A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)
EVOKE
A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)
3 other identifiers
interventional
1,840
34 countries
433
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Longer than P75 for phase_3
433 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2021
CompletedFirst Posted
Study publicly available on registry
March 2, 2021
CompletedStudy Start
First participant enrolled
May 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedApril 9, 2026
April 1, 2026
4.3 years
February 26, 2021
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
From baseline (week 0) to week 104
Secondary Outcomes (29)
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
From baseline (week 0) to week 104
Extension Phase:Change in the ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment ) score
From baseline (week 0) to week 156
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
From baseline (week 0) up to week 156
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
From baseline (week 0) to week 156
Main Phase: Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score
From baseline (week 0) to week 104
- +24 more secondary outcomes
Study Arms (2)
Oral Semaglutide
EXPERIMENTALParticipants are given oral semaglutide once daily
Placebo (semagludtide)
PLACEBO COMPARATORParticipants are given oral placebo once daily
Interventions
Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
Oral placebo (semaglutide) once-daily, The study will last for up to 173 weeks
Eligibility Criteria
You may qualify if:
- 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 trial unless medically necessary.
You may not qualify if:
- Brain MRI (or CT) scan suggestive of clinically significant structural CNS disease confirmed by central read (e.g. cerebral large-vessel disease \[large vessel (cortical) infarcts greater than 10 mm in diameter\], prior macro-haemorrhage \[greater than 1 cm\^3\], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus).
- Brain MRI (magnetic resonance imaging) (or CT) scan suggestive of significant small vessel pathology confirmed by central read and defined as greater than1 lacunar infarct and/or ARWMC (age-related white matter changes) greater than 2, (WM (white matter) greater than 20 mm) in the deep white matter and periventricular regions.
- 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 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, HIV (human immunodeficiency virus), 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 subject 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 trial per investigator's judgement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (444)
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Imaging Endpoints
Scottsdale, Arizona, 85258, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Tucson Neuroscience Research
Tucson, Arizona, 85710, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
Fullerton Neurology and Headache Center
Fullerton, California, 92835, United States
Pacific Research Network
Lemon Grove, California, 91945, United States
Torrance Clin Res Inst, Inc.
Lomita, California, 90717, United States
ASCLEPES Research Centers,
Long Beach, California, 90807, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA_Los Angeles
Los Angeles, California, 90095, United States
Wr-Pri, Llc
Newport Beach, California, 92660, United States
Well Care Medical Center
Panorama City, California, 91402, United States
Cedars-Sinai Medical Center
Pasadena, California, 90048, United States
Sharp Neurocog Res Ctr
San Diego, California, 92123, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Calfornia Neurosc Resrch Med
Sherman Oaks, California, 91403, United States
Southern California Research LLC
Simi Valley, California, 93065, United States
Mountain Neurological Research Center, Inc.
Basalt, Colorado, 81621, United States
Denver Neurological Research
Denver, Colorado, 80210, United States
Mile High Research Center
Denver, Colorado, 80218, United States
Yale University
Fairfield, Connecticut, 06824, United States
Topaz Clinical Research
Apopka, Florida, 32703, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Visionary Investigators Network
Aventura, Florida, 33180, United States
K2 Medical Research - Winter Garden
Clermont, Florida, 34711, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Integrity Clinical Research, LLC
Doral, Florida, 33122, United States
Neuropsychiatric Research Cent
Fort Myers, Florida, 33912, United States
Finlay Medical Research Group
Greenacres City, Florida, 33467, United States
Indago Research & Health Center Inc.
Hialeah, Florida, 33012, United States
Hlth Cr Family Rehab & Res Ctr
Hialeah, Florida, 33015, United States
Galiz Research
Hialeah, Florida, 33016, United States
K2 The Villages
Lady Lake, Florida, 32159, United States
K2 Medical Research, Maitland
Maitland, Florida, 32751, United States
Hlth Cr Family Rehab & Res Ctr
Miami, Florida, 33015, United States
Premier Clin Res Inst, Inc.
Miami, Florida, 33122, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, 33122, United States
Central Miami Medical Institute
Miami, Florida, 33125, United States
Novel Clinical Research Center, LLC
Miami, Florida, 33173, United States
IMIC, Inc- Medical Research
Miami, Florida, 33176, United States
The Neurology Research Group
Miami, Florida, 33176, United States
Visionary Inv Ntwrk_Miami
Miami, Florida, 33176, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
Suncoast Clin Res Port Richey
New Port Richey, Florida, 34652, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807, United States
Headlands Research Orlando
Orlando, Florida, 32819, United States
Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, 33410, United States
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
The Roskamp Institute, Inc.
