National Alzheimer's Project Act: Public Comments on Advisory Council Meeting, October 2016

• M. Ellenbogen  |  10-06-2016
• M. Hogan  |  10-25-2016
• M. Janicki  |  10-25-2016
• I. Kremer  |  10-25-2016
• R. Louie  |  10-24-2016
• J. Lyons  |  10-22-2016
• W. Mansbach  |  10-22-2016
• S. Peschin  |  10-25-2016
• N. Satyadev  |  10-21-2016
• M. Sharp  |  10-25-2016

• M. Sterling  |  10-25-2016

Thank you 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. Formation of summit advisory committees of people living with dementia and of caregivers, and their inclusion on the summit steering committee itself, reflect your commitment to the centrality of their role in decision-making. Their voices are essential to ensuring that the summit produces findings and recommendations that meaningfully improve their quality of life.

Thanks also to the National Institutes on Aging for its robust commitment to care and quality of life topics (https://www.nia.nih.gov/research/initiatives/concept-proposals-alzheimers-funding-opportunities#care) among 26 new Concept Proposals for Alzheimer's Funding Opportunities, (https://www.nia.nih.gov/research/initiatives/concept-proposals-alzheimers-funding-opportunities) approved at its recent NIA Advisory Council meeting. This reinforces positive steps planned in the FY 2018 professional judgment budget, (https://www.nia.nih.gov/alzheimers/publication/stopping-alzheimers-disease-and-related-dementias/about-fy-2018-bypass-budget) particularly NIH's proposal to nearly triple the amount of new funds dedicated to research on care and caregiver support from $9.8 million in the FY 2017 professional judgment budget to $28 million in the FY 2018 professional judgment budget.

I also offer congratulations to everyone who made possible the recently agreed upon Prescription Drug User Fee Act commitment letter. (http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) I hope the NAPA Advisory Council will urge Congress to adopt PDUFA VI reauthorization without delay. 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 Food & Drug Administration has all the tools necessary to efficiently review breakthroughs for safety and efficacy.

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The LEAD Coalition is a diverse and growing national coalition of 93 member organizations including patient advocacy and voluntary health non-profits, philanthropies and foundations, trade and professional associations, academic research and clinical institutions, home and residential care providers, and biotechnology and pharmaceutical companies. The LEAD Coalition is co-convened by USAgainstAlzheimer's and Volunteers of America. The coalition works collaboratively to focus the nation's strategic attention on Alzheimer's disease and related dementias and to accelerate transformational progress in: detection and diagnosis; care and support to enrich quality of life; and research leading to prevention, effective treatment and eventual cure. For more information about the LEAD Coalition, please contact: ikremer@leadcoalition.org.

I and Dr. Seth 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 RRTC on Developmental Disabilities and Health at the University of Illinois at Chicago.

The issue we wish to raise today concerns the issue of nomenclature related to dementia as it applies to intellectual disability. Reviews of publications (whether journal articles, book chapters, or reports and plans) involving intellectual disability show mixed uses of terms that generally relate to dementia or the diseases associated with it. Terms in use (including dementia, Alzheimer's, and other similar descriptors) lack precision or consistency when applied inappropriately. Some of this may be attributed to a lack of understanding of the distinction in the terms, the nuances involved with neuropathologies, or inconsistent use of language as well as absence of or inconsistency in an agreed upon core group of methods used in diagnosis. However, in the intellectual disability field this lack of precision in language in and of itself affects the understanding of the condition under discussion and confusion is further increased by a lack of agreement on common terminology in the domain of 'dementia'.

This lack of precision is not solely found in the intellectual disability field, as witnessed by recent efforts in the mainstream Alzheimer's and dementia field to address the same issue and in discussions held by the Council. The concern over coherency and lack of agreement on terminology within the intellectual disability field was recently discussed at the International Summit on Intellectual Disability and Dementia, held at the University of the West of Scotland (nr. Glasgow, Scotland) on October 13-14th -- which was co-sponsored by the NTG. Many of the same issues raised by the Council were echoed at the Summit, with the added concern that much needs to be done to reinforce and emphasize terminological precision and clarity among workers in the field of intellectual disability as the distinctions between the diseases associated with dementia and the expressions of dementia are often confused.

We recognized that the precision in terminology benefits reporting and communicating among researchers and enables the furtherance of scientific goals and findings. With this in mind, the Summit draft report recommended that scientific reports in the field of intellectual disability carry more precision with respect to terms employed and the final Summit report contain a taxonomy of terms typically found in dementia reports and documents, so as to provide guidance and a resource for researchers, administrators, clinicians, paid carers, and others who need to understand and use more precise terminology.

