Aug 2026 Advisory Council on Alzheimer’s Research, Care, and Services Meeting | August 3, Part 4

All right, we are on the homestretch folks. We have a One of the most important parts of our agenda where we do get to hear from the public So I'm going to turn it over to Maria to Launch us off for our public comments today, Maria. Oh, Maria's got a login Because we have this meeting in the building today Hhs social media just shared the RFI on their X and their Twitter. So please feel free to amplify Though that our call for input on the national plan Of course, we are so pleased to have everyone here who can make a public comment But that really spreads the opportunity for members of the public to weigh in on what will be in the national plan So I don't know what it's called. Now that it's X reacts retweet Retweet the post reshare on LinkedIn. That's probably more the vibe of this room and thank you in advance Thanks so much Helen, sorry, I didn't mention that before We will start off with Public comments, I think we'll start with the folks who are in person. So no particular order We'll start with Ian Kramer with the LEAD coalition And I think we're not in our usual microphone, but we're all the way in the corner Good afternoon, everybody I'm Ian Kramer executive director of the LEAD coalition where the uniting voice of approximately 260 member and allied organizations and over 500 university-based researchers Thank you for the opportunity to provide some public comments today And thank you all for your service on the Napa Council both federal and non-federal members the discussion today was enlightening and inspiring and the recommendations are Tremendously encouraging for not only what we can and need to do today for people that are already living with cognitive impairment But how we move forward and how we prepare for what is coming in the way of innovation In both clinical and non-clinical services and supports and and with a particular eye Not not the only thing we should focus on but with a particular eye to where? Dr. Bateman started us today and thinking about identifying individuals who are at an asymptomatic or preclinical stage and Being able to serve them better both clinically and non-clinically I think your recommendations really set a tremendous foundation and I'll just offer a few thoughts Maybe these are presentations you could have over the course of the next year of the Napa Council But there there are opportunities to build Readiness for that future that is coming and we don't know if those Diagnostics and those treatments will be here in six months six years or 16 years But we know inevitably they are coming and so just like the ASAP Act prepares us for a future state Hopefully not very far in the future, but a future state there are a number of other steps that I would recommend that the council consider building into your workflow over the course of the Next year and and just to give a couple examples, and I'm happy to follow up offline At greater length, but just to give a couple of examples Thinking again through that lens of asymptomatic or preclinical disease There there are some protections through GINA for people that are have genetic markers And there are some protections for people who have active disability through the Americans with Disabilities Act ADA There is an enormous gulf in between for people that have biological markers of disease So we could say they have Alzheimer's disease the pathology, but they are absolutely asymptomatic And we don't know at this point we will in the future which of those people will convert at what point on what? Path of progression, but while they are purely Asymptomatic they face enormous exposure as do their blood relatives at minimum for being discriminated against and we need a legal infrastructure to address that gap before before if at all possible people start in volume getting diagnosed as having the Pathology of Alzheimer's disease or any of the related disorders And before we we either have the option or the necessity to treat them We need to make sure they have the legal protections in place, so it's Ideally you would be able to sequence this and get all the legal protections in place first I don't know the science may may move faster than the legal reforms But we need to start yesterday on addressing those legal gaps so that if we aren't ready in advance We're not ready so late that a lot of people face societal harms personal harm through legal discrimination and And have that mitigate as a factor against them choosing to be diagnosed or choosing to be treated When we have those clinical options, so let's make sure we're building as we go And if we can do it in a logical order great But we may not science may not wait for us to catch up So let's get started even if we're a little late on some of these things a Second example, I promise all I'll stop after after this one. I think in your Recommendations there were a couple of opportunities and not at all a criticism of the recommendations But an opportunity to build from the foundation of the recommendations and be even more inclusive We heard references today to the work that FEMA is doing in a collaborative way to build out prepare Preparedness for people living with Alzheimer's disease and related disorders And I think there are opportunities to bring FEMA into that kind of public messaging campaign around preparing communities and individuals for natural disasters But also coping with the outcome of natural disasters similarly we heard of previous meetings about the role of the distinct challenges of Active duty military National Guard Reserve, but also veterans in TBI and other Manifestations that increase risk for Alzheimer's disease and related disorders And I think there would be ample opportunity to have some really rich discussion Before the council about about not only the unique challenges and different exposures That are important to identifying risk and people who are at elevated risk and how we might mitigate against those