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

April 7, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Early Alzheimer's Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1840

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1181ACH
    - Hospital Italiano
  - Buenos Aires, Argentina, C1012AAR
    - Instituto de Investigaciones Metabolicas (IDIM)
  - CABA, Argentina, 1427
    - Clínica Nuestra Señora de las Nieves
  - CABA, Argentina, 1428
    - FLENI
  - Córdoba, Argentina, X5004AOA
    - Instituto Privado Kremer
  - Mendoza, Argentina, 5500
    - Fundacion Scherbovsky
- Buenos Aires
  - Ciudad de Buenos Aires, Buenos Aires, Argentina, C1405CWB
    - Instituto Medico Especializado_Capital Federal
Australia
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2010
    - St Vincent's Hospital
  - Greenwich, New South Wales, Australia, 2065
    - HammondCare Greenwich
  - Kogarah, New South Wales, Australia, 2217
    - Southern Neurology
  - Waratah, New South Wales, Australia, 2298
    - Hunter New England Local Health District - Neuropsychiatry
- Queensland
  - Chermside, Queensland, Australia, 4032
    - The Prince Charles Hospital
- Victoria
  - Ivanhoe, Victoria, Australia, 3079
    - Medical and Cognitive Research Unit - Austin Health
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Australian Alzheimer's Research Foundation Incorporated
Austria
- - Graz, Austria, 8036
    - Universitätsklinik für Neurologie
  - Innsbruck, Austria, 6020
    - LKH-Univ. Kliniken Innsbruck
  - Innsbruck, Austria, 6020
    - Medizinische Univ. Innsbruck
  - Salzburg, Austria, 5020
    - Univ. Klinik für Neurologie
  - Vienna, Austria, 1090
    - Medizinische Universitat Wien
Belgium
- - Bruges, Belgium, 8000
    - AZ Sint-Jan - Campus Sint-Jan - Neurology
  - Edegem, Belgium, 2650
    - UZA - UZ Antwerpen - Department of Neurology
  - Kortrijk, Belgium, 8500
    - AZ Groeninge - Kortrijk - Neurologie
  - Liège, Belgium, 4000
    - Clinique CHC MontLégia - Service Neurologie
Brazil
- - Rio de Janeiro, Brazil, 22270-060
    - Centro de Psiquiatria Sandra Rushel
- Federal District
  - Brasília, Federal District, Brazil, 70200730
    - L2 IP Instituto de Pesquisas Clinicas Ltda
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30130-100
    - Hospital das Clínicas - Universidade Federal de Minas Gerais
- Paraná
  - Curitiba, Paraná, Brazil, 81210-310
    - Instituto de Neurologia de Curitiba
  - Maringá, Paraná, Brazil, 87013-250
    - Clinica Clinilive ltda
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
    - Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
- São Paulo
  - São Paulo, São Paulo, Brazil, 01228-000
    - Cpquali Pesquisa Clinica Ltda
  - São Paulo, São Paulo, Brazil, 04024-002
    - Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP
  - São Paulo, São Paulo, Brazil, 01236-030
    - BR Trials - Ensaios Clínicos e Consultoria Ltda.
  - São Paulo, São Paulo, Brazil, 05652-900
    - Sociedade Beneficente Israelita Bras Hosp Albert Einstein
Bulgaria
- - Sofia, Bulgaria, 1113
    - MHATNP Sveti Naum EAD
  - Sofia, Bulgaria, 1113
    - "MHATNP "Sv. Naum"" EAD
  - Sofia, Bulgaria, 1606
    - MMA, MHAT-Sofia, Neurology clinic
  - Sofia, Bulgaria, 1408
    - DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan OOD, Psychiatry
  - Sofia, Bulgaria, 1431
    - UMHAT Aleksandrovska EAD, Clinic of Neurology
  - Sofia, Bulgaria, 1606
    - MMA MHAT - Sofia, Neurology clinic
Canada
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 1Z9
    - OCT Research ULC (dba Okanagan Clinical Trials)
  - Penticton, British Columbia, Canada, V2A 5L5
    - Medical Arts Health Research Group_Kelowna
  - Victoria, British Columbia, Canada, V8R 1J8
    - Island Health (Research and Capacity Building)
  - West Vancouver, British Columbia, Canada, V7T 1C5
    - Medical Arts Health Research Group
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3S 1N2
    - True North Clinical Research - Halifax
  - New Minas, Nova Scotia, Canada, B4N 3R7
    - True North Clinical Research - New Minas
- Ontario
  - Ottawa, Ontario, Canada, K1Z 1G3
    - Ottawa Memory Clinic
  - Ottowa, Ontario, Canada, K1Z 1G3
    - Recherches Neuro-Hippocampe Inc
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Centre
  - Toronto, Ontario, Canada, M5T 2S8
    - University Health Network
  - Toronto, Ontario, Canada, M5T 2S8
    - University Health Network - Toronto Western Hospital
  - Toronto, Ontario, Canada, M3B2S7
    - Memory Program
  - Toronto, Ontario, Canada, M4G 3E8
    - Centricity Research LMC
- Quebec
  - Montreal, Quebec, Canada, H4H 1R3
    - Douglas Hosp Res Ctr
  - Québec, Quebec, Canada, G1J 1Z4
    - CHU de Quebec-Université Laval
Czechia
- - Brno-Líšeň, Czechia, 628 00
    - Neuro Health Centrum s.r.o.
  - Choceň, Czechia, 565 01
    - NEUROHK s.r.o.
  - Olomouc, Czechia, 77900
    - AGE Centrum
  - Prague, Czechia, 109 00
    - Ad71 S.R.O.
  - Prague, Czechia, 160 00
    - Neuropsychiatrie s.r.o.
  - Rychnov nad Kněžnou, Czechia, 51601
    - Vestra Clinics s.r.o.
