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

Early Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04777396
• Other study ID #: NN6535-4730
• Secondary ID: U1111-1259-29292
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 18, 2021
• Est. completion date: October 23, 2026

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.

Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1840
• Est. completion date: October 23, 2026
• Est. primary completion date: September 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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) Aß1-42 or CSF Aß1-42/Aß1-40 .

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Early Alzheimer's Disease

Intervention

Drug:
• Semagludtide
Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
• Placebo (semaglutide)
Oral placebo (semaglutide) once-daily, The study will last for up to 173 weeks

Locations

Country	Name	City	State
Argentina	Hospital Italiano	Buenos Aires
Argentina	Instituto de Investigaciones Metabolicas (IDIM)	Buenos Aires
Argentina	Clínica Nuestra Señora de las Nieves	Caba
Argentina	FLENI	Caba
Argentina	Neurosite	Caba
Argentina	Instituto Privado Kremer	Córdoba
Argentina	Fundación Scherbovsky	Mendoza
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Medical and Cognitive Research Unit - Austin Health	Ivanhoe	Victoria
Australia	Southern Neurology	Kogarah	New South Wales
Australia	Hunter New England Local Health District - Neuropsychiatry	Waratah	New South Wales
Austria	LKH-Univ. Kliniken Innsbruck	Innsbruck
Austria	Medizinische Univ. Innsbruck	Innsbruck
Austria	Univ. Klinik für Neurologie	Salzburg
Belgium	UZA - UZ Antwerpen - Department of Neurology	Edegem
Belgium	AZ Groeninge - Kortrijk - Neurologie	Kortrijk
Brazil	L2 IP Instituto de Pesquisas Clinicas Ltda	Brasília	Distrito Federal
Brazil	Instituto de Neurologia de Curitiba	Curitiba	Parana
Brazil	Clinica Clinilive Ltda	Maringa	Parana
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.	Porto Alegre	Rio Grande Do Sul
Brazil	Centro de Psiquiatria Sandra Rushel	Rio de Janeiro
Brazil	Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP	São Paulo	Sao Paulo
Brazil	BR Trials - Ensaios Clínicos e Consultoria Ltda.	São Paulo	Sao Paulo
Brazil	CPQuali Pesquisa Clínica Ltda	São Paulo	Sao Paulo
Bulgaria	"MHATNP "Sv. Naum"" EAD	Sofia
Bulgaria	"UMHAT "Aleksandrovska", Neurology clinic	Sofia
Bulgaria	DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan	Sofia
Bulgaria	MMA, MHAT-Sofia, Neurology clinic	Sofia
Canada	Recherchs Neuro-Hippocampe Inc	Gatineau	Quebec
Canada	True North Clinical Research - Halifax	Halifax	Nova Scotia
Canada	OCT Research ULC (dba Okanagan Clinical Trials)	Kelowna	British Columbia
Canada	Douglas Hosp Res Ctr	Montréal	Quebec
Canada	True North Clinical Research - New Minas	New Minas	Nova Scotia
Canada	Ottawa Memory Clinic	Ottawa	Ontario
Canada	Medical Arts Health Research Group_Kelowna	Penticton	British Columbia
Canada	CHU de Quebec-Universite Laval	Québec	Quebec
Canada	Centricity Research LMC	Toronto	Ontario
Canada	Memory Program	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	University Health Network - Toronto Western Hospital	Toronto	Ontario
Canada	Island Health (Research and Capacity Building)	Victoria	British Columbia
Czechia	Neuro Health Centrum s.r.o.	Brno-Lisen
Czechia	AGE Centrum	Olomouc
Czechia	AD71 s.r.o.	Praha 10
Czechia	Neuropsychiatrie	Praha 6 Dejvice
Czechia	Vestra Clinics s.r.o.	Rychnov nad Kneznou
Denmark	Aarhus Universitetshospital	Aarhus N
Denmark	Rigshospitalet - afsnit 8015	København Ø
Denmark	Sjællands Universitetshospital_Roskilde	Roskilde
Finland	CRST Helsinki	Helsinki
Finland	Aivotutkimusyksikkö	Kuopio
Finland	CRST Turku	Turku
France	Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin	Bordeaux
