enrollment is expected to occur through the Imaging Dementia -- Evidence for Amyloid Scanning (IDEAS) Study, which anticipates Medicare beneficiary enrollment of 18,488.7

To our knowledge, CMS has not provided a public update on this CED program at an advisory council meeting. We hope to hear an update from Dr. Ling as part of the Federal Workgroups Update at the next meeting on February 3, 2017. Considering that the theme of this advisory council meeting is clinical trials for Alzheimer's disease and related dementias and recruitment challenges, we urge the advisory council to request regular updates from CMS outlining the agency's progress on reviewing and approving new trials under the beta-amyloid PET imaging CED at the Council's public meetings.

Beta-amyloid PET imaging is intended to be used according to Appropriate Use Criteria developed by the Amyloid Imaging Task Force, Society of Nuclear Medicine and Molecular Imaging and the Alzheimer's Association, as an adjunct to other diagnostic evaluations in the following instances:

  1. A cognitive complaint with objectively confirmed impairment;
  2. Alzheimer's disease as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert; and
  3. When knowledge of the presence or absence of beta-amyloid plaque density is expected to increase diagnostic certainty and alter management.8

     

Between 15-20% of Americans aged 65 or older are estimated to suffer from Mild Cognitive Impairment (MCI).9 However, fewer than 19,000 Medicare beneficiaries have access to beta-amyloid PET imaging as a covered Medicare benefit, due to the lack of clinical trial approvals by CMS. This means that less than 1% of the estimated 8 million to 11 million Medicare beneficiaries with MCI have access to beta-amyloid PET imaging. This coverage ratio is lower than other Medicare CED programs, such as the National Oncologic PET Registry (NOPR), which enrolled over 100,000 Medicare beneficiaries10 and the Transcatheter Aortic Valve Replacement (TAVR) registry, which had registered almost 55,000 procedures by the end of 2015.11

While we recognize that CMS has the authority to institute CED decisions, Medicare is an entitlement program. All beneficiaries are supposed to have access to covered services and benefits. CMS is arbitrarily limiting coverage by refusing to approve additional clinical trials under the beta-amyloid PET imaging CED. This is blocking beneficiary access to this important diagnostic tool, a benefit to which the beneficiaries are entitled.

Furthermore, we are concerned that CMS has not approved clinical trials that will generate the evidence that the agency itself claims is required in order to determine whether or not beta-amyloid PET imaging meets Medicare's "reasonable and necessary" standards for coverage. In the CED decision memo, the agency stated that approved studies must address one of more aspects of the following questions:

For Medicare beneficiaries with cognitive impairment suspicious for AD, who may be at risk for developing AD:

  1. Do the results of PET Aβ imaging lead to improved health outcomes? Meaningful health outcomes of interest include: avoidance of futile treatment or tests; improving, or slowing the decline of quality of life; and survival.
  2. Are there specific subpopulations, patient characteristics or differential diagnoses that are predictive of improved health outcomes in patients whose management is guided by PET Aβ imaging?
  3. Does using PET Aβ imaging in guiding patient management, to enrich clinical trials seeking better treatments or prevention strategies for AD, by selecting patients on the basis of biological as well as clinical and epidemiological factors, lead to improved health outcomes?12

     

In talks with the IDEAS trial steering committee, agency staff have indicated that the flagship beta-amyloid CED trial that has been approved is not expected to generate enough evidence to reconsider the coverage decision. This is troubling, especially since CMS has not approved additional trials with a significant number of beneficiaries that would be expected to generate enough evidence to reconsider the coverage decision.

The Advisory Council should ask CMS to explain how the current trials that have been approved under the existing CED will generate the evidence the agency needs to reconsider the coverage determination and efforts by the agency to develop or recruit investigators to develop new clinical trials that will generate the evidence necessary to reconsider the coverage determination. Such an update provided in a public forum will inform stakeholders as to the current status of the CED determination, as well as publicize the types of research that the agency would like to see proposed in the near future.