Denmark
- - Aarhus N, Denmark, 8200
    - Aarhus Universitetshospital - Neurologisk Klinik
  - København Ø, Denmark, 2100
    - Rigshospitalet - afsnit 8015
  - København Ø, Denmark, 2100
    - Rigshospitalet - afsnit 8015 Hukommelsesklinikken
  - Roskilde, Denmark, 4000
    - Sjællands Universitetshospital_Roskilde
Finland
- - Helsinki, Finland, 00180
    - CRST Helsinki
  - Kuopio, Finland, 70210
    - Aivotutkimusyksikkö
  - Turku, Finland, 20520
    - CRST Turku
France
- - Bordeaux, France, 33000
    - Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
  - Bron, France, 69500
    - Hospices Civils de Lyon-Hopital Pierre Wertheimer
  - Dijon, France, 21000
    - Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
  - Lille, France, 59037
    - Hopital Roger Salengro
  - Lille, France, 59037
    - Centre Hospitalier Universitaire de Lille-Hopital Roger Salengro
  - Limoges, France, 87042
    - Centre Hospitalier Et Universitaire de Limoges-Hopital Dupuytren
  - Marseille, France, 13005
    - Assistance Publique Hopitaux de Marseille-Hopital de La Timone
  - Nice, France, 06100
    - Centre Hospitalier Universitaire de Nice-Institut Claude Pompidou
  - Paris, France, 75010
    - Aphp-Hopital Lariboisiere-1
  - Paris, France, 75013
    - Aphp-Hopital La Pitie Salpetriere-3
  - Paris, France, 75010
    - Aphp-Hopital Lariboisiere
  - Reims, France, 51092
    - Chu de Reims-Hopital Maison Blanche
  - Saint-Herblain, France, 44800
    - Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-2
  - Strasbourg, France, 67000
    - Les Hopitaux Universitaires de Strasbourg-Hopital de La Robertsau
  - Toulouse, France, 31300
    - Centre Hospitalier Universitaire de Toulouse-Hopital La Grave
  - Villeurbanne, France, 69100
    - Hospices Civils de Lyon-Hopital Des Charpennes
Germany
- - Aachen, Germany, 52074
    - Uniklinik Aachen - Neurologie
  - Böblingen, Germany, 71034
    - Studienzentrum Dr. Bischof GmbH
  - Cologne, Germany, 50937
    - Universitätsklinikum Köln - Klinik und Poliklinik für Psychiatrie und Psychotherapie
  - Erbach im Odenwald, Germany, 64711
    - Neuro Centrum Science GmbH
  - Göttingen, Germany, 37075
    - Uni-Med. Göttingen - Geriatrie
  - Hamburg, Germany, 20246
    - Universitätsklinikum Hamburg-Eppendorf, Psychiatrie
  - Mainz, Germany, 55131
    - Universitätsmedizin Mainz, Psychiatrie
  - Mainz, Germany, 55131
    - Universitätsmedizin der JGU Mainz - Psychiatrie
  - Mannheim, Germany, 68159
    - Zentralinstitut für Seelische Gesundheit - Psychiatrie und Psychotherapie
  - Mannheim, Germany, 68159
    - Zentralinstitut für Seelische Gesundheit (ZI) Mannheim - Psychiatrie und Psychotherapie
  - München, Germany, 81377
    - LMU Klinikum - Institut für Schlaganfall- und Demenzforschung (ISD)
  - Ulm, Germany, 89081
    - Universitätsklinikum Ulm - Neurologie
  - Westerstede, Germany, 26655
    - Studienzentrum Nord-West
- Hesse
  - Bad Homburg, Hesse, Germany, 61348
    - Zentrum für klinische Forschung Dr. med. Irma Schöll GmbH
Greece
- - Athens, Greece, GR-11521
    - Naval Hospital of Athens
  - Athens, Greece, 11526
    - Henry Dunant Hospital Center,2nd Neurological Department
  - Athens, Greece, 11528
    - Aiginitio Hospital, 1st Neurology Clinic
  - Athens, Greece, 15123
    - "Hygeia" General Hospital of Athens, Memory clinic
  - Athens, Greece, 11521
    - Naval Hospital of Athens - Neurology Department
  - Chaidari, Athens, Greece, GR-12462
    - University General Hospital of Athens "Attiko"
  - Marousi, Greece, 15125
    - Iatriko Athinon (Athens Medical Center),Memory Disorders Cli
  - Thessaloniki, Greece, 54636
    - AHEPA General University Hospital
  - Thessaloniki, Greece, 54643
    - EUROMEDICA General Clinic of Thessaloniki,Neurology Dpt
Hungary
- - Budapest, Hungary, 1083
    - Semmelweis Egyetem AOK
  - Budapest, Hungary, 1036
    - Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
  - Debrecen, Hungary, 4031
    - DE Kenézy Gyula Campus, Pszichiátriai és Pszichoterápiai Klinika
  - Debrecen, Hungary, 4032
    - DE Gyógyszerfejlesztési Koordinációs Központ Pszichiátria
  - Gyöngyös, Hungary, 3200
    - Bugat Pal Korhaz
  - Győr, Hungary, 9024
    - Petz Aladar Megyei Oktato Korhaz
  - Győr, Hungary, 9024
    - Petz Aladar Megyei Korhaz
  - Kalocsa, Hungary, 6300
    - DR. MÁTHÉ ÉS TÁRSA Egészségügyi és Szolgáltató Betéti Társaság
  - Kaposvár, Hungary, 7400
    - Somogy Megyei Kaposi Mor Oktato Korhaz
  - Pécs, Hungary, 7633
    - Psychotech Kft.
  - Tatabánya, Hungary, 2800
    - Szent Borbala Korhaz
  - Zalaegerszeg, Hungary, 8900
    - Belvarosi Egeszseghaz Kft.
