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

March 31, 2024 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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano
      • Buenos Aires, Argentina, C1012AAR
        • Instituto de Investigaciones Metabolicas (IDIM)
      • Caba, Argentina, 1405
        • NeuroSite
      • Caba, Argentina, 1427
        • Clínica Nuestra Señora de las Nieves
      • Caba, Argentina, 1428
        • FLENI
      • Córdoba, Argentina, X5004AOA
        • Instituto Privado Kremer
      • Mendoza, Argentina, 5500
        • Fundacion Scherbovsky
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's hospital
      • 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
  • Austria
      • Innsbruck, Austria, 6020
        • LKH-Univ. Kliniken Innsbruck
      • Innsbruck, Austria, 6020
        • Medizinische Univ. Innsbruck
      • Salzburg, Austria, 5020
        • Univ. Klinik für Neurologie
      • Wien, Austria, 1090
        • Medizinische Universitat Wien
  • Belgium
      • Edegem, Belgium, 2650
        • UZA - UZ Antwerpen - Department of Neurology
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Kortrijk - Neurologie
  • Brazil
      • Rio de Janeiro, Brazil, 22270-060
        • Centro de Psiquiatria Sandra Rushel
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70200730
        • L2 IP Instituto de Pesquisas Clinicas Ltda
    • Parana
      • Curitiba, Parana, Brazil, 81210-310
        • Instituto de Neurologia de Curitiba
      • Maringa, Parana, 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.
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica Ltda
      • São Paulo, Sao Paulo, Brazil, 04024-000
        • Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP
      • São Paulo, Sao Paulo, Brazil, 01236-030
        • BR Trials - Ensaios Clínicos e Consultoria Ltda.
  • Bulgaria
      • Sofia, Bulgaria, 1113
        • "MHATNP "Sv. Naum"" EAD
      • Sofia, Bulgaria, 1408
        • DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan
      • Sofia, Bulgaria, 1431
        • "UMHAT "Aleksandrovska", Neurology clinic
      • 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)
    • 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
      • 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
      • Gatineau, Quebec, Canada, J8T 8J1
        • Recherchs Neuro-Hippocampe Inc
      • Montréal, Quebec, Canada, H4H 1R3
        • Douglas Hosp Res Ctr
      • Québec, Quebec, Canada, G1J 1Z4
        • CHU de Quebec-Universite Laval
  • Czechia
      • Brno-Lisen, Czechia, 628 00
        • Neuro Health Centrum s.r.o.
      • Olomouc, Czechia, 77900
        • AGE Centrum
      • Praha 10, Czechia, 109 00
        • AD71 s.r.o.
      • Praha 6 Dejvice, Czechia, 16000
        • Neuropsychiatrie
      • Rychnov nad Kneznou, Czechia, 51601
        • Vestra Clinics s.r.o.
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital
      • København Ø, Denmark, 2100
        • Rigshospitalet - afsnit 8015
      • 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 CEDEX, France, 59037
        • Hopital Roger Salengro
      • Marseille, France, 13005
        • Assistance Publique Hopitaux de Marseille-Hopital de La Timone-1
      • 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
      • Reims cedex, France, 51092
        • Centre Hospitalier Universitaire Reims-Hopital Maison Blanche
      • Saint Herblain, France, 44800
        • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-2
      • Strasbourg cedex 2, France, 67098
        • Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-2
      • 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
        • Universitätsklinikum RWTH Aachen, Neurologie
      • Böblingen, Germany, 71034
        • Studienzentrum Dr. Bischof GmbH
      • Erbach, Germany, 64711
        • Neuro Centrum Science GmbH
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Psychiatrie
      • Köln, Germany, 50937
        • Universitätsklinikum Köln
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz, Psychiatrie
      • Mannheim, Germany, 68159
        • Zentralinstitut für Seelische Gesundheit (ZI)
      • München, Germany, 81377
        • LMU Klinikum
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm, Neurologie
      • Westerstede, Germany, 26655
        • Studienzentrum Nord-West
    • Hessen
      • Bad Homburg, Hessen, Germany, 61350
        • Zentrum für klinische Forschung Dr. med. Irma Schöll GmbH
  • Greece
      • Athens, Greece, GR-11521
        • Naval Hospital of Athens
      • Athens, Greece, GR-11526
        • Henry Dunant Hospital Center,2nd Neurological Department
      • Athens, Greece, GR-11528
        • Aiginitio Hospital, 1st Neurology Clinic
      • Athens, Greece, GR-15123
        • "Hygeia" General Hospital of Athens, Memory clinic
      • Chaidari, Athens, Greece, GR-12462
        • University General Hospital of Athens "Attiko"
      • Marousi, Greece, GR-15125
        • Iatriko Athinon (Athens Medical Center),Memory Disorders Cli
      • Thessaloniki, Greece, GR-54643
        • EUROMEDICA General Clinic of Thessaloniki,Neurology Dpt
      • Thessaloniki, Greece, GR54636
        • AHEPA General University Hospital
  • Hungary
      • Budapest, Hungary, H-1083
        • Semmelweis Egyetem AOK
      • Debrecen, Hungary, 4031
        • DE Kenézy Gyula Campus, Pszichiátriai és Pszichoterápiai Klinika
      • Debrecen, Hungary, 4032
        • DE Gyógyszerfejlesztési Koordinációs Központ Pszichiátria
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Korhaz
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Korhaz
      • Kaposvár, Hungary, H-7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
      • Pécs, Hungary, H-7633
        • Psychotech Kft.
      • Zalaegerszeg, Hungary, 8900
        • Belvárosi Egészségház Kft.
  • Ireland
      • Cork, Ireland, T12 WE28
        • Mercy Hospital Cork
      • Dublin, Ireland, D24 NR0A
        • Tallaght University Hospital
      • Dublin, Ireland, D04 VH51
