Public Comment Index for the National Alzheimer's Project Act . 2020 Comments

04/17/2020

JULY 2020 COMMENTS

A. Lam  |  07-30-2020

I am the Medical Research Program Director for the Physicians Committee for Responsible Medicine. We are a non-profit health advocacy group based in Washington D.C. with over 12,000 physician members. The COVID-19 pandemic has exposed issues that we as the Alzheimer's Disease and Related Dementias (ADRD) community have known for some time. Although it has been encouraging to see the presentations on how we may address emergency preparedness and advance health equity, these are not sufficient. Disparities in care and in research have clearly widened due to the global pandemic. The cracks in our ADRD systems of care have now become fissures.

Although the Advisory Council had already recognized that diversity and health disparities were major issues prior to COVID-19, fundamental issues were not addressed. Roadmaps and research implementation areas were being developed, but in practice the National Plan largely conceptualizes these issues as being addressed in clinical trials and care services. We call on the Advisory Council to recommend immediate action by the National Institutes of Health (NIH) to integrate diversity and health disparities factors throughout the entirety of the therapeutic development process. Relegation of the study of these factors to "the population studies and precision medicine" implementation areas or cross-cutting themes of the National Plan are insufficient. Integration of diversity must be foundational and start with human-based research in the therapeutic discovery phase within "disease mechanism and translational tools".

Thanks to substantial commitments from the public, the NIH has resources to immediately carve out new priorities to address these gaps in ADRD preclinical research. Without these human-based approaches that factor in diversity we hold back our understanding of ADRD and we prevent potential therapies from being developed and effectively applied in a highly heterogeneous society.

To be clear: Understanding human diversity will require human-based approaches. We cannot and should not reduce highly complex risk factors and human diversity factors into narrow subsets of features in animal models.

Fortunately, there are multitudes of modern ways to study the impact of human diversity on ADRD throughout many scales of biological and environmental interaction. We urge the national leadership to rebuild the framework of scientific practice. Research of diversity factors in ADRD must be clearly indivisible from research of the mechanisms and phenomenology of the disease. This should start by the creation of a new action plan for diversity factors in preclinical research.

Our six specific calls to action include:

  1. REPORTING & REPRIORITIZATION: Report the number of animal model grants. Shift this funding towards human-based methods of human diversity.

  2. CREATE NEW FUNDING: Create new dedicated human-based neuroscience research funding and other resources for high-quality basic neuroscience and preclinical ADRD research. These new projects must explicitly address human diversity factors. These opportunities may take the form of new Concept Clearances and RFPs that specifically stimulate research areas for human diversity using exclusively human-based methods.

  3. CHANGE THE REVIEW PROCESS: Overhaul the scientific review process so that (a) human-based research and (b) diversity are major factors in the scientific criteria and numerical "impact scores". It is inadequate to consider these only as "non-numerical scores".

  4. DIVERSE BIOSPECIMENS & NEW PARTNERSHIPS: Coordinate new partnerships that increase the availability of diverse human biospecimenrepositories. Set a timeline to ensure that resources are developed to represent disproportionally affected groups, such as ethnic and rural populations.

  5. HUMAN-BASED TRAINING: Create (a) new training programs for early career scientists where human-based diversity factors are foundational to their research and (b) new retraining requirements for established researchers to replace outdated approaches with modern human-based approaches that address diversity. The training should advance human-based methods and theoretic frameworks. It will be important to strongly partner -- equally and ethically -- with the communities experiencing health disparities.

  6. DIVERSITY & HUMAN-BASED RESEARCH TASK FORCE: Given the urgency of the matter and the disparities intensified by the pandemic, a taskforce should be created as soon as possible to implement the above recommendations. The action plan should be enacted by the next National ADRD Research Summit. The task force should include representation from all stakeholders.

We have no time to waste. As others have spoken today, we can emerge from this crisis more inclusive and equitable. The positions that the committee takes can make all the difference. You can help rally broad support for these most needed priorities of diversity and addressing health disparities in preclinical research, leading to better care and wellness for all. The Physicians Committee stands ready to help the Council and NIH in the next bold stages of the research priorities in the National Alzheimer's Plan.


 

N. Super  |  07-29-2020

  • Good afternoon! I am Nora Super, Senior Director of the Milken Institute's Center for the Future of Aging. Today, I'm happy to announce the creation of the Alliance to Improve Dementia Care, of which I will serve as Executive Director. [https://milkeninstitute.org/centers/center-for-the-future-of-aging/alliance-to-improve-dementia-care]

  • Last November, the Milken Institute released a comprehensive report to examine the evidence and put forward 25 actionable recommendations to reduce the cost and risk of dementia. We believe these recommendations align well with the goals of the Advisory Council on Alzheimer's Research, Care, and Services -- especially those that were presented today as cross-cutting recommendations. [https://milkeninstitute.org/reports/reducing-cost-and-risk-dementia]

  • After consulting with a broad network of stakeholders, we identified the need to establish an Alliance focused on improving dementia care to move these recommendations forward.

  • Using the convening experience and expansive network of the Milken Institute, the Alliance will bring together partners from health systems, industry, research, advocacy, philanthropy, and government to better communicate, collaborate, and advance recommendations to improve dementia care. [https://milkeninstitute.org/new-about]

  • We believe the Alliance comes at a critical moment to ensure we build workforce capacity and implement comprehensive dementia-care models to effectively identify people at risk for or living with dementia, tailor services to meet their needs and those of their caregivers, and ensure they get the right care at the right time.

  • With support from founding members AARP, the Alzheimer's Association, Bank of America, Biogen, and The John A. Hartford Foundation, we seek to partner with leaders across multiple sectors to create solutions to optimize the workforce, build system capacity, and integrate services and support.

  • We are also deeply committed to developing and promoting policies that reduce disparities in prevalence and access to services for populations at the highest risk for dementia, including women and communities of color.

