AzTrials
AzTrials

Early Alzheimer´s DiseasePhase 3EVOKE PlusNCT04777409

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

A Phase 3 study testing Semaglutide in people with Early Alzheimer´s Disease, run by Novo Nordisk A/S at 498 sites in 38 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Early Alzheimer´s Disease
What is being tested?
Semaglutide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,840 participants
Where
498 sitesin 38 countries
Study dates
18 May 2021to 30 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

498 sites in 38 countries.

498 sites in 38 countries

United States107 sites

  • Albuquerque neuroscience Inc

    Albuquerque, New Mexico, 87109

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

  • Topaz Clinical Research

    Apopka, Florida, 32703

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749

  • Visionary Investigators Network

    Aventura, Florida, 33180

  • Northern Light Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Mountain Neurological Research Center, Inc.

    Basalt, Colorado, 81621

  • Memory Clinic, Inc

    Bennington, Vermont, 05201

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718

  • Valley Medical Primary Care

    Centerville, Ohio, 45459

  • Lowcountry Center for Vet Res

    Charleston, South Carolina, 29403

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211

  • K2 Medical Research - Winter Garden

    Clermont, Florida, 34711

  • Neurology Consultants of Dallas

    Dallas, Texas, 75243

  • Nuvance Health, Associtd Neuro

    Danbury, Connecticut, 06810

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Denver Neurological Research

    Denver, Colorado, 80210

  • Mile High Research Center

    Denver, Colorado, 80218

  • Integrity Clinical Research, LLC

    Doral, Florida, 33122

  • Yale University

    Fairfield, Connecticut, 06824

  • Integrated Neurology Services

    Falls Church, Virginia, 22043

  • Neuropsychiatric Research Cent

    Fort Myers, Florida, 33912

  • Finlay Medical Research Group

    Greenacres City, Florida, 33467

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Indago Research & Health Center Inc.

    Hialeah, Florida, 33012

  • Hlth Cr Family Rehab & Res Ctr

    Hialeah, Florida, 33015

  • Galiz Research

    Hialeah, Florida, 33016

  • Hawaii Neuroscience, Memory Disorders Center

    Honolulu, Hawaii, 96817

  • Balyor College of Medicine

    Houston, Texas, 77030

  • Univ Of Texas Hlth Science Cntr

    Houston, Texas, 77054

  • Insight Clinical Trials LLC

    Independence, Ohio, 44131

  • Josephson Wallack Munshower

    Indianapolis, Indiana, 46256

  • The Clinical Trial Center

    Jenkintown, Pennsylvania, 19046

  • Mt. Olympus Medical Research

    Katy, Texas, 77450

  • Booth Gardner Parkinson's Cre

    Kirkland, Washington, 98034

  • Genesis Neuroscience Clinic

    Knoxville, Tennessee, 37909

  • K2 The Villages

    Lady Lake, Florida, 32159

  • Neurological Assoc Long Island

    Lake Success, New York, 11042

  • Cleveland Clinic_Lakewood

    Lakewood, Ohio, 44107

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • Wr-Crcn, Llc

    Las Vegas, Nevada, 89106

  • University of Kentucky_Lexington_0

    Lexington, Kentucky, 40504

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • ASCLEPES Research Centers,

    Long Beach, California, 90807

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA_Los Angeles

    Los Angeles, California, 90095

  • K2 Medical Research, Maitland

    Maitland, Florida, 32751

  • Feinstein Institute for Medical Research

    Manhasset, New York, 11030

  • AMC Research, LLC

    Matthews, North Carolina, 28105

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Velocity Clinical Research, Meridian

    Meridian, Idaho, 83642

  • Velocity Clinical Research

    Meridian, Idaho, 83642

  • ActivMed Practice & Research LLC

    Methuen, Massachusetts, 01844

  • Hlth Cr Family Rehab & Res Ctr

    Miami, Florida, 33015

  • Premier Clin Res Inst, Inc.

    Miami, Florida, 33122

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

  • Central Miami Medical Institute

    Miami, Florida, 33125

  • Novel Clinical Research Center, LLC

    Miami, Florida, 33173

  • IMIC, Inc- Medical Research

    Miami, Florida, 33176

  • The Neurology Research Group

    Miami, Florida, 33176

  • Visionary Inv Ntwrk_Miami

    Miami, Florida, 33176

  • Patient First MD,clinical Trials

    Middletown, New Jersey, 07748

  • Aqualane Clinical Research

    Naples, Florida, 34105

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37212

  • Suncoast Clin Res Port Richey

    New Port Richey, Florida, 34652

  • Suncoast Clinical Research, Inc._New Port Richey

    New Port Richey, Florida, 34652

  • NYU Grossman School of Med

    New York, New York, 10016

  • Wr-Pri, Llc

    Newport Beach, California, 92660

  • Research Center for Clinical Studies, Inc

    Norwalk, Connecticut, 06851

  • K2 Medical Research - Winter Garden

    Ocoee, Florida, 34761

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807

  • Headlands Research Orlando

    Orlando, Florida, 32819

  • Advanced Research Consultants, Inc.

    Palm Beach Gardens, Florida, 33410

  • Well Care Medical Center

    Panorama City, California, 91402

  • Cedars-Sinai Medical Center

    Pasadena, California, 90048

  • Bronson Lakeview Neurobehavioral Health

    Paw Paw, Michigan, 49079

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Coastal Neurology

    Port Royal, South Carolina, 29935

  • Summit Research Network Oregon Inc.

    Portland, Oregon, 97210

  • Neural Net Research, LLC

    Portland, Oregon, 97225

  • HealthPartners Center for Memory and Aging

    Saint Paul, Minnesota, 55130

  • Glenn Biggs Inst-Alzhm Neuro

    San Antonio, Texas, 78229

  • Sharp Neurocog Res Ctr

    San Diego, California, 92123

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

  • The Roskamp Institute, Inc.

