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NCT04777409

PHASE3

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

Official title: A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)

Key Details

Gender

All

Age Range

55 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1840

Start Date

2021-05-18

Completion Date

2026-01-30

Last Updated

2026-06-26

Healthy Volunteers

Conditions

Early Alzheimer´s Disease

Interventions

DRUG

Semaglutide

Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks

DRUG

Placebo (semaglutide)

Oral placebo (semaglutide) once-daily. The study will last for up to 173 weeks

Inclusion Criteria: * Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. * MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria. * CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home \& hobbies, community affairs) Or CDR global score of 1.0 * RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to (≤) 85 * MMSE (Mini-Mental State Examination) greater than or equal to (≥) 22 * Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aβ1-42 or CSF Aβ1-42/Aβ1-40. * If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase inhibitors, memantine or aducanumab) the dose must have been stable for at least 3 months prior to screening and should not be changed during the study unless medically necessary. Exclusion Criteria: * Brain Magnetic resonance imaging (MRI) (or Computed Tomography (CT)) scan suggestive of clinically significant structural CNS (central nervous system) disease confirmed by central read (e.g. cerebral large-vessel disease \[large vessel (cortical) infarcts greater than (\>) 10 milimeter (mm) in diameter\], prior macro-haemorrhage \[greater than 1 cubic centimetre (cm\^3)\], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus). * Brain MRI (or CT) scan suggestive of strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read. * Evidence of a relevant neurological disorder other than mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type at screening, including but not limited to Parkinson's disease, Lewy body disease, frontotemporal dementia of any type, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, human immunodeficiency virus (HIV), learning disability, intellectual disability, hypoxic cerebral damage, or significant head trauma with loss of consciousness that led to persistent cognitive deficits. * Evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including schizophrenia or other psychotic disorder, or bipolar disorder. A participant with a history of major depression who has not had an episode in the last 24 months before the day of screening and is considered in remission or whose depression is controlled with treatment can be included in the study per investigator's judgement.

Locations (498)

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Imaging Endpoints

Scottsdale, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Tucson Neuroscience Research

Tucson, Arizona, United States

Advanced Research Center, Inc.

Anaheim, California, United States

Torrance Clin Res Inst, Inc.

Lomita, California, United States

ASCLEPES Research Centers,

Long Beach, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

UCLA_Los Angeles

Los Angeles, California, United States

Wr-Pri, Llc

Newport Beach, California, United States

Well Care Medical Center

Panorama City, California, United States

Cedars-Sinai Medical Center

Pasadena, California, United States

Sharp Neurocog Res Ctr

San Diego, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

Calfornia Neurosc Resrch Med

Sherman Oaks, California, United States

Southern California Research LLC

Simi Valley, California, United States

Mountain Neurological Research Center, Inc.

Basalt, Colorado, United States

Denver Neurological Research

Denver, Colorado, United States

Mile High Research Center

Denver, Colorado, United States

Nuvance Health, Associtd Neuro

Danbury, Connecticut, United States

Yale University

Fairfield, Connecticut, United States

Research Center for Clinical Studies, Inc

Norwalk, Connecticut, United States

Topaz Clinical Research

Apopka, Florida, United States

JEM Research Institute

Atlantis, Florida, United States

Visionary Investigators Network

Aventura, Florida, United States

K2 Medical Research - Winter Garden

Clermont, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Integrity Clinical Research, LLC

Doral, Florida, United States

Neuropsychiatric Research Cent

Fort Myers, Florida, United States

Finlay Medical Research Group

Greenacres City, Florida, United States

Indago Research & Health Center Inc.

Hialeah, Florida, United States

Hlth Cr Family Rehab & Res Ctr

Hialeah, Florida, United States

Galiz Research

Hialeah, Florida, United States

K2 The Villages

Lady Lake, Florida, United States

K2 Medical Research, Maitland

Maitland, Florida, United States

Hlth Cr Family Rehab & Res Ctr

Miami, Florida, United States

Premier Clin Res Inst, Inc.

Miami, Florida, United States

Premier Clinical Research Institute, Inc.