  • The Alliance to Improve Dementia Care is accepting new members and supporters. For more information on the Alliance to Improve Dementia Care, please visit the Milken Institute website https://milkeninstitute.org/centers/center-for-the-future-of-aging/alliance-to-improve-dementia-care.


 

B. Ker  |  07-18-2020

i am against the use of animals in this and find the use of dogs, monkeys, cats, etc where they are terribly abused and then to be nothing but sadism. the fact is you use millions of anmals eveyr month at the nih and this waste is disgsuting. find people and find out what they ate, what their bdies are doing. there is absolutely no rason ever to use animals. and subject them to this horror. nih is wasting our tax dollars with their research. they paid somne lady named elizabth who was working on moneksys and subjecting them to terrible abuse for 30years and she found nothing o fhelp. nothing. we wasted our moneyu to give her a cushy job where she just killed animals for her worthlessness. this needs to stop. we are outraged over this misuse of animals in labs. it needs to be stopped. we do not want our tax dollars used for this purpose. this comemtn is for the public record. please receipt.


 

K.L. Haggerty  |  07-16-2020

I am Project Director at Education Development Center, a non-profit research and development organization. I prepared these public comments with Dr. Epstein-Lubow, a geriatric psychiatrist at Butler Hospital and Associate Professor at Brown University and Dr. Reuben, Professor of Medicine and Chief of the Division of Geriatrics at the David Geffen School of Medicine at UCLA. These comments are our own.

In an public comment at the January 27, 2020 meeting, we stated that the Assistant Secretary for Planning and Evaluation (ASPE) and this Advisory Council must address payment reform for dementia care and treatments. There are at least six working models in the US for dementia care that improve quality, achieve better clinical outcomes for persons living with dementia and caregivers, and some lower costs; but, dementia care using these models is not widely available.

ASPE should be aware that on Nov 7, 2019 a one-day meeting focused on "Payment Models for Comprehensive Dementia Care" convened over fifty clinicians, researchers, advocates, payers and other leaders with expertise in dementia care and healthcare payment. The conference was heldin Washington, D.C. with support from The John A. Hartford Foundation, Hebrew Senior Life, and Education Development Center. During the conference, these experts reviewed short-term solutions for payment reform and discussed next steps for accelerating the use of current and new payment models. A manuscript describing conference outcomes has been accepted for publication in the Journal of the American Geriatrics Society. The manuscript includes recommendations for improving access to comprehensive dementia care through payment reform, research, education and advancement of a population health approach to coverage based on risk and need. HHS should consider the expert recommendations in this manuscript when it becomes available.

In addition, HHS should act now to advance payment reform efforts through three activities:

  1. Continue work previously conducted by ASPE regarding Examining Models of Dementia Care, and how they have been modified during the COVID-19 pandemic;

  2. Convene at least one work group to address payment reform for comprehensive dementia care; and,

  3. Begin immediately to monitor how the inclusion of dementia as a risk adjustment modifier in the CMS Hierarchical Condition Category (HCC) coding affects the definitions of populations of people living with dementia, the quality of care, the types of care received, and the health outcomes of those individuals.

These recommendations are in alignment with the National Plan to Address Alzheimer's Disease's Strategy 1.E (Facilitate translation of findings into medical practice and public health programs) and all Strategies under Goal 2: Enhance Care Quality and Efficiency.

Thank you for considering these comments.


 

S. Stimson  |  07-11-2020

Where would I go to find a complete list of tribal nursing homes through out the USA?

ANSWER:

CMS has a Tribal Nursing Home and Assisted Living Facility Directory 2020 on their website at https://www.cms.gov/Outreach-and-Education/American-Indian-Alaska-Native/AIAN/LTSS-TA-Center/the-tribal-nursing-home-collaborative. Hope this helps.


 

H. Olds  |  07-9-2020

I was viewing the website for the trainings and was wondering if CEU's are going to be offered for these courses?


 

J. Shook  |  07-08-2020

My mom is in early stage dementia.


 

M. Ellenbogen  |  07-07-2020

Attached is my speech for the NAPA meeting. There is nothing wrong with the format as this is what I need to do in order to read it. It would be great if you can leave it that way so others can see what I must do to continue to be able to function as it may help another person with dementia who also has trouble reading any more.

Please let me know the next steps or if I need to do anything else. I may also add to my comments once I see the agenda and hear the discussion for that day.

ATTACHMENT:

My name is Michael Ellenbogen.          Some of you          may remember me          as I live with dementia;          but I am living life to the fullest          and making huge changes          in how people with dementia          should be treated,          wherever they live.         Although my request to speak          over the internet          for so many years was originally denied          a higher-level power          ensured that I had my chance to be heard here today          and I now understand          that all of those with dementia          can now be heard         no matter where they are in the US.          I remember          about 5-6 years ago          when I stood on the floor          and insisted you include people with dementia          as part of the process.          To my surprise          you rose to the top           and did exactly that          the following year.         For that I am extremely grateful.

I now want to commend you          for taking this action of listening to them         over the internet          which will make everyone          so much more knowledgable          as they are the true experts          when it comes to knowing what itsreally like  to live with this disease          and what it truly needs to improve our lives. 

But we still need a little more tweaking.          As part of this program,          you need to add one more person          living with dementia          to the NAPA board.         I have done this for a very long time          and it is my time to move on.          I do hope          that others will step up to the plate          and take over          where I left off.          So much more needs to be done;          but it will only happen          if others          with dementia         continue to fight          for our civil rights          and be heard         and included in the process          of all decisions being made.

It is important          for them to also understand         things do not happen by just saying it          once or twice.          But we must continue to repeat it          as many times as necessary          until it finally becomes part of the process.          I personally know         it is not easy          but we can not give up          as some things have taken 5 years          to finally happen.         Don'tbecome discouraged          if you are not successful;          but think outside the box          for a new method         to get your points across.

