Clinical trial NCT04777396: A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Early Alzheimer's Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-03-02
Enrollment: 1840
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.

Participants must have a study partner, who is willing to take part in the study.

Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score
timeFrame: From baseline (week 0) to week 104
Secondary outcomes:
measure: Main Phase: Change in the 24-item Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-ADL-MCI) score
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase:Change in the ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment ) score
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Time to progression to Clinical Dementia Rating (CDR) global score greater than or equal to (≥) 1.0 among patients with CDR global score equal to (=) 0.5 at baseline
timeFrame: From baseline (week 0) up to week 156
measure: Extension Phase: Time to progression to Clinical Dementia Rating (CDR) global score greater than or equal to (≥) 1.0 among patients with CDR global score equal to (=) 0.5 at baseline
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Change in the Montreal Cognitive Assessment (MoCA) score
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Change in the Montreal Cognitive Assessment (MoCA) score
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Change in the Alzheimer's Disease Composite Score (ADCOMS)
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Change in the Alzheimer's Disease Composite Score (ADCOMS)
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Change in the Mini-Mental State Examination (MMSE) score
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Change in the Mini-Mental State Examination (MMSE) score
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Time to progression in disease stage based on global CDR score
timeFrame: From baseline (week 0) up to week 156
measure: Extension Phase: Time to progression in disease stage based on global CDR score
timeFrame: From baseline (week 0) up to week 156
measure: Main Phase: Change in the composite Z-score based on the three outcome measures CDR-SB, ADCS-ADL-MCI, and ADAS-Cog-13
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Change in the composite Z-score based on the three outcome measures CDR-SB, ADCS-ADL-MCI, and ADAS-Cog-13
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Change in the 10-item Neuropsychiatric Inventory (NPI) score
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Change in the 10-item Neuropsychiatric Inventory (NPI) score
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Change in high sensitivity C-reactive protein level
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Change in high sensitivity C-reactive protein level
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) up to week 156
measure: Extension Phase: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) up to week 156
measure: Main Phase: Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and all-cause death
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and all-cause death
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Time to first occurrence of stroke
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Time to first occurrence of stroke
timeFrame: From baseline (week 0) to week 156
measure: Main Phase: Change in the EQ-5D-5L (proxy version) index score
timeFrame: From baseline (week 0) to week 104
measure: Extension Phase: Change in the EQ-5D-5L (proxy version) index score
timeFrame: From baseline (week 0) to week 156
measure: Extension phase: Change in the CDR-SB score
timeFrame: From baseline (week 0) to week 156
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Scottsdale
country: United States
facility: Imaging Endpoints
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Fullerton
country: United States
facility: Fullerton Neurology and Headache Center
state: California
city: Lemon Grove
country: United States
facility: Pacific Research Network
state: California
city: Lomita
country: United States
facility: Torrance Clin Res Inst, Inc.
state: California
city: Long Beach
country: United States
facility: ASCLEPES Research Centers,
state: California
city: Los Angeles
country: United States
facility: UCLA_Los Angeles
state: California
city: Panorama City
country: United States
facility: Well Care Medical Center
state: California
city: Pasadena
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Neurocog Res Ctr
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Calfornia Neurosc Resrch Med
state: California
city: Simi Valley
country: United States
facility: Southern California Research LLC
state: California
city: Basalt
country: United States
facility: Mountain Neurological Research Center, Inc.
state: Colorado
city: Denver
country: United States
facility: Denver Neurological Research
state: Colorado
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: Visionary Investigators Network
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Doral
country: United States
facility: Integrity Clinical Research, LLC
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Cent
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research Group
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center Inc.
state: Florida
city: Hialeah
country: United States
facility: Hlth Cr Family Rehab & Res Ctr
state: Florida
city: Lady Lake
country: United States
facility: K2 The Villages
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research, Maitland
state: Florida
city: Miami
country: United States
facility: Hlth Cr Family Rehab & Res Ctr
state: Florida
city: Miami
country: United States
facility: Premier Clin Res Inst, Inc.