risks But also particularly through the VA system to leverage opportunities again identified in your Recommendations to engage the clinical community within the VA for better detection diagnosis treatment Connection to social supports both within and beyond the VA so you have the VA reach model as as an example. That's already Tremendously evidence-based and effective but could always stand more scaling there are also opportunities to leverage that those learnings from the VA system in clinical and non-clinical sports into the broader ecosystem, so With all credit for the remarkable work that this council has done. I think there are opportunities to Build on what you've already put in your recommendations and iterate on those over the course of the next year. Thank you Really really good commentary really appreciate it To Matt Sharp with the Association for Frontotemporal Degeneration Hi everybody My name is Matt sharply said I'm with a FTD or the Association for Frontotemporal Degeneration and really appreciate this opportunity to address the council again As probably most of you know FTD is the most common form of dimension people under 60 It often strikes people in the prime of their working and parenting years and it can take up to five years or more on average three years for a diagnosis to be made During which time families can lose everything they can lose their money due to impulses spending They can lose their job. They can lose their freedom if police are involved and Most importantly they can lose the bonds that hold families together Unlike me when I come to these meetings I am often leave often leave filled with hope and all and all the work that's being done all the progress that's being made But most families when they look at the national plan, they don't see FTD Mainly because of three words a DRT And when the plan says a DRT without naming FTD, it makes people Families struggling with FTD you feel unseen unheard and ignored Which is unfortunately how the health care system the venture care systems also often make people with FTD feel So I was going to do a little very brief summary of our comments For the Napa RFI, but our primary ask really is that when the national plan? Talking about FTD we ask that you explicitly and consistently name it in the goals strategies metrics and implementation activities And that you also consistently recognize where FTD needs diverge from Alzheimer's disease Other than that the priorities that we see in a revised national plan include research Biomarkers are desperately needed in FTD across the board Biomarkers diagnostic biomarkers could be a game-changer in FTD and really resolve a lot of the issues that come along with misdiagnosis But we all are also needed For research as well as clinical assessment tools to support earlier diagnosis second The diagnosis and care too few providers still don't recognize FTD Misdiagnosis is routine. It's usually a misdiagnosis as a psychiatric disorder before it even goes into the world of neurology families need real access to specialists neuropsychological evaluations advanced imaging and particularly important in FTD genetic counseling up to 40% of cases in FTD have a genetic or familial basis unlike And if TD families need care models built for a younger onset dementia with behavioral symptoms communication loss and muscle and movement disorders And the care needs to change as the disease moves Third are the caregivers caregivers need education respite mental health care Financial and workplace support and help navigating systems that were not designed for them We need home and community-based services and residential facilities equipped to serve people with complex behavioral needs and a workforce clinicians direct care workers and even first responders that have been trained to understand and recognize the FTD and Finally, we ask that you measure what really happened what really matters to FTD families the communication independent safety quality of life and Connection to family that the disease robs Thank you, thank you, thank you so much Hi everyone, can you hear me fine? I hope you can hear me fine So good afternoon, and my name is Sudhir Sivakumaran and I serve as the chief scientific officer of the Lewy Body Dementia Association And I thank you all for the opportunity to comment Lewy body dementia is one of the most common causes of dementia yet It remains under diagnosed under researched and too often peripheral to national discussions about dementia research care and services individuals and families face prolonged diagnostic journeys limited treatment options fragmented care and complex cognitive movement behavioral sleep and autonomic symptoms Accurate diagnosis matters even in the absence of an approved disease modifying treatment People with LBD can experience marked sensitivity to antipsychotic medications commonly used to manage agitation or hallucinations in dementia These reactions can be severe and in some cases life-threatening We appreciate the council's recognition of LBD and mixed ecology dementia with an Alzheimer's disease and related dementia planning particularly the importance of mixed and co-occurring pathologies We now urge the council and the federal agencies to translate that recognition into specific measurable priorities within the national plan Three areas are particularly important first Support the development and validation of biomarkers clinical outcome assessments and biological staging approaches That are fit for purpose in LBD including biomarkers that characterize alpha-synuclein pathology as well as common co-pathologies such as amyloid and tau Second, build coordinated data infrastructure that can connect clinical, biomarker, imaging, pathology and patient-reported information Fragmented data sets will not generate the evidence needed to accelerate therapeutic development or improve care Third and most importantly involve people living with LBD and their care partners early in research Regulatory coverage and care delivery