Pivotal legislation to renew US commitment to addressing Alzheimer's signed into law

Abstract

Two pieces of critical legislation that renew the United States' commitment to the fight against Alzheimer's and other dementia were signed into law in October: the NAPA Reauthorization Act and the Alzheimer's Accountability and Investment Act. These bipartisan bills will continue the crucial work of the National Plan to Address Alzheimer's Disease to support Alzheimer's research and improve the delivery of clinical care and services for people impacted by Alzheimer's.

“With the NAPA Reauthorization Act and the Alzheimer's Accountability and Investment Act signed into law, our nation has taken a major step forward in the fight against this devastating disease,” said Robert Egge, Alzheimer's Association chief public policy officer and president of the Alzheimer's Impact Movement. “On behalf of the Alzheimer's Association, thank you to our outstanding congressional champions on both sides of the aisle for your steadfast leadership and tireless efforts to advance these bills across the finish line.”

The NAPA Reauthorization Act reauthorizes the National Alzheimer's Project Act (NAPA) (P.L. 111-375) by extending the strategic National Plan and emphasizing the importance of healthy aging and risk reduction. Prior to NAPA, there was no comprehensive plan to address Alzheimer's. In 2010, for every dollar the federal government spent on the cost of Alzheimer's care, it invested less than a penny on research for the disease. NAPA has fundamentally changed the way the nation addresses Alzheimer's and all other dementia.

The Alzheimer's Accountability and Investment Act builds on the original Alzheimer's Accountability Act (AAA), which was first enacted in 2014. This bipartisan legislation ensures Congress will continue to hear directly from scientists at the National Institutes of Health on the Alzheimer's and dementia research funding needed to achieve the goals in the National Plan.

“Today we can reflect on how far we've come since the passage of NAPA and AAA. We now have multiple Food and Drug Administration-approved Alzheimer's treatments, better understanding of risk factors and prevention, and improved dementia care and support, and we are closer than ever to biomarker tests, which will improve access to earlier and more accessible diagnosis,” said Egge. “With these two reauthorizations, the progress of the next decade will bring additional breakthroughs that improve the lives of people living with Alzheimer's and other dementia and their families.”

The NAPA Reauthorization Act and the Alzheimer's Accountability and Investment Act were introduced by Susan Collins (R-Maine), Ed Markey (D-Mass.), Shelley Moore Capito (R-W.Va.), and Mark Warner (D-Va.) in the Senate, and Chris Smith (R-N.J.), Paul Tonko (D-N.Y.), and Maxine Waters (D-Calif.) in the House of Representatives.

“Over the last decade, Congress has taken action to make historic investments in Alzheimer's research, expanded the dementia public health infrastructure and improved access to quality care and support,” said Egge. “Thanks to our incredible advocates and bipartisan congressional champions, our nation is enacting laws like the NAPA Reauthorization Act and the Alzheimer's Accountability and Investment Act, changing the trajectory of this devastating disease until we one day achieve our vision of a world without Alzheimer's and all other dementia.”

Nearly seven million Americans are living with Alzheimer's disease or a related dementia, which for decades was considered a hopeless diagnosis. However, with treatments approved by the United States Food and Drug Administration (FDA) that can change disease progression, coupled with more than 140 therapies aimed against Alzheimer's in clinical trials or under regulatory review, we are in a new era of treatment.

“In this new era of treatment, there is an urgent need to better understand how new and future Alzheimer's therapies work in real-world settings,” said Maria C. Carrillo, PhD, Alzheimer's Association chief science officer and medical affairs lead. “By gathering and analyzing real-world data from people treated with FDA-approved Alzheimer's treatments, we can better understand their long-term health and safety outcomes in everyday settings, beyond controlled clinical trials.”

The Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) is a first-of-its-kind Alzheimer's network dedicated to tracking real-world diagnostic and treatment outcomes. ALZ-NET is designed to work collaboratively with affiliated studies conducted by academia, industry, federal agencies, ALZ-NET project teams, and others.

As with all therapies in this class, there is an FDA postmarketing requirement (PMR) for a registry-based study to evaluate clinical safety outcomes. Eisai Inc.’s PMR study of Leqembi^® (lecanemab-irmb) is expected to begin in early 2025 and will last 10 years. Eisai Inc. will conduct a registry-based, prospective, observational study to evaluate clinical safety outcomes among people living with early Alzheimer's. ALZ-NET is collaborating with Eisai Inc. on an ALZ-NET-affiliated study that will collect real-world data to support the FDA postmarketing requirements.

“With ALZ-NET, we are unleashing a powerful tool in the fight against Alzheimer's disease: real-world data. ALZ-NET stands squarely at the intersection of treatment and care,” said Carrillo. “This is a textbook example of a study that utilizes the infrastructure of the national ALZ-NET provider-enrolled patient registry to conduct regulatory-grade data collection and sharing to support regulatory reporting requirements.”

To learn more about developing or conducting an ALZ-NET-affiliated study, visit alz-net.org.