Miami, Florida, United States

Central Miami Medical Institute

Miami, Florida, United States

Novel Clinical Research Center, LLC

Miami, Florida, United States

IMIC, Inc- Medical Research

Miami, Florida, United States

The Neurology Research Group

Miami, Florida, United States

Visionary Inv Ntwrk_Miami

Miami, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Suncoast Clin Res Port Richey

New Port Richey, Florida, United States

Suncoast Clinical Research, Inc._New Port Richey

New Port Richey, Florida, United States

K2 Medical Research - Winter Garden

Ocoee, Florida, United States

Combined Research Orlando Phase I-IV

Orlando, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

Advanced Research Consultants, Inc.

Palm Beach Gardens, Florida, United States

Intercoastal Medical Group

Sarasota, Florida, United States

The Roskamp Institute, Inc.

Sarasota, Florida, United States

Brain Matters Resrch Kane Cntr

Stuart, Florida, United States

Axiom Clinical Research of Florida

Tampa, Florida, United States

Stedman Clinical Trials LLC

Tampa, Florida, United States

Palm Beach Neuro Premiere Res

West Palm Beach, Florida, United States

Conquest Research

Winter Park, Florida, United States

iResearch Atlanta, LLC

Decatur, Georgia, United States

Hawaii Neuroscience, Memory Disorders Center

Honolulu, Hawaii, United States

Velocity Clinical Research, Meridian

Meridian, Idaho, United States

Velocity Clinical Research

Meridian, Idaho, United States

Josephson Wallack Munshower

Indianapolis, Indiana, United States

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, United States

University of Kentucky_Lexington_0

Lexington, Kentucky, United States

Northern Light Eastern Maine Medical Center

Bangor, Maine, United States

ActivMed Practice & Research LLC

Methuen, Massachusetts, United States

Bronson Lakeview Neurobehavioral Health

Paw Paw, Michigan, United States

HealthPartners Center for Memory and Aging

Saint Paul, Minnesota, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Altea Research Institute

Las Vegas, Nevada, United States

Wr-Crcn, Llc

Las Vegas, Nevada, United States

Patient First MD,clinical Trials

Middletown, New Jersey, United States

Advanced Memory Research Institute of NJ

Toms River, New Jersey, United States

Albuquerque neuroscience Inc

Albuquerque, New Mexico, United States

SPRI Clinical Trials, LLC

Brooklyn, New York, United States

Neurological Assoc Long Island

Lake Success, New York, United States

Feinstein Institute for Medical Research

Manhasset, New York, United States

NYU Grossman School of Med

New York, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

SUNY Upstate Medical University_Syracuse

Syracuse, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

AMC Research, LLC

Matthews, North Carolina, United States

NeuroScience Research Center, LLC

Canton, Ohio, United States

Valley Medical Primary Care

Centerville, Ohio, United States

Insight Clinical Trials LLC

Independence, Ohio, United States

Cleveland Clinic_Lakewood

Lakewood, Ohio, United States

Central States Research, LLC

Tulsa, Oklahoma, United States

Summit Research Network Oregon Inc.

Portland, Oregon, United States

Neural Net Research, LLC

Portland, Oregon, United States

The Clinical Trial Center

Jenkintown, Pennsylvania, United States

Suburban Research Associates

Media, Pennsylvania, United States

Lowcountry Center for Vet Res

Charleston, South Carolina, United States

Coastal Neurology

Port Royal, South Carolina, United States

Palmetto Clinical Research

Summerville, South Carolina, United States

Genesis Neuroscience Clinic

Knoxville, Tennessee, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

Texas Diabetes & Endocrinology

Austin, Texas, United States

Neurology Consultants of Dallas

Dallas, Texas, United States

Balyor College of Medicine

Houston, Texas, United States

Univ Of Texas Hlth Science Cntr

Houston, Texas, United States

Mt. Olympus Medical Research

Katy, Texas, United States

Glenn Biggs Inst-Alzhm Neuro

San Antonio, Texas, United States

Shirzadi Shahin, MD

Sugar Land, Texas, United States

Memory Clinic, Inc

Bennington, Vermont, United States

Integrated Neurology Services

Falls Church, Virginia, United States

Booth Gardner Parkinson's Cre

Kirkland, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Instituto Medico Especializado_Capital Federal