Thank you again          as we continue to make progress towards         "Nothing About Us Without Us".

P.S.         I would also like to thank          Arnold & Porter law firm          for standing up for all those          with dementia because if it were not for their assistance          our voices would have been kept silent.

WHEN ASKED IF HE WOULD LIKE TO UPDATE HIS COMMENTS:

Thanks so much for the opportunity to update but I have no Idea on what I sad because I only though about it an hour before my speech and I had no notes. I tend to live in the moment. Please use what you already have. Hope you show it the way I sent it in and let other know why I do that. Even that is becoming hard for me to read as I was really struggling this time. Butit worked great for about 8-10 year. Reading and writing is really become a big issue. Even following TV as the way people speak it'stoo fast to possess. Have a great day


 

JUNE 2020 COMMENTS

L. Gerdner  |  06-25-2020

We have corresponded before on my work with Individualized Music in persons with Dementia. I am hoping we might be able to collaborate on an extension of that work. Attached are two documents. Attached are two documents to explain further. I hope if you are interested, we might be able to discuss further with my colleagues.

ATTACHMENT 1:

We have corresponded previously and you have helped to distribute information on the Evidence-Based Protocol: Individualized Music for Person with Dementia. I would like to share a new opportunity to further collaborate with members of the Advisory Council that makes this intervention even easier to use.

I'm so excited to tell you about a new project with which I've recently become involved. The project involves the theory-driven intervention of Individualized music.

Last year I was approached by two gentlemen, David and Ethan Alpert (first cousins), who had it in mind to 'digitize' my protocol for individualized music as an intervention for agitation in persons with dementia. Since then, after quite a few phone calls and sharing of information with David and Ethan, I have agreed to become an principal advisor to, and director of, the company they founded: 'reMindA.I. -- Music Therapeutics'.

Briefly, our objective is to enable my evidence-based guideline to be capable of reaching far more effected seniors than might otherwise benefit from the original 'analog' protocol (that is, to scale, in the current vernacular) and, perhaps equally important in this perilous time for seniors, to permit the intervention to be conducted remotely -- without requiring the face-to-face contact with family members, nursing professionals and other caregivers, that would normally attend its implementation.

The application, currently under development, curates individualized music playlists in a manner consistent with my protocol, and delivers the resulting selections to a listening device specifically designed for use both by seniors with mild cognitive impairment, as well as those who may be otherwise unimpaired but who, unfortunately, suffer the effects of agitation, anxiety, and feelings of isolation all too often associated with aging.

Given the ambitious scope of this project, we feel strongly that it both requires and deserves as much expert guidance as we can assemble from the best minds in the field. Having gotten to know David and Ethan well during these past six months, I am confident that they share my firm resolve to ensure that it is properly developed and tested -- and, accordingly, I have agreed to do my utmost to facilitate that outcome.

To this end, I am reaching out to friends and colleagues like you, whom I know can add tremendous value to the development, iteration and trial of the product, in the hope that you might be willing to learn more about the solution, comment on its features and design, and provide us with any feedback that you feel will help us create a final product of which we can all be very proud.

Should you be kind enough to participate in this exciting project with us, I will have Ethan and David send you their non-disclosure agreement for review, after which they will provide you with more detailed information.

I would be so grateful for any input you are able to provide.

ATTACHMENT 2:

reMindA.I. Business Model Summary flyer.

 

S. Stimson  |  06-04-2020

Any way to let people know about the attached flyer?

ATTACHMENT:

Montessori Principles for Leadership and Staff Engagement flyer.

 

MAY 2020 COMMENTS

J. Kline  |  05-30-2020

Caring for elderly loved one.


 

C. Zometa  |  05-20-2020

I am working on a project that will look at how COVID 19 is affecting Latinos in the area of Alzheimer's. Do you know of organizations that work with the Latino population in the area of Alzheimer's?

I came across Jason Resendez from US against Alzheimer's.

ANSWER:

I have forwarded your email to the Council, who could best point you in the right direction. If you haven't received a reply by next week, please let me know.

In the meantime, the October 2016 Advisory Council meeting discussed racial and ethnic disparities. Check the panelist bios at https://aspe.hhs.gov/advisory-council-alzheimers-research-care-and-services-meetings#Oct2016 and you might find someone there.


 

APRIL 2020 COMMENTS

J. Agyenim-Boateng  |  04-14-2020

I am a graduate student studying Gerontology at Georgia State University. I am writing this email today because I have attached a letter that I would like to be made available to either of the Co-Chair of the Advisory Council on Alzheimer's Research, Care, and Services (Madam Katie Brandt & Dr. Allen Levey. This letter has some recommendations, and I hope to get some feedback very soon.

ATTACHMENT:

Recommendations to increase rates of Individual Awareness on Dementia Diagnosis.

I am a graduate student studying Gerontology at Georgia State University. I would like to make a few recommendations to the Advisory Council on Alzheimer's Research, Care, and Services on how to increase individual awareness on Dementia. According to an Issue brief released in January 2020 by the ASPE, personal knowledge on Dementia is very low as such people are not failing to report when asked about the Dementia status. Individual awareness is essential because it affects caregiving, healthcare, and family support. Apart from the fear of stigmatization for reporting Dementia status, individuals may not be aware of their diagnosis, and physicians are not communicating clearly to them. The most affected are people with low incomes, low education, and are also of a racial or ethnic minority group.

There is a possibility physicians may have inadequate skills and training to communicate a dementia to this vulnerable group.

My first recommendation will be to advise for the introduction of is Dementia education for healthcare providers, especially physicians, which will be focused on Dementia diagnosis communication and reporting to social minorities and those of low social class.