Registration is open for the Alzheimer's Association International Conference^® (AAIC^®) Neuroscience Next, a hybrid, no-cost conference to be held February 24–27, 2025, that aims to support and showcase the next generation of Alzheimer's and dementia researchers and clinicians. Participants will gain knowledge on topics spanning the breadth of neuroscience research, including Alzheimer's and dementia, and hear global perspectives through a virtual scientific program broadcast live from hubs around the world. Attendees can tune into the virtual core scientific program from anywhere in the world and participate in person at 1 of 12 hubs, which offer additional opportunities for engagement. The 2025 hubs are:

Barcelona, Spain

Belgrade, Serbia

Buenos Aires, Argentina

Ibadan, Nigeria

Indianapolis, Indiana, USA

Nairobi, Kenya

New Delhi, India

Pittsburgh, Pennsylvania, USA

Porto Alegre, Brazil

Santiago, Chile

Thessaloniki, Greece

Yaoundé, Cameroon

The Scientific Program Committee is committed to developing the most relevant and innovative content for AAIC^® Neuroscience Next. Committee members lead programming for their respective hubs. Each hub has one mid- or senior-career researcher lead and one early-career researcher lead. In addition to the scientific content, participants will have access to networking and award opportunities to advance their careers.

Registration is open for AAIC^®Advancements: APOE & Lipid Biology, taking place March 17-18, 2025, in Miami, Florida, USA, and online. This in-depth conference will connect neuroscience researchers at all career stages to discuss the latest research on the role of apolipoprotein E (APOE) and lipid biology in neurodegenerative diseases, including Alzheimer's disease (AD). The Scientific Program Committee, chaired by Takahisa Kanekiyo, MD, PhD, and Stacie Weninger, PhD, has developed a program that will provide access to cutting-edge research findings, emerging trends in the field, and new methodologies to move research forward.

After welcome remarks, Day 1 will begin with neurogeneticist John Hardy, PhD, of University College London, UK, who will kick off the scientific content of the meeting with a plenary session examining the past, present, and future of APOE genetics and AD. This will be followed by a state-of-the-field session with presentations exploring the effect of APOE in non-AD neurodegenerative diseases, the impact of ancestry on APOE, whether APOE acts in a sex-specific manner, and what is needed to successfully target APOE therapeutically. After lightning presentation rounds of submitted abstracts, lunch, and networking opportunities, afternoon plenary speaker David Holtzman, MD, of Washington University in St. Louis, Missouri, USA, will discuss the multiple mechanisms of APOE in AD. Speakers from Spain, the UK, and United States will drill further into APOE in the first afternoon session, which will focus on how APOE exerts its effects across different CNS cell types, including astrocytes, microglia, and oligodendrites.

The afternoon of Day 1 will continue with poster viewing and a session on protective APOE variants including APOE Christchurch, APOE2, APOE knockouts, and the APOE4 protective locus. The session will be moderated by Li Gan, PhD, of Cornell University, in Ithaca, New York, USA, who will discuss whether converging mechanisms underlie the protective APOE variants. An evening reception will close Day 1.

APOE and vasculature will be the focus of Day 2's first session, which will be moderated by Co-chair Kanekiyo of Mayo Clinic, Jacksonville, Florida, USA. Kanekiyo will open the session with an examination of how APOE-mediated vascular function contributes to AD and vascular cognitive impairment and dementia (VCID) pathogenesis. Participants will then hear about the links between APOE and cardiovascular diseases, the cerebrovascular system, cerebral amyloid angiopathy, and amyloid-related imaging abnormalities (ARIA).

After a break to view posters, participants will hear about the influence of APOE on lipid metabolism. Rik van der Kant, PhD, Vrije Universiteit Amsterdam, Netherlands, will moderate the session and open it with a discussion of how APOE brain lipid metabolism is connected to pathogenesis. Session presenters will specifically examine intracellular APOE4 and energy metabolism, lipid transport and astrocyte reactivity, lipid droplets in microglia, APOE4 and microglial activation, and the role of glial cells and APOE.

The broader landscape of lipid metabolism will be depicted in Day 2's afternoon session, which will feature discussions of a neurolipid atlas, presenilin (PSEN)/y-sec and cholesterol metabolism, ATP binding cassette subfamily A member 7 (ABCA7), lipids and reactive astrocytes, and lipid challenges and microglia. The last sessions of Day 2 will be publishing and funding workshops for early career researchers. For more information on AAIC^® Advancements: APOE & Lipid Biology, visit https://www.alz.org/apoe/overview.asp.

The Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment (ISTAART) will kick off 2025 with a January webinar series exploring key research discoveries in 2024. Each of the webinars in the year-in-review series is hosted by one of ISTAART's 30 Professional Interest Areas (PIAs). Webinars include a 30-minute summary of research progress over the previous year, followed by a panel discussion of priorities and predictions for the year to come with experts in the field. Webinar details are below. To see the full series, visit alz.org/YearInReview.