List of Comments
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Comments and questions, or alerts to broken links, should be sent to napa@hhs.gov.
PLEASE NOTE: The Public Comments included here are not an endorsement of the views or information by National Alzheimer's Project Act, its Advisory Council members, the Administration or the federal agencies involved in this project.
M. Japha | 1-23-2024
Eli Lilly and Company believes that the potential for meaningful change for people living with Alzheimer’s disease is upon us. However, the potential benefits of amyloid plaque targeted therapies may only be realized when patients have timely and equitable access to both diagnostics and therapeutics.
The National Alzheimer's Project Act (NAPA) seeks to accelerate the development of treatments that would prevent, halt, or reverse the course of Alzheimer’s disease (AD).i Indeed, Goal 1 of the National Plan is to “prevent and effectively treat Alzheimer’s Disease and Related Dementias by 2025.”ii Unfortunately, the Centers for Medicare and Medicaid Services (CMS) decision to severely restrict access to Food and Drug Administration (FDA)-approved amyloid-targeted therapies, through its April 2022 National Coverage Decision (NCD),iii undermines these important goals. As this Council knows, CMS made this decision at a time when there was only one FDA approved drug in the class. NAPA’s own 2023 report update acknowledges that the recently approved amyloid-targeting treatments “are an important step toward achieving the first goal of the National Plan, to prevent and effectively treat AD by 2025.”iv
Next generation Alzheimer’s therapies are here and more are coming. Indeed, since CMS first issued the NCD, two different therapeutic products have demonstrated, in peer-reviewed publications of Phase 3 clinical trials, clinically meaningful change in cognition and function. Yet to date, CMS has not revisited their 2022 coverage decision.
CMS has repeatedly and publicly stated that they would reconsider the amyloid therapeutic NCD when new evidence becomes available. Lilly will soon add to this body of evidence in a forthcoming publication of yet another peer-reviewed manuscript, which directly addresses how the donanemab data answers each of the three CED questions posed by CMS in the NCD. All of this new evidence exceeds the “high level of evidence” threshold which CMS set forth as the trigger to revisit the NCD.v
Time is of the essence for patients when it comes to CMS action on reconsideration. It can take upwards of nine months or more for CMS to complete the reconsideration process. Yet, each day, as many as 3,000 Medicare-covered individuals with Alzheimer’s may progress to moderate or severe Alzheimer’s Disease.vi
We believe that, in light of the evidence generated since the initial NCD decision, the NAPA Advisory Council should urge CMS to remove CED restrictions where positive confirmatory data is available and to recommend that CMS immediately reconsider the applicability of CED for such products.
AD patients deserve better than facing access barriers to FDA-approved therapies with positive confirmatory data, especially given the fatal nature of the disease and the high unmet need in Alzheimer’s disease.
References
- Pub. L. No. 111-375, § 2(c) (Jan. 4, 2011).
- Assistant Secretary for Planning and Evaluation (ASPE). NAPA Research Milestones for Goal #1 -- To Treat or Prevent Alzheimer's Disease by 2025 (2022). Available at: https://aspe.hhs.gov/napa-research-milestones-goal-1-treat-or-prevent-alzheimers-disease-2025.
- CMS, CAG-00460N, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (2022). (Amyloid NCD).
- https://aspe.hhs.gov/reports/national-plan-2023-update.
- See Amyloid NCD, Figure 1.
- https://www.milliman.com/-/media/milliman/pdfs/2023-articles/6-5-23_ad-severity-progression-populationestimates.ashx?la=en&hash=D0C2DC7D20AFE3C8E5DA8678FE0B1A07.
T. Walter | 1-22-2024
I am from California. I also am an Ambassador from Association Frontotemporal Degeneration. But more importantly, I am here to represent the Walter family.
The Walter family has had 6 family members that I know about pass from FTD/ALS. At one point in time there were 3 brothers in different stages of FTD/ALS. The oldest in the later stages, the middle brother in the middle stage and my husband the youngest in the early stages of FTD/ALS.
The Walter family is a genetic family. Due to the dedication of the 3 brothers participating in research the C9orf72 gene was discovered. Currently, there are 8 children, and 15 grandchildren at risk for the C9 gene and developing FTD, ALS or both.