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Novel Clinical Research Center, LLC
state: Florida
city: Miami
country: United States
facility: IMIC, Inc- Medical Research
state: Florida
city: Miami
country: United States
facility: The Neurology Research Group
state: Florida
city: Miami
country: United States
facility: Visionary Inv Ntwrk_Miami
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clin Res Port Richey
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc._New Port Richey
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Palm Beach Gardens
country: United States
facility: Advanced Research Consultants, Inc.
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Sarasota
country: United States
facility: The Roskamp Institute, Inc.
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials LLC
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neuro Premiere Res
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Gainesville
country: United States
facility: Center for Adv Res & Education
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Neuroscience, Memory Disorders Center
state: Hawaii
city: Meridian
country: United States
facility: Velocity Clinical Research, Meridian
state: Idaho
city: Meridian
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky_Lexington_0
state: Kentucky
city: Bangor
country: United States
facility: Northern Light Eastern Maine Medical Center
state: Maine
city: Saint Paul
country: United States
facility: HealthPartners Center for Memory and Aging
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Middletown
country: United States
facility: Patient First MD,clinical Trials
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ
state: New Jersey
city: Lake Success
country: United States
facility: Neurological Assoc Long Island
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Matthews
country: United States
facility: AMC Research, LLC
state: North Carolina
city: Beachwood
country: United States
facility: Insight Clinical Trials LLC
state: Ohio
city: Tulsa
country: United States
facility: Central States Research, LLC
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network Oregon Inc.
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center
state: Pennsylvania
city: Port Royal
country: United States
facility: Coastal Neurology
state: South Carolina
city: Knoxville
country: United States
facility: Genesis Neuroscience Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Houston
country: United States
facility: Univ Of Texas Hlth Science Cntr
state: Texas
city: San Antonio
country: United States
facility: Glenn Biggs Inst-Alzhm Neuro
state: Texas
city: Sugar Land
country: United States
facility: Shirzadi Shahin, MD
state: Texas
city: Falls Church
country: United States
facility: Integrated Neurology Services
state: Virginia
city: Ciudad de Buenos Aires
country: Argentina
facility: Instituto Medico Especializado_Capital Federal
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Metabolicas (IDIM)
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
city: Caba
country: Argentina
facility: Clínica Nuestra Señora de las Nieves
city: Caba
country: Argentina
facility: FLENI
city: Córdoba
country: Argentina
facility: Instituto Privado Kremer
city: Mendoza
country: Argentina
facility: Fundación Scherbovsky
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: Southern Neurology
state: New South Wales
city: Waratah
country: Australia
facility: Hunter New England Local Health District - Neuropsychiatry
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Ivanhoe
country: Australia
facility: Medical and Cognitive Research Unit - Austin Health
state: Victoria
city: Innsbruck
country: Austria
facility: LKH-Univ. Kliniken Innsbruck
city: Innsbruck
country: Austria
facility: Medizinische Univ. Innsbruck
city: Salzburg
country: Austria
facility: Univ. Klinik für Neurologie
city: Edegem
country: Belgium
facility: UZA - UZ Antwerpen - Department of Neurology
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Kortrijk - Neurologie
city: Brasília
country: Brazil
facility: L2 IP Instituto de Pesquisas Clinicas Ltda
state: Distrito Federal
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: Parana
city: Maringa
country: Brazil
facility: Clinica Clinilive Ltda
state: Parana
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica Ltda
state: Sao Paulo
city: São Paulo
country: Brazil
facility: BR Trials - Ensaios Clínicos e Consultoria Ltda.
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Assoc. Paulista para o Desenvolvimento da Medicina - UNIFESP
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Centro de Psiquiatria Sandra Rushel
city: Sofia
country: Bulgaria
facility: "MHATNP "Sv. Naum"" EAD
city: Sofia
country: Bulgaria
facility: DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan
city: Sofia
country: Bulgaria
facility: "UMHAT "Aleksandrovska", Neurology clinic
city: Sofia
country: Bulgaria
facility: MMA, MHAT-Sofia, Neurology clinic
city: Kelowna
country: Canada
facility: OCT Research ULC (dba Okanagan Clinical Trials)
state: British Columbia
city: Penticton
country: Canada
facility: Medical Arts Health Research Group_Kelowna
state: British Columbia
city: Victoria
country: Canada
facility: Island Health (Research and Capacity Building)
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research - Halifax
state: Nova Scotia
city: New Minas
country: Canada
facility: True North Clinical Research - New Minas
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Memory Clinic
state: Ontario
city: Ottowa
country: Canada
facility: Recherches Neuro-Hippocampe Inc
state: Ontario
city: Toronto
country: Canada
facility: Memory Program
state: Ontario
city: Toronto
country: Canada
facility: Centricity Research LMC
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: Douglas Hosp Res Ctr
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec-Universite Laval
state: Quebec
city: Brno-Lisen
country: Czechia
facility: Neuro Health Centrum s.r.o.