Sarasota, Florida, 34243, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Stedman Clinical Trials LLC
Tampa, Florida, 33613, United States
Palm Beach Neuro Premiere Res
West Palm Beach, Florida, 33407, United States
Conquest Research
Winter Park, Florida, 32789, United States
Center for Adv Res & Education
Gainesville, Georgia, 30501, United States
Hawaii Neuroscience, Memory Disorders Center
Honolulu, Hawaii, 96817, United States
Velocity Clinical Research, Meridian
Meridian, Idaho, 83642, United States
Velocity Clinical Research
Meridian, Idaho, 83642, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
University of Kentucky_Lexington_0
Lexington, Kentucky, 40504, United States
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401, United States
ActivMed Practice & Research LLC
Methuen, Massachusetts, 01844, United States
Bronson Lakeview Neurobehavioral Health
Paw Paw, Michigan, 49079, United States
HealthPartners Center for Memory and Aging
Saint Paul, Minnesota, 55130, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Wr-Crcn, Llc
Las Vegas, Nevada, 89106, United States
Patient First MD,clinical Trials
Middletown, New Jersey, 07748, United States
Advanced Memory Research Institute of NJ
Toms River, New Jersey, 08755, United States
Albuquerque neuroscience Inc
Albuquerque, New Mexico, 87109, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Neurological Assoc Long Island
Lake Success, New York, 11042, United States
NYU Grossman School of Med
New York, New York, 10016, United States
Richmond Behavioral Associates
Staten Island, New York, 10314, United States
New Hope Clinical Research
Charlotte, North Carolina, 28211, United States
AMC Research, LLC
Matthews, North Carolina, 28105, United States
Insight Clinical Trials LLC
Beachwood, Ohio, 44122, United States
NeuroScience Research Center, LLC
Canton, Ohio, 44718, United States
Valley Medical Primary Care
Centerville, Ohio, 45459, United States
Central States Research, LLC
Tulsa, Oklahoma, 74136, United States
Summit Research Network Oregon Inc.
Portland, Oregon, 97210, United States
Neural Net Research, LLC
Portland, Oregon, 97225, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Lowcountry Center for Vet Res
Charleston, South Carolina, 29403, United States
Coastal Neurology
Port Royal, South Carolina, 29935, United States
Genesis Neuroscience Clinic
Knoxville, Tennessee, 37909, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37212, United States
Texas Diabetes & Endocrinology
Austin, Texas, 78749, United States
Univ Of Texas Hlth Science Cntr
Houston, Texas, 77054, United States
Glenn Biggs Inst-Alzhm Neuro
San Antonio, Texas, 78229, United States
Shirzadi Shahin, MD
Sugar Land, Texas, 77478, United States
Memory Clinic, Inc
Bennington, Vermont, 05201, United States
Integrated Neurology Services
Falls Church, Virginia, 22043, United States
National Clin Res Inc.
Richmond, Virginia, 23294, United States
Booth Gardner Parkinson's Cre
Kirkland, Washington, 98034, United States
Instituto Medico Especializado_Capital Federal
Ciudad de Buenos Aires, Buenos Aires, C1405CWB, Argentina
Instituto de Investigaciones Metabolicas (IDIM)
Buenos Aires, C1012AAR, Argentina
Hospital Italiano
Buenos Aires, C1181ACH, Argentina
Clínica Nuestra Señora de las Nieves
CABA, 1427, Argentina
FLENI
CABA, 1428, Argentina
Instituto Privado Kremer
Córdoba, X5004AOA, Argentina
Fundación Scherbovsky
Mendoza, 5500, Argentina
St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
HammondCare Greenwich
Greenwich, New South Wales, 2065, Australia
Southern Neurology
Kogarah, New South Wales, 2217, Australia
Hunter New England Local Health District - Neuropsychiatry
Waratah, New South Wales, 2298, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Medical and Cognitive Research Unit - Austin Health
Ivanhoe, Victoria, 3079, Australia
Australian Alzheimer's Research Foundation Incorporated
Nedlands, Western Australia, 6009, Australia
Universitätsklinik für Neurologie
Graz, 8036, Austria
LKH-Univ. Kliniken Innsbruck
Innsbruck, 6020, Austria
Medizinische Univ. Innsbruck
Innsbruck, 6020, Austria
Univ. Klinik für Neurologie
Salzburg, 5020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
AZ Sint-Jan - Campus Sint-Jan - Neurology
Bruges, 8000, Belgium
UZA - UZ Antwerpen - Department of Neurology
Edegem, 2650, Belgium
AZ Groeninge - Kortrijk - Neurologie
Kortrijk, 8500, Belgium
Clinique CHC MontLégia - Service Neurologie
Liège, 4000, Belgium
L2 IP Instituto de Pesquisas Clinicas Ltda
Brasília, Federal District, 70200730, Brazil
Hospital das Clínicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310, Brazil
Clinica Clinilive Ltda
Maringá, Paraná, 87013-250, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000, Brazil
BR Trials - Ensaios Clínicos e Consultoria Ltda.