We appreciate the opportunity to provide these comments, and we look forward to working with the Advisory Council to change the trajectory of Alzheimer's disease and related dementias. If you have any additional questions, please do not hesitate to contact me.

NOTES

  1. Full Neuraceq Prescribing information is available online: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf.
  2. Beach TG, Monsell SE, Phillips LE, Kukull W. J. Accuracy of the clinical diagnosis of Alzheimer disease at National Institute on Aging Alzheimer Disease Centers, 2005-2010. Neuropathol Exp Neurol. 2012 Apr;71(4):266-73.
  3. AAN abstract 2012 Marwan Sabbagh (no published manuscript reference).
  4. Full Neuraceq Prescribing information is available online: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf.
  5. Schipke CG, Peters O, Heuser I, et al. Impact of beta-amyloid specific florbetaben PET imaging on confidence in early diagnosis of Alzheimer's Disease. Dementia and Geriatric Cognitive Disorders. 2012; 33:416-422.
  6. Additional details on CMS' coverage requirements are available online: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Amyloid-PET.html.
  7. IDEAS Study. ClinicalTrials.gov NCT 02420756: https://clinicaltrials.gov/ct2/show/NCT02420756.
  8. Full appropriate use criteria are available online: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3733252/.
  9. Alzheimer's Association. 2016 Alzheimer's Disease Facts and Figures. https://www.alz.org/documents_custom/2016-facts-and-figures.pdf.
  10. CMS. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/NaF-18-PET-forBone-Metastasis.html.
  11. Grover F et al. 2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Jour of Am Coll Cardiology (December 9, 2016). http://www.onlinejacc.org/content/early/2016/12/02/j.jacc.2016.11.033?_ga=1.92519133.1911975317.14 84767598.
  12. CMS. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/AmyloidPET.html.

 

M. Janicki  |  01-26-2017

I and Dr. S. Keller are the co-chairs of the National Task Group on Intellectual Disabilities and Dementia Practices (NTG), a group formed in 2010 with a mission to advocate for people with intellectual disability and their families and other caregivers when an adult with intellectual disability is affected by dementia (http://www.aadmd.org/ntg). The NTG is an affiliate of the American Academy of Developmental Medicine and Dentistry and is associated with the Rehabilitation Research and Training Center on Developmental Disabilities and Health at the University of Illinois at Chicago.

Subject: NTG Activities on Information Development and Dissemination

The notion we wish to raise today concerns our efforts to create and disseminate transformative information related to dementia and intellectual disabilities. We recognize, as does the Council, that much of the general public, health care professionals, and even workers in the field of intellectual disability, are relatively uninformed about the nuances of dementia and how it affects adults with intellectual disability, as well as their spouses, friends, and caregivers. In concert with colleagues within the Alzheimer's and other dementias, intellectual disability, and university educational community, the NTG continues to develop materials in various media to inform and disseminate such information.

The basis for this notion is that many families have difficulties obtaining reliable information on recognizing dementia and how to best provide care and supports, in particular when their relative with intellectual disability is in the late or advanced stage of dementia and needing end-of-life specialized care. Further, we recognized that there are many nuanced issues that at time mirror those affecting adults with dementia in general, but also there are recognizable differences posed by lifelong intellectual disability. These differences can pose barriers to acceptance into generic services or add to confusion about how to provide specialized services. It is our hope at the NTG, as it is among our international colleagues in the intellectual disability and aging community, that this information will provide a basis for increased understanding of how dementia affects people with intellectual disability (as it might among other recognized 'special populations') and constructively influence and affect state and local planning, public policies, and clinical and service practices.