    Sarasota, Florida, 34243

  • Imaging Endpoints

    Scottsdale, Arizona, 85258

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Calfornia Neurosc Resrch Med

    Sherman Oaks, California, 91403

  • Southern California Research LLC

    Simi Valley, California, 93065

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

  • Brain Matters Resrch Kane Cntr

    Stuart, Florida, 34997

  • Shirzadi Shahin, MD

    Sugar Land, Texas, 77478

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • SUNY Upstate Medical University_Syracuse

    Syracuse, New York, 13210

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Stedman Clinical Trials LLC

    Tampa, Florida, 33613

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Tucson Neuroscience Research

    Tucson, Arizona, 85710

  • Central States Research, LLC

    Tulsa, Oklahoma, 74136

  • Palm Beach Neuro Premiere Res

    West Palm Beach, Florida, 33407

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Japan63 sites

  • Iwaki Clinic_Psychosomatic medicine

    Anan, Tokushima, 774-0014

  • Yachiyo Hospital_Neurology

    Anjo-shi, Aichi, 446-8510

  • Abe Clinic

    Arakawa-ku,Tokyo, 116-0014

  • Memory Clinic Ochanomizu

    Bunkyo-ku, Tokyo, 113-0034

  • Institute of Science Tokyo Hospital_ Neurology

    Bunkyo-ku,Tokyo, 113-8519

  • Tokyo Medical And Dental University Hospital

    Bunkyo-ku,Tokyo, 113-8519

  • Kashiwado Hospital_Neurology

    Chib-shi, Chiba, 260-8656

  • Kashiwado Hospital

    Chib-shi, Chiba, 260-8656

  • Enomoto Internal Medicine Clinic

    Chofu-shi,Tokyo, 182-0036

  • Shinozuka Hospital_Neurology

    Fujioka-Shi, Gunma, 375-0017

  • P-one Clinic

    Hachioji-shi, Tokyo, 192-0071

  • National Hospital Organization Tenryu Hospital_Neurology

    Hamamatsu-shi, Shizuoka, 434-8511

  • National Hospital Organization Tenryu Hospital

    Hamamatsu-shi, Shizuoka, 434-8511

  • Hyogo Prefectural HarimaHimeji General Medical Center_Dept. of Aging Brain&Cognitive

    Himeji-shi, Hyogo, 670-8560

  • Tsukazaki Hospital_Department of Neurology

    Himeji-shi, Hyogo, 671-1227

  • Himeji Central Hospital Clinic_neurology

    Himeji-shi, Hyogo, 672-8043

  • Hatsuta Neurology Clinic

    Hirakata-Shi,Osaka, 573-1121

  • Imon Yukari Neurology Clinic

    Hiroshima-shi, Hiroshima, 732-0066

  • Hikaru-kai Medical Corporation Hiroshima Neurology Clinic

    Hiroshima-shi, Hiroshima, 732-0822

  • Hiroshima Neurology Clinic

    Hiroshima-shi, Hiroshima, 732-0822

  • Nagamitsu Clinic

    Hofu-shi, Yamaguchi, 747-0802

  • Ina Central Hospital_Neurology

    Ina-shi, Nagano, 396-8555

  • Ina Central Hospital

    Ina-shi, Nagano, 396-8555

  • Kawasaki Saiwai Clinic_Internal Medicine

    Kanagawa, 212-0016

  • Kishiro Mental Clinic

    Kawasaki-shi , Kanagawa, 214-0014

  • Koukan Clinic

    Kawasaki-shi, Kanagawa, 210-0852

  • Teikyo Univ. HP, Mizonokuchi_Neurosurgery

    Kawasaki-shi, Kanagawa, 213-8507

  • Teikyo University Hospital, Mizonokuchi_Kawasaki-shi, Kanagawa

    Kawasaki-shi, Kanagawa, 213-8507

  • Kobe University Hospital_Neurology

    Kobe-shi, Hyogo, 650-0017

  • Kobe University Hospital_Radiology

    Kobe-shi, Hyogo, 650-0017

  • National Center of Neurology and Psychiatry_Neurology

    Kodaira-shi, Tokyo, 187-8551

  • Southern Tohoku Medical Clinic

    Koriyama-shi, Fukushima, 963-8052

  • Katayama Medical Clinic

    Kurashiki-shi, Okayama, 710-0813

  • Nozomi Memory Clinic

    Mitaka-shi,Tokyo, 181-0013

  • Kikukawa clinic

    Nerima-ku, Tokyo, 179-0072

  • General Rehabilitation Center Midori Hospital_Neurology

    Niigata-shi, Niigata, 950-0983

  • General Rehabilitation Center · Midori Hospital

    Niigata-shi, Niigata, 950-0983

  • National Center for Geriatrics and Gerontology_Comprehensive care

    Obu-shi, Aichi, 474-8511

  • OKAYAMA KYOKUTO HOSPITAL_Radiology

    Okayama-shi, Okayama, 703-8265

  • Jichiidai Station Brain Clinic

    Shimotsuke-shi, Tochigi, 329-0403

  • Jichiidai Station Brain Clinic

    Shimotsuke-shi, Tochigi

  • ALZCLINIC PET LAB_Radiology

    Shinjuku-ku, Tokyo, 160-0017

  • Keio University Hospital_Neurology

    Shinjuku-ku, Tokyo, 160-8582

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • Shizuoka City Shimizu Hospital_Neurology

