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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04777409
Other study ID # NN6535-4725
Secondary ID U1111-1259-29202
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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 (central nervous system) disease confirmed by central read (e.g. cerebral large-vessel disease [large vessel (cortical) infarcts greater than10 mm in diameter], prior macro-haemorrhage [greater than1 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 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Semaglutide
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 KaRa Institute of Neurological Disease Pty Ltd Macquarie Park New South Wales
Australia HammondCare Malvern Victoria
Australia Alzheimer's Research Australia Nedlands Western Australia
Australia Australian Alzheimer's Research Foundation Incorporated Nedlands Western Australia
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
Austria Medizinische Universität Wien Wien
Belgium UZA - UZ Antwerpen - Department of Neurology Edegem
Belgium UZ Gent - Neurologie Gent
Belgium AZ Groeninge - Kortrijk - Neurologie Kortrijk
Belgium UZ Leuven - Geheugenkliniek Leuven
Belgium Clinique CHC MontLégia - Service Neurologie Liège
Brazil Hospital das Clínicas - Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais
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 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 MoCA Research Innovation Inc Greenfield-Park 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 Kawartha Centre Redefining Healthy Aging Peterborough Ontario
Canada CHU de Quebec-Universite Laval Québec Quebec
Canada Diex Recherche Sherbrooke Inc. Sherbrooke Quebec
Canada Centricity Research LMC Toronto Ontario
Canada Memory Program Toronto Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network Toronto Ontario
Canada Island Health (Research and Capacity Building) Victoria British Columbia
Canada Medical Arts Health Research Group West Vancouver British Columbia
China Baogang Hospital of Inner Mongolia-Neurology Baotou Inner Mongolia
China Beijing An Ding Hospital Capital Medical University Beijing Beijing
China Beijing Chao-Yang Hospital, Capital Medical University-Neuro Beijing Beijing
China Beijing Friendship Hospital, Capital Medical University-Neur Beijing Beijing
China Beijing Hospital-Neurology Beijing Beijing
China Beijing Huilongguan Hospital Beijing Beijing
China Beijing Tiantan Hospital, Capital Medical University Beijing Beijing
China Peking Union Medical College Hospital-Neurology Beijing Beijing
China Peking University Sixth Hospital Beijing Beijing
China Xuanwu Hospital Capital Medical University-Neurology Beijing Beijing
China The first Bethune Hospital of Jilin University, Neurology Changchun Jilin
China Xiangya Hospital Central South University-Neurology Changsha Hunan
China West China Hospital,Sichuan University-Mental health center Chengdu Sichuan
China The First Affiliated Hosp of Chongqing Medical Univer. Chongqing Chongqing
China Fujian Medical University Union Hospital-Neurology Fuzhou Fujian
China 2nd affiliated hospital of Guangzhou Medical University Guangzhou Guangdong
China Guangzhou First People's Hospital-Neurology Guangzhou Guangdong
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Neurol Guangzhou Guangdong
China The first Hospital of Zhejiang University-Neurology Hangzhou Zhejiang
China The Second Affiliated Hospital of Nanchang University-Neurol Nanchang Jiangxi
China Nanjing Brain Hospital Nanjing Jiangsu
China Nanjing Drum Tower Hospital-Neurology Nanjing Jiangsu
China Zhongda Hospital Southeast University-Neurology Nanjing Jiangsu
China Huashan Hospital Affiliated Fudan University Shanghai Shanghai
China Shanghai 6th People's Hosp. Affili. to SHJT Univer-Neurology Shanghai Shanghai
China Shanghai Dongfang Hospital Shanghai Shanghai
China General Hospital of Tianjin Medical University-Neurology Tianjin Tianjin
China Tianjin Huanhu Hospital Tianjin Tianjin
China Wuxi Mental Health Center Wuxi Jiangsu
China Qinghai Provincial People's Hospital-Geriatrics Xining Qinghai
China Northern Jiangsu People's Hospital-Neurology Yangzhou Jiangsu
China Henan Provincial People's Hospital-Neurology Zhengzhou Henan
Croatia KBC Zagreb, Klinika za neurologiju Zagreb
Croatia Poliklinika Bonifarm Zagreb
Croatia Poliklinika Solmed Zagreb Grad Zagreb
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 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 Köln Köln
Germany Universitätsklinikum Münster, Neurologie Münster
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 AHEPA General University Hospital Thessaloniki
Greece EUROMEDICA General Clinic of Thessaloniki,Neurology Dpt Thessaloniki
Hungary Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft. Budapest
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 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 AOU Careggi Firenze Firenze
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
Italy AOU Città della Salute e della Scienza di Torino Torino
Japan Iwaki Clinic_Psychosomatic medicine Anan, Tokushima
Japan Yachiyo Hospital Anjo-shi, Aichi
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
Netherlands Amphia Ziekenhuis Breda
Netherlands Brain Research Center Den Bosch
Netherlands Radboudumc Nijmegen
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 INSTYTUT ZDROWIA DR BOCZARSKA-JEDYNAKSp. z o.o. Sp. k. Oswiecim