        • St Vincent's University Hospital
      • Dublin, Ireland, D08 NHY1
        • Mercer's Institute for Successful Aging
  • Israel
      • Haifa, Israel, 3109601
        • The Stroke and Cognition Institute Rambam Medical Center
      • Petach Tikva, Israel, 49100
        • Cognitive Neurology Clinic, Rabin Campus, Beilinson Hospital
      • Tel Aviv, Israel, 6423906
        • Cognitive Neurology Sourasky Medical Center
      • Tel Hashomer, Ramat Gan, Israel, 5262000
        • Chaim Sheba Medical Center, Geriatric Rehabilitation Center
  • 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 Gabriele D'Annunzio Chieti-Pescara
      • Milano, Italy, 20122
        • Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
      • Milano, 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
      • 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
        • Policlinico Universitario A.Gemelli Servizio Neuropsicologia
  • Japan
      • Anan, Tokushima, Japan, 774-0014
        • Iwaki Clinic_Psychosomatic medicine
      • Anjo-shi, Aichi, Japan, 446-8510
        • Yachiyo Hospital
      • 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
      • Chib-shi, Chiba, Japan, 260-8656
        • Kashiwado Hospital
      • Chofu-shi,Tokyo, Japan, 182-0036
        • Enomoto Internal Medicine Clinic
      • Fujioka-Shi, Gunma, Japan, 375-0017
        • Shinozuka Hospital
      • Hachioji-shi, Tokyo, Japan, 192-0071
        • P-one Clinic
      • Hamamatsu-shi, Shizuoka, Japan, 434-8511
        • National Hospital Organization Tenryu Hospital
      • Himeji-city, Hyogo, Japan, 670-0981
        • Hyogo Brain and Heart Center
      • Himeji-shi, Hyogo, Japan, 671-1227
        • Tsukazaki Hospital
      • Himeji-shi, Hyogo, Japan, 672-8043
        • Himeji Central Hospital Clinic
      • 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
        • Hiroshima Neurology Clinic
      • Hofu-shi, Yamaguchi, Japan, 747-0802
        • Nagamitsu Clinic
      • Ina-shi, Nagano, Japan, 396-8555
        • Ina Central Hospital
      • 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
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Kobe University Hospital_Kobe-shi, Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Kobe University Hospital
      • Kodaira-shi, Tokyo, Japan, 187-8551
        • National Center of Neurology and Psychiatry
      • 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
      • Obu-shi, Aichi, Japan, 474-8511
        • National Center for Geriatrics and Gerontology
      • Okayama-shi, Okayama, Japan, 703-8265
        • Okayama Kyokuto Hospital
      • Shimotsuke-shi, Tochigi, Japan
        • Jichiidai Station Brain Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Shizuoka-shi, Shizuoka, Japan, 424-8636
        • Shizuoka City Shimizu Hospital_Neurology
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Kagawa Prefectural Central Hospital_Takamatsu-shi, Kagawa
      • Takatsuki-Shi, Osaka, Japan, 569-1192
        • Takatsuki General Hospital
      • Tokorozawa-shi,Saitama, Japan, 359-1141
        • Saino Clinic
      • Tokushima-shi, Tokushima, Japan, 770-0852
        • Itsuki Hospital
      • Tokyo, Japan, 136-0075
        • Juntendo Tokyo Koto Geriatric Medical Center
      • 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
      • 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
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Medical Center
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Medical Center
      • Seoul, Korea, Republic of, 07804
        • Ewha Womans University Seoul Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center_Seoul
  • Mexico
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25000
        • Hospital Universitario "Dr. Gonzalo Valdes Valdes"
    • 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
      • Culiacan, Sinaloa, Mexico, 80020
        • Hospital Angeles de Culiacan
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis
      • Den Bosch, Netherlands, 5223 LA
        • Brain Research Center
      • Nijmegen, Netherlands, 6525 GA
        • Radboudumc
  • Norway
      • Lørenskog, Norway, 1474
        • Akershus universitetssykehus - Hukommelsesklinikken
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus HF, Ullevål
      • Oslo, Norway
        • Master Centre - Dummy
  • Poland
      • Bydgoszcz, Poland, 85-163
        • Centrum Medyczne Neuromed
      • Kielce, Poland, 25-411
        • Centrum Zdrowia Psychicznego Biomed
      • Kraków, Poland, 30-688
        • Szpital Uniwersytecki w Krakowie od. Neurologii
      • Kraków, Poland, 31-505
        • Centrum Neurologii Klinicznej
      • Lublin, Poland, 20-818
        • NZOZ Neuromed
      • Poznan, Poland, 61-853
        • NZOZ NEURO - KARD Ilkowski i Partnerzy Sp. Part. Lekarzy
      • Scinawa, Poland, 59-330
        • Osrodek Alzheimerowski Sp. z o.o.
      • Sopot, Poland, 81-855
        • Centrum Medyczne SENIOR
      • Warszawa, Poland, 01-684
        • Centrum Medyczne Neuro Protect
      • Wroclaw, Poland, 53-659
        • NZOZ Wrocławskie Centrum Alzheimerowskie
    • Małopolskie
      • Kraków, Małopolskie, Poland, 30-721
        • Linden sp. z o.o. sp. k.
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3000-459
        • Centro Hospitalar e Universitario de Coimbra
      • Guimarães, Portugal, 4835-044
        • Hospital da Senhora da Oliveira - Guimarães
      • Lisboa, Portugal, 1349-019
        • Centro Hospitalar Lisboa Ocidental
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Angelo
      • Matosinhos, Portugal, 4464-513
        • Unidade Local de Saúde de Matosinhos
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto, E.P.E
      • Torres Vedras, Portugal, 2560-280
        • Campus Neurologico Senior
  • Romania
      • Bucharest, Romania, 011025
        • Sana Monitoring SRL
      • Constanta, Romania, 900123
        • Spitalul Clinic Cai Ferate Constanta
      • Constanta, Romania, 900591
        • Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
      • Sibiu, Romania, 550052
        • Aria Clinic SRL
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620075
        • Joint Stock Company "Medical technologies"
      • Krasnoyarsk, Russian Federation, 660037
        • Federal Siberian Research Clinical Center under FMBA of Rus
      • Moscow, Russian Federation, 119021
        • FSAEI 1st Moscow Federal Med University na Sechenov
      • Moscow, Russian Federation, 129226
        • Pirogov Russian National Research Medical University MoH
      • Moscow, Russian Federation, 125993
        • RMAPE
      • Omsk, Russian Federation, 644043
        • Ezramed Clinic Llc
      • Rostov-on-Don, Russian Federation, 344000
        • Research Center for Treatment and Rehabilitation "Phoenix"
      • Saint Petersburg, Russian Federation, 190121
        • Psychiatric hospital of st. Nicholas the wonderworker
      • Saint Petersburg, Russian Federation, 191015
        • N.-E. State Medical University n.a. Mechnikov
      • Saint Petersburg, Russian Federation, 194044
        • S.M. Kirov Military Medical Academy,Depart.&Clinic Nerv Dis
      • Tomsk, Russian Federation, 634009
        • Center of Clinica Trials "Nebbiolo"
      • Tomsk, Russian Federation, 634009
        • LLC "Clinic Stolet"
      • Ufa, Russian Federation, 450054
        • National medical holdiNational medical holding "Medstandard"
  • 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
      • Kosice, Slovakia, 041 66
        • Neurologicka klinika UPJS LF a UNLP
      • Vranov nad Toplou, Slovakia, 093 01
        • Crystal Comfort s.r.o.
  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • UKC Ljubljana, Department of Neurology
      • Maribor, Slovenia, SI-2000
        • UKC Maribor - neurology
  • 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
  • Spain
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain, 08028
        • Fundación ACE
      • Donostia, Spain, 20009
        • Fundación CITA
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Pozuelo de Alarcon, Spain, 28223
        • Hospital Quirón
      • 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
      • Malmö, Sweden, 205 02
        • Minnesmottagning specialiserad Malmö
      • Stockholm, Sweden, 141 86
        • Karolinska Universitetssjukhuset, Huddinge
      • Umeå, Sweden, 901 85
        • Geriatriskt centrum, Umeå
  • Switzerland
      • Biel-Bienne, Switzerland, 2501
        • Spitalzentrum Biel
      • Genève, Switzerland, 1205
        • Centre de la Mémoire
      • Lausanne, Switzerland, 1011
        • Centre Leenaards de la mémoire CHUV
      • St. Gallen, Switzerland, 9007
        • Klinik für Neurologie Kantonsspital St.Gallen
  • Turkey
      • Altindag/Ankara, Turkey, 06230
        • Hacettepe University Medical Faculty Hospital
      • Eskisehir, Turkey, 26040
        • Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma
      • Istanbul, Turkey, 34093
        • Istanbul University Medical Faculty Neurology Department
      • Izmir, Turkey, 35575
        • Izmir Economics University Medical Point Hospital Neurology D
      • Samsun, Turkey, 55200
        • Ondokuz Mayis University Saglik Uygulama ve Arastirma Merkez
  • Ukraine
      • Kyiv, Ukraine, 04114
        • Chebotarev State Institute of Gerontology of the NAMS of Ukr
  • 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,
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Gloucestershire, United Kingdom, GL53 9DZ
        • Fritchie Centre
      • London, United Kingdom, W12 0NN
        • Imperial College London
      • London, United Kingdom, SW17 0RE
        • St George's Hospital
      • London, United Kingdom, EC2Y 8EA
        • St Pancras Clinical Research
      • Manchester, United Kingdom, M13 9WL
        • Greater Manchester Mental Health NHS Foundation Trust
      • Motherwell, United Kingdom, ML1 4UF
        • Glasgow Memory Clinic
      • 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
  • 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
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
      • Fullerton, California, United States, 92835
        • Fullerton Neurology and Headache Center
      • Lomita, California, United States, 90717
        • Torrance Clin Res Inst, Inc.
      • Long Beach, California, United States, 90807
        • ASCLEPES Research Centers,
      • Los Angeles, California, United States, 90095
        • UCLA_Los Angeles
      • 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
      • San Diego, California, United States, 92103-5801
        • Pacific Research Network
      • 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
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Aventura, Florida, United States, 33180
        • Visionary Investigators Network
      • 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, 33012
        • Indago Research & Health Center Inc.
      • 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, 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 Clinical Research, Inc._New Port Richey
      • 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
    • Minnesota
      • Saint Paul, Minnesota, United States, 55130
        • HealthPartners Center for Memory and Aging
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic
    • 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 York
      • Lake Success, New York, United States, 11042
        • Neurological Assoc Long Island
      • 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
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Central States Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network Oregon Inc.
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center
    • South Carolina
      • 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
      • 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
    • Virginia
      • Falls Church, Virginia, United States, 22043
        • Integrated Neurology Services