However, with particular acknowledgement of the use of descriptors when employed in general applications, the participants at the Summit noted that it would be beneficial to avoid 'high science language' in documents directed toward general readership audiences so as to facilitate understanding. Yet, we recognized that terms and definitions that are in common usage can help to ensure the communication of messages, but may add to the lack of precision. Further, creating or using definitions that minimize the seriousness, course, and eventuality of brain changes leading to dementia -- which may lead the public to believe that dementia is no more impairing that a minor aging-related discomfort and thus not worthy of concern -- can leave conditions untreated and eventualities devoid of planning. This is a conundrum in the field of intellectual disability, as communicating the definition and process of dementia to people with intellectual disability often creates a challenge. With this in mind, we suggest that to enable understanding, language and phrasing needs to be at a word-level that persons communicating with self-advocates or adults affected by dementia can effectively convey concepts associated with dementia. Further, the concepts need to be communicated in a manner so as to convey the seriousness of the condition, while not creating confusion or undue anxiety.

Given the concerns raised, the NTG supports, with two caveats, recommendation #4 in the 2016 US National Plan Update, which states that "Emphasis should be given to the standardization of terminology in dealing with cognitive and dementing disorders." The Update further recommends that "an integrated conference should be convened to develop consistent language for cognitive disorders among the scientists, care providers and the public... [and there is a need to] engage all of the stakeholders around these issues to reach a consensus for the benefit of persons with dementia, their family members and caregivers, and the scientific and service communities." We support this recommendation with two caveats: First, that the discussions around standardization recognize varied comprehension levels and produce variations in standardized definitions the reflect the varied educational and intellectual levels of the readers. Second, that representatives of the field of intellectual disability be invited to be participants at the 'integrated conference'.

AFTD is committed to helping anyone and everyone living with an FTD disorder find the information, resources and support they need to cope with the challenges they face. As far as we know, outside of the few families carrying an autosomal dominant form of FTD, all people have an equal chance of developing the disease regardless of their racial or ethnic background. However, we also realize that statement reflects how much we still don't know about the biology and natural history of FTD as much as anything else.

As a rare disease advocacy organization AFTD knows how scarce appropriate care and services for FTD are and how hard it is for people to find help and support or even basic information about the disease. We shudder to think how many people the current prevalence estimate of 50-60 thousand people in the US are missed because they cannot find the expertise and resources required to diagnose a disease as unusual as FTD. We also understand that addressing the health disparities discussed today is an important part of addressing that problem and a necessary in order to make a more accurate prevalence estimate for FTD.

In contrast to many rare diseases, our understanding of the basic biology of FTD has made significant advances over the past few decades, which would not have been possible without the support and attention NIH and NINDS has given to FTD research. But there are still many basic questions about FTD that need to be answered before we can begin to understand health disparities in a disease as diverse and complicated as FTD.

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

I have 3 recommendations for today:

1. Our first request is for HHS to ask Dr. Hodes to include in his federal updates moving forward, data on clinical trial recruitment and participation numbers for each NIH- funded AD trial. These reports should include progress on recruitment of minority populations, as was highlighted today.

   Our collective hope would be for trials to meet recruitment targets. But research shows that this is unfortunately not always the case. The Tufts Center for the Study of Drug Development reported in 2013 that 37% of all clinical trial sites failed to meet their enrollment goals, and 11% never even enrolled a single patient.

   If this is the case with AD trials, in whole or in part, then clinical trial recruitment should play a bigger role in the council moving forward.

2. Our second request is for the NIH to bridge its Alzheimer's disease research priorities with regulatory gaps identified by the FDA in basic science, biomarkers/surrogate endpoints, and drug development. Since the science is developing rapidly, NIA and FDA would benefit from ongoing conversation and updates on progress toward filling the scientific gaps. The Accelerate Cure and Treatments for Alzheimer's Disease--or ACT-AD--coalition, which the Alliance chairs, will be tackling this topic at our upcoming meeting on Wednesday, November 16.

3. On a similar note, we will like to see the FDA's Division of Psychiatry Products (DPP) more involved in the council and National Plan recommendation process, particularly as the focus of the council has shifted to care and since there is now increased interest from industry in developing new treatments for behavioral symptoms. If they are not doing so already, DPP could participate in the NIH care summit planning work as well as CMS' National Partnership to Improve Dementia Care to start. Both disease-modifying and symptomatic regulatory approaches and challenges should be mutually regarded in HHS' National Plan to Address Alzheimer's Disease. AD and related dementias are commonly viewed as neurodegenerative diseases only, and we would like to see more focus on the mental health treatment and care issues that encompass these diseases.