My second recommendation to the Council is to advise for the increment of funding on educational programs so that more people get the opportunity to partake in it. This could also be achieved by forming a partnership with the WHO to fund and support the education programs.

I hope my recommendations will be discussed at your next meeting. I look forward to your reply soon.


 

K. Slocum  |  04-06-2020

We just wanted to express our gratitude for the Dementia Care Summit and for all the work that is being done.

Our memory care and assisted living facility in Washington (https://www.magnoliawa.com/) is so passionate about finding resources for our home and our residents.

I hope we can be in attendance sometime in the future!


 

FEBRUARY 2020 COMMENTS

B. Bauer  |  02-28-2020

Please find the subject input attached.

ATTACHMENT:

https://alzheimersabcs.com/

Shared Alzheimer's Disease information for anyone motivated to learn

ALZHEIMER'S DISEASE OBSTACLES

Do AD obstacles shape realism and hope? Can Alzheimer's Disease be Cured? Can Alzheimer's Disease be Prevented and/or Delayed? Why have so many trials failed over the past two decades? What are the obstacles? These are all questions that have sensitivity associated with them and realistic expectations may be viewed as being negative.

Realism and Hope

Bruce's realism: --> Alzheimer's Disease (AD) causes the death of neurons in the brain. With an overproduction of the Amyloid Precursor Protein (APP), amyloid peptides along with fragments are produced. Amyloid plaque is formed in responses to inflammation. Aggregates accumulate over many years (assume 10)to an unknown level where an unknown mechanism triggers fibrils and tangles in the Tau Protein. Fibrils and tangles are followed by the death of neurons, thereby beginning Alzheimer's Disease. Bruce's Hope:--> Implement Bruce's Prevention Hypothesis https://alzheimersabcs.com/2019/01/04/510/ by approving Solanezumab, Aducanumab, and Gantenerumab to treat amyloid accumulation during the assume 10 years of accumulation. In parallel perform basic research to identify an effective intervention to delay and/or halt neuron loss through preventing the amyloid trigger mechanism (currently unknown) of Tau Pathology.

Can Alzheimer's Disease be Cured

Alzheimer's disease cannot be cured today. Cure means correcting damage and returning to a normal state. At the symptomatic cognitive impairment stage of AD there is too much neuron damage to return to a normal state. However, with new knowledge and new technology, it might be possible in the future to develop a bypass implant that could replace damaged portions of the brain, such as the Entorhinal Cortex. Such knowledge and technology may take centuries.

Can Alzheimer's Disease be Prevented or Delayed?

Alzheimer's disease may possibly be prevented and delayed. Prevention takes intervening before neuron damage occurs in the Entorhinal Cortex (EC). Neuron loss is believed to start possibly 10 years before cognitive impairment is diagnosed as Mild Cognitive Impairment (MCI). Neuron loss is belief to start in theTtransentorhinal and Entorinal cortices.

Delaying AD is more of a challenge, as delay means to slow or stop disease progression, either before or after the disease has started and neurons have been lost. This optimally would be in the presymptomatic Prodromal AD stage, and possibly during the cognitive symptomatic MCI stage. Either period has challenging obstacles that involve the brain's immune system along with the varied forms of the Tau protein.

Recent basic research has reported encouraging Tau protective findings involving the ApoE gene. First was two ApoE 2 allele prevented AD. Second was a single nucleotide change in the DNA also appears to have delayed the disease. However, both had negative consequences on Cholesterol and heart issues.

Therefore, the issues are: a) What is the amount of neuron damage? b) What is the presymptomatic efficacy requirement for an intervention? c) What is the insurance coverage (before & after Medicare eligibility)

Why have clinical trials failed?

Three hypothesize obstacles may explain these AD trial failures: (a) Targeting the wrong pathophysiology mechanisms (proteins, peptides, etc.); (b) The drugs do not engage the intended targets; and (c) The drugs are hitting the right targets but are doing so at the wrong stage of the disease". (Reisa A Sperling et. al. Nov. 2011).

Bruce's reasons for Clinical Trial failure

  1. The wrong Stage of the Disease -- Patients selection criteria of Mild & Moderate Alzheimer's Disease (AD) had too much neuron damage to demonstrate the FDA efficacy requirement (Meaningful Cognitive Benefit) to attain market approval.

  2. Possible right drug & target, but wrong stage. Monoclonal Antibodies (MABs) demonstrated dissolving and removing amyloid but too late in the disease process. These drugs and the amyloid target have to be before neuron loss begins to be effective.

  3. FDA Market Requirement -- Meaningful cognitive benefits requirement is not possible once amyloid aggregates accumulation triggers neurons loss via Tau fibrils & tangles. There is no existing evidence to indicate that new neurons can be created.

What are the obstacles?

Bruce views the obstacles as "Disease Oriented", and "Stakeholder Oriented" as follows:

Disease Oriented Obstacles

  1. Biological biomarkers: Non-invasive, cost effective biological biomarker (Blood, neurofilament protein) are needed for Asymptomatic Prevention and Prodromal AD delay stages.
  2. ApoE Allele 2,3,and 4 role in Tau pathology along with possibility of genetic engineering changes to an allele currently lack basic research knowledge.
  3. Brain's immune system's role: Additional knowledge and understanding needed for delaying or halting AD during Prodromal stage once Tau fibrils and tangles start.
  4. Tau protein's isoforms: Additional knowledge and understanding of their role relative to AD, Supranuclear Palsy, and Frontotemporal Dementia.
  5. Tau Hyper-phosphorylation: Additional knowledge and understanding is needed relative to fibrils and tangles.
  6. Rate of neuron damage: needed for determining an efficacy criteria for delaying the disease process during the Prodromal AD stage.
  7. Rate of amyloid aggregate accumulation: Needed for Asymptomatic intervention efficacy, along with the trigger point causing Tau fibrils and tangles to begin.
  8. The amyloid accumulation mechanism that trigger Tau fibrils and tangles would be a significant finding.