Ireland
- - Cork, Ireland, T12 WE28
    - Mercy Hospital Cork
  - Dublin, Ireland, D24 NR0A
    - Tallaght University Hospital
  - Dublin, Ireland, D08 NHY1
    - Mercer's Institute for Successful Aging
  - Dublin, Ireland, D04 YN63
    - St Vincent's University Hospital
  - Dublin, Ireland, D04 YN63
    - Clinical Research Centre, St. Vincent's University Hospital,
Israel
- - Haifa, Israel, 3109601
    - Rambam MC - The Stroke and Cognition Institute
  - Petah Tikva, Israel, 49100
    - Rabin MC Beilinson - Cognitive Neurology Clinic
  - Tel Aviv, Israel, 6423906
    - Sourasky MC - Cognitive Neurology Department
  - Tel Hashomer, Ramat Gan, Israel, 5262000
    - Sheba MC - Memory Clinic
Italy
- - Ancona, Italy, 60126
    - AOU Ospedali Riuniti S.O.D
  - Brescia, Italy, 25123
    - Azienda Ospedaliera Spedali Civili di Brescia
  - Chieti, Italy, 66100
    - Università degli studi G. D'Annunzio di Chieti - CAST - Neurologia
  - Florence, Italy, 50134
    - AOU Careggi Firenze
  - Milan, Italy, 20122
    - Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
  - Milan, Italy, 20132
    - IRCCS Ospedale San Raffaele Milano
  - Monza, Italy, 20900
    - ASST Monza e Brianza Ospedale San Gerardo
  - Perugia, Italy, 06129
    - Ospedale Santa Maria Della Misericordia
  - Pisa, Italy, 56126
    - Azienda Ospedaliero Universitaria Pisana
  - Roma, Italy, 00133
    - Policlinico Tor Vergata
  - Roma, Italy, 00179
    - Fondazione Santa Lucia IRCCS
  - Roma, Italy, 00128
    - Pol. Uni. Campus Biomedico UOC Neurologia
  - Roma, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Neuroscienze, Organi di Senso e Torace
  - Torino, Italy, 10126
    - AOU Citta della Salute e della Scienza di Torino
Japan
- - Anan, Tokushima, Japan, 774-0014
    - Iwaki Clinic_Psychosomatic medicine
  - Anjo-shi, Aichi, Japan, 446-8510
    - Yachiyo Hospital
  - Anjo-shi, Aichi, Japan, 446-8510
    - Yachiyo Hospital_Neurology
  - Arakawa-ku,Tokyo, Japan, 116-0014
    - Abe Clinic
  - Bunkyo-ku, Tokyo, Japan, 113-0034
    - Memory Clinic Ochanomizu
  - Bunkyo-ku,Tokyo, Japan, 113-8519
    - Tokyo Medical and Dental University Hospital
  - Bunkyo-ku,Tokyo, Japan, 113-8519
    - Institute of Science Tokyo Hospital_ Neurology
  - Chib-shi, Chiba, Japan, 260-8656
    - Kashiwado Hospital
  - Chib-shi, Chiba, Japan, 260-8656
    - Kashiwado Hospital_Neurology
  - Chofu-shi,Tokyo, Japan, 182-0036
    - Enomoto Internal Medicine Clinic
  - Fujioka-Shi, Gunma, Japan, 375-0017
    - Shinozuka Hospital_Neurology
  - Hachioji-shi, Tokyo, Japan, 192-0071
    - P-One Clinic
  - Hamamatsu-shi, Shizuoka, Japan, 434-8511
    - National Hospital Organization Tenryu Hospital
  - Hamamatsu-shi, Shizuoka, Japan, 434-8511
    - National Hospital Organization Tenryu Hospital_Neurology
  - Himeji-shi, Hyogo, Japan, 672-8043
    - Himeji Central Hospital Clinic
  - Himeji-shi, Hyogo, Japan, 670-8560
    - Hyogo Prefectural HarimaHimeji General Medical Center_Dept. of Aging Brain&Cognitive
  - Himeji-shi, Hyogo, Japan, 671-1227
    - Tsukazaki Hospital_Department of Neurology
  - Hirakata-Shi,Osaka, Japan, 573-1121
    - Hatsuta Neurology Clinic
  - Hiroshima-shi, Hiroshima, Japan, 732-0066
    - Imon Yukari Neurology Clinic
  - Hiroshima-shi, Hiroshima, Japan, 732-0822
    - Hikaru-kai Medical Corporation Hiroshima Neurology Clinic
  - Hofu-shi, Yamaguchi, Japan, 747-0802
    - Nagamitsu Clinic
  - Ina-shi, Nagano, Japan, 396-8555
    - Ina Central Hospital
  - Ina-shi, Nagano, Japan, 396-8555
    - Ina Central Hospital_Neurology
  - Kanagawa, Japan, 212-0016
    - Kawasaki Saiwai Clinic_Internal Medicine
  - Kawasaki-shi , Kanagawa, Japan, 214-0014
    - Kishiro Mental Clinic
  - Kawasaki-shi, Kanagawa, Japan, 210-0852
    - Koukan Clinic
  - Kawasaki-shi, Kanagawa, Japan, 213-8507
    - Teikyo University Hospital, Mizonokuchi_Kawasaki-shi, Kanagawa
  - Kawasaki-shi, Kanagawa, Japan, 213-8507
    - Teikyo Univ. HP, Mizonokuchi_Neurosurgery
  - Kobe-shi, Hyogo, Japan, 650-0017
    - Kobe University Hospital_Neurology
  - Kobe-shi, Hyogo, Japan, 650-0017
    - Kobe University Hospital_Radiology
  - Kodaira-shi, Tokyo, Japan, 187-8551
    - National Center of Neurology and Psychiatry_Neurology
  - Koriyama-shi, Fukushima, Japan, 963-8052
    - Southern TOHOKU Medical Clinic
  - Kurashiki-shi, Okayama, Japan, 710-0813
    - Katayama Medical Clinic