Thank you for the opportunity to comment!

Thank you for this opportunity to once again address the Council. As you may know I have a vested interest in people with Down syndrome (DS) who are at an increased risk to develop Alzheimer's disease at a much earlier age.

People with ID are specifically included in Strategy 2 H: Improve care for populations disproportionately affected by Alzheimer's disease and populations facing care challenges. Today we heard about the Gaps and Barriers to reaching and treating racial and ethnic groups referred to in Strategy 2 H. I am hopeful that we can continue to address and discuss the Barriers and Gaps in reaching and treating those with Intellectual Disabilities including DS, as part of Strategy 2 H.

In August 2016 I was at the Advisory Council meeting and heard the presentations from Indiana University and UCLA on their Aging Brain and Dementia care programs. We heard also about Team Integration and Home Based Workforce and lastly about the Value of Palliative Care. Since our public comments in August were limited to what was previously submitted, I would like to briefly to return to two of these topics.

The Aging Brain and Dementia care programs included specific goals that were directed at the general population and caregivers. The UCLA program included a dyad approach, recognition of the ADRD journey, comprehensive community based care with direct services to patients and families and a co-management model of care utilizing the services of a NP Dementia Care Manager. It included workforce development and family training. The outcome reflected patient, caregiver and physician outcomes that were all very favorable.

This type of support system would be most beneficial for individuals with ID, their family members, care partners, along with attending physicians.

• How can we create opportunities to experiment with this model for those disproportionately affected by AD, including those with ID/DS?
• How can we better integrate effective models of care to be inclusive of all of our diverse populations affected by ADRD?
• When we have separate service delivery models, we often do not have equal service delivery. How can we reduce the gaps in reaching and treating all of those referred to in Strategy 2 H?
• How can we create confidence and foster dialogue and inclusion across providers, i.e. Aging, Dementia, Healthcare?

   

The presentation on Palliative Care resonated strongly for me. Like many individuals with DS and ID, my brother Bill had numerous co-occurring conditions that resulted in pain. With the diagnosis of AD, there was little regard for the impact that these conditions continued to have on him. In the presence of a diagnosis of AD, all was attributed to this disease process. As a result he suffered greatly for the last year and a half of his life, despite our best efforts to advocate for pain management.

Individuals with ID have a history of marginalization in health care. Individuals with AD have experienced this same marginalization in the past, especially in the area of palliative care. It is encouraging to see the increased awareness and availability of palliative care for those in the general population diagnosed with ADRD. It is time to expand palliative care to include those with DS and other forms of ID.

The World Alzheimer's Report 2016 points out the importance of palliative care. In essence it states in part:

• Every person with a progressive illness has a right to palliative care.
• That good dementia care implicitly reflects a palliative care approach

   

In small nations like the UK, Scotland and Ireland, there appears to be both a greater discussion of and improved system of delivery of dementia care, including palliative care. We have much to learn from these countries.

In an effort to enhance awareness of issues related to pain for those with ID and dementia, I have attached material from the UK.

• How can replicate/disseminate this information in the US?
• How can we raise awareness of behavior as communication of an unmet need even in those with ID and ADRD?
• Lastly, how do we eliminate the possibility that those with ID and dementia will be left to suffer needlessly?

   

Thank you once again for your willingness to listen, reflect and act on behalf of this underserved population.

Do You Recognise Pain in Someone with a Learning Difficulty and Dementia? [Available as a separate link: https://aspe.hhs.gov/pdf-report/napa-public-comment-attachment-guide-gps]

Good afternoon. I'm MaryAnne Sterling. I am the co-founder of Connected Health Resources, (http://www.connectedhealthresources.com/) Ambassador for PCORI, (http://www.pcori.org/) Advisory Council member for the Alzheimer's Patient and Caregiver Powered Research Network, (http://www.alzheimerspcprn.org/) and recovering family caregiver for multiple parents with dementia.

Since I last spoke to you, my mom's journey with dementia has come to an end. Her loss leaves a huge hole in the world, but her legacy remains. As a nurse, her focus on person-centered care -- that she delivered for 40 years to each and every patient -- is a model for aspiring nurses everywhere.

As a 42-year breast cancer survivor, her participation in several important breast cancer studies continues thanks to a wonderful research team at Johns Hopkins.