city: Olomouc
country: Czechia
facility: AGE Centrum
city: Praha 10
country: Czechia
facility: AD71 s.r.o.
city: Praha 6 Dejvice
country: Czechia
facility: Neuropsychiatrie
city: Rychnov nad Kneznou
country: Czechia
facility: Vestra Clinics s.r.o.
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: København Ø
country: Denmark
facility: Rigshospitalet - afsnit 8015
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital_Roskilde
city: Helsinki
country: Finland
facility: CRST Helsinki
city: Kuopio
country: Finland
facility: Aivotutkimusyksikkö
city: Turku
country: Finland
facility: CRST Turku
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
city: Bron
country: France
facility: Hospices Civils de Lyon-Hopital Pierre Wertheimer
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon-Hopital Le Bocage
city: Lille CEDEX
country: France
facility: Hôpital Roger Salengro
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille-Hopital de La Timone-1
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice-Institut Claude Pompidou
city: Paris
country: France
facility: Aphp-Hopital Lariboisiere-1
city: Paris
country: France
facility: Aphp-Hopital La Pitie Salpetriere-3
city: Reims cedex
country: France
facility: Centre Hospitalier Universitaire Reims-Hopital Maison Blanche
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-2
city: Strasbourg
country: France
facility: Les Hopitaux Universitaires de Strasbourg-Hopital de La Robertsau
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital La Grave
city: Villeurbanne
country: France
facility: Hospices Civils de Lyon-Hopital Des Charpennes
city: Bad Homburg
country: Germany
facility: Zentrum für klinische Forschung Dr. med. Irma Schöll GmbH
state: Hessen
city: Aachen
country: Germany
facility: Universitätsklinikum RWTH Aachen, Neurologie
city: Böblingen
country: Germany
facility: Studienzentrum Dr. Bischof GmbH
city: Erbach
country: Germany
facility: Neuro Centrum Science GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Psychiatrie
city: Köln
country: Germany
facility: Universitätsklinikum Köln - Klinik und Poliklinik für Psychiatrie und Psychotherapie
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Psychiatrie
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit - Psychiatrie und Psychotherapie
city: München
country: Germany
facility: LMU Klinikum - Institut für Schlaganfall- und Demenzforschung (ISD)
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Neurologie
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West
city: Athens
country: Greece
facility: Henry Dunant Hospital Center,2nd Neurological Department
city: Athens
country: Greece
facility: Aiginitio Hospital, 1st Neurology Clinic
city: Athens
country: Greece
facility: "Hygeia" General Hospital of Athens, Memory clinic
city: Athens
country: Greece
facility: Naval Hospital of Athens
city: Chaidari, Athens
country: Greece
facility: University General Hospital of Athens "Attiko"
city: Marousi
country: Greece
facility: Iatriko Athinon (Athens Medical Center),Memory Disorders Cli
city: Thessaloniki
country: Greece
facility: AHEPA General University Hospital
city: Thessaloniki
country: Greece
facility: EUROMEDICA General Clinic of Thessaloniki,Neurology Dpt
city: Budapest
country: Hungary
facility: Semmelweis Egyetem ÁOK
city: Debrecen
country: Hungary
facility: DE Kenézy Gyula Campus, Pszichiátriai és Pszichoterápiai Klinika
city: Debrecen
country: Hungary
facility: DE Gyógyszerfejlesztési Koordinációs Központ Pszichiátria
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Korhaz
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Gyöngyös
country: Hungary
facility: Bugát Pál Kórház
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Pécs
country: Hungary
facility: Psychotech Kft.