São Paulo, São Paulo, 01236-030, Brazil
Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP
São Paulo, São Paulo, 04024-002, Brazil
Sociedade Beneficente Israelita Bras Hosp Albert Einstein
São Paulo, São Paulo, 05652-900, Brazil
Centro de Psiquiatria Sandra Rushel
Rio de Janeiro, 22270-060, Brazil
"MHATNP "Sv. Naum"" EAD
Sofia, 1113, Bulgaria
MHATNP Sveti Naum EAD
Sofia, 1113, Bulgaria
DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan OOD, Psychiatry
Sofia, 1408, Bulgaria
UMHAT Aleksandrovska EAD, Clinic of Neurology
Sofia, 1431, Bulgaria
MMA MHAT - Sofia, Neurology clinic
Sofia, 1606, Bulgaria
MMA, MHAT-Sofia, Neurology clinic
Sofia, 1606, Bulgaria
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, V1Y 1Z9, Canada
Medical Arts Health Research Group_Kelowna
Penticton, British Columbia, V2A 5L5, Canada
Island Health (Research and Capacity Building)
Victoria, British Columbia, V8R 1J8, Canada
Medical Arts Health Research Group
West Vancouver, British Columbia, V7T 1C5, Canada
True North Clinical Research - Halifax
Halifax, Nova Scotia, B3S 1N2, Canada
True North Clinical Research - New Minas
New Minas, Nova Scotia, B4N 3R7, Canada
Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3, Canada
Recherches Neuro-Hippocampe Inc
Ottowa, Ontario, K1Z 1G3, Canada
Memory Program
Toronto, Ontario, M3B2S7, Canada
Centricity Research LMC
Toronto, Ontario, M4G 3E8, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
University Health Network
Toronto, Ontario, M5T 2S8, Canada
Douglas Hosp Res Ctr
Montreal, Quebec, H4H 1R3, Canada
CHU de Quebec-Universite Laval
Québec, Quebec, G1J 1Z4, Canada
Neuro Health Centrum s.r.o.
Brno-Líšeň, 628 00, Czechia
NeuroHK s.r.o.
Choceň, 565 01, Czechia
AGE Centrum
Olomouc, 77900, Czechia
AD71 s.r.o.
Prague, 109 00, Czechia
Neuropsychiatrie s.r.o.
Prague, 160 00, Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, 51601, Czechia
Aarhus Universitetshospital - Neurologisk Klinik
Aarhus N, 8200, Denmark
Rigshospitalet - afsnit 8015 Hukommelsesklinikken
København Ø, 2100, Denmark
Rigshospitalet - afsnit 8015
København Ø, 2100, Denmark
Sjællands Universitetshospital_Roskilde
Roskilde, 4000, Denmark
CRST Helsinki
Helsinki, 00180, Finland
Aivotutkimusyksikkö
Kuopio, 70210, Finland
CRST Turku
Turku, 20520, Finland
Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
Bordeaux, 33000, France
Hospices Civils de Lyon-Hopital Pierre Wertheimer
Bron, 69500, France
Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
Dijon, 21000, France
Centre Hospitalier Universitaire de Lille-Hopital Roger Salengro
Lille, 59037, France
Hôpital Roger Salengro
Lille, 59037, France
Centre Hospitalier Et Universitaire de Limoges-Hopital Dupuytren
Limoges, 87042, France
Assistance Publique Hopitaux de Marseille-Hopital de La Timone
Marseille, 13005, France
Centre Hospitalier Universitaire de Nice-Institut Claude Pompidou
Nice, 06100, France