And I am honoring her legacy as a caregiver by working with my friend Denise Brown at Caregiving.com to host the first annual National Caregiving Conference, (http://www.caregiving.com/national-caregiving-conference-hub/) December 2nd and 3rd, in Chicago. This is a conference by, about, and for family caregivers -- to include those who care for individuals with dementia. Sorry, but we just couldn't wait for the 2017 Care and Services Summit!

Our conference is part of a movement to ensure that all family caregivers have the help and support they need so they don't have to give up their lives while caregiving, but have the solutions they need to KEEP their lives. We want to spark important conversations about what we need as family caregivers and former family caregivers in our communities, our workplaces and our healthcare system.

We want family caregivers (and professionals who support them) to connect and share, to learn, to be inspired. We have a very special guest joining us to do just that: former caregiver and Grammy-award winner Patti Austin (http://pattiaustin.com/) will bring her incredible voice to our conference venue.

True to form, I will be teaching a pre-conference intensive course, (http://www.caregiving.com/national-caregiving-conference-hub/first-annual-national-caregiving-conference-agenda/pre-conference-intensives/) appropriately named "Turning Caregiving into Activism."

Please join us in Chicago for this ground-breaking event, which would not be possible without wonderful sponsors like Eli Lilly! You can find details at Caregiving.com.

Reading the meeting summaries from January, April and August this year, I saw very little about promoting therapeutic clinical trials (aside from caregiving), except for mentioning of the AD Clinical Trials Consortium with very few details (I did find the FOA/RFA). I noticed that both NINDS Director Koroshetz and NIA Director Hodes included the NEJM Satizabel /Framingham paper in their research / funding reports. Although this paper shows that AD incidence may be decreasing in the Framingham cohort, US AD mortality is increasing in contrast to heart disease and stroke, according to the CDC (cited in our blog piece below). Our blog piece examines publications as a surrogate for clinical research efforts.

http://www.seattletimes.com/opinion/appoint-an-alzheimers-czar-and-treat-it-like-aids-or-cancer/

http://thehealthcareblog.com/blog/2016/04/20/will-new-funding-improve-alzheimers-dementia-outcomes/

My name is Dr. William Mansbach, and I am the CEO & Founder of Mansbach Health Tools, LLC and the CEO & President of CounterPoint Health Services. I am honored to sit on the Maryland Governor's Alzheimer's Disease Council.

At our research center, we are currently engaged in two important projects. First, we are working on the development of a construct called cognitive-functional hardship (CFH) which will help identify at-risk adults and older adults in the community. The term "at-risk" refers to people who have challenges performing everyday tasks due to cognitive impairments, especially in the area of judgment. Second, we are developing a new test of practical judgment.

While researchers search for a cure, there is an immediate need to address the challenges of those affected by dementia now. This includes increasing early detection and mitigating safety risks posed by the disease.

First is the challenge of identifying dementia. Everyone on the Council understands the importance of early detection and identification of dementia. We at Mansbach Health Tools, through our Brief Cognitive Assessment Tools (the BCAT), are able to identify people as early as during the Mild Cognitive Impairment (MCI) stage and to differentiate among the different subtypes of MCI. Ideally, people with cognitive impairment would receive an early diagnosis which then would allow them and their families to create realistic plans and expectations for their future care needs. However, obtaining a diagnosis often is difficult. Access to screening can be challenging due to geography, mobility, and socioeconomic status -- creating health disparities. To help mitigate some of those challenges, we are able to provide screening through our Virtual Visits -- telemedicine available to anyone who has access to a telephone, computer, or tablet with a camera and phone service. We strongly recommend that the Council further explore telemedicine opportunities in identifying dementia.

Second is the challenge of addressing the safety risks caused by living with dementia. To best address these challenges, we need to identify the person's level of Cognitive Functional Hardship (CFH). We define cognitive-functional hardship as the difficulty one experiences in independently maintaining one's home environment and performing (without assistance) everyday activities as a result of cognitive decline. Persons with CFH have difficulties performing activities of daily living (ADLs) and / or instrumental activities of daily living (IADL) because of cognitive deficits. Once CFH is identified, a plan can be developed to protect vulnerable individuals at-risk for a myriad of problems, including falls, re-hospitalizations, medication errors, and other injuries.

It is important that all screening tools be sensitive, specific, and appropriate for the target patient. It is also important that the tools provide practical information valuable to the patient and caregivers. For example, someone with CFH might be able to remember THAT they have to take medication but not remember HOW to take the medicine correctly. Armed with relevant and accurate data, people with dementia and their caregivers can identify and mitigate risks to safety through developing accurate care plans, allocating appropriate resources, and implementing monitoring plans to identify when needs change.