  - Mitaka-shi,Tokyo, Japan, 181-0013
    - Nozomi Memory Clinic
  - Nerima-ku, Tokyo, Japan, 179-0072
    - Kikukawa clinic
  - Niigata-shi, Niigata, Japan, 950-0983
    - General Rehabilitation Center · Midori Hospital
  - Niigata-shi, Niigata, Japan, 950-0983
    - General Rehabilitation Center Midori Hospital_Neurology
  - Obu-shi, Aichi, Japan, 474-8511
    - National Center for Geriatrics and Gerontology_Comprehensive care
  - Okayama-shi, Okayama, Japan, 703-8265
    - OKAYAMA KYOKUTO HOSPITAL_Radiology
  - Shimotsuke-shi, Tochigi, Japan
    - Jichiidai Station Brain Clinic
  - Shimotsuke-shi, Tochigi, Japan, 329-0403
    - Jichiidai Station Brain Clinic
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Keio University Hospital
  - Shinjuku-ku, Tokyo, Japan, 160-0017
    - ALZCLINIC PET LAB_Radiology
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Keio University Hospital_Neurology
  - Shizuoka-shi, Shizuoka, Japan, 424-8636
    - Shizuoka City Shimizu Hospital_Neurology
  - Takamatsu-shi, Kagawa, Japan, 760-8557
    - Kagawa Prefectural Central Hospital_Takamatsu-shi, Kagawa
  - Takamatsu-shi, Kagawa, Japan, 760-8557
    - Kagawa Prefectural Central Hospital_Neurology
  - Takatsuki-Shi, Osaka, Japan, 569-1192
    - Takatsuki General Hospital_Neurology
  - Tokorozawa-shi,Saitama, Japan, 359-1141
    - Saino Clinic
  - Tokushima-shi, Tokushima, Japan, 770-0852
    - Itsuki Hospital_Neurology
  - Tokyo, Japan, 103-0028
    - Tokyo Center Clinic
  - Tokyo, Japan, 100-0005
    - Alzclinic Tokyo
  - Tokyo, Japan, 156-0041
    - Kurumi Clinic
  - Tokyo, Japan, 160-0023
    - Tokyo Medical Univ. Hospital
  - Tokyo, Japan, 136-0075
    - Juntendo Tokyo Koto Geriatric Medical Center_psychiatry
  - Tokyo, Japan, 160-0017
    - ALZCLINIC PET LAB_Psychiatry
  - Toride-shi, Ibaraki, Japan, 302-0004
    - Memory Clinic Toride
  - Toyonaka-shi, Osaka, Japan, 560-0004
    - MI Clinic
  - Wako-shi, Saitama, Japan, 351-0111
    - Medical Corporation Midorikai Wako Hospital_Psychiatry
  - Yokohama-shi, Kanagawa, Japan, 223-0059
    - Yuaikai Yuai Clinic
Mexico
- Coahuila
  - Saltillo, Coahuila, Mexico, 25000
    - Hospital Universitario "Dr. Gonzalo Valdes Valdes"
- Jalisco
  - Guadalajara, Jalisco, Mexico, 25000
    - Hospital Mexico Americano
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64710
    - Avix Investigación Clinica, S.C.
  - Monterrey, Nuevo León, Mexico, 64460
    - Hospital Universitario Dr. José Eleuterio González_Monterrey
  - Monterrey, Nuevo León, Mexico, 64620
    - Centro de Estudios Clínicos y Especialidades Médicas S.C.
- Sinaloa
  - Culiacán, Sinaloa, Mexico, 80020
    - Hospital Angeles de Culiacan
Netherlands
- - 's-Hertogenbosch, Netherlands, 5223 LA
    - Brain Research Center
  - Breda, Netherlands, 4818 CK
    - Amphia Ziekenhuis
  - Haarlem, Netherlands, 2035 RC
    - Spaarne Gasthuis Haarlem
  - Nijmegen, Netherlands, 6525 GA
    - Radboudumc
Norway
- - Lørenskog, Norway, 1474
    - Akershus universitetssykehus - Hukommelsesklinikken
  - Oslo, Norway, 0450
    - Oslo Universitetssykehus HF, Ulleval
  - Oslo, Norway
    - Master Centre - Dummy
Poland
- - Bydgoszcz, Poland, 85-163
    - Centrum Medyczne NEUROMED
  - Kielce, Poland, 25-411
    - Centrum Zdrowia Psychicznego Biomed
  - Krakow, Poland, 31-505
    - Centrum Neurologii Klinicznej
  - Krakow, Poland, 30-688
    - Szpital Uniwersytecki w Krakowie od. Neurologii
  - Lublin, Poland, 20-818
    - NZOZ Neuromed
  - Oświęcim, Poland, 32-600
    - Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
  - Poznan, Poland, 61-853
    - NZOZ NEURO - KARD Ilkowski i Partnerzy Sp. Part. Lekarzy
  - Sopot, Poland, 81-855
    - Centrum Medyczne SENIOR
  - Warsaw, Poland, 01-684
    - Centrum Medyczne Neuro Protect
  - Wroclaw, Poland, 53-659
    - NZOZ Wrocławskie Centrum Alzheimerowskie
  - Wroclaw, Poland, 53-659
    - NZOZ Wroclawskie Centrum Alzheimerowskie
  - Ścinawa, Poland, 59-330
    - Osrodek Alzheimerowski Sp. z o.o.
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-721
    - Linden sp. z o.o. sp. k.
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-016
    - Indywidualna Praktyka Lekarska prof. Konrad Rejdak
Portugal
- - Braga, Portugal, 4710-243
    - ULS De Braga, E.P.E. - Hospital de Braga
  - Coimbra, Portugal, 3000-561
    - Unidade Local de Saúde de Coimbra, E.P.E.