Aphp-Hopital Lariboisiere-1
Paris, 75010, France
Aphp-Hopital Lariboisiere
Paris, 75010, France
Aphp-Hopital La Pitie Salpetriere-3
Paris, 75013, France
Chu de Reims-Hopital Maison Blanche
Reims, 51092, France
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-2
Saint-Herblain, 44800, France
Les Hopitaux Universitaires de Strasbourg-Hopital de La Robertsau
Strasbourg, 67000, France
Centre Hospitalier Universitaire de Toulouse-Hopital La Grave
Toulouse, 31300, France
Hospices Civils de Lyon-Hopital Des Charpennes
Villeurbanne, 69100, France
Zentrum für klinische Forschung Dr. med. Irma Schöll GmbH
Bad Homburg, Hesse, 61348, Germany
Uniklinik Aachen - Neurologie
Aachen, 52074, Germany
Studienzentrum Dr. Bischof GmbH
Böblingen, 71034, Germany
Universitätsklinikum Köln - Klinik und Poliklinik für Psychiatrie und Psychotherapie
Cologne, 50937, Germany
Neuro Centrum Science GmbH
Erbach im Odenwald, 64711, Germany
Uni-Med. Göttingen - Geriatrie
Göttingen, 37075, Germany
Universitätsklinikum Hamburg-Eppendorf, Psychiatrie
Hamburg, 20246, Germany
Universitätsmedizin der JGU Mainz - Psychiatrie
Mainz, 55131, Germany
Universitätsmedizin Mainz, Psychiatrie
Mainz, 55131, Germany
Zentralinstitut für Seelische Gesundheit (ZI) Mannheim - Psychiatrie und Psychotherapie
Mannheim, 68159, Germany
Zentralinstitut für Seelische Gesundheit - Psychiatrie und Psychotherapie
Mannheim, 68159, Germany
LMU Klinikum - Institut für Schlaganfall- und Demenzforschung (ISD)
München, 81377, Germany
Universitätsklinikum Ulm - Neurologie
Ulm, 89081, Germany
Studienzentrum Nord-West
Westerstede, 26655, Germany
Naval Hospital of Athens - Neurology Department
Athens, 11521, Greece
Henry Dunant Hospital Center,2nd Neurological Department
Athens, 11526, Greece
Aiginitio Hospital, 1st Neurology Clinic
Athens, 11528, Greece
"Hygeia" General Hospital of Athens, Memory clinic
Athens, 15123, Greece
Naval Hospital of Athens
Athens, GR-11521, Greece
University General Hospital of Athens "Attiko"
Chaidari, Athens, GR-12462, Greece
Iatriko Athinon (Athens Medical Center),Memory Disorders Cli
Marousi, 15125, Greece
AHEPA General University Hospital
Thessaloniki, 54636, Greece
EUROMEDICA General Clinic of Thessaloniki,Neurology Dpt
Thessaloniki, 54643, Greece
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, 1036, Hungary
Semmelweis Egyetem ÁOK
Budapest, 1083, Hungary
DE Kenézy Gyula Campus, Pszichiátriai és Pszichoterápiai Klinika
Debrecen, 4031, Hungary
DE Gyógyszerfejlesztési Koordinációs Központ Pszichiátria
Debrecen, 4032, Hungary
Bugát Pál Kórház
Gyöngyös, 3200, Hungary
Petz Aladar Megyei Korhaz
Győr, 9024, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
DR. MÁTHÉ ÉS TÁRSA Egészségügyi és Szolgáltató Betéti Társaság
Kalocsa, 6300, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
Psychotech Kft.
Pécs, 7633, Hungary
Szent Borbála Kórház
Tatabánya, 2800, Hungary
Belvárosi Egészségház Kft.