Currently FTD is misdiagnosed and under diagonaised and takes up to 3 years or longer to get diagnosed. In those years families are put in turmoil both emotionally and financially. Personally, it has taken me close to 20 years to get financially put back together.
This is why I am so passionate that FTD/ALS still be part of NAPA and that their funding continues.
D. Sciullo | 1-22-2024
Hi, my name is Dana Sciullo, and I am so thankful for the opportunity to speak today.
I come to you with a unique perspective. Professionally, I am the Health Programs Coordinator for the National Down Syndrome Society. I lead or assist with all the health and wellness related programming, resource creation, events, and advocacy. Many of these are related to Alzheimer’s disease. The overall lifetime risk of developing Alzheimer's disease is more than 90% for individuals with Down syndrome. This is the devastating reality for families across the country and world.
NDSS continually hears from desperate families and individuals looking for treatments and a cure for Alzheimer’s disease. To help address this, we produced a guidebook and hosted a webinar last month on Down syndrome and Alzheimer’s disease. Both can be accessed through our website: ndss.org.
But all of that is only part of the reason I’m here today. The most important reason is Anthony.
Anthony loves to bowl, go to restaurants, do arts and crafts, hunt and fish, see his friends, and work at his job assisting with car oil changes. He spends his spare time exchanging handwritten letters with elderly community members who are ill or lonely, all of whom have grown to love him. Anthony is not just one of the estimated 250,000 Americans with Down syndrome. He’s my best friend. He’s my only sibling. He’s my little brother.
When Anthony was 23 years old, he began having seizures. As part of his medical care, he received scans of his brain. The doctor was grave when they told us Anthony’s brain was already showing visible plaque deposits, signs of early Alzheimer’s disease. My parents cried as they talked about it in hushed voices later when they thought I couldn’t hear.
Now, Anthony is aware of his high risk of developing Alzheimer's disease. He is watching our grandmother progress through each increasingly horrifying stage of the disease. Sometimes, he asks if that is what it will be like for him. Each time, I rack my brain to find an answer that includes hope. The best I’ve come up with is to tell him I am doing everything in my power to keep that from happening.
Today, I’m asking you to do everything in your power to give Anthony, and the thousands of other individuals who have Down syndrome, hope for a future free from the devasting effects of Alzheimer's disease. This can be done by increasing access to quality clinical care by specifically discussing Down syndrome and Alzheimer’s disease in medical school curricula, increasing funding for Down syndrome and Alzheimer’s disease research, encouraging inclusion in clinical trials for Alzheimer’s disease interventions, granting access to Alzheimer’s disease treatments which are covered by insurance, and educating long term care facilities about serving individuals with Down syndrome and Alzheimer’s disease.
On behalf of Anthony, my family, and the many Americans who share our lived experience, thank you for your time, the work you do, and the work you will continue to do to fight this disease.
P. D’Antonio | 1-17-2024
Addressing Brain Health in Adults With Intellectual Disabilities and Developmental Disabilities: A Companion to the KAER Toolkit for Primary Care Providers
Good afternoon and thank you for your time today. I am Vice President of Policy & Professional Affairs for the Gerontological Society of America.
Our mission at GSA is to cultivate excellence in interdisciplinary aging research to advance innovations in practice and policy. GSA’s 5,500 members include gerontologists, health professionals, behavioral & social scientists, biologists, demographers, economists, and many other disciplines. These experts study all facets of aging with a life-course orientation. The multidisciplinary nature of the GSA membership is a valued strength, enabling the Society to provide a 360-degree perspective on the issues facing our population as we age. GSA is advancing major initiatives related to improving adult immunization rates, earlier detection of cognitive impairment, improving oral, hearing, and vision health, framing our language to improve the public’s understanding of aging, and understanding the impact of the longevity economy.
Our flagship activity addressing brain health is the GSA KAER Toolkit for Primary Care Teams, which supports primary care teams in implementing a comprehensive approach to initiating conversations about brain health and cognitive impairment, detecting cognitive impairment, initiating earlier diagnostic evaluation, and making referrals for educational and supportive community services for people with dementia. The four steps--Kickstart, Assess, Evaluate, and Refer (KAER)--are intended to improve health-related outcomes and well-being for people living with dementia and their families. Today, I am pleased to share how GSA has adapted the KAER Framework to support primary care teams and others better address brain health in adults with intellectual disabilities (ID) and developmental disabilities (DD; collectively I/DD).
