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Abstract Details

Baseline Characteristics from Evoke and Evoke+: Two Phase 3 Randomized Placebo-controlled Trials of Oral Semaglutide in Patients with Early Alzheimer's Disease
Aging, Dementia, and Behavioral Neurology
P11 - Poster Session 11 (5:30 PM-6:30 PM)
9-013
We report the preliminary baseline characteristics in the ongoing phase 3 evoke and evoke+ trials investigating the safety and efficacy of oral semaglutide for early AD.
Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), is approved for use in type 2 diabetes (T2D) or obesity. 
evoke (NCT04777396) and evoke+ (NCT04777409) are multicenter, randomized, double-blind, placebo-controlled trials. Eligible individuals were 55–85 years, amyloid-positive, with mild cognitive impairment (MCI) due to AD and Mini-Mental State Examination (MMSE) score ≥22. Participants were randomized 1:1 to once-daily oral semaglutide 14 mg (titrated from 3 mg for the initial 4 weeks and 7 mg for the following 4 weeks) or placebo plus standard of care for 156 weeks (104 weeks + 52-week extension). The primary endpoint is change in the CDR – Sum of Boxes (CDR-SB). Baseline characteristics of enrolled patients were compiled after completion of enrollment on September 8, 2023. Trials are ongoing, data may be subject to minor changes until database lock. 
evoke and evoke+ enrolled 1,855 and 1,835 participants each; data from 118 randomized participants from evoke+ are not included here. Mean (SD) age was 71.8 (7.1) and 72.6 (7.1) years; 53.0% and 51.8% of participants were female; most participants (76.6%) were White; 59.7% and 54.5% were in receipt of AD medication. Mean (SD) CDR-SB score was 3.7 (1.5) and 3.7 (1.6); ADCS-ADL-MCI score was 39.4 (7.3) and 38.9 (7.5); 72.5% and 68.7% of participants had a CDR global score of 0.5.

evoke and evoke+ are the first large-scale phase 3 trials to investigate the disease-modifying potential of semaglutide in early AD. Both studies recruited a very similar population.

Authors/Disclosures
Honglan Li, PhD (Novo Nordisk)
PRESENTER 		Dr. Li has received personal compensation for serving as an employee of Novo Nordisk Inc. Dr. Li has stock in Novo Nordisk Inc.
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.
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.
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.
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.
Filip Knop No disclosure on file
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.
Claus Dethlefsen (Novo Nordisk) No disclosure on file
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.
Teresa Leon No disclosure on file
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.