Zalaegerszeg, 8900, Hungary
Mercy Hospital Cork
Cork, T12 WE28, Ireland
Clinical Research Centre, St. Vincent's University Hospital,
Dublin, D04 YN63, Ireland
St Vincent's University Hospital
Dublin, D04 YN63, Ireland
Mercer's Institute for Successful Aging
Dublin, D08 NHY1, Ireland
Tallaght University Hospital
Dublin, D24 NR0A, Ireland
Rambam MC - The Stroke and Cognition Institute
Haifa, 3109601, Israel
Rabin MC Beilinson - Cognitive Neurology Clinic
Petah Tikva, 49100, Israel
Sourasky MC - Cognitive Neurology Department
Tel Aviv, 6423906, Israel
Sheba MC - Memory Clinic
Tel Hashomer, Ramat Gan, 5262000, Israel
AOU Ospedali Riuniti S.O.D
Ancona, 60126, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
Università degli studi G. D'Annunzio di Chieti - CAST - Neurologia
Chieti, 66100, Italy
AOU Careggi Firenze
Florence, 50134, Italy
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS Ospedale San Raffaele Milano
Milan, 20132, Italy
ASST Monza e Brianza Ospedale San Gerardo
Monza, 20900, Italy
Ospedale Santa Maria della Misericordia
Perugia, 06129, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Pol. Uni. Campus Biomedico UOC Neurologia
Roma, 00128, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Neuroscienze, Organi di Senso e Torace
Roma, 00168, Italy
Fondazione Santa Lucia IRCCS
Roma, 00179, Italy
AOU Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Iwaki Clinic_Psychosomatic medicine
Anan, Tokushima, 774-0014, Japan
Yachiyo Hospital_Neurology
Anjo-shi, Aichi, 446-8510, Japan
Yachiyo Hospital
Anjo-shi, Aichi, 446-8510, Japan
Abe Clinic
Arakawa-ku,Tokyo, 116-0014, Japan
Memory Clinic Ochanomizu
Bunkyo-ku, Tokyo, 113-0034, Japan
Institute of Science Tokyo Hospital_ Neurology
Bunkyo-ku,Tokyo, 113-8519, Japan
Tokyo Medical And Dental University Hospital
Bunkyo-ku,Tokyo, 113-8519, Japan
Kashiwado Hospital_Neurology
Chib-shi, Chiba, 260-8656, Japan
Kashiwado Hospital
Chib-shi, Chiba, 260-8656, Japan
Enomoto Internal Medicine Clinic
Chofu-shi,Tokyo, 182-0036, Japan
Shinozuka Hospital_Neurology
Fujioka-Shi, Gunma, 375-0017, Japan
P-one Clinic
Hachioji-shi, Tokyo, 192-0071, Japan
National Hospital Organization Tenryu Hospital_Neurology
Hamamatsu-shi, Shizuoka, 434-8511, Japan
National Hospital Organization Tenryu Hospital
Hamamatsu-shi, Shizuoka, 434-8511, Japan
Hyogo Prefectural HarimaHimeji General Medical Center_Dept. of Aging Brain&Cognitive
Himeji-shi, Hyogo, 670-8560, Japan
Tsukazaki Hospital_Department of Neurology
Himeji-shi, Hyogo, 671-1227, Japan
Himeji Central Hospital Clinic
Himeji-shi, Hyogo, 672-8043, Japan
Hatsuta Neurology Clinic
Hirakata-Shi,Osaka, 573-1121, Japan
Imon Yukari Neurology Clinic
Hiroshima-shi, Hiroshima, 732-0066, Japan
Hikaru-kai Medical Corporation Hiroshima Neurology Clinic
Hiroshima-shi, Hiroshima, 732-0822, Japan
Nagamitsu Clinic
Hofu-shi, Yamaguchi, 747-0802, Japan
Ina Central Hospital_Neurology
Ina-shi, Nagano, 396-8555, Japan
Ina Central Hospital
Ina-shi, Nagano, 396-8555, Japan
Kawasaki Saiwai Clinic_Internal Medicine
Kanagawa, 212-0016, Japan
Kishiro Mental Clinic
Kawasaki-shi , Kanagawa, 214-0014, Japan
Koukan Clinic
Kawasaki-shi, Kanagawa, 210-0852, Japan
Teikyo Univ. HP, Mizonokuchi_Neurosurgery
Kawasaki-shi, Kanagawa, 213-8507, Japan
Teikyo University Hospital, Mizonokuchi_Kawasaki-shi, Kanagawa
Kawasaki-shi, Kanagawa, 213-8507, Japan
Kobe University Hospital_Neurology
Kobe-shi, Hyogo, 650-0017, Japan
Kobe University Hospital_Radiology
Kobe-shi, Hyogo, 650-0017, Japan
National Center of Neurology and Psychiatry_Neurology
Kodaira-shi, Tokyo, 187-8551, Japan
Southern Tohoku Medical Clinic
Koriyama-shi, Fukushima, 963-8052, Japan
Katayama Medical Clinic
Kurashiki-shi, Okayama, 710-0813, Japan
