A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

NCT ID: NCT03114657

Last Updated: 2020-07-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

806 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-29

Study Completion Date

2019-06-11

Brief Summary

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This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Crenezumab

Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.

Group Type EXPERIMENTAL

Crenezumab

Intervention Type DRUG

Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Interventions

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Crenezumab

Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Intervention Type DRUG

Placebo

Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Weight between 40 and 120 kilograms (Kg) inclusive
* Availability of a person (referred to as the "caregiver") who in the investigator's judgment:
* Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities
* Fluency in the language of the tests used at the study site
* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
* Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid(1-42) test system or amyloid PET scan by qualitative read by the core/central PET laboratory
* Demonstrated abnormal memory function at screening (up to 4 weeks before screening begins) or screening (FCSRT cueing index =\<0.67 AND free recall =\<27)
* Screening mini mental state examination (MMSE) score of greater than or equal to (\>=) 22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0
* Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment (MCI)
* If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening
* Participant must have completed at least 6 years of formal education after the age of 5 years

Exclusion Criteria

* Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
* History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
* At risk of suicide in the opinion of the investigator
* Any abnormal MRI findings, such as presence of cerebral vascular pathology, cortical stroke, etc or inability to tolerate MRI procedures or contraindication to MRI
* Unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney or liver disease
* Uncontrolled hypertension
* Screening hemoglobin A1c (HbA1C) \>8%
* Poor peripheral venous access
* History of cancer except:

If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy

\- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Imaging End Points Clinical Research

Scottsdale, Arizona, United States

Site Status

Health Initiatives Research, PLLC

Fayetteville, Arkansas, United States

Site Status

Clinical Trials Inc.

Little Rock, Arkansas, United States

Site Status

Neuro-Therapeutics Inc.

Pasadena, California, United States

Site Status

Desert Valley Medical Group

Rancho Mirage, California, United States

Site Status

Anderson Clinical Research, Inc.

Redlands, California, United States

Site Status

University of California, Davis; Alzheimers Disease Center, Department of Neurology

Sacramento, California, United States

Site Status

UCSF - Memory and Aging Center

San Francisco, California, United States

Site Status

MCB Clinical Research Centers

Colorado Springs, Colorado, United States

Site Status

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, United States

Site Status

KI Health Partners, LLC; New England Institute for Clinical Research

Stamford, Connecticut, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

JEM Research LLC

Atlantis, Florida, United States

Site Status

Bradenton Research Center

Bradenton, Florida, United States

Site Status

Neuropsychiatric Research; Center of Southwest Florida

Fort Myers, Florida, United States

Site Status

Alzheimer's Research and Treatment Center

Lake Worth, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Bioclinica Research

Orlando, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Columbus Memory Center

Columbus, Georgia, United States

Site Status

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, United States

Site Status

Alzheimers Disease Center; Neurology

Winchester, Massachusetts, United States

Site Status

Health Partners Institute for Education and Research

Saint Paul, Minnesota, United States

Site Status

Precise Research Centers

Flowood, Mississippi, United States

Site Status

University of Nebraska Medical Center; Dept of Neurological Sciences

Omaha, Nebraska, United States

Site Status

Cleveland Clinic Lou Ruvo; Center for Brain Research

Las Vegas, Nevada, United States

Site Status

The Cognitive and Research Center of New Jersey

Summit, New Jersey, United States

Site Status

Advanced Memory Research Institute of NJ

Toms River, New Jersey, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Burke Rehabilitation Hospital

White Plains, New York, United States

Site Status

Behavioral Health Research

Charlotte, North Carolina, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, United States

Site Status

Ohio State University; College of Medicine

Columbus, Ohio, United States

Site Status

Dayton Center for Neuro Disorders

Dayton, Ohio, United States

Site Status

Summit Research Network Inc.

Portland, Oregon, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Northeastern Pennsylvania Memory

Plains, Pennsylvania, United States

Site Status

Abington Neurological Associates

Willow Grove, Pennsylvania, United States

Site Status

Neurology Clinic PC

Cordova, Tennessee, United States

Site Status

Senior Adults Specialty Research

Austin, Texas, United States

Site Status

Gadolin Research, LLC

Beaumont, Texas, United States

Site Status

Texas Neurology PA

Dallas, Texas, United States

Site Status

Kerwin Research Center, LLC

Dallas, Texas, United States

Site Status

Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

Houston, Texas, United States

Site Status

Clinical Trials of Texas, Inc

San Antonio, Texas, United States

Site Status

Sentara Medical Group

Norfolk, Virginia, United States

Site Status

National Clinical Research Inc.-Richmond

Richmond, Virginia, United States

Site Status

Hospital Italiano

Buenos Aires, , Argentina

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Universidad Maimonides

Caba, , Argentina

Site Status

DAMIC

Córdoba, , Argentina

Site Status

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status

Central Coast Neurosciences Research

Erina, New South Wales, Australia

Site Status

Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care

Hornsby, New South Wales, Australia

Site Status

The Queen Elizabeth Hospital; Neurology

Woodville, South Australia, Australia

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AZ Sint Jan

Bruges, , Belgium

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AZ Groeninge

Kortrijk, , Belgium

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UZ Leuven Gasthuisberg

Leuven, , Belgium

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CCBR - Brasilia

Brasília, Federal District, Brazil

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Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais, Brazil

Site Status

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Site Status

Centro Psiquiatria Sandra Ruschel Ltda

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

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Clínica Dr. Norton Sayeg LTDA - EPP

São Paulo, São Paulo, Brazil

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OCT Research ULC

Kelowna, British Columbia, Canada

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Vancouver Island Health Authority

Victoria, British Columbia, Canada

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True North Clinical Research-Halifax

Halifax, Nova Scotia, Canada

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True North Clinical Research Kentville

Kentville, Nova Scotia, Canada

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Providence Care; Mental Health Services

Kingston, Ontario, Canada

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Parkwood Hospital; Geriatric Medicine

London, Ontario, Canada

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Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, Canada

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The Centre for Memory and Aging

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

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Devonshire Clinical Research Inc.