In their 2022 report, Examining Adults with Neuroatypical Conditions for MCI/Dementia During Cognitive Impairment Assessments: Report of the Neuroatypical Conditions Expert Consultative Panel, the National Task Group on Intellectual Disabilities and Dementia Practices (or The NTG) and the LuMind IDSC Foundation documented a multitude of challenges associated with detection of cognitive impairment in adults with pre-existing neuroatypical or neurodivergent conditions. In the report, the authors describe these conditions as including common adult conditions that affect normative intellectual development and function (such as ID and ID with conjoint psychiatric condition), communication functions (such as conditions on the autism spectrum and hearing/vision impairments), and others. Their recommendations included enhancing education for clinicians about neuroatypical conditions and how to appropriately detect and diagnose mild cognitive impairment or dementia in this underserved population.
According to experts at NTG and the Ohio Council for Cognitive Health (OCFCH), there is a paucity of primary care providers or neurological specialists with experience in caring for adults with I/DD. In addition, they noted that individuals with I/DD who reach a certain age (for example, 50-60 years old) are often automatically assumed to have Alzheimer’s disease or a related dementia (ADRD) when they experience certain cognitive changes without having received a comprehensive diagnostic evaluation. Some are even diagnosed with the conditions over the phone--without any exam at all. Such care practices are complicated by the all-too-often common false belief that Alzheimer’s disease is inevitable for people with certain I/DD.
We are pleased to share that GSA, in collaboration with The NTG, the Ohio Association of County Boards of Developmental Disabilities (OACB), and the OCFCH, has taken important steps to address this issue. With support from Eisai, GSA developed Addressing Brain Health in Adults With Intellectual Disabilities and Developmental Disabilities: A Companion to the KAER Toolkit for Primary Care Providers. This publication, which will be freely available on geron.org/brainhealth, describes how the guidance in the GSA KAER Toolkit for Primary Care Teams can be applied to meet the unique needs of adults with I/DD.
To address the needs of adults with I/DD who develop dementia, the goals of this companion document are to:
- Raise awareness of unique needs of adults living with I/DD.
- Equip and encourage caregivers and health care teams to engage in appropriate brain health conversations with adults with I/DD.
- Promote brain health conversations and early detection of changes in cognitive and adaptive function for adults with I/DD.
- Assist with the identification of community supports and resource networks aimed at enhancing function and quality of life for adults with dementia and I/DD.
GSA introduced the 88 county boards of developmental disabilities to the KAER Framework and the information in the new companion publication during an educational program at the OACB 40th Annual Convention in the fall. Participants in the program noted that they believe the new publication will support direct service providers and medical providers to detect and address changes in function and cognition that might indicate dementia in an adult with I/DD, and they expressed excitement that it may serve to foster collaboration between their boards of developmental disabilities and their county aging services providers. We are beginning to see these collaborations as county leaders and others in Ohio have begun to reach out to GSA to facilitate educational sessions for their development disabilities and aging services providers. We look forward to continuing to work with our collaborating organizations to spread this work further and support primary care providers to feel more confident and better prepared to address brain health with all adults, including those with I/DD.
As always, thank you for your commitment and service on the Council and to people living with dementia and their care partners.
K. Bishop | 1-17-2024
It should be noted that the views expressed below are my own, and not necessarily the views of NTG or the other collaborating agencies mentioned in the public comments.
Direct Support Professionals (DSPs) in organizations serving people with intellectual and developmental disabilities (IDD) are the backbone of care, essential to the day-to-day care and support. In residential sites their responsibilities include nurturing the health and well-being of each person, providing meals, communicating with other shifts, and establishing routines to make sure all activities of daily living are completed before residents leave for their day activities out of the residence or when they return from day activities. If the organization is federally and state funded the activities are documented and written as plans, like plans written by teachers, that must be followed consistently as written.