Nozomi Memory Clinic
Mitaka-shi,Tokyo, 181-0013, Japan
Kikukawa clinic
Nerima-ku, Tokyo, 179-0072, Japan
General Rehabilitation Center Midori Hospital_Neurology
Niigata-shi, Niigata, 950-0983, Japan
General Rehabilitation Center · Midori Hospital
Niigata-shi, Niigata, 950-0983, Japan
National Center for Geriatrics and Gerontology_Comprehensive care
Obu-shi, Aichi, 474-8511, Japan
OKAYAMA KYOKUTO HOSPITAL_Radiology
Okayama-shi, Okayama, 703-8265, Japan
Jichiidai Station Brain Clinic
Shimotsuke-shi, Tochigi, 329-0403, Japan
Jichiidai Station Brain Clinic
Shimotsuke-shi, Tochigi, Japan
ALZCLINIC PET LAB_Radiology
Shinjuku-ku, Tokyo, 160-0017, Japan
Keio University Hospital_Neurology
Shinjuku-ku, Tokyo, 160-8582, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Shizuoka City Shimizu Hospital_Neurology
Shizuoka-shi, Shizuoka, 424-8636, Japan
Kagawa Prefectural Central Hospital_Neurology
Takamatsu-shi, Kagawa, 760-8557, Japan
Kagawa Prefectural Central Hospital_Takamatsu-shi, Kagawa
Takamatsu-shi, Kagawa, 760-8557, Japan
Takatsuki General Hospital_Neurology
Takatsuki-Shi, Osaka, 569-1192, Japan
Saino Clinic
Tokorozawa-shi,Saitama, 359-1141, Japan
Itsuki Hospital_Neurology
Tokushima-shi, Tokushima, 770-0852, Japan
Alzclinic Tokyo
Tokyo, 100-0005, Japan
Tokyo Center Clinic
Tokyo, 103-0028, Japan
Juntendo Tokyo Koto Geriatric Medical Center_psychiatry
Tokyo, 136-0075, Japan
Kurumi CLINIC
Tokyo, 156-0041, Japan
ALZCLINIC PET LAB_Psychiatry
Tokyo, 160-0017, Japan
Tokyo Medical Univ. Hospital
Tokyo, 160-0023, Japan
Memory Clinic Toride
Toride-shi, Ibaraki, 302-0004, Japan
MI Clinic
Toyonaka-shi, Osaka, 560-0004, Japan
Medical Corporation Midorikai Wako Hospital_Psychiatry
Wako-shi, Saitama, 351-0111, Japan
Yuaikai Yuai Clinic
Yokohama-shi, Kanagawa, 223-0059, Japan
Hospital Universitario "Dr. Gonzalo Valdes Valdes"
Saltillo, Coahuila, 25000, Mexico
Hospital Mexico Americano
Guadalajara, Jalisco, 25000, Mexico
Hospital Universitario Dr. José Eleuterio González_Monterrey
Monterrey, Nuevo León, 64460, Mexico
Centro de Estudios Clínicos y Especialidades Médicas S.C.
Monterrey, Nuevo León, 64620, Mexico
Avix Investigación Clínica, S.C.
Monterrey, Nuevo León, 64710, Mexico
Hospital Angeles de Culiacan
Culiacán, Sinaloa, 80020, Mexico
Brain Research Center
's-Hertogenbosch, 5223 LA, Netherlands
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Spaarne Gasthuis Haarlem
Haarlem, 2035 RC, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Akershus universitetssykehus - Hukommelsesklinikken
Lørenskog, 1474, Norway
Oslo universitetssykehus HF, Ullevål
Oslo, 0450, Norway
Master Centre - Dummy
Oslo, 0, Norway
Linden sp. z o.o. sp. k.
Krakow, Lesser Poland Voivodeship, 30-721, Poland
Indywidualna Praktyka Lekarska prof. Konrad Rejdak
Lublin, Lublin Voivodeship, 20-016, Poland
Centrum Medyczne Neuromed
Bydgoszcz, 85-163, Poland
Centrum Zdrowia Psychicznego Biomed
Kielce, 25-411, Poland
Szpital Uniwersytecki w Krakowie od. Neurologii
Krakow, 30-688, Poland
Centrum Neurologii Klinicznej
Krakow, 31-505, Poland
Nzoz Neuromed
Lublin, 20-818, Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, 32-600, Poland
NZOZ NEURO - KARD Ilkowski i Partnerzy Sp. Part. Lekarzy
Poznan, 61-853, Poland
Centrum Medyczne SENIOR
Sopot, 81-855, Poland
Osrodek Alzheimerowski Sp. z o.o.
Ścinawa, 59-330, Poland
Centrum Medyczne Neuro Protect
Warsaw, 01-684, Poland
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, 53-659, Poland
NZOZ Wrocławskie Centrum Alzheimerowskie
Wroclaw, 53-659, Poland
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal
ULS De Braga, E.P.E. - Hospital de Braga
Braga, 4710-243, Portugal
Unidade Local De Saúde De Coimbra, E.P.E.