    Shizuoka-shi, Shizuoka, 424-8636

  • Kagawa Prefectural Central Hospital_Neurology

    Takamatsu-shi, Kagawa, 760-8557

  • Kagawa Prefectural Central Hospital_Takamatsu-shi, Kagawa

    Takamatsu-shi, Kagawa, 760-8557

  • Takatsuki General Hospital_Neurology

    Takatsuki-Shi, Osaka, 569-1192

  • Saino Clinic_Internal Medicine

    Tokorozawa-shi,Saitama, 359-1141

  • Saino Clinic

    Tokorozawa-shi,Saitama, 359-1141

  • Itsuki Hospital_Neurology

    Tokushima-shi, Tokushima, 770-0852

  • Alzclinic Tokyo

    Tokyo, 100-0005

  • Tokyo Center Clinic

    Tokyo, 103-0028

  • Juntendo Tokyo Koto Geriatric Medical Center_psychiatry

    Tokyo, 136-0075

  • Juntendo Tokyo Koto Geriatric Medical Center

    Tokyo, 136-0075

  • Kurumi CLINIC

    Tokyo, 156-0041

  • ALZCLINIC PET LAB_Psychiatry

    Tokyo, 160-0017

  • Tokyo Medical Univ. Hospital_Geriatric Medicine

    Tokyo, 160-0023

  • Tokyo Medical Univ. Hospital

    Tokyo, 160-0023

  • Memory Clinic Toride

    Toride-shi, Ibaraki, 302-0004

  • MI Clinic

    Toyonaka-shi, Osaka, 560-0004

  • Medical Corporation Midorikai Wako Hospital_Psychiatry

    Wako-shi, Saitama, 351-0111

  • Yuaikai Yuai Clinic

    Yokohama-shi, Kanagawa, 223-0059

Other trials in Japan

China36 sites

  • Baogang Hospital of Inner Mongolia-Neurology

    Baotou, Inner Mongolia, 014010

  • Beijing Chao-Yang Hospital, Capital Medical University-Neuro

    Beijing, Beijing Municipality, 100020

  • Beijing Friendship Hospital, Capital Medical University-Neurology

    Beijing, Beijing Municipality, 100050

  • Beijing Hospital-Neurology

    Beijing, Beijing Municipality, 100050

  • Xuanwu Hospital Capital Medical University-Neurology

    Beijing, Beijing Municipality, 100053

  • Beijing Tiantan Hospital, Capital Medical University-Neurology Center

    Beijing, Beijing Municipality, 100070

  • Beijing Anding Hospital Capital Medical University-Geriatric Psychiatry

    Beijing, Beijing Municipality, 100088

  • Peking University Sixth Hospital-Geriatrics

    Beijing, Beijing Municipality, 100089

  • Beijing Huilongguan Hospital-Geriatrics

    Beijing, Beijing Municipality, 100096

  • Peking Union Medical College Hospital-Neurology

    Beijing, Beijing Municipality, 100730

  • The first Bethune Hospital of Jilin University, Neurology

    Changchun, Jilin, 130031

  • The First Bethune Hospital of Jilin University-Neurology

    Changchun, Jilin, 130031

  • Xiangya Hospital Central South University-Neurology

    Changsha, Hunan, 410008

  • West China Hospital Sichuan University-Mental health center

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Chongqing Medical University-Geriatrics

    Chongqing, Chongqing Municipality, 400016

  • Fujian Medical University Union Hospital-Neurology

    Fuzhou, Fujian, 350001

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Neurology

    Guangzhou, Guangdong, 510120

  • Guangzhou First People's Hospital-Neurology

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital of Guangzhou Medical University-Neurology

    Guangzhou, Guangdong, 510260

  • The Affiliated Brain Hospital of Guangzhou Medical University-Neurology

    Guangzhou, Guangdong, 510370

  • The First Affiliated Hospital of Zhejiang University School of Medicine-Neurology

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital of Nanchang University-Neurol

    Nanchang, Jiangxi, 330006

  • Nanjing Brain Hospital-Neurology

    Nanjing, Jiangsu, 210000

  • Nanjing Drum Tower Hospital-Neurology

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University-Nephrology

    Nanjing, Jiangsu, 210009

  • Huashan Hospital Fudan University-Neurology

    Shanghai, Shanghai Municipality, 200040

  • Dongfang Hospital Affiliated to Shanghai Tongji University-Neurology

    Shanghai, Shanghai Municipality, 200123

  • Shanghai 6th People's Hosp. Affili. to SHJT Univer-Neurology

    Shanghai, Shanghai Municipality, 200233

  • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University-Neurology

    Shanghai, Shanghai Municipality, 200233

  • Tianjin Medical University General Hospital-Neurology

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Huanhu Hospital-Neurology

    Tianjin, Tianjin Municipality, 300350

  • Wuxi Mental Health Center-Psychiatry

    Wuxi, Jiangsu, 214000

  • Wuxi Mental Health Center

    Wuxi, Jiangsu, Psychiatry

  • Qinghai Provincial People's Hospital-Geriatrics

    Xining, Qinghai, 810007

  • Northern Jiangsu People's Hospital-Neurology

    Yangzhou, Jiangsu, 225001

  • Henan Provincial People's Hospital-Neurology

    Zhengzhou, Henan, 450003

Other trials in China

Canada20 sites

  • MoCA Research Innovation Inc

    Greenfield Park, Quebec, J4V 2J2

  • True North Clinical Research - Halifax

    Halifax, Nova Scotia, B3S 1N2

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Kelowna, British Columbia, V1Y 1Z9

  • Douglas Hosp Res Ctr

    Montreal, Quebec, H4H 1R3

  • True North Clinical Research - New Minas

    New Minas, Nova Scotia, B4N 3R7

  • Medical Arts Health Research Group

    North Vancouver, British Columbia, V7P 2T4

  • Ottawa Memory Clinic

    Ottawa, Ontario, K1Z 1G3

  • Recherches Neuro-Hippocampe Inc

    Ottowa, Ontario, K1Z 1G3

  • Medical Arts Health Research Group_Kelowna

    Penticton, British Columbia, V2A 5L5

  • Kawartha Centre Redefining Healthy Aging

    Peterborough, Ontario, K9H2P4

  • CHU de Quebec-Universite Laval

    Québec, Quebec, G1J 1Z4

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec, J1L 0H8

  • Memory Program

    Toronto, Ontario, M3B2S7

  • Centricity Research LMC (Toronto)

    Toronto, Ontario, M4G 3E8

  • Centricity Research LMC

    Toronto, Ontario, M4G 3E8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1X1

  • University Health Network

    Toronto, Ontario, M5T 2S8

  • Island Health (Research and Capacity Building)

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

Russia18 sites

  • SAI of Health "Interregional Clinic Diagnostic Center"

    Kazan', 420101

  • SAHI Kuzbass Hospital(former Regional clinical hospital)

    Kemerovo, 650066

  • Federal Siberian Research Clinical Center under FMBA of Rus

    Krasnoyarsk, 660037

  • FSBI "Mental Health Research Center"

    Moscow, 115522

  • FSAEI 1st Moscow Federal Med University na Sechenov

    Moscow, 119021

  • RMAPE

    Moscow, 125373

  • Pirogov Russian National Research Medical University MoH

    Moscow, 129226

  • Ezramed Clinic Llc

    Omsk, 644043

  • Research Center for Treatment and Rehabilitation "Phoenix"