Depending on the size of the organization and resources available, DSPs may be transporting individuals to the day activities, assisting with those activities, and then returning to the residence to clean, cook, schedule appointments, grocery shopping, and running errands while making sure all documentation for funding is accurately completed or attending a mandated virtual training. There may be individuals who stay home because of sickness, have multiple doctor’s appointments, or have Alzheimer’s disease or a related dementia (ADRD) and no longer able to tolerate day program or the car ride to the program. Most agencies have aging in place policies but have minimal resources to staff for those changing needs, especially after COVID’s impact.
It is like managing your own home but for as many as 5-6 people who sometimes need total assistance and care as well as working with 10-15 clinical, Frontline Supervisors, and other DSPs. DSPs may work 8-24 hour shifts and be mandated to work a double shift because of call-ins, thereby needing to find care for their own family. All of this must be conducted with caring about everyone’s emotional needs and expected to understand the complexity of the program plan. There are people in each residence and day program with multiple and differing needs for care. DSPs are trained, rightfully so, that each person is an individual who must be treated uniquely with full respect.
I began my career as a Pre-School Teacher in one of the largest institutions in the country, the Rome State School in upstate New York. If any of you are familiar with the infamous television documentary by Geraldo Riveras, Willowbrook: The Last Great Disgrace there are scenes in the documentary from the Rome State School including an image of Robert F. Kennedy speaking in front of one of the very foreboding buildings where I taught. I learned quickly that I needed to depend on the DSPs, then called ward attendants, to dress, feed, clothe, and escort my children to my class. My success in teaching was totally dependent on developing respectful relationships with the staff who did the work to make everything happen.
I recall driving to school one day to hear the announcement that the Rome State School was closing within the year. No staff, and certainly no ward attendants, were given any forewarning that our lives would be turned upside down within days. For a good reason, but no one included in the planning for closure who knew the individuals living in the institution or how to transfer so many people quickly with as little stress as possible. I later became an ICF Program Manager when deinstitutionalization thankfully happened, still dependent on the same people, to carry out my plans, make sure the two community supervised residents I oversaw met all regulations including clean homes and following the elaborate plans.
Today as a Gerontologist, active member of the National Task Group with Dementia Capable Care Foundational Training and other activities, an Adjunct professor at Utica University, and consultant for many organizations providing recommendations and support for older adults with IDD, health care advocacy, and dementia capable care. Though I am retired from the New York State Office for People with Developmental Disabilities (OPWDD) and he University of Rochester School of Medicine and Dentistry, I continue to rely on the same direct support staff to carry out my plans and provide the care needed for a quality of life in later years even if there is the disease of ADRD.
For those people with IDD whose families are not able to care for their loved ones or were part of institutionalization who never met their families, they rely on the organizations to provide care with compassion and dignity of care. The organizations of care that provide residential and day program supports rely on the same DSPs with different titles but the same responsibilities with more added on. The work is accomplished by people who often make this their career even though underpaid with sometimes few benefits such as their own healthcare for the necessary work caring for and about the people they support.
This article is not the article I originally planned to submit to NAPA two days before the due date. I had completed the article, decided to sleep on it for final edits, and then woke in the middle of the night to realize I had written an academic article with no sense of the people who performed the essential tasks of caring. I apologize if these are not the typical comments submitted to NAPA. The value of the care provided by DSPs and the need to recognize those dedicated staff are the reasons for the model collaborative project presented below.
The public comments today are intended to increase awareness of a model program for DSPs through the extensive NAPA outreach. DSPs are the backbone for providing day to day care and support to people with IDD. With the increased percentage of adults aging closer to the life expectancy of adults in the general population, there is a greater incidence of adults diagnosed with ADRDs.
Thus, training and understanding of dementia capable care for adults challenged by this disease or suspected to have the disease without a thorough diagnostic process including a differential diagnosis is essential for organizations and families supporting older adults with IDD. The model presented today is an approach for training to DSPs developed by three collaborating agencies: the National Task Group on Intellectual Disabilities and Dementia Practices (NTG), the National Alliance for Direct Support Professionals (NADSP), and Merakey. Collaboratively, the representatives from the three organizations created the model and worked together to implement the model through a grant from the Pennsylvania Office of Developmental Programs.
The three collaborative organizations are NTG, NADSP, and Merakey of Pennsylvania. The organizations are presented below.