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

No

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

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

Outcome Measure
Measure Description
Time Frame
Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADL-MCI)
Time Frame: From baseline (week 0) to week 104
Score on scale (0 to 53) An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment.
From baseline (week 0) to week 104
Time to progression to dementia (CDR global greater than or equal to 1.0) among subjects with MCI (CDR global equal to 0.5) at baseline
Time Frame: From baseline (week 0) to week 104
Week(s)
From baseline (week 0) to week 104
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
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
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
Time to progression in disease stage based on global CDR score
Time Frame: From baseline (week 0) to week 104
Week(s)
From baseline (week 0) to week 104
Number of treatment emergent adverse events (TEAEs)
Time Frame: From baseline (week 0) to week 104
Number of events
From baseline (week 0) to week 104
Change in high sensitivity C-reactive protein level
Time Frame: From baseline (week 0) to week 104
Ratio
From baseline (week 0) to week 104
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
Time to first occurrence of stroke
Time Frame: From baseline (week 0) to week 104
Week(s
From baseline (week 0) to week 104
Change in the EQ-5D-5L proxy 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 CDR-SB score
Time Frame: From baseline (week 0) to week 156

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 156
Change in the ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment ) score
Time Frame: From baseline (week 0) to week 156
Score on scale (0 to 53) An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment.
From baseline (week 0) to week 156
Time to progression to dementia (CDR global greater than or equal to 1.0) among subjects with MCI (CDR global equal to 0.5) at baseline
Time Frame: From baseline (week 0) to week 156
Week(s)
From baseline (week 0) to week 156

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

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 (Estimated)

September 19, 2025

Study Completion (Estimated)

October 23, 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 2, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

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))
  • 2020-004848-29 (Registry Identifier: European Medicines Agency (EudraCT))

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

No

product manufactured in and exported from the U.S.

No

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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