Stakeholder Oriented Obstacles

  1. Awareness and understanding of AD by caregiver, patient & the general population.
  2. Leadership, who appear driven by psychiatry educated medical methods and guide research from their past experience of treating cognitive impairment symptoms as opposed to addressing Biological causes for neuron loss.
  3. FDA market requirement -- (Meaningful Cognitive Benefit) -- is not appropriate for presymptomatic patient with no cognitive symptoms.
  4. Government's Health and Human Services Structure: A Separate Agency is needed like NASA. Centers and Research Laboratories outside of Washington should focus on a segment of the overall Alzheimer's Disease and Related Dementia mental disorders. Patient Care should be a separate Center.
  5. Pharmaceuticals incentives balanced to risks are needed.

Conclusions

Bruce's strategic prioritization would be Asymptomatic stage to remove amyloid, prevent aggregate accumulation and initiate prevention for future candidates. Second would Prodromal AD and the many Tau protein issues. In parallel conduct basic research for Tau Protection and stopping Tauopathy. Finally, Symptomatic AD care needs realistic communication. Patient Care for symptomatic AD before the inability to sustain Activities of Daily Living (ADL) is a manageable lifestyle. The inability to sustain ADL is the trigger point to caregiver issues that need focus, support, and creative approaches.


 

JANUARY 2020 COMMENTS

M. Hogan  |  01-24-2020

Good morning. Thanks to Helen for taking time to read my brief comments. I had hoped to be in attendance for this first meeting in 2020, a new decade, to support my dear friend Jane as she spoke to you today. I had hope, too, to be present to thank Dr. Levey for reminding me of the importance of a worldview that would include a "glass half full" and for helping me connect with those involved in the development of the Savvy Caregiver Training and subsequent recent research on the Savvy Tele-health model that was presented to the Council in January 2019.

Jane's story of her sister Ellen is a very poignant journey and reinforces the challenges experienced by many individuals with intellectual disabilities and their families. Last year Jane presented at the NDSS Adult Summit along with a Medical Ethicist. Collectively they conveyed the importance of maintaining quality of life until the end of life for one and all and of the importance of the medical pledge to do no harm as people face end of life challenges.

2020 is a number that my brother Bill would have embraced wholeheartedly. He was a man who loved dates and calendars and kept daily a fastidious health record on his calendar for years.

2020 would have been the year of Bill's 60th birthday. I often wonder how he would have aged and what wisdom he would have imparted as they years went by. I wonder too, if he would have continued to love Julia Robert and maintained his alias, Harrison Ford, as he traveled by plane independently and introduced himself to the flight crew using his alias!

Bill died on February 25th, 2010 of complications of Alzheimer's disease. He was 49 years old. I will forever remain haunted by his end of life experience. Nonetheless, as I reflect on these 10 years since his departure I am reminded that the "glass is, indeed, half full".

In this time span I have been gifted with the opportunity to meet and work with many incredible people that I would not have met, had it not been for my brother Bill. This includes so many families from across the globe, each with their own compelling stories of love, commitment and life long challenges. Some of you who have been at this table for many years will recall such heart wrenching stories laden with challenges that I related to you...like Betty, Frank and Richard.

For the past several years I have been given the opportunity to come to this table and give voice to the special issues that people with Down syndrome and other intellectual disabilities and their families' experience. I am grateful that some of you have been able to relate to these unique issues encountered by a unique population, a population that can enable each of us to reflect on life's meaning on compassion, kindness, equality and inclusiveness.

I believe that Bill left behind what I consider divine energy. He helped me step out of my comfort zone and speak, often and adamantly about people that are often forgotten and voiceless. He helped me impart his loving healthy perspective as I attempted to convey what is needed to by so many with intellectual disabilities as they age and face the challenges of AD or other dementia. He challenged me to think about who is really disabled, is it those with the label or is it those of us with limited vision who cannot see what each of us has the capacity to contribute in life.

In 10 years time many things have been accomplished...added research dollars, inclusion in the National Plan, dollars spent on training, increased dialogue about this special population along with new voices and faces who can continue as engaged advocates for those who often cannot voice their own needs. In the next 10 years may we have the wisdom, capacity and the ability to recognize the necessity to continue our efforts on behalf of this very important group of people.

For these things I am grateful.


 

J. Boyle  |  01-22-2020

I am from Sea Girt, NJ.

I was sister, legal guardian, primary caregiver, housemate, and sidekick for my sister Ellen Boyle, a woman with Down syndrome. We lived together. She died at home on hospice from end stage Alzheimer's Disease at age 52 in 2018.

When she was born in 1965, our family was told her life expectancy would be into her 20s. She lived at home her entire life graduating from high school at age 21, worked for 20 years and then attended day programs. She was extremely active in special olympics, social, civic and church activities. She was well known in the community and was beloved. She exceeded so many expectations, but at age 50 was diagnosed with Alzheimer's, something we never imagined. This marked start of a steady and fast decline that resulted in her death just two years later.

We now know that those with trisomy 21--Down syndrome--are at very high risk for Alzheimer's/Dementia and for many signs become evident in their 40s and 50s.

Alzheimer's caused changes in Ellen that were baffling to understand, painful to watch, and extremely difficult to adapt to. But it was equally challenging to access the information and the resources needed to navigate the disease process, to preserve a quality of life, ensure comfort, and ultimately support a peaceful death. Her accurate diagnosis was as devastating as it was difficult to obtain. We encountered the reality that at the time there was less understanding of Alzheimer's in persons with Down Syndrome.

At the urging of the National Task Group on Dementia on I/DD, in New Jersey we have begun a Family Support Group for Down syndrome and Alzheimers/Dementia. In just one year, 40 families have joined us seeking support, information and resources. As word spreads, we hear from more families each month. Sadly we had 4 deaths this past year.