The NTG is a 501©3 not-for-profit organization incorporated in Maine in 2020 after ten years as a voluntary organization under the auspices of the American Academy of Developmental Medicine and Dentistry (AADMD). The NTG began in 2010 with a small group of clinicians, family members, and academics who were concerned about the lack of resources, research, and funding to support programs and services for older adults with IDD challenged by dementia, their families, caregivers, advocates, and self-advocates. One of the primary objectives for NTG at the beginning and today is to ensure that the interests of adults with IDD who are affected by dementia are considered as part of the NAPA National Plan to Address Alzheimer’s Disease.
As one of the lead creators of the NTG Dementia Capable Care Foundational two-day training, a lead trainer and Master Trainer who with other NTG colleagues, NTG has trained over four thousand plus individuals in this curriculum with approximately nine hundred attending the Third Day Train-the-Trainer to become part of the NTG network providing resources to their states or regions as NTG Affiliated Regional Trainers (NTG ARTs).
The second collaborative organization is the NADSP. The NADSP was founded in 1996 by a small and dedicated group of visionary professionals, committed to the provision of quality services for people with disabilities. The group’s best-known visionary was John F. Kennedy, Jr., who was the President of Reaching Up and working closely with the City University of New York. The founders shared a vision of improving outcomes for individuals with disabilities by improving the support, training, conditions, and level of expectation for the direct service professionals, who work with individuals with IDD daily. These workers require an ethical standard, proficiency, and professional support to effectively care for people as they strive for lives of full inclusion in their communities.
The NADSP launched the NADSP E-Badge Academy to address the need for the training and development in DSPs and their Frontline Supervisors who are also significant contributors for the day-to-day delivery of competent and knowledgeable care. Through the E-Badge Academy participants, supported by their organizations as paid members of the academy, can earn national certification through “stackable electronic badges. The badges demonstrate the knowledge, skills, and values that these professionals utilize every day and meant to recognize the importance of providing practical and easily accessible training to promote the professional development which might otherwise go unacknowledged.
E-Badge participants submit specific examples, experience, and education highlighting their contributions to human services. The electronic platform has multiple options of E-Badges that are skills most often used by DSPs. The E-Badges are all completed virtually with agencies providing the technical support. DSP users upload their testimonials summarizing how they meet the requirements for understanding the skill for review by NADSP reviewers for approval or to send back for adjustments. DSPs accumulate E-Badges towards the required number for the completion of the specific E-Badge. Upon completion of reach required to submit to complete the recognized nationally recognized certifications.
Merakey is the third Collaborator in the model E-Badge program to develop DSPs in dementia capable care skills. Merakey is a leading developmental, behavioral health and education provider of integrated services including people with IDD in 12 states. Merakey, Pennsylvania was the collaborating chapter located throughout the state of Pennsylvania. As with other organizations around the country the mean age of the individuals with IDD served by Merakey continues to increase, thus increasing the organizational needs for specialized training related to aging and dementia.
A long-time partner with NTG and the NADSP, it was a natural fit to work together to create a program to increase the dementia capable care competency of DSPs. The organizations de developed the E-Badge competency skills and the process for completion of the E-Badge series of E-Badge competency-based ‘Dementia Capable Care’ option developed by the three collaborators.
The Merakey Education and Training Administrator worked with her staff to respond to an RFP for funding or a pilot program for DSPs utilizing the newly created E-Badge series. Unique to this collaborative E-Badge program and grant was the concept of DSPs attending the NTG two-day Dementia Capable Care Training along with their Frontline Supervisors and the Merakey Training department who will train a condensed version of this training after the completion of the 18-month grant. This is the only badge that includes formal training. It was felt the training for DSPs was essential for thorough understanding. Three sessions were held, one each in Pittsburg, Philadelphia, and Harrisburg.
Over 150 participants attended, the majority DSPs, the others future trainers that became NTG ARTs, and the DSPs’ Frontline Supervisors. Completion of the two-day training awarded each DSP the first E-badge in the Dementia Capable Care E-Badge competency. For successful completion of the Dementia Capable E-Badge DSPs need to complete a total of five E-Badges in the series. Once each successfully completes the required five, as part of the pilot grant-funded program each will receive 50 cents an hour raises and the title of Dementia Capable Care Specialist along with their DSP title. As a result of the implementation of this pilot, Merakey, the supporting organization, will more likely retain the Specialists as DSP longer and the organization gains greater understanding of dementia capable care. The Education and Training Administrator, who is an NTG ART and a Master Trainer as one of the participants in developing the two-day curriculum will work with NTG and NADSP to expand this pilot program to other organizations including other national Merakey sites.