Coimbra, 3000-561, Portugal
ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães
Guimarães, 4835-044, Portugal
Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, 1349-019, Portugal
Hospital Beatriz Ângelo
Loures, 2674-514, Portugal
ULS De Santo António, E.P.E. - Hospital de Santo António
Porto, 4099-001, Portugal
Campus Neurologico Senior (CNS) Saude Lda
Torres Vedras, 2560-280, Portugal
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, Mureș County, 540136, Romania
CMI Neurologie Dr Popa Izabela
Timișoara, Timiș County, 300766, Romania
Sana Monitoring SRL
Bucharest, 011025, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Clinic Cai Ferate Constanta
Constanța, 900123, Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Constanța, 900591, Romania
Med Anima Iasi
Iași, 700004, Romania
CMI Dr. Buhaș Ramocea Elena Daniela - Cabinet Medical de Psihiarie
Oradea, 410027, Romania
Aria Clinic SRL
Sibiu, 550052, Romania
Centrul Medical Neuro Therapy
Timișoara, 300416, Romania
SAI of Health "Interregional Clinic Diagnostic Center"
Kazan', 420101, Russia
SAHI Kuzbass Hospital(former Regional clinical hospital)
Kemerovo, 650066, Russia
Federal Siberian Research Clinical Center under FMBA of Rus
Krasnoyarsk, 660037, Russia
FSBI "Mental Health Research Center"
Moscow, 115522, Russia
FSAEI 1st Moscow Federal Med University na Sechenov
Moscow, 119021, Russia
RMAPE
Moscow, 125993, Russia
Pirogov Russian National Research Medical University MoH
Moscow, 129226, Russia
Ezramed Clinic Llc
Omsk, 644043, Russia
Research Center for Treatment and Rehabilitation "Phoenix"
Rostov-on-Don, 344000, Russia
Psychiatric hospital of st. Nicholas the wonderworker
Saint Petersburg, 190121, Russia
N.-E. State Medical University n.a. Mechnikov
Saint Petersburg, 191015, Russia
S.M. Kirov Military Medical Academy,Depart.&Clinic Nerv Dis
Saint Petersburg, 194044, Russia
SHI "Saratov City Clinical Hospital #2 n.a. V.Razumovskij"
Saratov, 410028, Russia
Center of Clinica Trials "Nebbiolo"
Tomsk, 634009, Russia
LLC "Clinic Stolet"
Tomsk, 634009, Russia
National medical holdiNational medical holding "Medstandard"
Ufa, 450054, Russia
SAHI SR "Sverdlovsk Regional Clinical Psychiatric Hospital"
Yekaterinburg, 620030, Russia
Joint Stock Company "Medical technologies"
Yekaterinburg, 620075, Russia
Neurology clinic, University Clinical Center of Serbia
Belgrade, 11000, Serbia
Special Hospital for Psychiatric Disorders "Kovin"
Kovin, 26220, Serbia
University clinical center of Vojvodina, Neurology clinic
Novi Sad, 21000, Serbia
Psych. amb. CENTRUM ZDRAVIA R.B.K., s.r.o. Bardejov
Bardejov, 085 01, Slovakia
I. neurologicka klinika LF UK a UNB
Bratislava, 813 69, Slovakia
Psychiatricka klinika LF UK a UNB
Bratislava, 813 69, Slovakia
Neurologicka klinika UPJS LF a UNLP
Košice, 041 66, Slovakia
Crystal Comfort s.r.o.