On behalf of those aging with Down syndrome and their families and caregivers, please be aware of the significant impact of Alzheimer's Disease on those with Down syndrome and consider their special needs in your work.


 

D. Ervin  |  01-22-2020

I am the Chief Executive Officer for Jewish Foundation for Group Homes, a Montgomery County, MD-based provider of community living supports to adults with developmental disabilities. I began my career in this particular field in 1987, and have watched both the systems of services and supports, as well as the philosophies that inform them, change in overlapping ways over the ensuing 32 years.

At the turn of the 20th Century, the average lifespan of a person born with a developmental disability was 19 years. By the turn of the 21st Century, the average lifespan had grown to 66 years. Advancing science and medical technology has had a profound and lasting impact on lifespan, and people with developmental disabilities are living longer than at any point in human history. We rightly celebrate longer, fuller lives for people with developmental disabilities--my organization, JFGH supports a woman who is 92. She is, by virtually any standard, a miracle.

At the same time, people with developmental disabilities living longer brings challenges to systems of long term supports and services and healthcare systems, to name but two, for which we are inadequately prepared and resourced. More specifically, Medicaid-financed systems of supports for Americans with developmental disabilities are ill-prepared to support people who are experiencing forms of early-onset dementia and Alzheimer's disease; and, while Home and Community Based Service (i.e., Medicaid waiver) programs have proliferated across the US since the 1980s to support people in community settings, very little attention has been paid to how these programs can shift to support people with developmental disabilities as they age. Concepts that are bandied about as colloquialisms, such as ‘aging in place', for people who develop neurotypically, and models of care and support are being developed. For people with intellectual and developmental disabilities (IDD), these models of care are much slower in their development, and are broadly inaccessible.

Among the Council's membership, Dr Matthew Janicki, a recognized expert in the relationship of IDD to dementia and dementia care, and a small band of his colleagues, have informed the research literature as to approaches to supporting people with IDD and dementia in community settings. And, there is enough in the literature to create a body of best practice for community-based organizations like JFGH. However, the public funding that pays for community-based supports is not aligned with those best practices at best, and at worst, is simply insufficient to provide any meaningful care that is tailored to the needs of people with IDD receiving Medicaid waiver supports who are experiencing dementia.

As an example, JFGH supports a gentleman--"John"--with Down syndrome who is 61 years old. As you all perhaps know, people with Down syndrome experience early onset dementia and Alzheimer's disease at a disproportionally higher rate than their neurotypically developing peers. To some extent, John was a bit atypical to the extent that he lived well into his 50s without experiencing any signs of dementia. Three years ago, John's life changed radically and seemingly overnight. Signs of advancing dementia, subtle at first, because substantial. In an exceptionally short period of time, John lost basic skills in activities of daily living, including his abilities to feed himself, use the bathroom independently, and even ambulate independently about his environment. More substantial than these losses was the radical change to his personality. A once gregarious, fun loving friend and colleague to many stopped speaking, interacting socially, making eye contact, and the host of other personality traits that had once earned him the nickname "Disco John."

As the direct support and other staff at JFGH watched this process, we were unprepared as an organization to support the staff's process of adjusting to John's fast-evolving support needs, as well as how to support staff emotionally as they experienced John's loss of connection to them. While staff aren't--and arguably should not be--family, they experienced John's loss of capabilities every bit like a family member might.

As JFGH grapples with fitting John into a service system that is not equipped and resourced to support his needs, we are left to grapple with the potential of simply discharging his from our care as "medically complex," knowing that he would live out his days in a nursing home, a strange and unpredictable environment at which John will never be "home."

In JFGH's community living supports, 40% of the people we currently serve are aged 40 years or more. These are people for whom supports must evolve to both acknowledge the aging process, the onset of dementia that is likely, and how best to support them where and how they age. Dr Janicki and others have provided a support framework designed to deliver quality outcomes for people with IDD and dementia--we have a good idea of what to do.

What we don't have is the means with which to do it.

My call to action to you today is several fold.

To whatever extent the Council can, I urge you to consider taking a specific position(s) that:

  1. Advances a wider, intentional dialogue on practical solutions that are culturally appropriate and accessible to people with intellectual and developmental disabilities who are experiencing dementia;
  2. Advocates for resources being explicitly dedicated to the support needs of people with intellectual and developmental disabilities who are experiencing dementia--from research funding to specialized services and supports (through, for example, demonstration waivers) that are fully funded; and,
  3. Informs the development of a set of universal support standards to address the care needs of people with IDD and dementia that can be used to assess system ‘readiness' to support the aging population of people with IDD.

In full disclosure, those of us in the field of long term supports and services for people with IDD have made an art form of "admiring the problem."

In 2002, then-16th United States Surgeon General, Dr David Satcher, issued a report in which he lamented the lack of access to quality healthcare for people with IDD that could deliver an improved health status and better health outcomes. Eighteen years later, progress has been glacial.

In 2013, Dr Janicki and colleagues published Guidelines for Structuring Community Care and Supports for People with Intellectual Disabilities Affected by Dementia.

And, in 2020, organizations like JFGH, largely funded through Medicaid waivers, continue to grapple with how best to support people like John with funding that is inflexible and simply doesn't contemplate shifts in supports needed to allow John to age in place, to be supported through his journey, to be surrounded by the people most committed to the quality of his life.

The Guidelines are developed, JFGH and countless other agencies like ours are ready to implement and test them, to amass data that inform the evolution of best--and actually evidence-based--practices, and to support people with IDD as they age in place in their homes and their communities. To any extent the Council can push this agenda, you have a willing partner in JFGH, and I stand at your beckon call.


 

M. Sharp  |  01-22-2020

I am the Program Manager for The Association for Frontotemporal Degeneration. I appreciate this opportunity to offer comments from AFTD.