    Rostov-on-Don, 344000

  • Psychiatric hospital of st. Nicholas the wonderworker

    Saint Petersburg, 190121

  • N.-E. State Medical University n.a. Mechnikov

    Saint Petersburg, 191015

  • S.M. Kirov Military Medical Academy,Depart.&Clinic Nerv Dis

    Saint Petersburg, 194044

  • SHI "Saratov City Clinical Hospital #2 n.a. V.Razumovskij"

    Saratov, 410028

  • Center of Clinica Trials "Nebbiolo"

    Tomsk, 634009

  • LLC "Clinic Stolet"

    Tomsk, 634009

  • National medical holdiNational medical holding "Medstandard"

    Ufa, 450054

  • SAHI SR "Sverdlovsk Regional Clinical Psychiatric Hospital"

    Yekaterinburg, 620030

  • Joint Stock Company "Medical technologies"

    Yekaterinburg, 620075

Other trials in Russia

United Kingdom16 sites

  • Royal Cornhill Hospital

    Aberdeen, AB25 2ZH

  • RICE - The Research Institute for the Care of Older People

    Bath, BA1 3NG

  • Fritchie Centre

    Cheltenham, Gloucestershire, GL53 9DZ

  • Dementia Research Unit,

    Crowborough, TN6 1NY

  • Dementia Research Unit

    Crowborough, TN6 1NY

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Western General Hospital

    Edinburgh, EH4 2XU

  • St Pancras Clinical Research

    London, EC2Y 8EA

  • St Georges Hospital

    London, SW17 0RE

  • Imperial College London - Imperial College Memory Research Centre

    London, W12 0HS

  • Greater Manchester Mental Health NHS Foundation Trust

    Manchester, M13 9WL

  • NeuroClin

    Motherwell, ML1 4UF

  • Newcastle University

    Newcastle upon Tyne, NE4 5PL

  • Warneford Hospital

    Oxford, OX3 7JX

  • Moorgreen Hospital

    Southampton, SO30 3JB

  • Kings Hill Research Centre

    Swindon, SN3 6BW

Other trials in United Kingdom

France15 sites

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

    Bordeaux, 33000

  • Hospices Civils de Lyon-Hopital Pierre Wertheimer

    Bron, 69500

  • Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage

    Dijon, 21000

  • Centre Hospitalier Universitaire de Lille-Hopital Roger Salengro

    Lille, 59037

  • Centre Hospitalier Et Universitaire de Limoges-Hopital Dupuytren

    Limoges, 87042

  • Assistance Publique Hopitaux de Marseille-Hopital de La Timone

    Marseille, 13005

  • Centre Hospitalier Universitaire de Nice-Institut Claude Pompidou

    Nice, 06100

  • Aphp-Hopital Lariboisiere-1

    Paris, 75010

  • Aphp-Hopital Lariboisiere

    Paris, 75010

  • Aphp-Hopital La Pitie Salpetriere-3

    Paris, 75013

  • Chu de Reims-Hopital Maison Blanche

    Reims, 51092

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-2

    Saint-Herblain, 44800

  • Les Hopitaux Universitaires de Strasbourg-Hopital de La Robertsau

    Strasbourg, 67000

  • Centre Hospitalier Universitaire de Toulouse-Hopital La Grave

    Toulouse, 31300

  • Hospices Civils de Lyon-Hopital Des Charpennes

    Villeurbanne, 69100

Other trials in France

Italy14 sites

  • AOU Ospedali Riuniti S.O.D

    Ancona, 60126

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

  • Università degli studi G. D'Annunzio di Chieti - CAST - Neurologia

    Chieti, 66100

  • AOU Careggi Firenze

    Florence, 50134

  • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale San Raffaele Milano

    Milan, 20132

  • ASST Monza e Brianza Ospedale San Gerardo

    Monza, 20900

  • Ospedale Santa Maria della Misericordia

    Perugia, 06129

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Pol. Uni. Campus Biomedico UOC Neurologia

    Roma, 00128

  • Policlinico Tor Vergata

    Roma, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Neuroscienze, Organi di Senso e Torace

    Roma, 00168

  • Fondazione Santa Lucia IRCCS

    Roma, 00179

  • AOU Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Poland14 sites

  • Centrum Medyczne Neuromed

    Bydgoszcz, 85-163

  • Centrum Zdrowia Psychicznego Biomed

    Kielce, 25-411

  • Linden sp. z o.o. sp. k.

    Krakow, Lesser Poland Voivodeship, 30-721

  • Szpital Uniwersytecki w Krakowie od. Neurologii

    Krakow, 30-688

  • Centrum Neurologii Klinicznej

    Krakow, 31-505

  • Indywidualna Praktyka Lekarska prof. Konrad Rejdak

    Lublin, Lublin Voivodeship, 20-016

  • Nzoz Neuromed

    Lublin, 20-818

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

    Oświęcim, 32-600

  • NZOZ NEURO - KARD Ilkowski i Partnerzy Sp. Part. Lekarzy

    Poznan, 61-853

  • Osrodek Alzheimerowski Sp. z o.o.

    Ścinawa, 59-330

  • Centrum Medyczne SENIOR

    Sopot, 81-855

  • Centrum Medyczne Neuro Protect

    Warsaw, 01-684

  • NZOZ Wroclawskie Centrum Alzheimerowskie

    Wroclaw, 53-659

  • NZOZ Wrocławskie Centrum Alzheimerowskie

    Wroclaw, 53-659

Other trials in Poland

South Korea14 sites

  • Dong-A University Hospital

    Busan, 49201

  • Chungnam National University Hospital

    Daejeon, 35015

  • MyongJi Hospital

    Goyang-si, Gyeonggi-do, 10475

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Hanyang University Medical Center

    Seoul, 04763

  • Hanyang university seoul hospital

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center_Seoul

    Seoul, 06351

  • Ewha Womans University Seoul Hospital

    Seoul, 07804

Other trials in South Korea

Hungary12 sites

  • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1033

  • Semmelweis Egyetem ÁOK

    Budapest, 1083

  • DE Kenézy Gyula Campus, Pszichiátriai és Pszichoterápiai Klinika

    Debrecen, 4031

  • DE Gyógyszerfejlesztési Koordinációs Központ Pszichiátria

    Debrecen, 4032

  • Bugát Pál Kórház

    Gyöngyös, 3200

  • Petz Aladar Megyei Korhaz

    Győr, 9024

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • DR. MÁTHÉ ÉS TÁRSA Egészségügyi és Szolgáltató Betéti Társaság

    Kalocsa, 6300

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Psychotech Kft.