decisions rather than after priorities have already been established LBDA is committed to working with federal agencies, researchers, clinicians, industry and the patient community to improve diagnosis, strengthen prioritiness, generate better evidence and accelerate access to meaningful treatments and care We ask the council to make LBD visible, measurable and accountable within the national plan Families cannot afford for this disease to remain at the margins. Thank you all once again Thank you so much Thank you very much and I certainly associate my remarks with those of the previous speakers But in my limited time, I'm Scott Fry, Senior Vice President of Public Policy and Government Relations at the Alliance for Aging Research On behalf of Project PAUSE, a coalition of patient and professional organizations focused on improving long-term care for individuals who have neuropsychiatric symptoms associated with Alzheimer's and other neurocognitive conditions I'd like to discuss our long-standing concerns about CMS's long-stay antipsychotic quality measure, which we believe is fundamentally flawed and has for too long unintentionally denied many individuals from consistently receiving clinically appropriate care While intended to reduce inappropriate antipsychotic use, something we support, the measure relies on a one-size-fits-all approach that does not distinguish between clinically appropriate and inappropriate prescribing Instead, it measures only three exempt conditions. How many individuals in a facility received an With only three exempt conditions, how many individuals in a facility received an antipsychotic It overlooks clinically appropriate indications fails to reflect newer FDA-approved therapies and incorrectly equates lower prescribing to high-quality care As a result, it creates pressure to reduce clinically appropriate treatment, which leads to involuntary discharges barriers to nursing home admission and unnecessary suffering for individuals with neuropsychiatric symptoms as well as their families To address these issues, we respectfully continue to urge CMS to retire the current measure and replace it with a targeted low-burden improvement To the minimum data set that strengthens prescribing documentation reinforced multidisciplinary clinical oversight and better distinguishes clinically appropriate care from this view CMS can modernize the measure, advance person-centered care, and safeguard patients We look forward to partnering with CMS and all of you to advance these reforms. Thank you Thank you so much Hi, my name is Dee Stuckelbaum We live in St. Louis, Missouri, and we have a 38-year-old daughter, Susie, who has Down syndrome. Susie is great She lives in an independent residential facility, works at TJ Maxx, and has a great social life Susie currently shows no signs of Alzheimer's. Sadly, she has lost a few friends from her living facility who did develop Alzheimer's and had to move to their parent's home or in two cases actually move to a nursing home Susie has felt this loss deeply The parents of these friends have shared the very difficult times that they have had caring for these children who have Down syndrome but also have Alzheimer's Parents have had to make accommodations in their home, get extra home care because the parents are aging as well And in many cases siblings have had to quit their job Susie has been participating in Alzheimer's research for adults with Down syndrome for almost 10 years at Washington University Susie's had MRIs, PET scans, lots of lab work, and even two lumbar punctures Cognitive testing has also been done at least every 18 months Most recently she started a study that she used her cell phone three times a day for seven days to answer questions She did great Susie loves to be on her phone She loves the attention she gets from the great people at Washington University But more importantly she loves to boast about the money she gets paid for these studies Susie's dad and I have also participated in a parent study We don't know what the future holds for Susie But the thought of her losing her spark as many of her friends parents have said is heartbreaking We keep Susie active. She has takes a GLP-1 to keep her weight under control She wears a CPAP. She gets vaccines and eats mostly healthy and exercises daily all in an effort to keep her thriving The studies indicate that even adults with Down syndrome who are high functioning and Susie would be considered high functioning Still develop Alzheimer's often as early as in their mid-40s We will continue to encourage Susie to take part in these studies and when Appropriate a medication if it becomes available. We've been told that the scans typically show Indications of Alzheimer's up to 10 years before symptoms show in people with Down syndrome So when that happens, we will have decisions to make I was recently a presenter before the FDA to encourage drug manufacturers to include individuals with Down syndrome in their Alzheimer's drug trials Thank you, and we encourage you to continue looking for answers to this dreadful disease that affects many people with Down syndrome And the population as a whole. Thank you Thank you, Dee and thank you for sharing so much about Susie Hi, thank you so much, yes, um Kate had a last-minute emergency arise So my name is Margo Rondeau and I am the chief programs officer at the National Down Syndrome Society Thank you for this opportunity to raise awareness of the impact that Alzheimer's disease has on individuals with Down syndrome and to reiterate Why the Down syndrome community must be included in the work of the advisory council on Alzheimer's research care and services? I am also the mother of an eight-year-old daughter with Down syndrome So I speak as a mother who's desperate for a different future for her daughter and really hopeful that you all will work to ensure this As Dr. Rafi explained earlier in today's meeting Individuals with Down syndrome have a 90% risk of developing Alzheimer's disease in their lifetime because