Scientifically validated, highly sensitive, and accurate screening tools that can be administered in person or through Virtual Visits are an important means of early identification of dementia and of monitoring changes as the diseases progress. They also are the basis of creating practical care, safety, and financial plans to help those who are living with dementia and their families.

More detailed information is available on my website: http://www.theBCAT.com. I am happy to provide any additional information as needed.

My name is Jodi Lyons, and I am an author and care consultant who helps older adults find the care they need throughout the country. Most of the people I serve have some form of dementia. Many have behavioral issues that make it difficult for them to remain safely at home and difficult for them and their families to find an appropriate care setting.

I often refer to my clients (usually the adult children of the person with dementia) as the Club Sandwich generation -- stuffed between parents, children, careers, spouses, financial security, and community expectations. To further the sandwich analogy, a health crisis often acts like a panini press -- squishing everything together, applying heat, gluing all the parts together with cheese, and toasting the edges. One hopes that it doesn't burn the entire thing. It's impossible to undo.

To further complicate things, the practical manifestations of dementia look different in different settings. People living with dementia at home face different challenges than those who are living in an assisted living, memory care, nursing home, etc. Even within the same type of care setting, there are different costs, different services, and different styles. There is no one-size-fits-all solution.

The practical aspects of dealing with dementia require a team approach joining the public and private sectors with people with cognitive issues and their families.

To that end, I urge the Advisory Council to:

1. Establish additional public/private partnerships that address medical, financial, legal, practical, family, and housing needs.
2. Create an educated consumer base
3. Partner with programs to keep caregivers healthy -- including cognitive and emotional health.

    

Thank you for your time. I would be pleased to provide additional information. And, if the Council would find it helpful, I would be pleased to organize a bus tour to show what dementia looks like in various care settings.

I am so thankful to be still here. Many of my friends who were living with dementia have died and others are no longer capable of speaking. I am one of the lucky ones. My Alzheimer's is progressing very slowly. While that is good news it is also bad news. I will be forced to endure the worst part of this disease even longer than most. Knowing what I know now that will be like being tortured until I die. While I try to stay positive theses days and live life to the fullest, I am in pain every day from the frustration of not being able to be the person I was once. I continue to decline in to a childlike state.

Dementia, including Alzheimer's, is the most expensive disease we face. It is costing us more than heart disease and cancer. It is the third cause of death in the United States; more than 500,000 people die from Alzheimer's each year! We all get caught up in the big numbers, so I will break them down so they are more relatable.

• 41,666 is the average monthly death rate
• 9,615 is the average weekly death rate
• 1369 is the average daily death rate
• 57 is the average hourly death rate.

   

This is equivalent to almost three 747s crashing every day. Yet there is much neglect and discrimination regarding funding for Alzheimer's and related dementia research.

Preventative measures for breast cancer, heart disease and HIV have all made tremendous progress since the federal government made significant investments into research. Comparable investments must be made for dementia so we can accomplish the same successes, while saving millions of lives and trillions of dollars.

If we don't act now this disease has the potential to bankrupt this county. This is the most expensive disease in America. In 2016 $236 billion will be spent on Alzheimer's in terms of care and medication, with Medicaid and Medicare spending $160 billion. And unless you take action, the cost to Medicare alone will increase 365 percent to $589 billion by 2050.

Our investment today will lead to huge savings for the government and public, not to mention the lives saved. People with dementia are faced with discrimination at many levels and they lose their civil rights. That must change; we are still people and deserve to be treated as such. A person with cancer would never be treated the way we are. We need you to start making more of an effort to educate the public and restore our rights.

A few years ago I would have said I had no hope, but that has changed to 2.5 percent. I do believe we are closer to a cure today based on what has been learned from all the failures. I am so grateful that the budget has been increased to $991 million, but that is still far short of the two billion dollars that was said was needed years ago.

In my opinion we need a czar for dementia just like Vice President Joe Biden is to cancer and it sure worked for HIV. We are definitely at the tipping point. You have the power to make this happen. Please, I implore the House of Representatives, the Senate and the respective appropriations committees: Make the hard choices; increase funding for Alzheimer's disease by at least one billion dollars. Do everything necessary to ensure that Alzheimer's disease gets the exposure, commitment and funding necessary to change the course of the disease.

If you have not yet been touched by this devastating and debilitating disease it's just a matter of time.