    Pécs, 7633

  • Szent Borbála Kórház

    Tatabánya, 2800

  • Belvárosi Egészségház Kft.

    Zalaegerszeg, 8900

Other trials in Hungary

Turkey (Türkiye)12 sites

  • Hacettepe University Medical Faculty Hospital

    Altindag/Ankara, 06230

  • Hacettepe Üniversitesi Hastanesi- Nöroloji

    Altindag/Ankara, 06230

  • Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi- Nöroloji

    Balcova / Izmir, 35330

  • Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma

    Eskişehir, 26040

  • Eskişehir Osmangazi Üniversitesi Hastanesi- Nöroloji

    Eskişehir, 26040

  • Istanbul Bezmi Alem Vakif University Tip Faculty Hospital

    Istanbul, 34093

  • Istanbul University Medical Faculty Neurology Department

    Istanbul, 34093

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Nöroloji

    Istanbul, 34093

  • Izmir Economics University Medical Point Hospital Neurology D

    Izmir, 35575

  • İzmir Ekonomi Üniversitesi Medicalpoint Hastanesi-Nöroloji

    Izmir, 35575

  • Ondokuz Mayis University Saglik Uygulama ve Arastirma Merkez

    Samsun, 55200

  • Ondokuz Mayıs Üniversitesi Hastanesi- Nöroloji

    Samsun, 55200

Other trials in Turkey (Türkiye)

Taiwan11 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 833

  • Chang Gung Memorial Hospital - Kaoshiung Branch

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung University Hospital

    Tainan, 704302

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital_main

    Taipei, 100

  • Taipei Veteran General Hospital_Dept of Neurology

    Taipei, 112

  • Taipei Veteran General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

  • Chang Gung Memorial Hospital Linkou

    Taoyuan City, 333

Other trials in Taiwan

Australia10 sites

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • HammondCare Greenwich

    Greenwich, New South Wales, 2065

  • Medical and Cognitive Research Unit - Austin Health

    Ivanhoe, Victoria, 3079

  • Southern Neurology

    Kogarah, New South Wales, 2217

  • KaRa Institute of Neurological Disease Pty Ltd

    Macquarie Park, New South Wales, 2113

  • HammondCare

    Malvern, Victoria, 3144

  • Alzheimer's Research Australia

    Nedlands, Western Australia, 6009

  • Australian Alzheimer's Research Foundation Incorporated

    Nedlands, Western Australia, 6009

  • Hunter New England Local Health District - Neuropsychiatry

    Waratah, New South Wales, 2298

Other trials in Australia

Brazil10 sites

  • Hospital das Clínicas - Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

  • L2 IP Instituto de Pesquisas Clinicas Ltda

    Brasília, Federal District, 70200730

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

  • Clinica Clinilive Ltda

    Maringá, Paraná, 87013-250

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Centro de Psiquiatria Sandra Rushel

    Rio de Janeiro, 22270-060

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

  • BR Trials - Ensaios Clínicos e Consultoria Ltda.

    São Paulo, São Paulo, 01236-030

  • Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP

    São Paulo, São Paulo, 04024-002

  • Sociedade Beneficente Israelita Bras Hosp Albert Einstein

    São Paulo, São Paulo, 05652-900

Other trials in Brazil

Greece10 sites

  • Naval Hospital of Athens - Neurology Department

    Athens, 11521

  • Henry Dunant Hospital Center,2nd Neurological Department

    Athens, 11526

  • Aiginitio Hospital, 1st Neurology Clinic

    Athens, 11528

  • "Hygeia" General Hospital of Athens, Memory clinic

    Athens, 15123

  • Naval Hospital of Athens

    Athens, GR-11521

  • Aiginitio Hospital, 1st Neurology Clinic

    Athens, GR-11528

  • University General Hospital of Athens "Attiko"

    Chaidari, Athens, GR-12462

  • Iatriko Athinon (Athens Medical Center),Memory Disorders Cli

    Marousi, 15125

  • AHEPA General University Hospital

    Thessaloniki, 54636

  • EUROMEDICA General Clinic of Thessaloniki,Neurology Dpt

    Thessaloniki, 54643

Other trials in Greece

Romania10 sites

  • Sana Monitoring SRL

    Bucharest, 011025

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Cai Ferate Constanta

    Constanța, 900123

  • Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta

    Constanța, 900591

  • Med Anima Iasi

    Iași, 700004

  • CMI Dr. Buhaș Ramocea Elena Daniela - Cabinet Medical de Psihiarie

    Oradea, 410027

  • Aria Clinic SRL

    Sibiu, 550052

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Târgu Mureş, Mureș County, 540136

  • CMI Neurologie Dr Popa Izabela

    Timișoara, Timiș County, 300766

  • Centrul Medical Neuro Therapy

    Timișoara, 300416

Other trials in Romania

Ukraine10 sites

  • Chernivtsi Emergency Hospital - Center of Emergency Neurology

    Chernivtsi, 58023

  • Medical Center 'Neiron'

    Kharkiv, 61091

  • Medical Centre 'Neiron'

    Kharkiv, 61091

  • Chebotarev Institute of Gerontology of NAMSU - Age Physiology and Pathology department