France	Hospices Civils de Lyon-Hopital Pierre Wertheimer	Bron
France	Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage	Dijon
France	Hôpital Roger Salengro	Lille CEDEX
France	Assistance Publique Hopitaux de Marseille-Hopital de La Timone-1	Marseille
France	Centre Hospitalier Universitaire de Nice-Institut Claude Pompidou	Nice
France	Aphp-Hopital La Pitie Salpetriere-3	Paris
France	Aphp-Hopital Lariboisiere-1	Paris
France	Centre Hospitalier Universitaire Reims-Hopital Maison Blanche	Reims cedex
France	Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-2	Saint Herblain
France	Les Hopitaux Universitaires de Strasbourg-Hopital de La Robertsau	Strasbourg
France	Centre Hospitalier Universitaire de Toulouse-Hopital La Grave	Toulouse
France	Hospices Civils de Lyon-Hopital Des Charpennes	Villeurbanne
Germany	Universitätsklinikum RWTH Aachen, Neurologie	Aachen
Germany	Zentrum für klinische Forschung Dr. med. Irma Schöll GmbH	Bad Homburg	Hessen
Germany	Studienzentrum Dr. Bischof GmbH	Böblingen
Germany	Neuro Centrum Science GmbH	Erbach
Germany	Universitätsklinikum Hamburg-Eppendorf, Psychiatrie	Hamburg
Germany	Universitätsklinikum Köln	Köln
Germany	Universitätsmedizin Mainz, Psychiatrie	Mainz
Germany	Zentralinstitut für Seelische Gesundheit (ZI)	Mannheim
Germany	LMU Klinikum	München
Germany	Universitätsklinikum Ulm, Neurologie	Ulm
Germany	Studienzentrum Nord-West	Westerstede
Greece	"Hygeia" General Hospital of Athens, Memory clinic	Athens
Greece	Aiginitio Hospital, 1st Neurology Clinic	Athens
Greece	Henry Dunant Hospital Center,2nd Neurological Department	Athens
Greece	Naval Hospital of Athens	Athens
Greece	University General Hospital of Athens "Attiko"	Chaidari, Athens
Greece	Iatriko Athinon (Athens Medical Center),Memory Disorders Cli	Marousi
Greece	AHEPA General University Hospital	Thessaloniki
Greece	EUROMEDICA General Clinic of Thessaloniki,Neurology Dpt	Thessaloniki
Hungary	Semmelweis Egyetem ÁOK	Budapest
Hungary	DE Gyógyszerfejlesztési Koordinációs Központ Pszichiátria	Debrecen
Hungary	DE Kenézy Gyula Campus, Pszichiátriai és Pszichoterápiai Klinika	Debrecen
Hungary	Bugát Pál Kórház	Gyöngyös
Hungary	Petz Aladar Megyei Korhaz	Gyor
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár
Hungary	Psychotech Kft.	Pécs
Hungary	Belvárosi Egészségház Kft.	Zalaegerszeg
Ireland	Mercy Hospital Cork	Cork
Ireland	Mercer's Institute for Successful Aging	Dublin
Ireland	St Vincent's University Hospital	Dublin
Ireland	Tallaght University Hospital	Dublin
Israel	The Stroke and Cognition Institute Rambam Medical Center	Haifa
Israel	Cognitive Neurology Clinic, Rabin Campus, Beilinson Hospital	Petach Tikva
Israel	Cognitive Neurology Sourasky Medical Center	Tel Aviv
Israel	Chaim Sheba Medical Center, Geriatric Rehabilitation Center	Tel Hashomer, Ramat Gan
Italy	AOU Ospedali Riuniti S.O.D	Ancona
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Università degli studi Gabriele D'Annunzio Chieti-Pescara	Chieti
Italy	Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	IRCCS Ospedale San Raffaele Milano	Milano
Italy	ASST Monza e Brianza Ospedale San Gerardo	Monza
Italy	Ospedale Santa Maria della Misericordia	Perugia
Italy	Fondazione Santa Lucia IRCCS	Roma
Italy	Pol. Uni. Campus Biomedico UOC Neurologia	Roma
Italy	Policlinico Tor Vergata	Roma
Italy	Policlinico Universitario A.Gemelli Servizio Neuropsicologia	Roma
Japan	Iwaki Clinic_Psychosomatic medicine	Anan, Tokushima
Japan	Yachiyo Hospital	Anjo-shi, Aichi
Japan	Abe Clinic	Arakawa-ku,Tokyo
Japan	Memory Clinic Ochanomizu	Bunkyo-ku, Tokyo
Japan	Tokyo Medical And Dental University Hospital	Bunkyo-ku,Tokyo
Japan	Kashiwado Hospital	Chib-shi, Chiba
Japan	Enomoto Internal Medicine Clinic	Chofu-shi,Tokyo
Japan	Shinozuka Hospital	Fujioka-Shi, Gunma
Japan	P-one Clinic	Hachioji-shi, Tokyo