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 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 SAHI SR "Sverdlovsk Regional Clinical Psychiatric Hospital" Ekaterinburg
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 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 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 NEURES, neurologicka ambulancia Krompachy
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 de la Santa Creu i Sant Pau Barcelona
Spain Hospital 12 de Octubre Madrid
Spain Hospital Quirón Pozuelo de Alarcon
Spain Hospital Universitari General de Catalunya Sant Cugat del Vallès
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
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Chang Gung Memorial Hospital - Kaoshiung Branch Kaohsiung City
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan City
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veteran General Hospital Taipei
Taiwan Chang Gung Memorial Hospital Linkou Taoyuan City
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 Medical Center 'Neiron' Kharkiv
Ukraine Odesa Regional Medical Center for Mental Health Odesa
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 Texas Diabetes & Endocrinology Austin Texas
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 Memory Clinic, Inc Bennington Vermont
United States NeuroScience Research Center, LLC Canton Ohio
United States New Hope Clinical Research Charlotte North Carolina
United States Nuvance Health, Associtd Neuro Danbury Connecticut
United States iResearch Atlanta, LLC Decatur Georgia
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 Integrated Neurology Services Falls Church Virginia
United States Neuropsychiatric Research Cent Fort Myers Florida
United States Finlay Medical Research Group Greenacres City Florida
United States Hattiesburg Clinic Hattiesburg Mississippi
United States Galiz Research Hialeah Florida
United States Indago Research & Health Center Inc. Hialeah Florida
United States Hawaii Neuroscience, Memory Disorders Center Honolulu Hawaii
United States Balyor College of Medicine Houston Texas
United States Univ Of Texas Hlth Science Cntr Houston Texas
United States Josephson Wallack Munshower Indianapolis Indiana
United States Mt. Olympus Medical Research Katy Texas
United States Booth Gardner Parkinson's Cre Kirkland Washington
United States Genesis Neuroscience Clinic Knoxville Tennessee
United States Neurological Assoc Long Island Lake Success New York
United States Cleveland Clinic_Lakewood Lakewood Ohio
United States Wr-Crcn, Llc Las Vegas Nevada
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 K2 Medical Research, Maitland Maitland Florida
United States Feinstein Institute for Medical Research Manhasset New York
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 Central Miami Medical Institute Miami Florida
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 Clinical Research, Inc._New Port Richey New Port Richey Florida
United States Research Center for Clinical Studies, Inc Norwalk Connecticut
United States K2 Medical Research - Winter Garden Ocoee 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 Neural Net Research, LLC Portland Oregon
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 Sharp Neurocog Res Ctr San Diego California
United States Syrentis Clinical Research Santa Ana California
United States Intercoastal Medical Group Sarasota Florida
United States Harborview Medical Center Seattle Washington
United States Calfornia Neurosc Resrch Med Sherman Oaks California
United States Richmond Behavioral Associates Staten Island New York
United States Brain Matters Resrch Kane Cntr Stuart Florida
United States Shirzadi Shahin, MD Sugar Land Texas
United States Palmetto Clinical Research Summerville South Carolina
United States Banner Sun Health Research Institute Sun City Arizona
United States SUNY Upstate Medical University_Syracuse Syracuse New York
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 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,  China,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  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-ADLMCI) 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 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 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score Score on scale (0 to 85) Measures the severity of cognitive impairment in various domains including memory, language, orientation, praxis and executive function. The total scores on the scale range from 0 to 85 with higher scores representing greater impairment. From baseline (week 0) to week 104
Secondary Change in the Montreal Cognitive Assessment (MoCA) score Score on scale (0 to 30) The assessment includes 8 domains of cognitive function with total scores ranging from 0 to 30 and lower scores indicating greater impairment. 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 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
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 allcause death Week(s) From baseline (week 0) to week 104
Secondary Time to first occurrence of stroke Weeks 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 Extension phase: Change in the ADCS-ADL-MCI score Score on scale (0 to 53) An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment. From baseline (week 0) to week 156
Secondary Extension phase: 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