    Kyiv, 04114

  • Volyn Regional Clinical Hospital - Neurology department

    Lutsk, 43000

  • Main Unit of 'Odesa Regional Medical Centre for Mental Health' - Department 18

    Odesa, 65031

  • Odesa Regional Medical Center for Mental Health

    Odesa, 65031

  • Sumy Regional Clinical Hospital - Neurology department

    Sumy, 40000

  • Medical Centre 'SALUTEM' - Medical and preventive care department

    Vinnytsia, 21050

  • Zaporizhia Regional Clinical Hospital - Department of neurology No. 1

    Zaporizhzhya, 69600

Other trials in Ukraine

Portugal8 sites

  • ULS De Braga, E.P.E. - Hospital de Braga

    Braga, 4710-243

  • Unidade De Coimbra, E.P.E. - Hospital da Universidade de Coimbra

    Coimbra, 3000-561

  • ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães

    Guimarães, 4835-044

  • ULS De Lisboa Ocidental E.P.E. - Hospital Egas Moniz

    Lisbon, 1349-019

  • Hospital Beatriz Ângelo

    Loures, 2674-514

  • ULS De Santo António, E.P.E. - Hospital de Santo António

    Porto, 4099-001

  • ULS De Matosinhos E.P.E.- Hospital Pedro Hispano

    Senhora Da Hora, Matosinhos, Matosinhos, 4464-513

  • Campus Neurologico Senior (CNS) Saude Lda

    Torres Vedras, 2560-280

Other trials in Portugal

Spain8 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Fundación ACE

    Barcelona, 08028

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital 12 de Octubre

    Madrid, 28041

  • H.U. Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès, 08195

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Doctor Peset

    Valencia, 46017

Other trials in Spain

Argentina7 sites

  • Instituto de Investigaciones Metabolicas (IDIM)

    Buenos Aires, C1012AAR

  • Hospital Italiano

    Buenos Aires, C1181ACH

  • Clínica Nuestra Señora de las Nieves

    CABA, 1427

  • FLENI

    CABA, 1428

  • Instituto Medico Especializado_Capital Federal

    Ciudad de Buenos Aires, Buenos Aires, C1405CWB

  • Instituto Privado Kremer

    Córdoba, X5004AOA

  • Fundación Scherbovsky

    Mendoza, 5500

Other trials in Argentina

South Africa7 sites

  • IATROS International

    Bloemfontein, Free State, 9301

  • ACF Neurological service

    Cape Town, Western Cape, 7405

  • Flexivest Fourteen Research Centre

    Cape Town, Western Cape, 7550

  • Cape Trial Centre

    Cape Town, Western Cape, 7560

  • Excellentis Clinical Trial Consultants

    George, Eastern Cape, 6529

  • Dr Stanley Lipschitz Clinic Inc

    Johannesburg, Gauteng, 2196

  • Denmar Psychiatric Hospital

    Pretoria, Gauteng, 0042

Other trials in South Africa

Belgium6 sites

  • AZ Sint-Jan - Campus Sint-Jan - Neurology

    Bruges, 8000

  • UZA - UZ Antwerpen - Department of Neurology

    Edegem, 2650

  • UZ Gent - Neurologie

    Ghent, 9000

  • AZ Groeninge - Kortrijk - Neurologie

    Kortrijk, 8500

  • UZ Leuven - Geheugenkliniek

    Leuven, 3000

  • Clinique CHC MontLégia - Service Neurologie

    Liège, 4000

Other trials in Belgium

Bulgaria6 sites

  • "MHATNP "Sv. Naum"" EAD

    Sofia, 1113

  • MHATNP Sveti Naum EAD

    Sofia, 1113

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

    Sofia, 1408

  • UMHAT Aleksandrovska EAD, Clinic of Neurology

    Sofia, 1431

  • MMA MHAT - Sofia, Neurology clinic

    Sofia, 1606

  • MMA, MHAT-Sofia, Neurology clinic

    Sofia, 1606

Other trials in Bulgaria

Czechia6 sites

  • Neuro Health Centrum s.r.o.

    Brno-Líšeň, 628 00

  • NeuroHK s.r.o.

    Choceň, 565 01

  • AGE Centrum

    Olomouc, 77900

  • AD71 s.r.o.

    Prague, 109 00

  • Neuropsychiatrie s.r.o.

    Prague, 160 00

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 51601

Other trials in Czechia

Austria5 sites

  • Universitätsklinik für Neurologie

    Graz, 8036

  • LKH-Univ. Kliniken Innsbruck

    Innsbruck, 6020

  • Medizinische Univ. Innsbruck

    Innsbruck, 6020

  • Univ. Klinik für Neurologie

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Ireland5 sites

  • Mercy Hospital Cork

    Cork, T12 WE28

  • St Vincent's Neurology Dept

    Dublin, D04 VH51

  • St Vincent's University Hospital

    Dublin, D04 VH51

  • Mercer's Institute for Successful Aging

    Dublin, D08 NHY1

  • Tallaght University Hospital

    Dublin, D24 NR0A

Other trials in Ireland

Slovakia5 sites

  • I. neurologicka klinika LF UK a UNB

    Bratislava, 813 69

  • Psychiatricka klinika LF UK a UNB

    Bratislava, 813 69

  • Neurologicka klinika UPJS LF a UNLP

    Košice, 041 66

  • NEURES, neurologicka ambulancia

    Krompachy, 053 42

  • Crystal Comfort s.r.o.

    Vranov nad Topľou, 093 01

Other trials in Slovakia

Croatia4 sites

  • Poliklinika Solmed

    Zagreb, City of Zagreb, 10000

  • KBC Zagreb, Klinika za neurologiju

    Zagreb, 10000

  • KBC Zagreb_Neurology

    Zagreb, 10000

  • Poliklinika Bonifarm

    Zagreb, 10000

Other trials in Croatia

Israel4 sites

  • Rambam MC - The Stroke and Cognition Institute

    Haifa, 3109601

  • Rabin MC Beilinson - Cognitive Neurology Clinic

    Petah Tikva, 49100

  • Sourasky MC - Cognitive Neurology Department

    Tel Aviv, 6423906

  • Sheba MC - Memory Clinic

    Tel Hashomer, Ramat Gan, 5262000

Other trials in Israel

Netherlands4 sites

  • Brain Research Center

    's-Hertogenbosch, 5223 LA

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Spaarne Gasthuis Haarlem

    Haarlem, 2035 RC

  • RadboudUMC

    Nijmegen, 6525 GA

Other trials in Netherlands

Switzerland4 sites

  • Spitalzentrum Biel

    Biel/Bienne, 2502

  • Centre de la Mémoire

    Geneva, 1205

  • Centre Leenaards de la mémoire CHUV

    Lausanne, 1011

  • Klinik für Neurologie Kantonsspital St.Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