they are born with an extra copy of the 21st chromosome at a devastatingly early age People with Down syndrome experience the changes in behavior thinking and memory related to Down syndrome associated Alzheimer's disease the average age of onset in individuals with Down syndrome Before with an average disease duration of four years given realities The Down syndrome community advocates with a profound sense of urgency on this matter Success together with other support organizations and experts like Dr. Rafi Is working on multiple fronts to ensure that people with Down syndrome have access to existing emerging diagnosis therapeutic treatments for Alzheimer's disease on June 2nd NDSS convened an externally externally, excuse me, led patient focused drug development or ELPFDD meeting with the Food and Drug Administration Bringing the Down syndrome community together to focus on the lived experience of DSAD in a public forum This was a really important milestone for our community more than 160 participants engaged throughout the day Including 20 adults with Down syndrome and caregivers who share their experiences They were joined by subject matter experts all the national Down syndrome organizations multiple pharmaceutical companies and the Alzheimer's association The meeting drew strong FDA participation with 28 FDA staff members in attendance The follow-on from that meeting will include the publication of the voice of the patient report A formal recording of the findings of the meeting that we look forward to sharing with this council and a more technical scientific workshop on DSAD in 2027 In addition our organization educates Alzheimer's research who are beginning Alzheimer's researchers Excuse me who are beginning to welcome people with Down syndrome into clinical trials We recently launched an on-demand digital training that provides tools and strategies to help research teams adapt to include individuals with Down syndrome at their study sites NDSS was proud to work with Congress on the 2024 NAPPA Reauthorization Act which expanded the number of non-federal members on this council from 12 to 15 And created a new seat to represent an underserved population with an elevated lifetime risk of developing Alzheimer's disease And made explicit reference to the Down syndrome community as such an underserved community We strongly represent we strongly excuse me recommend that a representative of the Down syndrome community be included on this council In light of the body of compelling data the overwhelming impact this disease has on the Down syndrome community and the exciting advances in research Presented by Dr. Raffi all evidence points to this pivotal moment when action is critical We urge this council to ensure that people with Down syndrome have a seat at every table and a voice in every decision By doing so we can advance equitable research Accelerate progress and improve outcomes for the Down syndrome community and all those who are affected by Alzheimer's disease. Thank you Thank you so much Hi My name is Donna Garrick from Massachusetts I am the daughter of Jim Tobin who lives with behavioral variant frontal temporal degeneration or FPD I also serve as an AFPD ambassador Thank you for this opportunity to speak today The progress made through NAPPA has been significant but families living with FPD and other younger onset dementors are still being left behind By policies that were built primarily around Alzheimer's disease My father was diagnosed before the age of 65 and because of his age many dementia services simply weren't available to him Our family as caregivers Responsibility increased and so did the financial strain on our family Families like ours often lose not only one income But two while still raising children having mortgages and possibly helping to pay for college yet Many programs remain tied to aid instead of need Even when services were available to us They were designed specifically around Alzheimer's disease in his nursing facility Like every other resident with dementia But behavioral variant FPD is different his memory remains relatively intact So techniques commonly used for Alzheimer's such as therapeutic sitting only increased his frustrations because he knew he was being lied to Later after we brought him home We thought palliative care for him a nurse reviewed his condition and agreed that he met the dementia criteria until she learned that he had FPD Not Alzheimer's She closed her notebook said he no longer qualified stood up and walked out of my house without even examining him No family should lose access to care simply because their loved one has a different form of dementia I respectfully ask the council to ensure equitable access to dementia services regardless of age or diagnosis Expand education on FPD and other dementias throughout the health care system And continue building a national dementia strategy that recognizes Alzheimer's is not the only form of dementia Thank you for your time and for considering the needs of all families living with dementia Hi, my name is dawn kirby and i'm from illinois and i'm an ambassador for the association of frontal temporal Degeneration as well. I want to echo what my fellow ambassador said and also those Comments from matt sharp and who talked about the difficulty with very early onset dementia It is the most common under the age of 60 And a lot of times you will see many talk about those that are diagnosed between the ages of 45 and 65 Unfortunately, my daughter was in her 20s. She was a nurse. She had just had a baby We had lost some loved ones she was married, but She was finally diagnosed at mayo clinic with behavioral variant fpd at the age of 29 after two years of being misunderstood misdiagnosed due to the lack of education in the medical community as far as where fpd Even exists let alone The effect of the very young onset and at the time. I don't know if you can see this picture This was about five months after carol was diagnosed She was not even she was getting ready to turn 30 