Japan	National Hospital Organization Tenryu Hospital	Hamamatsu-shi, Shizuoka
Japan	Hyogo Brain and Heart Center	Himeji-city, Hyogo
Japan	Himeji Central Hospital Clinic	Himeji-shi, Hyogo
Japan	Tsukazaki Hospital	Himeji-shi, Hyogo
Japan	Hatsuta Neurology Clinic	Hirakata-Shi,Osaka
Japan	Hiroshima Neurology Clinic	Hiroshima-shi, Hiroshima
Japan	Imon Yukari Neurology Clinic	Hiroshima-shi, Hiroshima
Japan	Nagamitsu Clinic	Hofu-shi, Yamaguchi
Japan	Ina Central Hospital	Ina-shi, Nagano
Japan	Kawasaki Saiwai Clinic_Internal Medicine	Kanagawa
Japan	Kishiro Mental Clinic	Kawasaki-shi , Kanagawa
Japan	Koukan Clinic	Kawasaki-shi, Kanagawa
Japan	Teikyo University Hospital, Mizonokuchi_Kawasaki-shi, Kanagawa	Kawasaki-shi, Kanagawa
Japan	Kobe University Hospital	Kobe-shi, Hyogo
Japan	Kobe University Hospital_Kobe-shi, Hyogo	Kobe-shi, Hyogo
Japan	National Center of Neurology and Psychiatry	Kodaira-shi, Tokyo
Japan	Southern Tohoku Medical Clinic	Koriyama-shi, Fukushima
Japan	Katayama Medical Clinic	Kurashiki-shi, Okayama
Japan	Nozomi Memory Clinic	Mitaka-shi,Tokyo
Japan	Kikukawa clinic	Nerima-ku, Tokyo
Japan	General Rehabilitation Center · Midori Hospital	Niigata-shi, Niigata
Japan	National Center for Geriatrics and Gerontology	Obu-shi, Aichi
Japan	Okayama Kyokuto Hospital	Okayama-shi, Okayama
Japan	Jichiidai Station Brain Clinic	Shimotsuke-shi, Tochigi
Japan	Keio University Hospital	Shinjuku-ku, Tokyo
Japan	Shizuoka City Shimizu Hospital_Neurology	Shizuoka-shi, Shizuoka
Japan	Kagawa Prefectural Central Hospital_Takamatsu-shi, Kagawa	Takamatsu-shi, Kagawa
Japan	Takatsuki General Hospital	Takatsuki-Shi, Osaka
Japan	Saino Clinic	Tokorozawa-shi,Saitama
Japan	Itsuki Hospital	Tokushima-shi, Tokushima
Japan	Alzclinic Tokyo	Tokyo
Japan	Juntendo Tokyo Koto Geriatric Medical Center	Tokyo
Japan	Kurumi CLINIC	Tokyo
Japan	Tokyo Center Clinic	Tokyo
Japan	Tokyo Medical Univ. Hospital	Tokyo
Japan	Memory Clinic Toride	Toride-shi, Ibaraki
Japan	MI Clinic	Toyonaka-shi, Osaka
Japan	Medical Corporation Midorikai Wako Hospital	Wako-shi, Saitama
Korea, Republic of	Dong-A University Medical Center	Busan
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center_Seoul	Seoul
Mexico	Hospital Angeles de Culiacan	Culiacan	Sinaloa
Mexico	Avix Investigación Clínica, S.C.	Monterrey	Nuevo León
Mexico	Centro de Estudios Clínicos y Especialidades Médicas S.C.	Monterrey	Nuevo León
Mexico	Hospital Universitario Dr. José Eleuterio González_Monterrey	Monterrey	Nuevo León
Mexico	Hospital Universitario "Dr. Gonzalo Valdes Valdes"	Saltillo	Coahuila
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Brain Research Center	Den Bosch
Netherlands	Radboudumc	Nijmegen
Norway	Akershus universitetssykehus - Hukommelsesklinikken	Lørenskog
Norway	Master Centre - Dummy	Oslo
Norway	Oslo universitetssykehus HF, Ullevål	Oslo
Poland	Centrum Medyczne Neuromed	Bydgoszcz
Poland	Centrum Zdrowia Psychicznego Biomed	Kielce
Poland	Centrum Neurologii Klinicznej	Kraków
Poland	Linden sp. z o.o. sp. k.	Kraków	Malopolskie
Poland	Szpital Uniwersytecki w Krakowie od. Neurologii	Kraków
Poland	Nzoz Neuromed	Lublin
Poland	NZOZ NEURO - KARD Ilkowski i Partnerzy Sp. Part. Lekarzy	Poznan
Poland	Osrodek Alzheimerowski Sp. z o.o.	Scinawa
Poland	Centrum Medyczne SENIOR	Sopot
Poland	Centrum Medyczne Neuro Protect	Warszawa
Poland	NZOZ Wroclawskie Centrum Alzheimerowskie	Wroclaw
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar e Universitário de Coimbra	Coimbra
Portugal	Hospital da Senhora da Oliveira - Guimarães	Guimarães
Portugal	Centro Hospitalar Lisboa Ocidental	Lisboa
Portugal	Hospital Beatriz Ângelo	Loures
Portugal	Unidade Local de Saúde de Matosinhos	Matosinhos
Portugal	Unidade Local de Saúde de Santo António, E.P.E	Porto
Portugal	Campus Neurologico Senior	Torres Vedras