In the 2023 Alzheimer’s Association Facts and Figures Report, the link available below, the need for training of those who provide the daily care is essential to attract and retain workers. It was also noted in the report that the health care workforce, including in human services, were integral to diagnosing, treating, and caring for people with dementia. While not mentioned directly in this report it is even more essential for DSPs to provide support to adults with IDD who often cannot report symptoms of functional and cognitive loss or pain and discomfort.
DSPs who participate in this E-Badge series are trained in Health Care Advocacy including skills of observation and reporting that can provide essential information to the Health Care Provider (HCP) in conducting a differential diagnosis. In many organizations supporting people with IDD, DSPs accompany individuals on their Health Care Appointments and are expected to provide helpful information to HCPs who often are unfamiliar with older adults with IDD. In other organizations it is the DSPs who provide the information to family or clinicians who go on the appointments. The information they provide is essential for screening, assessment, and appropriate interventions if indicated. For the DSPs who complete the E-Badge series they are better prepared to provide the relevant information.
The 2023 Report above also indicates that approximately 30% of people who were diagnosed with a ADRD did not demonstrate the typical pathology expected to be found during autopsy after death. The Report mentions that there may have been other underlying causes for the symptoms of loss and changes observed. Adults with IDD, especially adults with Down syndrome, are more likely to not receive a differential diagnosis, the standard for diagnosis of ADRDs.
Adults with Down syndrome are known to have a higher risk for ADRD than the general population. Trained DSPs are more likely to report changes and symptoms that may help HCPs make diagnostic decisions and also encourage HCPs to conduct more thorough ruling in or out possible other causes for decline.
Additional information given in the NTG Foundational Training includes understanding normal aging versus disease process in adults with IDD, further health care advocacy skills, environmental awareness, and practical modifications to address needs as people lose capacity to perform previous skills or participate in former interests, and general therapies such as “Therapeutic Fiblets.” Therapeutic Fiblets are techniques of distracting, and validating the emotion and reality of each person, a therapy researched as effective strategy for many with a ADRD. This strategy is often the opposite of historical training for care of people with IDD, who are usually encouraged to be in the reality of the moment rather than memories of the past.
I have tried to provide sufficient information that can help the listener or reader understand the issues and the value of the collaborative E-Badge program in developing DSPs. Below is an abbreviated resource list for further information.
It has been an honor to present these public comments to the NAPA Council. Funding for such programs as this model collaborative E-Badge program or other programs to support DSP development through grants and other sources is needed and would be well spent to make a difference for individuals with IDD challenged by dementia, family and paid caregivers, and the communities/organizations that provide the supports. Thank you for your time. I am available through my email address above to answer any follow-up questions the Council may have.
Abbreviated list of References for Public Comment to NAPA, January 22, 2024
2023 Alzheimer's disease facts and figures - 2023 - Alzheimer's & Dementia - Wiley Online Library. https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.13016.
Bishop, K. (2017) Aging and developmental disabilities. In K.R. Podori (Ed.), Geriatric Rehabilitation: From Bedside to Curbside (pp. 517-529). CRC Press. https://www.crcpress.com/Geriatric-Rehabilitation-From-Bedside-to-Curbside/Poduri/p/book/9781482211221.
Bishop, KM, Hogan, M, Janicki, MP, Keller, SM, Lucchino, R, Mughal, DT, Perkins, EA, Singh, BK, Service, K, & Wolfson, S. (2015). Guidelines for dementia-related health advocacy for adults with intellectual disability and dementia: National Task Group on Intellectual Disabilities and Dementia Practices. Intellectual and Developmental Disabilities, 53(1), 2-19. https://doi.org/10.1352/1934-9556-53.1.2.
Bishop, KM, Robinson, LM, & VanLare, S. (Jan 2013). Health Aging for older adults with intellectual and developmental disabilities. J Psychosoc Nurs Men Health Services. doi: 10.3928/02793695-20121218-02.