Ciudad de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Metabolicas (IDIM)

Buenos Aires, Argentina

Hospital Italiano

Buenos Aires, Argentina

Clínica Nuestra Señora de las Nieves

CABA, Argentina

FLENI

CABA, Argentina

Instituto Privado Kremer

Córdoba, Argentina

Fundación Scherbovsky

Mendoza, Argentina

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

HammondCare Greenwich

Greenwich, New South Wales, Australia

Southern Neurology

Kogarah, New South Wales, Australia

KaRa Institute of Neurological Disease Pty Ltd

Macquarie Park, New South Wales, Australia

Hunter New England Local Health District - Neuropsychiatry

Waratah, New South Wales, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Medical and Cognitive Research Unit - Austin Health

Ivanhoe, Victoria, Australia

HammondCare

Malvern, Victoria, Australia

Alzheimer's Research Australia

Nedlands, Western Australia, Australia

Australian Alzheimer's Research Foundation Incorporated

Nedlands, Western Australia, Australia

Universitätsklinik für Neurologie

Graz, Austria

LKH-Univ. Kliniken Innsbruck

Innsbruck, Austria

Medizinische Univ. Innsbruck

Innsbruck, Austria

Univ. Klinik für Neurologie

Salzburg, Austria

Medizinische Universität Wien

Vienna, Austria

AZ Sint-Jan - Campus Sint-Jan - Neurology

Bruges, Belgium

UZA - UZ Antwerpen - Department of Neurology

Edegem, Belgium

UZ Gent - Neurologie

Ghent, Belgium

AZ Groeninge - Kortrijk - Neurologie

Kortrijk, Belgium

UZ Leuven - Geheugenkliniek

Leuven, Belgium

Clinique CHC MontLégia - Service Neurologie

Liège, Belgium

L2 IP Instituto de Pesquisas Clinicas Ltda

Brasília, Federal District, Brazil

Hospital das Clínicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Clinica Clinilive Ltda

Maringá, Paraná, Brazil

Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

Porto Alegre, Rio Grande do Sul, Brazil

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, Brazil

BR Trials - Ensaios Clínicos e Consultoria Ltda.

São Paulo, São Paulo, Brazil

Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP

São Paulo, São Paulo, Brazil

Sociedade Beneficente Israelita Bras Hosp Albert Einstein

São Paulo, São Paulo, Brazil

Centro de Psiquiatria Sandra Rushel

Rio de Janeiro, Brazil

"MHATNP "Sv. Naum"" EAD

Sofia, Bulgaria

MHATNP Sveti Naum EAD

Sofia, Bulgaria

DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan OOD, Psychiatry

Sofia, Bulgaria

UMHAT Aleksandrovska EAD, Clinic of Neurology

Sofia, Bulgaria

MMA MHAT - Sofia, Neurology clinic

Sofia, Bulgaria

MMA, MHAT-Sofia, Neurology clinic

Sofia, Bulgaria

OCT Research ULC (dba Okanagan Clinical Trials)

Kelowna, British Columbia, Canada

Medical Arts Health Research Group

North Vancouver, British Columbia, Canada

Medical Arts Health Research Group_Kelowna

Penticton, British Columbia, Canada

Island Health (Research and Capacity Building)

Victoria, British Columbia, Canada

True North Clinical Research - Halifax

Halifax, Nova Scotia, Canada

True North Clinical Research - New Minas

New Minas, Nova Scotia, Canada

Ottawa Memory Clinic

Ottawa, Ontario, Canada

Recherches Neuro-Hippocampe Inc

Ottowa, Ontario, Canada

Kawartha Centre Redefining Healthy Aging

Peterborough, Ontario, Canada

Memory Program

Toronto, Ontario, Canada

Centricity Research LMC (Toronto)

Toronto, Ontario, Canada

Centricity Research LMC

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

MoCA Research Innovation Inc

Greenfield Park, Quebec, Canada

Douglas Hosp Res Ctr

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval

Québec, Quebec, Canada

Diex Recherche Sherbrooke

Sherbrooke, Quebec, Canada

Beijing Chao-Yang Hospital, Capital Medical University-Neuro