city: Zalaegerszeg
country: Hungary
facility: Belvárosi Egészségház Kft.
city: Cork
country: Ireland
facility: Mercy Hospital Cork
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: Mercer's Institute for Successful Aging
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Haifa
country: Israel
facility: The Stroke and Cognition Institute Rambam Medical Center
city: Petach Tikva
country: Israel
facility: Cognitive Neurology Clinic, Rabin Campus, Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Cognitive Neurology Sourasky Medical Center
city: Tel Hashomer, Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center, Heart Screening Clinic, 1st floor, Room 317
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti S.O.D
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Chieti
country: Italy
facility: Università degli studi Gabriele D'Annunzio Chieti-Pescara
city: Milano
country: Italy
facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele Milano
city: Monza
country: Italy
facility: ASST Monza e Brianza Ospedale San Gerardo
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Roma
country: Italy
facility: Pol. Uni. Campus Biomedico UOC Neurologia
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Policlinico Universitario A.Gemelli Servizio Neuropsicologia
city: Roma
country: Italy
facility: Fondazione Santa Lucia IRCCS
city: Anan, Tokushima
country: Japan
facility: Iwaki Clinic_Psychosomatic medicine
city: Anjo-shi, Aichi
country: Japan
facility: Yachiyo Hospital
city: Arakawa-ku,Tokyo
country: Japan
facility: Abe Clinic
city: Bunkyo-ku, Tokyo
country: Japan
facility: Memory Clinic Ochanomizu
city: Bunkyo-ku,Tokyo
country: Japan
facility: Tokyo Medical And Dental University Hospital
city: Chib-shi, Chiba
country: Japan
facility: Kashiwado Hospital
city: Chofu-shi,Tokyo
country: Japan
facility: Enomoto Internal Medicine Clinic
city: Fujioka-Shi, Gunma
country: Japan
facility: Shinozuka Hospital
city: Hachioji-shi, Tokyo
country: Japan
facility: P-one Clinic
city: Hamamatsu-shi, Shizuoka
country: Japan
facility: National Hospital Organization Tenryu Hospital
city: Himeji-city, Hyogo
country: Japan
facility: Hyogo Brain and Heart Center
city: Himeji-shi, Hyogo
country: Japan
facility: Tsukazaki Hospital
city: Himeji-shi, Hyogo
country: Japan
facility: Himeji Central Hospital Clinic
city: Hirakata-Shi,Osaka
country: Japan
facility: Hatsuta Neurology Clinic
city: Hiroshima-shi, Hiroshima
country: Japan
facility: Imon Yukari Neurology Clinic
city: Hiroshima-shi, Hiroshima
country: Japan
facility: Hikaru-kai Medical Corporation Hiroshima Neurology Clinic
city: Hofu-shi, Yamaguchi
country: Japan
facility: Nagamitsu Clinic
city: Ina-shi, Nagano
country: Japan
facility: Ina Central Hospital
city: Kanagawa
country: Japan
facility: Kawasaki Saiwai Clinic_Internal Medicine
city: Kawasaki-shi , Kanagawa
country: Japan
facility: Kishiro Mental Clinic
city: Kawasaki-shi, Kanagawa
country: Japan
facility: Koukan Clinic
city: Kawasaki-shi, Kanagawa
country: Japan
facility: Teikyo University Hospital, Mizonokuchi_Kawasaki-shi, Kanagawa
city: Kobe-shi, Hyogo
country: Japan
facility: Kobe University Hospital_Kobe-shi, Hyogo
city: Kodaira-shi, Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
city: Koriyama-shi, Fukushima
country: Japan
facility: Southern Tohoku Medical Clinic
city: Kurashiki-shi, Okayama
country: Japan
facility: Katayama Medical Clinic