This morning's presentations on the epidemiology of dementia were excellent. As you may know, the epidemiology of FTD disorders remains largely unknown. Even basic facts such as the prevalence and incidence of FTD are uncertain. AFTD's estimate of 60 thousands cases in the US is based on a combination of sources and covers all the clinical diagnoses that fall under the umbrella of frontotemporal degeneration. This includes Progressive supranuclear palsy, corticobasal degeneration, all types of primary progressive aphasia, as well as behavioral variant FTD.

Sixty thousand cases is probably an underestimate, considering how often FTD is misdiagnosed. Adding to the challenge is that FTD is probably not a single disease and is associated with several different pathologies, most notably the proteins tau and TDP-43, and a handful of genes including C9orf72 which overlaps with ALS. Until this complex puzzle of pathologies and overlapping clinical syndromes is sorted out, large-scale epidemiological studies will be untenable.

The key to this puzzle are biomarkers. This is reflected in the research recommendations generated by the 2019 ADRD research summits, where the term biomarker is used 48 times. In FTD, developing biomarkers for diagnosis, prediction and disease monitoring in the next 2-7 years is a top priority. In response to the critical importance of biomarkers, AFTD launched the FTD biomarkers initiative. Since 2016 AFTD has awarded 13 grants to develop a variety of FTD imaging tests and fluid biomarkers for clinical trials and diagnosis. There are more details about current and past biomarkers project on AFTD's website and most studies are included in the NIA's IADRP database.

If you are interested in more information AFTD Biomarker Initiative or any of the other research funded by AFTD please do not hesitate to reach to me or any of AFTD's research staff.


 

P. D'Antonio  |  01-22-2020

Good afternoon and thank you for your time today. I am Vice President of Professional Affairs for The Gerontological Society of America (GSA). GSA honors aging across the lifespan and is the oldest and largest interdisciplinary organization devoted to research, education, and practice in the field of aging. GSA's principal mission--and that of our 5,500 members--is to promote the study of aging and disseminate information to scientists, practitioners, decision makers, and the public. A large segment of our membership is devoted to clinical practice and research on Alzheimer's Disease and Related Dementias and some of our members are current or past members of the Council.

As we wait for a cure to emerge, how can we better support persons with dementia and their care partners?

On behalf of GSA, I'd like to highlight one promising area: improved recognition and management of neuropsychiatric symptoms associated with dementia.

Evidence suggests that persons with neuropsychiatric symptoms - or NPS - experience worse outcomes than those without NPS. These outcomes include greater impairment in activities of daily living, earlier institutionalization, and accelerated mortality.

Among the various NPS, dementia-related psychosis includes delusions (false beliefs) and hallucinations (seeing or hearing things that others do not see or hear). These symptoms can be frequent, severe, persistent, and distressing to persons with dementia and their care partners.

Dementia-related psychosis is distinct from psychosis experienced by individuals with schizophrenia and other psychiatric illness, and it can be highly stigmatizing for persons with dementia. Dementia-related psychosis is also one of the factors that may lead families and care providers to seek long-term care placement for their loved ones with dementia.

In August 2019, GSA published a report "Dementia Related Psychosis: Gaps and Opportunities for Improving Quality of Care." The report was developed in collaboration with experts in geriatrics, psychiatry, neurology, pharmacy and nursing. In it, we summarize best practices and propose several improvements to advancing quality of care that we hope will be widely read and implemented.

Three key recommendations are:

  1. Providers need better ways to document a diagnosis of dementia-related psychosis so they can develop appropriate care plans.
  2. Care teams need more training and resources, so they may proactively communicate with persons with dementia and their care partners about symptom progression and how to cope.
  3. More research is needed to support evidence-based strategies for treatment.

We invite the Council Members to review our full report on the GSA website (https://www.geron.org/programs-services/alliances-and-multi-stakeholder-collaborations/dementia-related-psychosis).

Thank you for your dedication and service on the Council and to people living with dementia and their care partners.


 

A. Taylor  |  01-22-2020

Thank you for another opportunity to provide public comment to the Advisory Council.

In November, I had the pleasure of attending the Neurological Conditions Surveillance Summit, which was an all-day event for national leaders and stakeholder organizations in neurological disorders. The event was organized by Association of State and Territorial Health Officials (ASTHO) and hosted at the Centers for Disease Control and Prevention (CDC) Headquarters in Atlanta, GA.

The following introduction was included in the event materials:

"As a part of the 21st Century Cures Act, Congress authorized the Centers for Disease Control and Prevention (CDC) to develop a National Neurological Conditions Surveillance System (NNCSS) that provides useful estimates of neurological conditions in the United States. CDC will use existing data and emerging tools to create efficient, reusable processes and models that can be applied to multiple conditions to provide disease-specific surveillance information."

In the first half of the day, attendees learned about the NNCSS, the advocacy efforts behind its origins, funding details, and the progress made in developing and pilot testing in two initial disorders--multiple sclerosis and Parkinson's disease. Presentations included descriptions of 3 stages of the initial project plan starting in FY2019 and continuing beyond FY2022, pending further funding.

During the afternoon, attendees participated in small group discussions to brainstorm potential criteria that might be considered for the selection of the next several diseases to be added into the NCSS as early as FY2022. Representatives of each small group then presented a summary of their group's suggestions. Based on the composition of each small group, the recommendations varied widely from the perspectives of rare disorders to very common disorders.

I bring this initiative to the attention of the Advisory Council for several reasons.

First, this is a project of direct relevance to AD/ADRD and as such may be a topic of interest for a future council meeting. While quite a bit is known about the incidence and prevalence of Alzheimer's disease, there is insufficient data on Alzheimer's disease-related dementias. The NNCSS appears to be an important resource for narrowing that informational gap.

