Abstract Details

Title ICARE AD-US: Design of a Prospective, Single-Arm, Multicenter, Noninterventional, Real-World Study of Aducanumab in the United States

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 016

Objective

The ICARE AD-US study is designed to collect longitudinal clinical, imaging, and pharmacoeconomic data to evaluate the safety and effectiveness of aducanumab in real-world clinical practice.

Background

Aducanumab was approved for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) or mild dementia due to AD by the US Food and Drug Administration (FDA) under the accelerated approval pathway. Aducanumab is the first FDA-approved AD treatment that selectively targets aggregated forms of amyloid beta (Aβ). The efficacy and safety of aducanumab have been evaluated in 2 Phase 3 studies, and it is now critical to evaluate its long-term impact in the real world.

Design/Methods ICARE AD-US is a prospective, single-arm, multicenter, noninterventional study of aducanumab as prescribed in a postmarketing, real-world US setting. This Phase 4 observational study is designed to evaluate the safety and effectiveness of aducanumab in clinical practice per its FDA-approved labeling. The primary objectives are to evaluate real-world, long-term changes in cognition, function, and neuropsychiatric status in aducanumab-treated patients and characterize the longitudinal impact of aducanumab on quality of life, disease burden, and health care resource utilization. ICARE AD-US will also assess long-term safety as measured by serious adverse events and the incidence of amyloid-related imaging abnormalities–edema (ARIA-E). Biobanking of collected blood will provide opportunities for future biomarker studies.

Results ICARE AD-US aims to enroll ~6000 patients with AD over 4 years, including ~500 African American and ~500 Hispanic/Latinx patients, at ~200 US sites. Patients will be monitored for up to 5 years.

Conclusions The study will collect a harmonized core dataset to assess the long-term effectiveness and safety of aducanumab treatment in real-world clinical practice and the effectiveness and safety of aducanumab in patients from underrepresented racial and ethnic minority groups to inform real-world clinical practice.

Authors/Disclosures
PRESENTER	No disclosure on file
Jeffrey L. Cummings, MD, FAAN	Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia, Actinogen, Acumen, AlphaCognition, ALZpath, Aprinoia, AriBio, Artery, Biogen, Biohaven, BioVie, BioXcel, Bristol-Myers Squib, Cassava, Cerecin, Diadem, Eisai, GAP Foundation, GemVax, Janssen, Jocasta, Karuna, Lighthouse, Lilly, Lundbeck, LSP/eqt, Mangrove Therapeutics, Merck, NervGen, New Amsterdam, Novo Nordisk, Oligomerix, ONO, Optoceutics, Otsuka, Oxford Brain Diagnostics, Prothena, ReMYND, Roche, Sage Therapeutics, Signant Health, Simcere, sinaptica, Suven, TrueBinding, Vaxxinity, and Wren pharmaceutical, assessment, and investment companies. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia, Biogen, Genentech, Grifols, Janssen, Karuna, Otsuka, reMYND, Roche, Signant Health. Dr. Cummings has stock in Artery, Vaxxinity, Behrens, Alzheon, MedAvante-Prophase, and Acumen. Dr. Cummings has received research support from NIH. Dr. Cummings has received research support from NIGMS. Dr. Cummings has received intellectual property interests from a discovery or technology relating to health care.
Mihaela Levitchi	Mihaela Levitchi has received personal compensation for serving as an employee of Biogen. Mihaela Levitchi has received stock or an ownership interest from Biogen.
Carl DeMoor	Carl DeMoor has received personal compensation for serving as an employee of Biogen. Carl DeMoor has received stock or an ownership interest from Biogen. An immediate family member of Carl DeMoor has received personal compensation in the range of $100,000-$499,999 for serving as a Program Director with NIH.
Alireza Atri, MD, PhD (Banner Sun Health Research Institute)	Dr. Atri has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Prothena. Dr. Atri has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. Dr. Atri has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novo Nordisk. Dr. Atri has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Atri has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Atri has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Life Molecular Imaging. Dr. Atri has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novo Nordisk. Dr. Atri has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Atri has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lunbeck. Dr. Atri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ONO. Dr. Atri has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Atri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AriBio. Dr. Atri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vaxxinity. The institution of Dr. Atri has received research support from National Institute of Aging (NIA). The institution of Dr. Atri has received research support from AZ Department of Health Services. The institution of Dr. Atri has received research support from Gates Ventures. The institution of Dr. Atri has received research support from Multiple companies, universities & consortia for contracted clinical trials to institution. The institution of Dr. Atri has received research support from Washington University in St. Louis. The institution of Dr. Atri has received research support from Foundation for NIH. The institution of Dr. Atri has received research support from ACTC/NIH. Dr. Atri has received publishing royalties from a publication relating to health care.
Verna R. Porter, MD, FAAN (Pacific Neuroscience Institute/Providence St. Johns Santa Monica)	Dr. Porter has nothing to disclose.
Ivana Rubino	Ivana Rubino has received personal compensation for serving as an employee of Biogen. Ivana Rubino has received stock or an ownership interest from Biogen.

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