city: Mitaka-shi,Tokyo
country: Japan
facility: Nozomi Memory Clinic
city: Nerima-ku, Tokyo
country: Japan
facility: Kikukawa clinic
city: Niigata-shi, Niigata
country: Japan
facility: General Rehabilitation Center · Midori Hospital
city: Obu-shi, Aichi
country: Japan
facility: National Center for Geriatrics and Gerontology
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Jichiidai Station Brain Clinic
city: Shinjuku-ku, Tokyo
country: Japan
facility: Keio University Hospital
city: Shizuoka-shi, Shizuoka
country: Japan
facility: Shizuoka City Shimizu Hospital_Neurology
city: Takamatsu-shi, Kagawa
country: Japan
facility: Kagawa Prefectural Central Hospital_Takamatsu-shi, Kagawa
city: Tokorozawa-shi,Saitama
country: Japan
facility: Saino Clinic
city: Tokushima-shi, Tokushima
country: Japan
facility: Itsuki Hospital
city: Tokyo
country: Japan
facility: Alzclinic Tokyo
city: Tokyo
country: Japan
facility: Tokyo Center Clinic
city: Tokyo
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
city: Tokyo
country: Japan
facility: Kurumi CLINIC
city: Tokyo
country: Japan
facility: Tokyo Medical Univ. Hospital
city: Toride-shi, Ibaraki
country: Japan
facility: Memory Clinic Toride
city: Toyonaka-shi, Osaka
country: Japan
facility: MI Clinic
city: Wako-shi, Saitama
country: Japan
facility: Medical Corporation Midorikai Wako Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang university seoul hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center_Seoul
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Saltillo
country: Mexico
facility: Hospital Universitario "Dr. Gonzalo Valdes Valdes"
state: Coahuila
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González_Monterrey
state: Nuevo León
city: Monterrey
country: Mexico
facility: Centro de Estudios Clínicos y Especialidades Médicas S.C.
state: Nuevo León
city: Monterrey
country: Mexico
facility: Avix Investigación Clínica, S.C.
state: Nuevo León
city: Culiacan
country: Mexico
facility: Hospital Angeles de Culiacan
state: Sinaloa
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Bosch
country: Netherlands
facility: Brain Research Center
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus - Hukommelsesklinikken
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF, Ullevål
city: Oslo
country: Norway
facility: Master Centre - Dummy
city: Kraków
country: Poland
facility: Linden sp. z o.o. sp. k.
state: Małopolskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Neuromed
city: Kielce
country: Poland
facility: Centrum Zdrowia Psychicznego Biomed
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie od. Neurologii
city: Kraków
country: Poland
facility: Centrum Neurologii Klinicznej
city: Lublin
country: Poland
facility: Nzoz Neuromed
city: Poznan
country: Poland
facility: NZOZ NEURO - KARD Ilkowski i Partnerzy Sp. Part. Lekarzy
city: Scinawa
country: Poland
facility: Osrodek Alzheimerowski Sp. z o.o.
city: Sopot
country: Poland
facility: Centrum Medyczne SENIOR
city: Warszawa
country: Poland
facility: Centrum Medyczne Neuro Protect
city: Wroclaw
country: Poland
facility: NZOZ Wrocławskie Centrum Alzheimerowskie
city: Senhora Da Hora, Matosinhos
country: Portugal
facility: Unidade Local De Saude De Matosinhos E.P.E.
state: Matosinhos
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Unidade Local de Saúde de Coimbra, E.P.E.
city: Guimarães
country: Portugal
facility: Unidade Local de Saude do Alto Ave, E.P.E.