Romania	Sana Monitoring SRL	Bucharest
Romania	Spitalul Clinic Cai Ferate Constanta	Constanta
Romania	Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta	Constanta
Romania	Aria Clinic SRL	Sibiu
Russian Federation	Joint Stock Company "Medical technologies"	Ekaterinburg
Russian Federation	Federal Siberian Research Clinical Center under FMBA of Rus	Krasnoyarsk
Russian Federation	FSAEI 1st Moscow Federal Med University na Sechenov	Moscow
Russian Federation	Pirogov Russian National Research Medical University MoH	Moscow
Russian Federation	RMAPE	Moscow
Russian Federation	Ezramed Clinic Llc	Omsk
Russian Federation	Research Center for Treatment and Rehabilitation "Phoenix"	Rostov-on-Don
Russian Federation	N.-E. State Medical University n.a. Mechnikov	Saint Petersburg
Russian Federation	Psychiatric hospital of st. Nicholas the wonderworker	Saint Petersburg
Russian Federation	S.M. Kirov Military Medical Academy,Depart.&Clinic Nerv Dis	Saint Petersburg
Russian Federation	Center of Clinica Trials "Nebbiolo"	Tomsk
Russian Federation	LLC "Clinic Stolet"	Tomsk
Russian Federation	National medical holdiNational medical holding "Medstandard"	Ufa
Serbia	Neurology clinic, University Clinical Center of Serbia	Belgrade
Serbia	Special Hospital for Psychiatric Disorders "Kovin"	Kovin
Serbia	University clinical center of Vojvodina, Neurology clinic	Novi Sad
Slovakia	Psych. amb. CENTRUM ZDRAVIA R.B.K., s.r.o. Bardejov	Bardejov
Slovakia	I. neurologicka klinika LF UK a UNB	Bratislava
Slovakia	Psychiatricka klinika LF UK a UNB	Bratislava
Slovakia	Neurologicka klinika UPJS LF a UNLP	Kosice
Slovakia	Crystal Comfort s.r.o.	Vranov nad Toplou
Slovenia	UKC Ljubljana, Department of Neurology	Ljubljana
Slovenia	UKC Maribor - neurology	Maribor
South Africa	IATROS International	Bloemfontein	Free State
South Africa	ACF Neurological service	Cape Town	Western Cape
South Africa	Cape Trial Centre	Cape Town	Western Cape
South Africa	Flexivest Fourteen Research Centre	Cape Town	Western Cape
South Africa	Excellentis Clinical Trial Consultants	George	Eastern Cape
South Africa	Dr Stanley Lipschitz Clinic Inc	Johannesburg	Gauteng
South Africa	Denmar Psychiatric Hospital	Pretoria	Gauteng
Spain	Fundación ACE	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Fundación CITA	Donostia
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Quirón	Pozuelo de Alarcon
Spain	Hospital Universitari General de Catalunya	Sant Cugat del Vallès
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Universitario Doctor Peset	Valencia
Sweden	Minnesmottagning specialiserad Malmö	Malmö
Sweden	Karolinska Universitetssjukhuset, Huddinge	Stockholm
Sweden	Geriatriskt centrum, Umeå	Umeå
Switzerland	Spitalzentrum Biel	Biel-Bienne
Switzerland	Centre de la Mémoire	Genève
Switzerland	Centre Leenaards de la mémoire CHUV	Lausanne
Switzerland	Klinik für Neurologie Kantonsspital St.Gallen	St. Gallen
Turkey	Hacettepe University Medical Faculty Hospital	Altindag/Ankara
Turkey	Eskisehir Osmangazi University Saglik Uygulama ve Arastirma	Eskisehir
Turkey	Istanbul University Medical Faculty Neurology Department	Istanbul
Turkey	Izmir Economics University Medical Point Hospital Neurology D	Izmir
Turkey	Ondokuz Mayis University Saglik Uygulama ve Arastirma Merkez	Samsun
Ukraine	Chebotarev State Institute of Gerontology of the NAMS of Ukr	Kyiv
United Kingdom	Royal Cornhill Hospital	Aberdeen
United Kingdom	RICE - The Research Institute for the Care of Older People	Bath
United Kingdom	Dementia Research Unit,	Crowborough
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Fritchie Centre	Gloucestershire
United Kingdom	Imperial College London	London
United Kingdom	St George's Hospital	London
United Kingdom	St Pancras Clinical Research	London
United Kingdom	Greater Manchester Mental Health NHS Foundation Trust	Manchester
United Kingdom	Glasgow Memory Clinic	Motherwell
United Kingdom	Newcastle University	Newcastle Upon Tyne
United Kingdom	Warneford Hospital	Oxford
United Kingdom	Moorgreen Hospital	Southampton
United Kingdom	Kings Hill Research Centre	Swindon
United States	Advanced Research Center, Inc.	Anaheim	California
United States	JEM Research Institute	Atlantis	Florida
United States	Visionary Investigators Network	Aventura	Florida
United States	Northern Light Eastern Maine Medical Center	Bangor	Maine
United States	Mountain Neurological Research Center, Inc.	Basalt	Colorado
United States	Insight Clinical Trials LLC	Beachwood	Ohio
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	Brain Matters Research	Delray Beach	Florida
United States	Denver Neurological Research	Denver	Colorado
United States	Mile High Research Center	Denver	Colorado
United States	Integrity Clinical Research, LLC	Doral	Florida
United States	Integrated Neurology Services	Falls Church	Virginia
United States	Neuropsychiatric Research Cent	Fort Myers	Florida
United States	Fullerton Neurology and Headache Center	Fullerton	California
United States	Center for Adv Res & Education	Gainesville	Georgia
United States	Finlay Medical Research Group	Greenacres City	Florida
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Indago Research & Health Center Inc.	Hialeah	Florida
United States	Hawaii Neuroscience, Memory Disorders Center	Honolulu	Hawaii
United States	Univ Of Texas Hlth Science Cntr	Houston	Texas
United States	The Clinical Trial Center	Jenkintown	Pennsylvania
United States	Genesis Neuroscience Clinic	Knoxville	Tennessee
United States	K2 The Villages	Lady Lake	Florida
United States	Neurological Assoc Long Island	Lake Success	New York
United States	University of Kentucky_Lexington_0	Lexington	Kentucky
United States	Torrance Clin Res Inst, Inc.	Lomita	California
United States	ASCLEPES Research Centers,	Long Beach	California
United States	UCLA_Los Angeles	Los Angeles	California
United States	K2 Medical Research, Maitland	Maitland	Florida
United States	AMC Research, LLC	Matthews	North Carolina
United States	Velocity Clinical Research	Meridian	Idaho
United States	Velocity Clinical Research, Meridian	Meridian	Idaho
United States	Hlth Cr Family Rehab & Res Ctr	Miami	Florida
United States	IMIC, Inc- Medical Research	Miami	Florida
United States	Novel Clinical Research Center, LLC	Miami	Florida
United States	Premier Clin Res Inst, Inc.	Miami	Florida
United States	Premier Clinical Research Institute, Inc.	Miami	Florida
United States	The Neurology Research Group	Miami	Florida
United States	Visionary Inv Ntwrk_Miami	Miami	Florida
United States	Patient First MD,clinical Trials	Middletown	New Jersey
United States	Aqualane Clinical Research	Naples	Florida
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Suncoast Clin Res Port Richey	New Port Richey	Florida
United States	Suncoast Clinical Research, Inc._New Port Richey	New Port Richey	Florida
United States	Combined Research Orlando Phase I-IV	Orlando	Florida
United States	Advanced Research Consultants, Inc.	Palm Beach Gardens	Florida
United States	Well Care Medical Center	Panorama City	California
United States	Cedars-Sinai Medical Center	Pasadena	California
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Coastal Neurology	Port Royal	South Carolina
United States	Summit Research Network Oregon Inc.	Portland	Oregon
United States	HealthPartners Center for Memory and Aging	Saint Paul	Minnesota
United States	Glenn Biggs Inst-Alzhm Neuro	San Antonio	Texas
United States	Pacific Research Network	San Diego	California
United States	Sharp Neurocog Res Ctr	San Diego	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Intercoastal Medical Group	Sarasota	Florida
United States	The Roskamp Institute, Inc.	Sarasota	Florida