Vranov nad Topľou, 093 01, Slovakia
UKC Ljubljana, Department of Neurology
Ljubljana, SI-1000, Slovenia
UKC Maribor - neurology
Maribor, 2000, Slovenia
Private Neurology Practice - Nova Gorica
Nova Gorica, 5000, Slovenia
Excellentis Clinical Trial Consultants
George, Eastern Cape, 6529, South Africa
IATROS International
Bloemfontein, Free State, 9301, South Africa
Dr Stanley Lipschitz Clinic Inc
Johannesburg, Gauteng, 2196, South Africa
Denmar Psychiatric Hospital
Pretoria, Gauteng, 0042, South Africa
ACF Neurological service
Cape Town, Western Cape, 7405, South Africa
Flexivest Fourteen Research Centre
Cape Town, Western Cape, 7550, South Africa
Cape Trial Centre
Cape Town, Western Cape, 7560, South Africa
MyongJi Hospital
Goyang-si, Gyeonggi-do, 10475, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Hanyang University Medical Center
Seoul, 04763, South Korea
Hanyang university seoul hospital
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center_Seoul
Seoul, 06351, South Korea
Ewha Womans University Seoul Hospital
Seoul, 07804, South Korea
Hospital Santa Creu i Sant Pau
Barcelona, 08025, Spain
Fundación ACE
Barcelona, 08028, Spain
Fundación CITA
Donostia / San Sebastian, 20009, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
H.U. Quirónsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 08195, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Minnesmottagning Malmö
Malmo, 205 02, Sweden
Karolinska Universitetssjukhuset, Huddinge
Stockholm, 141 86, Sweden
Geriatriskt centrum Umeå - NU
Umeå, 901 85, Sweden
Spitalzentrum Biel
Biel/Bienne, 2502, Switzerland
Centre de la Mémoire
Geneva, 1205, Switzerland
Centre Leenaards de la mémoire CHUV
Lausanne, 1011, Switzerland
Klinik für Neurologie Kantonsspital St.Gallen
Sankt Gallen, 9007, Switzerland
Hacettepe University Medical Faculty Hospital
Altindag/Ankara, 06230, Turkey (Türkiye)
Hacettepe Üniversitesi Hastanesi- Nöroloji
Altindag/Ankara, 06230, Turkey (Türkiye)
Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi- Nöroloji
Balcova / Izmir, 35330, Turkey (Türkiye)
Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma
Eskişehir, 26040, Turkey (Türkiye)
Eskişehir Osmangazi Üniversitesi Hastanesi- Nöroloji
Eskişehir, 26040, Turkey (Türkiye)
Istanbul Bezmi Alem Vakif University Tip Faculty Hospital
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Medical Faculty Neurology Department
Istanbul, 34093, Turkey (Türkiye)
İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Nöroloji
Istanbul, 34093, Turkey (Türkiye)
Izmir Economics University Medical Point Hospital Neurology D
Izmir, 35575, Turkey (Türkiye)
İzmir Ekonomi Üniversitesi Medicalpoint Hastanesi-Nöroloji
Izmir, 35575, Turkey (Türkiye)
Ondokuz Mayis University Saglik Uygulama ve Arastirma Merkez
Samsun, 55200, Turkey (Türkiye)
Ondokuz Mayıs Üniversitesi Hastanesi- Nöroloji
Samsun, 55200, Turkey (Türkiye)
Chernivtsi Emergency Hospital - Center of Emergency Neurology
Chernivtsi, 58023, Ukraine
Medical Centre 'Neiron'
Kharkiv, 61091, Ukraine
Chebotarev Institute of Gerontology of NAMSU - Age Physiology and Pathology department
Kyiv, 04114, Ukraine
Volyn Regional Clinical Hospital - Neurology department
Lutsk, 43000, Ukraine
Main Unit of 'Odesa Regional Medical Centre for Mental Health' - Department 18
Odesa, 65031, Ukraine
Sumy Regional Clinical Hospital - Neurology department
Sumy, 40000, Ukraine
Medical Centre 'SALUTEM' - Medical and preventive care department
Vinnytsia, 21050, Ukraine
Zaporizhia Regional Clinical Hospital - Department of neurology No. 1
Zaporizhzhia, 69600, Ukraine
Fritchie Centre
Cheltenham, Gloucestershire, GL53 9DZ, United Kingdom
Royal Cornhill Hospital
Aberdeen, AB25 2ZH, United Kingdom
RICE - The Research Institute for the Care of Older People
Bath, BA1 3NG, United Kingdom
Dementia Research Unit,
Crowborough, TN6 1NY, United Kingdom
Dementia Research Unit
Crowborough, TN6 1NY, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
St Pancras Clinical Research
London, EC2Y 8EA, United Kingdom
St Georges Hospital
London, SW17 0RE, United Kingdom
Imperial College London - Imperial College Memory Research Centre
London, W12 0HS, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
NeuroClin
Motherwell, ML1 4UF, United Kingdom
Newcastle University
Newcastle upon Tyne, NE4 5PL, United Kingdom
Warneford Hospital
Oxford, OX3 7JX, United Kingdom
Moorgreen Hospital
Southampton, SO30 3JB, United Kingdom
Kings Hill Research Centre
Swindon, SN3 6BW, United Kingdom
Related Publications (3)
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 Mar 19:S0140-6736(26)00459-9. doi: 10.1016/S0140-6736(26)00459-9. Online ahead of print.
PMID: 41865758DERIVEDCummings 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.
PMID: 39780249DERIVEDvan 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.
PMID: 38901446DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (Dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 2, 2021
Study Start
May 18, 2021
Primary Completion
September 16, 2025
Study Completion
January 30, 2026
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com