city: Lisboa
country: Portugal
facility: Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo
city: Porto
country: Portugal
facility: Unidade Local de Saúde de Santo António, E.P.E
city: Torres Vedras
country: Portugal
facility: Campus Neurologico Senior
city: Bucharest
country: Romania
facility: Sana Monitoring SRL
city: Constanta
country: Romania
facility: Spitalul Clinic Cai Ferate Constanta
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
city: Sibiu
country: Romania
facility: Aria Clinic SRL
city: Ekaterinburg
country: Russian Federation
facility: Joint Stock Company "Medical technologies"
city: Krasnoyarsk
country: Russian Federation
facility: Federal Siberian Research Clinical Center under FMBA of Rus
city: Moscow
country: Russian Federation
facility: FSAEI 1st Moscow Federal Med University na Sechenov
city: Moscow
country: Russian Federation
facility: RMAPE
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University MoH
city: Omsk
country: Russian Federation
facility: Ezramed Clinic Llc
city: Rostov-on-Don
country: Russian Federation
facility: Research Center for Treatment and Rehabilitation "Phoenix"
city: Saint Petersburg
country: Russian Federation
facility: Psychiatric hospital of st. Nicholas the wonderworker
city: Saint Petersburg
country: Russian Federation
facility: N.-E. State Medical University n.a. Mechnikov
city: Saint Petersburg
country: Russian Federation
facility: S.M. Kirov Military Medical Academy,Depart.&Clinic Nerv Dis
city: Tomsk
country: Russian Federation
facility: Center of Clinica Trials "Nebbiolo"
city: Tomsk
country: Russian Federation
facility: LLC "Clinic Stolet"
city: Ufa
country: Russian Federation
facility: National medical holdiNational medical holding "Medstandard"
city: Belgrade
country: Serbia
facility: Neurology clinic, University Clinical Center of Serbia
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Disorders "Kovin"
city: Novi Sad
country: Serbia
facility: University clinical center of Vojvodina, Neurology clinic
city: Bardejov
country: Slovakia
facility: Psych. amb. CENTRUM ZDRAVIA R.B.K., s.r.o. Bardejov
city: Bratislava
country: Slovakia
facility: I. neurologicka klinika LF UK a UNB
city: Bratislava
country: Slovakia
facility: Psychiatricka klinika LF UK a UNB
city: Kosice
country: Slovakia
facility: Neurologicka klinika UPJS LF a UNLP
city: Vranov nad Toplou
country: Slovakia
facility: Crystal Comfort s.r.o.
city: Ljubljana
country: Slovenia
facility: UKC Ljubljana, Department of Neurology
city: Maribor
country: Slovenia
facility: UKC Maribor - neurology
city: George
country: South Africa
facility: Excellentis Clinical Trial Consultants
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: IATROS International
state: Free State
city: Johannesburg
country: South Africa
facility: Dr Stanley Lipschitz Clinic Inc
state: Gauteng
city: Pretoria
country: South Africa
facility: Denmar Psychiatric Hospital
state: Gauteng
city: Cape Town
country: South Africa
facility: ACF Neurological service
state: Western Cape
city: Cape Town
country: South Africa
facility: Flexivest Fourteen Research Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Cape Trial Centre
state: Western Cape
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Fundación ACE
city: Donostia
country: Spain
facility: Fundación CITA
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quirón
city: Sant Cugat del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Malmö
country: Sweden
facility: Minnesmottagning specialiserad Malmö
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Huddinge
city: Umeå
country: Sweden
facility: Geriatriskt centrum, Umeå
city: Biel-Bienne
country: Switzerland
facility: Spitalzentrum Biel
city: Genève
country: Switzerland
facility: Centre de la Mémoire
city: Lausanne
country: Switzerland
facility: Centre Leenaards de la mémoire CHUV
city: St. Gallen
country: Switzerland
facility: Klinik für Neurologie Kantonsspital St.Gallen
city: Altindag/Ankara
country: Turkey
facility: Hacettepe University Medical Faculty Hospital
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma
city: Istanbul
country: Turkey
facility: Istanbul University Medical Faculty Neurology Department
city: Izmir
country: Turkey
facility: Izmir Economics University Medical Point Hospital Neurology D
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Saglik Uygulama ve Arastirma Merkez
city: Kyiv
country: Ukraine
facility: Chebotarev State Institute of Gerontology of the NAMS of Ukr
city: Cheltenham
country: United Kingdom
facility: Fritchie Centre
state: Gloucestershire
city: Aberdeen
country: United Kingdom
facility: Royal Cornhill Hospital
city: Bath
country: United Kingdom
facility: RICE - The Research Institute for the Care of Older People
city: Crowborough
country: United Kingdom
facility: Dementia Research Unit,
city: Crowborough
country: United Kingdom
facility: Dementia Research Unit
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: St Pancras Clinical Research
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Imperial College London - Imperial College Memory Research Centre
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
city: Motherwell
country: United Kingdom
facility: NeuroClin
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle University
city: Oxford
country: United Kingdom
facility: Warneford Hospital
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
city: Swindon
country: United Kingdom
facility: Kings Hill Research Centre
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (Dept. 2834)
role: STUDY_DIRECTOR
References: