Abstract Details

Title Comparison of Eligibility Criteria and Baseline Characteristics Between the Patient Populations of evoke and evoke+, Clarity AD and TRAILBLAZER-ALZ-2

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P12 - Poster Session 12 (11:45 AM-12:45 PM)

Poster/Presentation
Number 3-018

Objective To compare the evoke and evoke+ trial populations with other phase 3 programs for disease-modifying therapy (DMT) in early Alzheimer’s disease (AD).

Background evoke and evoke+ are phase 3, randomized, placebo-controlled trials currently investigating the glucagon-like peptide-1 receptor agonist semaglutide DMT in persons with early AD.

Design/Methods We compared the inclusion/exclusion criteria and baseline characteristics of the evoke/evoke+ trial populations with those of Clarity AD (lecanemab) and TRAILBLAZER-ALZ-2 (donanemab): two recent phase 3 trials assessing anti-amyloid monoclonal antibodies in persons with early AD. A descriptive comparison is presented.

Results All four trials reported a total randomized sample of 7337 participants (3806 in evoke/evoke+, 1795 in Clarity AD and 1736 in TRAILBLAZER-ALZ-2). The broadest age range was in Clarity AD (50–90 years vs 55–85 years in evoke/evoke+ and 60–85 years in TRAILBLAZER-ALZ-2). Race and ethnicity differed across trials, with the highest absolute number of non-White participants in evoke/evoke+ (741 vs 402 in Clarity AD and 148 in TRAILBLAZER-ALZ-2; US Hispanic participation, 23.6% in evoke/evoke+ vs 11.4% in TRAILBLAZER-ALZ-2). Cognitive inclusion criteria also differed: evoke/evoke+ and Clarity AD required deficits in episodic memory at screening (based on WMS IV–Logical Memory II test and Repeatable Battery for Neuropsychological Status Delayed Memory Index, respectively). All studies required participants to demonstrate amyloid positivity. TRAILBLAZER-ALZ-2 included tau pathology by positron emission tomography (PET) at screening. The TRAILBLAZER-ALZ-2 population had more impairment on CDR-Sum of Boxes, Mini-Mental State Examination and CDR global.

Conclusions All four studies targeted biologically defined early-stage AD but differed in cognitive inclusion criteria. Unlike evoke/evoke+ and Clarity AD, TRAILBLAZER-ALZ-2 recruited more patients with impairment and used tau PET for staging. A higher number of non-White participants were included in evoke, evoke+ and Clarity AD vs TRAILBLAZER-ALZ-2. Data for evoke and evoke+ are still subject to cleaning.

Authors/Disclosures
Paul Mystkowski, MD (Novo Nordisk) PRESENTER	Dr. Mystkowski has received personal compensation for serving as an employee of Novo Nordisk. Dr. Mystkowski has stock in Novo Nordisk.
Howard Feldman, MD, FAAN (University of California San Diego)	The institution of Dr. Feldman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novo Nordisk. The institution of Dr. Feldman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen Research & Development LLC. The institution of Dr. Feldman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Tau Consortium. The institution of Dr. Feldman has received research support from US National Institute of Health NIH/NIA. The institution of Dr. Feldman has received research support from Vivoryon Therapeutics. The institution of Dr. Feldman has received research support from US National Institute of Health NIH/NIA. The institution of Dr. Feldman has received research support from US National Institute of Health NIH/NIA. The institution of Dr. Feldman has received research support from US National Institute of Health NIH/NIA. The institution of Dr. Feldman has received research support from US National Institute of Health NIH/NIA. The institution of Dr. Feldman has received research support from US National Institute of Health NIH/NIA. The institution of Dr. Feldman has received research support from Allyx Pharmaceuticals. The institution of Dr. Feldman has received research support from Canadian Institutes of Health Research . Dr. Feldman has received intellectual property interests from a discovery or technology relating to health care. Dr. Feldman has a non-compensated relationship as a Medical Advisory Council with Association for Frontotemporal Degeneration (AFTD) that is relevant to AAN interests or activities. Dr. Feldman has a non-compensated relationship as a International Scientific Advisory Board with Translating Research in Elder Care (TREC) that is relevant to AAN interests or activities. Dr. Feldman has a non-compensated relationship as a Conference, Presenter with Royal Society of Canada that is relevant to AAN interests or activities. Dr. Feldman has a non-compensated relationship as a Conference, Presenter with Banner Health that is relevant to AAN interests or activities. Dr. Feldman has a non-compensated relationship as a Conference, Presenter, Manuscript Author with University of British Columbia that is relevant to AAN interests or activities.
Philip Scheltens, MD, PhD, FAAN (Alzheimer Center Amsterdam University medical Center)	Dr. Scheltens has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for NOVO NOrdisk.
Oskar Hansson	Oskar Hansson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for from Alzpath, BioArctic, Biogen, Bristol Meyer Squibb, Eisai, Eli Lilly, Fujirebio, Merck, Novartis, Novo Nordisk, Roche, Sanofi and Siemens. Oskar Hansson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for from Alzpath, BioArctic, Biogen, Bristol Meyer Squibb, Eisai, Eli Lilly, Fujirebio, Merck, Novartis, Novo Nordisk, Roche, Sanofi and Siemens. Oskar Hansson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for from Alzpath, BioArctic, Biogen, Bristol Meyer Squibb, Eisai, Eli Lilly, Fujirebio, Merck, Novartis, Novo Nordisk, Roche, Sanofi and Siemens. The institution of Oskar Hansson has received research support from AVID Radiopharmaceuticals, Biogen, C2N Diagnostics, Eli Lilly, Eisai, Fujirebio, GE Healthcare, and Roche.
Mary Sano, PhD (Mount Sinai Sch of Med & Bronx VA Med Ctr)	Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for Avenir. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for Biogen Idec. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for BioXcel. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for CogRx. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for Eisai. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for Genentech. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for F. Hoffman LaRoche. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for Minerva Neuroscience. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for NovoNordisk. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for Pfizer. Dr. Sano has received personal compensation in the range of $0-$499 for serving as a Consultant for vTv Therapeutics. Dr. Sano has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Syneos. Dr. Sano has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Alzheimer's Association. Dr. Sano has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for International Psychogeriatric Association.
Wiesje van der Flier, PhD	The institution of Prof. van der Flier has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Prof. van der Flier has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli-Lilly. The institution of Prof. van der Flier has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NovoNordisk. The institution of Prof. van der Flier has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NovoNordisk. The institution of Prof. van der Flier has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai.
Lars Bardtrum, MSc	Mr. Bardtrum has received personal compensation for serving as an employee of Novo Nordisk A/S. Mr. Bardtrum has stock in Novo Nordisk A/S.
Peter Johannsen, MD (Novo Nordisk)	Dr. Johannsen has received personal compensation for serving as an employee of Novo Nordisk. Dr. Johannsen has or had stock in Novo Nordisk.
Rose Jeppesen, MD, PhD	Dr. Jeppesen has received personal compensation for serving as an employee of Novo Nordisk. Dr. Jeppesen has stock in Novo Nordisk.
Teresa Leon, MD, PhD (Novo Nordisk)	Dr. Leon has received personal compensation for serving as an employee of Novo Nordisk A/S Copenhagen. Dr. Leon has stock in Novo Nordisk. Dr. Leon has stock in Pharma Mar.
Charlotte Thim Hansen (Novo Nordisk A/S)	Charlotte Thim Hansen has received personal compensation for serving as an employee of Novo Nordisk A/S.
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.

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