  - Guimarães, Portugal, 4835-044
    - ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães
  - Lisbon, Portugal, 1349-019
    - Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
  - Loures, Portugal, 2674-514
    - Hospital Beatriz Angelo
  - Porto, Portugal, 4099-001
    - ULS De Santo António, E.P.E. - Hospital de Santo António
  - Torres Vedras, Portugal, 2560-280
    - Campus Neurologico Senior (CNS) Saude Lda
- Matosinhos
  - Senhora Da Hora, Matosinhos, Matosinhos, Portugal, 4464-513
    - ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Romania
- - Bucharest, Romania, 022328
    - Institutul Clinic Fundeni
  - Bucharest, Romania, 011025
    - Sana Monitoring SRL
  - Constanța, Romania, 900591
    - Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
  - Constanța, Romania, 900123
    - Spitalul Clinic Cai Ferate Constanta
  - Iași, Romania, 700004
    - Med Anima Iasi
  - Oradea, Romania, 410027
    - CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie
  - Sibiu, Romania, 550052
    - Aria Clinic SRL
  - Timișoara, Romania, 300416
    - Centrul Medical Neuro Therapy
- Mureș County
  - Târgu Mureş, Mureș County, Romania, 540136
    - Spitalul Clinic Judetean de Urgenta Targu Mures
- Timiș County
  - Timișoara, Timiș County, Romania, 300766
    - CMI Neurologie Dr Popa Izabela
Russia
- - Kazan', Russia, 420101
    - SAI of Health "Interregional Clinic Diagnostic Center"
  - Kemerovo, Russia, 650066
    - SAHI Kuzbass Hospital(former Regional clinical hospital)
  - Krasnoyarsk, Russia, 660037
    - Federal Siberian Research Clinical Center under FMBA of Rus
  - Moscow, Russia, 129226
    - Pirogov Russian National Research Medical University MoH
  - Moscow, Russia, 119021
    - FSAEI 1st Moscow Federal Med University na Sechenov
  - Moscow, Russia, 125993
    - RMAPE
  - Moscow, Russia, 115522
    - FSBI "Mental Health Research Center"
  - Omsk, Russia, 644043
    - Ezramed Clinic Llc
  - Rostov-on-Don, Russia, 344000
    - Research Center for Treatment and Rehabilitation "Phoenix"
  - Saint Petersburg, Russia, 190121
    - Psychiatric hospital of st. Nicholas the wonderworker
  - Saint Petersburg, Russia, 191015
    - N.-E. State Medical University n.a. Mechnikov
  - Saint Petersburg, Russia, 194044
    - S.M. Kirov Military Medical Academy,Depart.&Clinic Nerv Dis
  - Saratov, Russia, 410028
    - SHI "Saratov City Clinical Hospital #2 n.a. V.Razumovskij"
  - Tomsk, Russia, 634009
    - Center of Clinica Trials "Nebbiolo"
  - Tomsk, Russia, 634009
    - LLC "Clinic Stolet"
  - Ufa, Russia, 450054
    - National medical holdiNational medical holding "Medstandard"
  - Yekaterinburg, Russia, 620030
    - SAHI SR "Sverdlovsk Regional Clinical Psychiatric Hospital"
  - Yekaterinburg, Russia, 620075
    - Joint Stock Company "Medical technologies"
Serbia
- - Belgrade, Serbia, 11000
    - Neurology clinic, University Clinical Center of Serbia
  - Kovin, Serbia, 26220
    - Special Hospital for Psychiatric Disorders "Kovin"
  - Novi Sad, Serbia, 21000
    - University clinical center of Vojvodina, Neurology clinic
Slovakia
- - Bardejov, Slovakia, 085 01
    - Psych. amb. CENTRUM ZDRAVIA R.B.K., s.r.o. Bardejov
  - Bratislava, Slovakia, 813 69
    - I. neurologicka klinika LF UK a UNB
  - Bratislava, Slovakia, 813 69
    - Psychiatricka klinika LF UK a UNB
  - Košice, Slovakia, 041 66
    - Neurologicka klinika UPJS LF a UNLP
  - Vranov nad Topľou, Slovakia, 093 01
    - Crystal Comfort s.r.o.
Slovenia
- - Ljubljana, Slovenia, SI-1000
    - UKC Ljubljana, Department of Neurology
  - Maribor, Slovenia, 2000
    - UKC Maribor - neurology
  - Nova Gorica, Slovenia, 5000
    - Private Neurology Practice - Nova Gorica
South Africa
- Eastern Cape
  - George, Eastern Cape, South Africa, 6529
    - Excellentis Clinical Trial Consultants
- Free State
  - Bloemfontein, Free State, South Africa, 9301
    - IATROS International
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2196
    - Dr Stanley Lipschitz Clinic Inc
  - Pretoria, Gauteng, South Africa, 0042
    - Denmar Psychiatric Hospital
- Western Cape
  - Cape Town, Western Cape, South Africa, 7405
    - ACF Neurological service
  - Cape Town, Western Cape, South Africa, 7550
    - Flexivest Fourteen Research Centre
  - Cape Town, Western Cape, South Africa, 7560
    - Cape Trial Centre
South Korea
- - Busan, South Korea, 49201
    - Dong-A University Hospital
  - Daejeon, South Korea, 35015
    - Chungnam national university hospital
  - Gwangju, South Korea, 61469
    - Chonnam National University Hospital
  - Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Incheon, South Korea, 21565
    - Gachon University Gil Medical Center
  - Incheon, South Korea, 22332
    - Inha University Hospital
  - Seoul, South Korea, 05505
    - Asan Medical Center
  - Seoul, South Korea, 05030
    - Konkuk University Medical Center
  - Seoul, South Korea, 04763
    - Hanyang University Medical Center
  - Seoul, South Korea, 04763
    - Hanyang University Seoul Hospital
  - Seoul, South Korea, 07804
    - Ewha Womans University Seoul Hospital
  - Seoul, South Korea, 06351
    - Samsung Medical Center_Seoul
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10475
    - Myongji Hospital
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
Spain
- - Barcelona, Spain, 08025
    - Hospital Santa Creu i Sant Pau
  - Barcelona, Spain, 08028
    - Fundación ACE
  - Donostia / San Sebastian, Spain, 20009
    - Fundación CITA
  - Madrid, Spain, 28034
    - Hospital Ramon y Cajal
  - Madrid, Spain, 28041
    - Hospital 12 de Octubre
  - Pozuelo de Alarcón, Spain, 28223
    - H.U. Quirónsalud Madrid
  - Sant Cugat del Vallès, Spain, 08195
    - Hospital Universitari General de Catalunya
  - Santander, Spain, 39008
    - Hospital Universitario Marques de Valdecilla
  - Valencia, Spain, 46017
    - Hospital Universitario Doctor Peset
Sweden
- - Malmo, Sweden, 205 02
    - Minnesmottagning Malmö
  - Stockholm, Sweden, 141 86
    - Karolinska Universitetssjukhuset, Huddinge
  - Umeå, Sweden, 901 85
    - Geriatriskt centrum Umeå - NU