Janicki, MP, Dalton, AJ, Henderson, C, & Davidson, P. (1999). Disability and Rehabilitation, 21(5/6), 284-294.
Merakey website: www.merakey.org.
National Alliance for Direct Support Professionals website: https://nadsp.org.
National Task Group on Intellectual Disabilities and Dementia Practice website: https://nadsp.org; Please see Education and Training for further information on the 2-day Dementia Capable Care Foundational Training and the Third Day Train the Trainer to become NTG Affiliated Regional Trainers.
National Task Group on Intellectual Disabilities and Dementia Practice. (2012). My Thinker’s Not Working’: A National Strategy for Enabling Adults with Intellectual Disabilities Affected by Dementia to Remain in Their Community and Receive Quality Supports. http://ntg.org/ntg/thinker.
National Down Syndrome Society (NDSS: August 11, 2019). Alzheimer’s Disease & Down Syndrome. https://www.ndss.org/resources/alzheimers/.
Perkins, EA, Moran, JA. Aging adults with intellectual disabilities. JAMA. 2010;304(1): 91-2.
A. Taylor | 1-16-2024
In addition to being a caregiver for my father who passed from Lewy body dementia, I am the Vice President of Strategic Partnerships at the Lewy Body Dementia Association--LBDA--where I lead our research and advocacy efforts on behalf of people with LBD.
First, please let me extend a thank you to the Advisory Council and the federal agencies represented here for their ongoing efforts to better understand and address the needs of families affected by non-AD dementias and the increasing appreciation that most cases of dementia have multiple etiologies.
We celebrate the approval of disease-modifying therapies for Alzheimer’s disease, and are we are mindful that they were made possible in part by the past 20 years of work to develop amyloid PET imaging and other in vivo biomarkers of Alzheimer’s disease pathology. This technology, and in particular, its rapid inclusion into the ADNI study, laid the groundwork for a more clear understanding of the biology of Alzheimer’s disease and created opportunities for better and faster clinical trials.
In Lewy body dementia, 2023 saw the validation in several major cohort studies of an extremely high sensitivity of and specificity of a biomarker for the underlying pathophysiology of LBD (and also Parkinson’s disease), misfolded alpha-synuclein. This new biomarker--alpha-synuclein seeding amplification assay (or a-syn-SAA)--accurately identifies people with underlying Lewy body disease across the disease continuum and may be detected a decade or more before symptom onset. These cohort studies include the Parkinson Progression Marker Initiative (PPMI), the NIH-funded Parkinson’s Disease Biomarkers Project (PDBP), the Swedish BioFinder study, and ADNI, among others.
Importantly, and similar to the state of Alzheimer’s research before biomarkers, we are learning that as many as a third of people in LBD and Parkinson’s cohort studies may actually not have the hallmark pathological protein, severely impacting drug development research.
Furthermore, it has been well-established in autopsy studies that approximately 50% of people with Alzheimer’s have co-existent Lewy pathology, while about 80% of people with Lewy body dementia have Alzheimer’s pathology. So although we understand Alzheimer’s much better today than we did before the appearance of amyloid and tau biomarkers, there is still much to learn about the role of Lewy body disease pathology in AD, and vice versa.
We suggest to the council that the advent of a-syn-SAA represents a scientific and medical opportunity similar in nature to the advent of accurate and reliable AD biomarkers 20 years ago. Given the strength of the data from the cohort studies, we believe that a-syn-SAA should be extensively included where appropriate in studies of LBD and AD. Doing so will increase experimental control and allow researchers to better understand the biological substrates of LBD, as well as implications of comorbid pathologies in AD clinical trials.
We applaud the NINDS council for approving a NOFO concept for a clinical trial of amyloid-lowering monoclonal antibodies in people with mixed AD and LBD, and also for soliciting administrative supplement requests for inclusion of a-syn-SAA into existing LBD studies. We also thank the NIA for their interest in this new enabling technology, as well. These are encouraging signs that the scientists at NIH see the value of a-syn-SAA both in further understanding Alzheimer’s and in opening a new era of research into Lewy body diseases.
Thank you for the opportunity to share these thoughts today.