Next, during the event attendees learned that initial funding for the NNCSS presents budgetary limitations for dedicated project management and neurology staff assigned to the project. As such, the NNCSS presents an opportunity for the sub-committees to consider funding recommendations.

Lastly, the addition of future disorders to the NNCSS database will also require the involvement of patient advocacy organizations and disease experts. The Advisory Council on Alzheimer's Research, Care and Services serves as an important intersection between federal agencies and a variety of dementia stakeholder types. I see an advocacy opportunity to collaborate on messaging to the CDC about including dementia in its next round of diseases to be added to the database.

I hope these comments will be useful to the Advisory Council and the dementia stakeholders both in the room and watching remotely.

With continued respect and admiration for the work of the Advisory Council on Alzheimer's' Research, Care and Services.


 

G. Epstein-Lubow  |  01-21-2020

I am a geriatric psychiatrist at Butler Hospital and Associate Professor at Brown University. I prepared these public comments with the Professor of Medicine and Chief of the Division of Geriatrics at UCLA. These comments are our own.

The Assistant Secretary for Planning and Evaluation (ASPE) and this Advisory Council must address payment reform for dementia care and treatments. There are at least six working models in the US for dementia care which improve quality, achieve better clinical outcomes for persons living with dementia and caregivers, and lower costs; but, care from these models is not widely available.

ASPE should be aware that on Nov 7, 2019 a one-day meeting called "The Payment Models for Comprehensive Dementia Care" conference convened over fifty clinicians, researchers, advocates, payers and other leaders with expertise in dementia care and healthcare payment. Conference goals were to review short-term solutions for payment reform and describe next steps to accelerate use of current and new payment models. The conference was held in Washington D.C. with support from The John A. Hartford Foundation and Hebrew SeniorLife. Conference outcomes will be published this year.

Meanwhile, HHS should act now to advance payment reform efforts through three activities:

  1. Continue work previously conducted by ASPE regarding Examining Models of Dementia Care;
  2. Convene at least one work group to address payment reform for comprehensive dementia care; and,
  3. Begin immediately to monitor how the inclusion of dementia as a risk adjustment modifier in the CMS Heirarchical Condition Category (HCC) coding affects the definitions of populations of people living with dementia, the quality of care, the types of care received, and the health outcomes of those individuals.

These recommendations are in alignment with the National Plan to Address Alzheimer's Disease's Strategy 1.E (Facilitate translation of findings into medical practice and public health programs) and all Strategies under Goal 2: Enhance Care Quality and Efficiency.


 

M. Murphy  |  01-19-2020

I am 46 years old and I have Down Syndrome. I live in New Jersey with my parents. I graduated from high school and I have worked at Banana Republic for 15 years. I take watercolor and dancing lessons. I love to do things with my friends.

I grew up with a very close group of friends and we all have Down Syndrome. We have been together since the 1980's. There were eight of us and we all enjoyed Special Olympics, bowling, dances and parties. Four of my eight friends have died from Alzheimer's Disease in their early 50's. They are Tricia, Judith, Danny and Craig.

None of us knew this would happen to us and our families. People who have Down Syndrome get Alzheimer's Disease very early.

I am afraid for what the future holds for me and my family. Please include us in the programs you develop.

Thank you for your attention.


 

L. Murphy  |  01-19-2020

My daughter is also providing written testimony today. When she was born with Down Syndrome in 1973, my husband and I were told that she would live to be 40. None of the medical experts knew much more than that at the time. No one anticipated the ravages of Alzheimer's Disease that were coming our way.

As parents we kept our children home. We started Early Intervention and Pre-School programs for them. We fought to have them integrated into school systems and to be provided transportation. We advocated for job training so they could be productive citizens. We created Transitional Services from the school system to the work force.

The "Good News' is people with Down Syndrome are living longer than ever. The "Bad News" is there are no services for them as they age prematurely and develop Alzheimer's Disease. As parents we have been advocating for them their whole lives.

I helped start a Caregiver Support Group in New Jersey for families who are caring for a loved one who has Down Syndrome and Alzheimer's Disease. We started the group in January 2019 and we have been overwhelmed by families who have reached out to us. At this time we have 40 members. We meet monthly in person or participants can also join by phone or computer. These families kept their loved ones home and are now facing a very cruel end to the efforts, love and support they have already given.

Please keep those who have Down Syndrome who are aging in your future plans and services.


 

D. Yobs  |  01-03-2020

On behalf of patients and families who have been affected by the always-fatal diagnosis of Prion Disease and who are desperately hoping for new discoveries and a cure, we ask for assistance in gaining recognition of Prion Disease as a "Related Dementia" wherever ADRDs are defined.

CJD (Creutzfeldt-Jakob Disease) is a rapidly progressive dementia caused by prions, normal proteins that misfold in the brain and cause disease, much like a-beta and tau in Alzheimer's Disease and Frontotemporal Dementia, and alpha-synuclein in Lewy Body Dementia. Advances in the field of Prion Disease directly led to the discovery of protein mechanisms, which is currently being exploited to improve diagnosis and develop treatment targets through protein amplification assays like real-time quaking induced conversion (RT-QuIC). Further discoveries about Prion Diseases would be equally applicable to other ADRDs.

Prion Disease/CJD parallels AD in many ways, including the disease mechanism, treatment targets, symptoms, patient experience, and caregiving experience.

Diagnostics and breakthroughs discovered for one protein misfolding disease will continue to assist the others. Prion Diseases naturally occur in animals and are transmissible, which makes Prion Disease the protein misfolding disease with the most valid animal models for research.

To exclude CJD/Prion Disease from "Related Dementias" does not serve patients, caregivers, doctors and scientists. Excluding Prion Disease from the ADRD label prevents valuable research that would improve the ADRD field. We respectfully ask for your assistance in recognizing Prion Disease/CJD as part of the Alzheimer's Disease and Related Dementias group.


 

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