This past October, the NTG partnered with colleagues at the University of the West of Scotland and the University of Stirling (near Glasgow, Scotland) and held an International Summit on Intellectual Disability and Dementia. Invitees from numerous countries within Europe and from the USA and Canada attended and discussed a number of topical issues and deliberated on the state of knowledge. From these discussions, a number of working groups were charged to produce background materials summarizing the issues and producing publishable reports. These reports encapsulate the key aspects of the issues and contain information and recommendations that can help expand knowledge, influence policy, and enhance services affecting adults with dementia and intellectual disability. The NTG's goal in this effort is to complement the activities of the Council and the various federal and organizational partners, and continue to make such information available and help transform policies and services so as to be more helpful to families and adults affected by dementia.

Thus, we are pleased to report that since October the participants of the Summit and their host organizations and associations have been busy on developing a series of summative reports. To date, one of the prepared reports, "Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to Nomenclature" has been accepted for publication by the American Association on Intellectual and Developmental Disabilities' journal, Intellectual and Developmental Disabilities. Another, "Consensus Statement of the International Summit on Intellectual Disability and Dementia Related to End-of-life Care in Advanced Dementia" has been reviewed and is pending acceptance for a special issue on end-of-care topics, in the British journal, the Journal of Applied Research in Intellectual Disability. A third, "International Summit Consensus Statement: Intellectual Disability Inclusion in National Dementia Plans" has been submitted to the American Journal of Alzheimer's Disease and other Dementias and is pending review. A fourth, "Defining Advanced Dementia in People with Down Syndrome and other Intellectual Disabilities: Consensus Statement of the International Summit on Intellectual Disability and Dementia" has been submitted to the Journal of Intellectual Disability Research, a British publication, and is also pending review.

Another grouping of reports and summative statements are in various states of preparation. These will attend to a variety of additional topics, including the needs of family caregivers, the perspectives toward dementia of people with intellectual disability, quality of life and dementia, post-diagnostic approaches to care, and dementia-capable services design for providers.

It is our hope that the Council will consider the substance and recommendations of these reports when constructing future updates of the National Plan to Address Alzheimer's Disease.

These reports and publications are available from us and also posted on the NTG website -- http://www.aadmd.org/ntg.


 

M. Ellenbogen  |  01-25-2017

By way of this speech I am making a formally request that the NAPA committee takes this issue to the top level of the HHS management as I believe what you are doing is not complying with the law.

On Friday, January 6, 2017 1:07 PM I sent a email for the February 3 Meeting Attendance as you can see below. I was denied this access and I am not being treated fairly under the disability guidelines. For two years now I have been ignored and so many others with dementia are not being heard. This must change.

"Hi,

I am requesting to speak at the next meeting public comments for the February 3 for NAPA. I am specifically requesting: reasonable accommodation under section 504 of ADA (Americans with Disability Act) to present my portion of the speech presentation by computer-link with video, or a telephone link-up such as conference call.

Thanks so much for your consideration."


 

W. Mansbach  |  01-24-2017

I am the CEO of Mansbach Health Tools and CounterPoint Health Services. Many of you on the Council are familiar with our BCAT - Brief Cognitive Assessment Tools. I am honored to sit on the Maryland Governor's Alzheimer's Disease Council.

I ask this Council to include scientifically validated brain health programs as part of its comprehensive recommendations.

Our new ENRICH® program is one example:

There are four "steps" to ENRICH®:

  1. an explanation of the six brain-healthy habits to mitigate your risk for dementia;
  2. the free ENRICH® Calculator which measures how well you currently are managing these habits;
  3. the opportunity to take a cognitive self-assessment or schedule a "virtual" BCAT cognitive assessment; and
  4. suggested "next steps."

     

We developed this program to address the needs of family caregivers, adult children of those with dementia, and others who are concerned about their risk for developing dementia. Modifying risk factors, increasing brain health, and screening are important factors in early detection and perhaps in delaying the onset of cognitive impairment.

We'd be happy to assist the Council in developing programs to promote brain health, to screen for cognitive impairment, and to provide non-pharmacological interventions for those who are cognitively impaired.