This is her and that is her grandmother my mother-in-law who had early stage alzheimer's My husband and I were now Sandwiched in between taking care of our young daughter whose husband divorced her We had to put our job refinance our mortgage And stay home to care for kara as we cared for our parents in our mid and here we are in our mid-50s What I would love for the council to be aware of is the enormous burden not only financially, but also Emotionally and traumatizing as she had a young son Who wasn't even two years old at the time? unfortunately My mother-in-law well, fortunately, I should say my mother-in-law lived in a care facility And this was nine years ago. This picture was my mother-in-law is in a care facility and will be 92 next week my daughter What lived with us for four years and died at the age of 33? If it had taken us as long as it typically takes for FTD Individuals to be diagnosed we would have lost Valuable time with her the one thing that is very upsetting as a as a mother of a young person is that Alzheimer's and other related dementias That is is upsetting to me because rare does not mean Insignificant and more than likely it's rarely diagnosed as it was in our daughter's case She was sent to a psychiatric unit I lived in North Carolina for two and a half months as she was in a perinatal psychiatric unit There needs to be as in my mind We need to be more seen because I can name these names and there are only a few Kara, Justin, Jessica, Daria Christina Christian these are all Larry Matt that have either died from FTD and I have an actually longer list that That these are young individuals who haven't even hit their 40s yet My daughter was not even 30 when she was diagnosed So I believe that we need to be seen and more needs to be done because there's too many trapped in the psychiatric diagnosis Thank you Thank you so much Yes, hello, thank you for the opportunity to provide public comment, my name is Julia Wood I'm an occupational therapist and the director of professional and community education at the Lewy Body Dementia Association. I Urge the Napa Council to elevate a preventable patient safety issue affecting people living with Lewy Body Dementia The use of haloperidol or haldol and other high-potency dopamine blocking antipsychotics Lewy Body Dementia including dementia with Lewy Bodies and Parkinson's Disease Dementia is associated with severe neuroleptic sensitivity LBDA clinical guidance warns that typical antipsychotics such as haloperidol should be avoided Severe reactions can include worsening parkinsonism sedation immobility confusion autonomic dysfunction symptoms that resemble neuroleptic sensitivity and even death The FDA approved labeling for haldol is also clear Haldol is not approved for dementia related psychosis and Parkinson's Disease and dementia with Lewy Bodies are listed as contraindication In practice this means that a person with Lewy Body Dementia who receives haloperidol in an emergency department Hospital or long-term care setting may rapidly become rigid, sedated less able to swallow or communicate at a greater risk for falls Aspiration hospitalization institutionalization or even death For families, this is not abstract Too often we hear stories that they are expected to prevent these unsafe medication exposure errors during moments of crisis When they're frightened and least able to advocate for their loved ones That burden should not fall on families alone. It should be addressed through dementia capable systems of care LBDA Respectfully asked the council to recognize haloperidol exposure in Lewy Body Dementia as a national patient safety priority. We urge practical safeguards that include clinician and first responder education emergency department and hospital protocol long-term care training medication reconciliation prompt Electronic health record alerts and inclusion of Lewy Body Dementia specific psychosis guidance in dementia care models and quality measures The National Dementia Strategy must reflect the realities of related dementia as you've heard from many of us today Not only Alzheimer's disease The clear national message is needed Haloperidol and other typical Antipsychotics can be dangerous and sometimes fatal for people with Lewy Body Dementia Safer care begins with recognition diagnosis family and provider education Clinician training and systems that prevent contraindicated medications from being administered in moments of crisis Thank you Thank you all so much. Does that conclude our public comments? So I shared with you that this is some of the most important time is the public comments because it reminds us who we're working for who we're searching for answers for and It deeply humbles me each time I hear from them and inspires me So I'm both humbled and inspired but we've got lots of work to do council don't we? Yeah, we so you heard a lot today a lot of hopeful conversation around research and policy and recommendations But of course, there's more to do so I just wanted to again say thank you to our ASPE leadership Helen and Maria for taking such good care of us and getting us set up and for the work on the National Alzheimer's Plan I can't thank you enough for all the work and dedication that goes into that To all of our members both federal and non Thank you so much for the hope for the direction for the recommendations for the care For the work that's to come that I know will continue coming in for Providing so much hope I think we are at it. I say it a lot I think we're at the most critical time we've ever been and if for those of us that have been working in this space for A long time, you know, it's true. Don't you? So with that we will conclude our meeting. We'll see you again I think it's going to be November 19th or the 26th. I mean, I'm sorry October 19th or the 26th this time. Hopefully my luggage comes with me and I come on time Thank you again to everybody and safe travels for all of you who came to DC. Thank you produced by the US Department of Health and Human Services