Denmark3 sites

  • Aarhus Universitetshospital - Neurologisk Klinik

    Aarhus N, 8200

  • Rigshospitalet - afsnit 8015 Hukommelsesklinikken

    København Ø, 2100

  • Sjællands Universitetshospital_Roskilde

    Roskilde, 4000

Other trials in Denmark

Finland3 sites

  • CRST Helsinki

    Helsinki, 00180

  • Aivotutkimusyksikkö

    Kuopio, 70210

  • CRST Turku

    Turku, 20520

Other trials in Finland

Serbia3 sites

  • Neurology clinic, University Clinical Center of Serbia

    Belgrade, 11000

  • Special Hospital for Psychiatric Disorders "Kovin"

    Kovin, 26220

  • University clinical center of Vojvodina, Neurology clinic

    Novi Sad, 21000

Other trials in Serbia

Slovenia3 sites

  • UKC Ljubljana, Department of Neurology

    Ljubljana, SI-1000

  • UKC Maribor - neurology

    Maribor, 2000

  • Private Neurology Practice - Nova Gorica

    Nova Gorica, 5000

Other trials in Slovenia

Sweden3 sites

  • Skåne US - Minnesmottagning Malmö

    Malmö, 205 02

  • Karolinska Universitetssjukhuset, Huddinge

    Stockholm, 141 86

  • Geriatriskt centrum Umeå - NU

    Umeå, 901 85

Other trials in Sweden

Germany2 sites

  • Universitätsklinikum Köln - Klinik und Poliklinik für Psychiatrie und Psychotherapie

    Cologne, 50937

  • Universitätsklinikum Münster - Neurologie

    Münster, 48149

Other trials in Germany

About this study

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)

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.

Read more

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.

Being tested
Semaglutide, Placebo (semaglutide)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

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

  • Placebo (semaglutide)Drug

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

Study groups in NCT04777409
Study groupRoleWhat they receive
Oral semaglutideExperimentalParticipants are given oral semaglutide once daily
Receives: Drug: Semaglutide
Placebo (semaglutide)Placebo comparatorParticipants are given oral placebo once daily
Receives: Drug: Placebo (semaglutide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score

    Score on scale (0 to 18)

    Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease:

    • Cognitive domains: memory, orientation, and judgement and problem solving
    • Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains.

    The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment.

    Measured: From baseline (week 0) to week 104

Secondary outcomes (29)

  1. Main Phase: Change in the 24-item Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-ADL-MCI) score

    Score on scale (0 to 53). An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment.

    Measured: From baseline (week 0) to week 104

  2. Extension phase: Change in the ADCS-ADL-MCI score

    Score on scale (0 to 53) An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment.

    Measured: From baseline (week 0) to week 156

  3. Main Phase: Time to progression to Clinical Dementia Rating (CDR) global score greater than or equal to (≥)1.0 among patients with CDR global score equal to (=) 0.5 at baseline

    Week(s)

    Measured: From baseline (week 0) up to week 156

  4. Extension Phase: Time to progression to Clinical Dementia Rating (CDR) global score greater than or equal to (≥)1.0 among patients with CDR global score equal to (=) 0.5 at baseline

    Week(s)

    Measured: From baseline (week 0) to week 156

  5. Main Phase: Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score

    Score on scale (0 to 85) Measures the severity of cognitive impairment in various domains including memory, language, orientation, praxis and executive function. The total scores on the scale range from 0 to 85 with higher scores representing greater impairment.

    Measured: From baseline (week 0) to week 104

  6. Extension Phase: Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score

    Score on scale (0 to 85) Measures the severity of cognitive impairment in various domains including memory, language, orientation, praxis and executive function. The total scores on the scale range from 0 to 85 with higher scores representing greater impairment.

    Measured: From baseline (week 0) to week 156

  7. Main Phase: Change in the Montreal Cognitive Assessment (MoCA) score

    Score on scale (0 to 30) The assessment includes 8 domains of cognitive function with total scores ranging from 0 to 30 and lower scores indicating greater impairment.

    Measured: From baseline (week 0) to week 104

  8. Extension Phase: Change in the Montreal Cognitive Assessment (MoCA) score

    Score on scale (0 to 30) The assessment includes 8 domains of cognitive function with total scores ranging from 0 to 30 and lower scores indicating greater impairment.

    Measured: From baseline (week 0) to week 156

  9. Main Phase: Change in the Alzheimer's Disease Composite Score (ADCOMS)

    Score on scale (0 to 1.97) The ADCOMS is a composite clinical outcome comprising 4 items from the ADAS-Cog-13, 2 items from the MMSE and all 6 items from the CDR-SB.32 The total scores on the scale range from 0 to 1.97 with higher scores indicating greater impairment.

    Measured: From baseline (week 0) to week 104

  10. Extension Phase: Change in the Alzheimer's Disease Composite Score (ADCOMS)

    Score on scale (0 to 1.97) The ADCOMS is a composite clinical outcome comprising 4 items from the ADAS-Cog-13, 2 items from the MMSE and all 6 items from the CDR-SB.32 The total scores on the scale range from 0 to 1.97 with higher scores indicating greater impairment.

    Measured: From baseline (week 0) to week 156

  11. Main Phase: Change in the Mini-Mental State Examination (MMSE) score

    Score on scale (0 to 30) The MMSE measures orientation, attention, memory, language and visuo-spatial function. The total scores on the scale range from 0 to 30 with lower scores indicating greater impairment.

    Measured: From baseline (week 0) to week 104

  12. Extension Phase: Change in the Mini-Mental State Examination (MMSE) score

    Score on scale (0 to 30) The MMSE measures orientation, attention, memory, language and visuo-spatial function. The total scores on the scale range from 0 to 30 with lower scores indicating greater impairment.