Switzerland
- - Biel/Bienne, Switzerland, 2502
    - Spitalzentrum Biel
  - Geneva, Switzerland, 1205
    - Centre de la Mémoire
  - Lausanne, Switzerland, 1011
    - Centre Leenaards de la mémoire CHUV
  - Sankt Gallen, Switzerland, 9007
    - Klinik für Neurologie Kantonsspital St.Gallen
Turkey (Türkiye)
- - Altindag/Ankara, Turkey (Türkiye), 06230
    - Hacettepe University Medical Faculty Hospital
  - Altindag/Ankara, Turkey (Türkiye), 06230
    - Hacettepe Üniversitesi Hastanesi- Nöroloji
  - Balcova / Izmir, Turkey (Türkiye), 35330
    - Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi- Nöroloji
  - Eskişehir, Turkey (Türkiye), 26040
    - Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma
  - Eskişehir, Turkey (Türkiye), 26040
    - Eskişehir Osmangazi Üniversitesi Hastanesi- Nöroloji
  - Istanbul, Turkey (Türkiye), 34093
    - Istanbul University Medical Faculty Neurology Department
  - Istanbul, Turkey (Türkiye), 34093
    - Istanbul Bezmi Alem Vakif University Tip Faculty Hospital
  - Istanbul, Turkey (Türkiye), 34093
    - İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Nöroloji
  - Izmir, Turkey (Türkiye), 35575
    - Izmir Economics University Medical Point Hospital Neurology D
  - Izmir, Turkey (Türkiye), 35575
    - İzmir Ekonomi Üniversitesi Medicalpoint Hastanesi-Nöroloji
  - Samsun, Turkey (Türkiye), 55200
    - Ondokuz Mayis University Saglik Uygulama ve Arastirma Merkez
  - Samsun, Turkey (Türkiye), 55200
    - Ondokuz Mayıs Üniversitesi Hastanesi- Nöroloji
Ukraine
- - Chernivtsi, Ukraine, 58023
    - Chernivtsi Emergency Hospital - Center of Emergency Neurology
  - Kharkiv, Ukraine, 61091
    - Medical Centre 'Neiron'
  - Kyiv, Ukraine, 04114
    - Chebotarev Institute of Gerontology of NAMSU - Age Physiology and Pathology department
  - Lutsk, Ukraine, 43000
    - Volyn Regional Clinical Hospital - Neurology department
  - Odesa, Ukraine, 65031
    - Main Unit of 'Odesa Regional Medical Centre for Mental Health' - Department 18
  - Sumy, Ukraine, 40000
    - Sumy Regional Clinical Hospital - Neurology department
  - Vinnytsia, Ukraine, 21050
    - Medical Centre 'SALUTEM' - Medical and preventive care department
  - Zaporizhzhia, Ukraine, 69600
    - Zaporizhia Regional Clinical Hospital - Department of neurology No. 1
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZH
    - Royal Cornhill Hospital
  - Bath, United Kingdom, BA1 3NG
    - RICE - The Research Institute for the Care of Older People
  - Crowborough, United Kingdom, TN6 1NY
    - Dementia Research Unit,
  - Crowborough, United Kingdom, TN6 1NY
    - Dementia Research Unit
  - Dundee, United Kingdom, DD1 9SY
    - Ninewells Hospital
  - Edinburgh, United Kingdom, EH4 2XU
    - Western General Hospital
  - London, United Kingdom, EC2Y 8EA
    - St Pancras Clinical Research
  - London, United Kingdom, SW17 0RE
    - St Georges Hospital
  - London, United Kingdom, W12 0HS
    - Imperial College London - Imperial College Memory Research Centre
  - Manchester, United Kingdom, M13 9WL
    - Greater Manchester Mental Health NHS Foundation Trust
  - Motherwell, United Kingdom, ML1 4UF
    - NeuroClin
  - Newcastle upon Tyne, United Kingdom, NE4 5PL
    - Newcastle University
  - Oxford, United Kingdom, OX3 7JX
    - Warneford Hospital
  - Southampton, United Kingdom, SO30 3JB
    - Moorgreen Hospital
  - Swindon, United Kingdom, SN3 6BW
    - Kings Hill Research Centre
- Gloucestershire
  - Cheltenham, Gloucestershire, United Kingdom, GL53 9DZ
    - Fritchie Centre
United States
- Arizona
  - Phoenix, Arizona, United States, 85006
    - Banner Alzheimer's Institute
  - Scottsdale, Arizona, United States, 85258
    - Imaging Endpoints
  - Sun City, Arizona, United States, 85351
    - Banner Sun Health Research Institute
  - Tucson, Arizona, United States, 85710
    - Tucson Neuroscience Research
- California
  - Anaheim, California, United States, 92805
    - Advanced Research Center, Inc.
  - Fullerton, California, United States, 92835
    - Fullerton Neurology and Headache Center
  - Lemon Grove, California, United States, 91945
    - Pacific Research Network
  - Lomita, California, United States, 90717
    - Torrance Clin Res Inst, Inc.
  - Long Beach, California, United States, 90807
    - ASCLEPES Research Centers,
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90095
    - UCLA_Los Angeles
  - Newport Beach, California, United States, 92660
    - Wr-Pri, Llc
  - Panorama City, California, United States, 91402
    - Well Care Medical Center
  - Pasadena, California, United States, 90048
    - Cedars-Sinai Medical Center
  - San Diego, California, United States, 92123
    - Sharp Neurocog Res Ctr
  - Santa Ana, California, United States, 92705
    - Syrentis Clinical Research
  - Sherman Oaks, California, United States, 91403
    - Calfornia Neurosc Resrch Med
  - Simi Valley, California, United States, 93065
    - Southern California Research LLC
- Colorado
  - Basalt, Colorado, United States, 81621
    - Mountain Neurological Research Center, Inc.
  - Denver, Colorado, United States, 80218
    - Mile High Research Center
  - Denver, Colorado, United States, 80210
    - Denver Neurological Research
- Connecticut
  - Fairfield, Connecticut, United States, 06824
    - Yale University
- Florida
  - Apopka, Florida, United States, 32703
    - Topaz Clinical Research
  - Atlantis, Florida, United States, 33462
    - JEM Research Institute
  - Aventura, Florida, United States, 33180
    - Visionary Investigators Network
  - Clermont, Florida, United States, 34711
    - K2 Medical Research - Winter Garden
  - Delray Beach, Florida, United States, 33445
    - Brain Matters Research
  - Doral, Florida, United States, 33122
    - Integrity Clinical Research, LLC
  - Fort Myers, Florida, United States, 33912
    - Neuropsychiatric Research Cent
  - Greenacres City, Florida, United States, 33467
    - Finlay Medical Research Group
  - Hialeah, Florida, United States, 33016
    - Galiz Research
  - Hialeah, Florida, United States, 33012
    - Indago Research & Health Center Inc.