For more information, please visit our new website, http://www.enrichvisits.com.


 

J. Lyons  |  01-23-2017

I am an author and care consultant who helps older adults find the care they need throughout the country.

Today, I'll discuss challenges that arise due to the behavioral and psychological symptoms of dementia. These often cause people to become combative and dangerous to themselves and others. They can't always be calmed or redirected. Sometimes, the police become involved because the situation is too volatile for EMTs.

Situations like this necessitate our: identifying triggers, identifying causes of delirium, and determining both pharmacological and non-pharmacological tools for dealing with the behaviors.

Unfortunately, the system isn't designed to deal with behavioral crises in those with dementia.

As examples:

Short stay evaluation for medication adjustment in specialized non-rehab communities is private pay only.

Medication adjustment can be done in short term rehab but Medicare only pays after a 3 day qualifying hospital stay plus a demonstrated need for PT, OT, or Speech Therapy.

Or, medication adjustment can be done in a hospital. But, many hospitals aren't equipped to handle people who wander or are aggressive. Those with that capacity are few and far between and often don't have beds available.

We need a more streamlined system to obtain and pay for care in a dementia crisis. Requiring qualifying hospital stays raises costs to Medicare. Using observation beds to avoid the appearance of unnecessary hospital readmissions prevents patients from qualifying for rehab.

I ask the Council to identify a way to allow Medicare to pay for medication adjustment and behavioral health in qualified facilities without requiring that the patient first be admitted to the hospital for three days.


 

N. Tatton  |  01-19-2017

Frontotemporal Degeneration Disorders -- the Rare Disease of the AD Related Dementias

Frontotemporal Degeneration (FTD) is the most common dementia in people under the age of 60. It is a rare disease affecting at best estimate approximately 60,000 people in the United States. As such, it presents unique challenges when recruiting for clinical trials compared to Alzheimer's Disease which currently affects more than 5 million people in the US.

FTD is a diverse group of disorders that can present with behavioral, cognitive, language and motor dysfunction. Clinically these disorders are grouped as behavioral variant FTD, primary progressive aphasia, progressive supranuclear palsy, corticobasal degeneration and FTD with ALS. Diagnosis is challenging because it is a rare disease and most health care providers have no or limited experience with FTD disorders. Less than 30% of the FTD disorders are caused by a known gene mutation. FTD disorders also progress fairly rapidly, patients live on average 6-11 years after diagnosis. And for behavioral variant FTD, published studies have reported that it may take as much as 3.5 years before an accurate diagnosis is made.

Persons with FTD can display clinical symptoms that overlap between the disorder subtypes and this can complicate obtaining an accurate diagnosis. And some of the symptoms of FTD can be confused with psychiatric disorders. Currently there is no simple test to distinguish if someone has FTD versus another dementia or psychiatric disorder.

  • Recruiting for clinical trials for FTD disorders presents unique challenges because of this complex history. Some of these challenges are:
  • Recruiting adequate numbers of patients for a trial because of it is a rare disease. Sporadic behavioral variant FTD account for about 70% of the FTD disorders. Multi-site clinical trials are often necessary to find adequate numbers of volunteers who are able to participate in a trial.
  • Enrolling the right patient in the right trial. A definitive FTD diagnosis is only made at autopsy. While the patient is alive, the diagnosis is considered 'possible' or 'probable' depending on the clinical symptoms that are observed. At present we cannot distinguish between sporadic behavioral variant FTD patients that have an underlying tauopathy versus sporadic patients with an underlying TDP-43 proteinopathy -- the two major protein pathology subtypes found at autopsy with FTD.
  • Identifying patients early enough in the progression of their disease state so that there is a possibility that the putative drugs may have an effect. Diagnosing FTD early and accurately contributes to this recruitment challenge.
  • Retaining patients for the full duration of the trial can be a challenge because of a narrow window of opportunity that the patient is physically capable of completing the trial requirements and understands informed consent.

 


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