    Measured: From baseline (week 0) to week 156

  13. Main Phase: Time to progression in disease stage based on CDR global score

    Week(s)

    Measured: From baseline (week 0) up to week 156

  14. Extension Phase: Time to progression in disease stage based on CDR global score

    Week(s)

    Measured: From baseline (week 0) to week 156

  15. Main Phase: Change in the composite Z-score based on the three outcome measures CDR-SB, ADCS-ADL-MCI, and ADAS-Cog-13

    Score

    Measured: From baseline (week 0) to week 104

  16. Extension Phase: Change in the composite Z-score based on the three outcome measures CDR-SB, ADCS-ADL-MCI, and ADAS-Cog-13

    Score

    Measured: From baseline (week 0) to week 156

  17. Main Phase: Change in the 10-item Neuropsychiatric Inventory (NPI) score

    104 Score on scale (0 to 120) The 10-item scale assesses symptoms including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability and aberrant motor activity. For each domain the frequency (4-point scale) and severity (3-point scale) of symptoms is reported. The score for each domain is calculated by multiplying the frequency and severity score. The total 10-item NPI score is 0 to 120 with higher scores indicating a greater symptomatology.

    Measured: From baseline (week 0) to week 104

  18. Extension Phase: Change in the 10-item Neuropsychiatric Inventory (NPI) score

    104 Score on scale (0 to 120) The 10-item scale assesses symptoms including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability and aberrant motor activity. For each domain the frequency (4-point scale) and severity (3-point scale) of symptoms is reported. The score for each domain is calculated by multiplying the frequency and severity score. The total 10-item NPI score is 0 to 120 with higher scores indicating a greater symptomatology.

    Measured: From baseline (week 0) to week 156

  19. Main Phase: Change in high sensitivity C-reactive protein level

    Ratio to baseline

    Measured: From baseline (week 0) to week 104

  20. Extension Phase: Change in high sensitivity C-reactive protein level

    Ratio to baseline

    Measured: From baseline (week 0) to week 156

  21. Main Phase: Number of treatment emergent adverse events (TEAEs)

    Number of events

    Measured: From baseline (week 0) up to week 156

  22. Extension Phase: Number of treatment emergent adverse events (TEAEs)

    Number of events

    Measured: From baseline (week 0) to week 156

  23. Main Phase: Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and allcause death

    Week(s)

    Measured: From baseline (week 0) to week 104

  24. Extension Phase: Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and allcause death

    Week(s)

    Measured: From baseline (week 0) to week 156

  25. Main Phase: Time to first occurrence of stroke

    Weeks

    Measured: From baseline (week 0) to week 104

  26. Extension Phase: Time to first occurrence of stroke

    Weeks

    Measured: From baseline (week 0) to week 156

  27. Main Phase: Change in the EQ-5D-5L (proxy version) index score

    Score The EQ-5D-5L descriptive system comprises mobility, self-care, usual activities, pain/discomfort and anxiety/depression with five response levels each (no problems, slight problems, moderate problems, severe problems, unable to /extreme problems). The EQ-5D-5L proxy version 1 (the study partner is asked to rate how he/she [the proxy] would rate the subject´s health) will be used in this trial.

    Measured: From baseline (week 0) to week 104

  28. Extension Phase: Change in the EQ-5D-5L (proxy version) index score

    Score The EQ-5D-5L descriptive system comprises mobility, self-care, usual activities, pain/discomfort and anxiety/depression with five response levels each (no problems, slight problems, moderate problems, severe problems, unable to /extreme problems). The EQ-5D-5L proxy version 1 (the study partner is asked to rate how he/she [the proxy] would rate the subject´s health) will be used in this trial.

    Measured: From baseline (week 0) to week 156

  29. Extension phase: Change in the CDR-SB score

    Score on scale (0 to 18)

    Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease:

    • Cognitive domains: memory, orientation, and judgement and problem solving
    • Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains.

    The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment.

    Measured: From baseline (week 0) to week 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2021
  2. Study start18 May 2021
  3. Primary completion15 Sep 2025
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04777409
Sponsor's protocol ID
NN6535-4725
Other IDs
U1111-1259-2920, 2023-506918-45, 2023
Acronym
EVOKE Plus
Status last verified
Jun 2026
First submitted
26 Feb 2021
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Cummings JL, Atri A, Sano M, Zetterberg H, Scheltens P, Knop FK, Johannsen P, Wichmann CA, Abschneider RM, Leon T, Feldman HH. Efficacy and safety of oral semaglutide 14 mg (flexible dose) in early-stage symptomatic Alzheimer's disease (evoke and evoke+): two phase 3, randomised, placebo-controlled trials. Lancet. 2026 May 30;407(10544):2167-2179. doi: 10.1016/S0140-6736(26)00459-9. Epub 2026 Mar 19.

    PubMed 41865758

  • Scheltens P, Atri A, Feldman HH, Zetterberg H, Sano M, Johannsen P, Colombo TL, Bardtrum L, Jeppesen R, Hansen CT, Cummings JL. Baseline characteristics from evoke and evoke+: Two phase 3 randomized placebo-controlled trials of semaglutide in participants with early-stage symptomatic Alzheimer's disease. Alzheimers Dement (N Y). 2026 Jan 10;12(1):e70200. doi: 10.1002/trc2.70200. eCollection 2026 Jan-Mar.

    PubMed 41522368

  • Cummings JL, Atri A, Feldman HH, Hansson O, Sano M, Knop FK, Johannsen P, Leon T, Scheltens P. evoke and evoke+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating efficacy, safety, and tolerability of semaglutide in early-stage symptomatic Alzheimer's disease. Alzheimers Res Ther. 2025 Jan 8;17(1):14. doi: 10.1186/s13195-024-01666-7.

    PubMed 39780249

  • van Sloten TT, Luchsinger JA, Launer LJ, Strachan M, Cukierman-Yaffe T, Gerstein HC, Sattar N, Biessels GJ. Call for effective therapies for preventing dementia in people with type 2 diabetes. Lancet Diabetes Endocrinol. 2024 Aug;12(8):510-513. doi: 10.1016/S2213-8587(24)00158-X. Epub 2024 Jun 17. No abstract available.

    PubMed 38901446

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide in people with Early Alzheimer´s Disease, run by Novo Nordisk A/S at 498 sites in 38 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 498 sites in United States, Japan, China, Canada, Russia and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score (time frame: From baseline (week 0) to week 104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04777409, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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