  - Hialeah, Florida, United States, 33015
    - Hlth Cr Family Rehab & Res Ctr
  - Lady Lake, Florida, United States, 32159
    - K2 The Villages
  - Maitland, Florida, United States, 32751
    - K2 Medical Research, Maitland
  - Miami, Florida, United States, 33122
    - Premier Clinical Research Institute, Inc.
  - Miami, Florida, United States, 33176
    - The Neurology Research Group
  - Miami, Florida, United States, 33125
    - Central Miami Medical Institute
  - Miami, Florida, United States, 33015
    - Hlth Cr Family Rehab & Res Ctr
  - Miami, Florida, United States, 33122
    - Premier Clin Res Inst, Inc.
  - Miami, Florida, United States, 33173
    - Novel Clinical Research Center, LLC
  - Miami, Florida, United States, 33176
    - IMIC, Inc- Medical Research
  - Miami, Florida, United States, 33176
    - Visionary Inv Ntwrk_Miami
  - Naples, Florida, United States, 34105
    - Aqualane Clinical Research
  - New Port Richey, Florida, United States, 34652
    - Suncoast Clin Res Port Richey
  - Orlando, Florida, United States, 32819
    - Headlands Research Orlando
  - Orlando, Florida, United States, 32807
    - Combined Research Orlando Phase I-IV
  - Palm Beach Gardens, Florida, United States, 33410
    - Advanced Research Consultants, Inc.
  - Sarasota, Florida, United States, 34239
    - Intercoastal Medical Group
  - Sarasota, Florida, United States, 34243
    - The Roskamp Institute, Inc.
  - Tampa, Florida, United States, 33609
    - Axiom Clinical Research of Florida
  - Tampa, Florida, United States, 33613
    - Stedman Clinical Trials LLC
  - West Palm Beach, Florida, United States, 33407
    - Palm Beach Neuro Premiere Res
  - Winter Park, Florida, United States, 32789
    - Conquest Research
- Georgia
  - Gainesville, Georgia, United States, 30501
    - Center for Adv Res & Education
- Hawaii
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Neuroscience, Memory Disorders Center
- Idaho
  - Meridian, Idaho, United States, 83642
    - Velocity Clinical Research
  - Meridian, Idaho, United States, 83642
    - Velocity Clinical Research, Meridian
- Kansas
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Clinical Research Center
- Kentucky
  - Lexington, Kentucky, United States, 40504
    - University of Kentucky_Lexington_0
- Maine
  - Bangor, Maine, United States, 04401
    - Northern Light Eastern Maine Medical Center
- Massachusetts
  - Methuen, Massachusetts, United States, 01844
    - ActivMed Practice & Research LLC
- Michigan
  - Paw Paw, Michigan, United States, 49079
    - Bronson Lakeview Neurobehavioral Health
- Minnesota
  - Saint Paul, Minnesota, United States, 55130
    - HealthPartners Center for Memory and Aging
- Mississippi
  - Hattiesburg, Mississippi, United States, 39401
    - Hattiesburg Clinic
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Altea Research Institute
  - Las Vegas, Nevada, United States, 89106
    - Wr-Crcn, Llc
- New Jersey
  - Middletown, New Jersey, United States, 07748
    - Patient First MD,clinical Trials
  - Toms River, New Jersey, United States, 08755
    - Advanced Memory Research Institute of NJ
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Albuquerque neuroscience Inc
- New York
  - Brooklyn, New York, United States, 11235
    - SPRI Clinical Trials, LLC
  - Lake Success, New York, United States, 11042
    - Neurological Assoc Long Island
  - New York, New York, United States, 10016
    - NYU Grossman School of Med
  - Staten Island, New York, United States, 10314
    - Richmond Behavioral Associates
- North Carolina
  - Charlotte, North Carolina, United States, 28211
    - New Hope Clinical Research
  - Matthews, North Carolina, United States, 28105
    - AMC Research, LLC
- Ohio
  - Beachwood, Ohio, United States, 44122
    - Insight Clinical Trials LLC
  - Canton, Ohio, United States, 44718
    - Neuroscience Research Center, LLC
  - Centerville, Ohio, United States, 45459
    - Valley Medical Primary Care
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - Central States Research, LLC
- Oregon
  - Portland, Oregon, United States, 97225
    - Neural Net Research, LLC
  - Portland, Oregon, United States, 97210
    - Summit Research Network Oregon Inc.
- Pennsylvania
  - Jenkintown, Pennsylvania, United States, 19046
    - The Clinical Trial Center
  - Media, Pennsylvania, United States, 19063
    - Suburban Research Associates
- South Carolina
  - Charleston, South Carolina, United States, 29403
    - Lowcountry Center for Vet Res
  - Port Royal, South Carolina, United States, 29935
    - Coastal Neurology
- Tennessee
  - Knoxville, Tennessee, United States, 37909
    - Genesis Neuroscience Clinic
  - Nashville, Tennessee, United States, 37212
    - Vanderbilt Medical Center
- Texas
  - Austin, Texas, United States, 78749
    - Texas Diabetes & Endocrinology
  - Houston, Texas, United States, 77054
    - Univ Of Texas Hlth Science Cntr
  - San Antonio, Texas, United States, 78229
    - Glenn Biggs Inst-Alzhm Neuro
  - Sugar Land, Texas, United States, 77478
    - Shirzadi Shahin, MD
- Vermont
  - Bennington, Vermont, United States, 05201
    - Memory Clinic, Inc
- Virginia
  - Falls Church, Virginia, United States, 22043
    - Integrated Neurology Services
  - Richmond, Virginia, United States, 23294
    - National Clin Res Inc.
- Washington
  - Kirkland, Washington, United States, 98034
    - Booth Gardner Parkinson's Cre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria.
CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home & hobbies, community affairs) Or CDR global score of 1.0
RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to 85
MMSE (Mini-Mental State Examination) greater than or equal to 22
Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aβ1-42 or CSF Aβ1-42/Aβ1-40 .
If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase inhibitors, memantine or aducanumab) the dose must have been stable for at least 3 months prior to screening and should not be changed during the trial unless medically necessary.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Semaglutide Participants are given oral semaglutide once daily	Drug: Semagludtide Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
Placebo Comparator: Placebo (semagludtide) Participants are given oral placebo once daily	Drug: Placebo (semaglutide) Oral placebo (semaglutide) once-daily, The study will last for up to 173 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score Time Frame: From baseline (week 0) to week 104	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 Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2021

Primary Completion (Actual)

September 16, 2025

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NN6535-4730
U1111-1259-2929 (Other Identifier: World Health Organization (WHO))
2023-506919-18 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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 Time Frame: From baseline (week 0) up to week 156	Week(s)	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 Time Frame: From baseline (week 0) to week 156	Week(s)	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 Time Frame: From baseline (week 0) to week 104	Score on scale (0 to 85) ADAS-Cog-13 measures the severity of cognitive impairment in various domains including memory, language, orientation, praxis and executive function. The ADAS-Cog-13 is composed of tasks in the original 11-item ADAS-Cog as well as delayed word recall and number cancellation items. The total scores on the scale range from 0 to 85 with higher scores representing greater impairment.	From baseline (week 0) to week 104
Extension Phase: Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score Time Frame: From baseline (week 0) to week 156	Score on scale (0 to 85) ADAS-Cog-13 measures the severity of cognitive impairment in various domains including memory, language, orientation, praxis and executive function. The ADAS-Cog-13 is composed of tasks in the original 11-item ADAS-Cog as well as delayed word recall and number cancellation items. The total scores on the scale range from 0 to 85 with higher scores representing greater impairment.	From baseline (week 0) to week 156
Main Phase: Change in the Montreal Cognitive Assessment (MoCA) score Time Frame: From baseline (week 0) to week 104	Score on scale (0 to 30) The MoCA is a brief assessment of cognitive abilities including orientation, short-term memory, clock-drawing test, executive function, language abilities, animal naming, attention and abstrac-tion. The assessment includes 8 domains of cognitive function with total scores ranging from 0 to 30 and lower scores indicating greater impairment.	From baseline (week 0) to week 104
Extension Phase: Change in the Montreal Cognitive Assessment (MoCA) score Time Frame: From baseline (week 0) to week 156	Score on scale (0 to 30) The MoCA is a brief assessment of cognitive abilities including orientation, short-term memory, clock-drawing test, executive function, language abilities, animal naming, attention and abstrac-tion. The assessment includes 8 domains of cognitive function with total scores ranging from 0 to 30 and lower scores indicating greater impairment.	From baseline (week 0) to week 156
Main Phase: Change in the Alzheimer's Disease Composite Score (ADCOMS) Time Frame: From baseline (week 0) to week 104	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.	From baseline (week 0) to week 104
Extension Phase: Change in the Alzheimer's Disease Composite Score (ADCOMS) Time Frame: From baseline (week 0) to week 156	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.	From baseline (week 0) to week 156
Main Phase: Change in the Mini-Mental State Examination (MMSE) score Time Frame: From baseline (week 0) to week 104	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.	From baseline (week 0) to week 104
Extension Phase: Change in the Mini-Mental State Examination (MMSE) score Time Frame: From baseline (week 0) to week 156	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.	From baseline (week 0) to week 156
Main Phase: Time to progression in disease stage based on global CDR score Time Frame: From baseline (week 0) up to week 156	Week(s)	From baseline (week 0) up to week 156
Extension Phase: Time to progression in disease stage based on global CDR score Time Frame: From baseline (week 0) up to week 156	Week(s)	From baseline (week 0) up to week 156
Main Phase: Change in the composite Z-score based on the three outcome measures CDR-SB, ADCS-ADL-MCI, and ADAS-Cog-13 Time Frame: From baseline (week 0) to week 104	Score	From baseline (week 0) to week 104
Extension Phase: Change in the composite Z-score based on the three outcome measures CDR-SB, ADCS-ADL-MCI, and ADAS-Cog-13 Time Frame: From baseline (week 0) to week 156	Score	From baseline (week 0) to week 156
Main Phase: Change in the 10-item Neuropsychiatric Inventory (NPI) score Time Frame: From baseline (week 0) to week 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.	From baseline (week 0) to week 104
Extension Phase: Change in the 10-item Neuropsychiatric Inventory (NPI) score Time Frame: From baseline (week 0) to week 156	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.	From baseline (week 0) to week 156
Main Phase: Change in high sensitivity C-reactive protein level Time Frame: From baseline (week 0) to week 104	Ratio to baseline	From baseline (week 0) to week 104
Extension Phase: Change in high sensitivity C-reactive protein level Time Frame: From baseline (week 0) to week 156	Ratio to baseline	From baseline (week 0) to week 156
Main Phase: Number of treatment emergent adverse events (TEAEs) Time Frame: From baseline (week 0) up to week 156	Number of events	From baseline (week 0) up to week 156
Extension Phase: Number of treatment emergent adverse events (TEAEs) Time Frame: From baseline (week 0) up to week 156	Number of events	From baseline (week 0) up to week 156
Main Phase: Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and all-cause death Time Frame: From baseline (week 0) to week 104	Week(s)	From baseline (week 0) to week 104
Extension Phase: Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and all-cause death Time Frame: From baseline (week 0) to week 156	Week(s)	From baseline (week 0) to week 156
Main Phase: Time to first occurrence of stroke Time Frame: From baseline (week 0) to week 104	Week(s	From baseline (week 0) to week 104
Extension Phase: Time to first occurrence of stroke Time Frame: From baseline (week 0) to week 156	Week(s	From baseline (week 0) to week 156
Main Phase: Change in the EQ-5D-5L (proxy version) index score Time Frame: From baseline (week 0) to week 104	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.	From baseline (week 0) to week 104
Extension Phase: Change in the EQ-5D-5L (proxy version) index score Time Frame: From baseline (week 0) to week 156	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.	From baseline (week 0) to week 156

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)

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