United States	Imaging Endpoints	Scottsdale	Arizona
United States	Calfornia Neurosc Resrch Med	Sherman Oaks	California
United States	Southern California Research LLC	Simi Valley	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Shirzadi Shahin, MD	Sugar Land	Texas
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	Stedman Clinical Trials LLC	Tampa	Florida
United States	Advanced Memory Research Institute of NJ	Toms River	New Jersey
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	Central States Research, LLC	Tulsa	Oklahoma
United States	Palm Beach Neuro Premiere Res	West Palm Beach	Florida
United States	Conquest Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score	Score on scale (0 to 18); Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease: Cognitive domains: memory, orientation, and judgement and problem solving; Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains.; The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment.	From baseline (week 0) to week 104
Secondary	Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADL-MCI)	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
Secondary	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	Week(s)	From baseline (week 0) to week 104
Secondary	Change in the Alzheimer's Disease Composite Score (ADCOMS)	Score on scale (0 to 1.97) The ADCOMS is a composite clinical outcome comprising 4 items from the ADAS-Cog-13, 2 items from the MMSE and all 6 items from the CDR-SB.32 The total scores on the scale range from 0 to 1.97 with higher scores indicating greater impairment.	From baseline (week 0) to week 104
Secondary	Change in the Mini-Mental State Examination (MMSE) score	Score on scale (0 to 30) The MMSE measures orientation, attention, memory, language and visuo-spatial function. The total scores on the scale range from 0 to 30 with lower scores indicating greater impairment.	From baseline (week 0) to week 104
Secondary	Change in the 10-item Neuropsychiatric Inventory (NPI) score	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
Secondary	Time to progression in disease stage based on global CDR score	Week(s)	From baseline (week 0) to week 104
Secondary	Number of treatment emergent adverse events (TEAEs)	Number of events	From baseline (week 0) to week 104
Secondary	Change in high sensitivity C-reactive protein level	Ratio	From baseline (week 0) to week 104
Secondary	Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and all-cause death	Week(s)	From baseline (week 0) to week 104
Secondary	Time to first occurrence of stroke	Week(s	From baseline (week 0) to week 104
Secondary	Change in the EQ-5D-5L proxy score	Score The EQ-5D-5L descriptive system comprises mobility, self-care, usual activities, pain/discomfort and anxiety/depression with five response levels each (no problems, slight problems, moderate problems, severe problems, unable to /extreme problems). The EQ-5D-5L proxy version 1 (the study partner is asked to rate how he/she [the proxy] would rate the subject´s health) will be used in this trial.	From baseline (week 0) to week 104
Secondary	Extension phase: Change in the CDR-SB score	Score on scale (0 to 18); Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease: Cognitive domains: memory, orientation, and judgement and problem solving; Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains.; The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment.	From baseline (week 0) to week 156
Secondary	Change in the ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment ) score	Score on scale (0 to 53) An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment.	From baseline (week 0) to week 156
Secondary	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	Week(s)	From baseline (week 0) to week 156