Woodstock, Ontario, Canada

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Clinique Neuro Rive-Sud

Greenfield Park, Quebec, Canada

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ALPHA Recherche Clinique

Québec, , Canada

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Beijing Union Hospital

Beijing, , China

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Tianjin Medical University General Hospital

Tianjin (天津), , China

Site Status

Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

Aarhus N, , Denmark

Site Status

Rigshospitalet, Hukommelsesklinikken

København Ø, , Denmark

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Laane-Tallinna Keskhaigla

Tallinn, , Estonia

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Hopital Pellegrin; Cmrr Aquitaine

Bordeaux, , France

Site Status

Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie

Colmar, , France

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Hopital Roger Salengro; Service de Neurologie

Lille, , France

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CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

Limoges, , France

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Hopital Broca

Paris, , France

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CH Pitie Salpetriere; IM2A

Paris, , France

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Hôpital Maison Blanche

Reims, , France

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CHU Rennes - Hopital Pontchaillou

Rennes, , France

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CHU de Rouen Hopital; Service de Neurologie

Rouen, , France

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Hop Guillaume Et Rene Laennec; Cmrr St Herblain

Saint-Herblain, , France

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Hopital des Charpennes

Villeurbanne, , France

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ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

Berlin, , Germany

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Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik

Frankfurt, , Germany

Site Status

Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie

Freiburg im Breisgau, , Germany

Site Status

Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

Homburg/Saar, , Germany

Site Status

PANAKEIA - Arzneimittelforschung Leipzig GmbH

Leipzig, , Germany

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Pharmakologisches Studienzentrum

Mittweida, , Germany

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Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

München, , Germany

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Rambam Medical Center

Haifa, , Israel

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Sheba Medical Center; Psychiatry Department

Ramat Gan, , Israel

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Tel Aviv Sourasky Medical Center; Department of Neurology

Tel Aviv, , Israel

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Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

Rome, Lazio, Italy

Site Status

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, Italy

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Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

Rome, Lazio, Italy

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IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

Brescia, Lombardy, Italy

Site Status

Irccs Multimedica Santa Maria; Unita' Di Neurologia

Castellanza, Lombardy, Italy

Site Status

IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

Milan, Lombardy, Italy

Site Status

Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia

Milan, Lombardy, Italy

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Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa

Milan, Lombardy, Italy

Site Status

Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer

Passirana, Lombardy, Italy

Site Status

IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

Pozzilli, Molise, Italy

Site Status

AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria

Turin, Piedmont, Italy

Site Status

A.O. Universitaria Pisana; Neurologia

Pisa, Tuscany, Italy

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National Center for Geriatrics and Gerontology

Aichi, , Japan

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Inage Neurology and Memory Clinic

Chiba, , Japan

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Fukuoka Mirai Hospital

Fukuoka, , Japan

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National Hospital Organization Hiroshima-Nishi Medical Center

Hiroshima, , Japan

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Tsukazaki Hospital

Hyōgo, , Japan

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Kagawa Prefectural Central Hospital

Kagawa, , Japan

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Fujisawa City Hospital

Kanagawa, , Japan

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National Hospital Organization Sagamihara National Hospital

Kanagawa, , Japan

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Ijinkai Takeda General Hospital

Kyoto, , Japan

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Rakuwakai Otowarehabilitation Hospital

Kyoto, , Japan

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National Hospital Organization Matsumoto Medical Center

Nagano, , Japan

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Iwate Medical University Hospital

Numakunai, , Japan

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Katayama Medical Clinic

Okayama, , Japan

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Osaka University Hospital

Osaka, , Japan

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Asakayama General Hospital

Osaka, , Japan

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NHO Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, , Japan

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Kanto Central Hospital

Tokyo, , Japan

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Tokyo Medical University Hospital

Tokyo, , Japan

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Shinjuku Research Park Clinic

Tokyo, , Japan

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Tokyo Metropolitan Geriatric Hospital

Tokyo, , Japan

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National Center of Neurology and Psychiatry

Tokyo, , Japan

Site Status

Tokyo Medical University Hachioji Medical Center

Tokyo, , Japan

Site Status

Akershus universitetssykehus HF; Nevroklinikken S203

Lørenskog, , Norway

Site Status

Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken

Oslo, , Norway

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Clinica Internacional; Unidad De Investigacion

Lima, , Peru

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Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

Lima, , Peru

Site Status

NZOZ Dom Sue Ryder

Bydgoszcz, , Poland

Site Status

Centrum Medyczne Euromedis Sp. z o.o.

Szczecin, , Poland

Site Status

Centrum Medyczne NeuroProtect

Warsaw, , Poland

Site Status

NZOZ WCA

Wroclaw, , Poland

Site Status

Hospital de Braga; Servico de Neurologia

Braga, , Portugal

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HUC; Servico de Neurologia

Coimbra, , Portugal

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Hospital Pedro Hispano; Servico de Neurologia

Matosinhos Municipality, , Portugal

Site Status

Hospital Geral de Santo Antonio; Servico de Neurologia

Porto, , Portugal

Site Status

LLC Baltic Medicine

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita

Yekaterinburg, Sverdlovsk Oblast, Russia

Site Status

State Autonomous Healthcare Institution "Republican Clinical Neurological Center

Kazan', , Russia

Site Status

State autonomous institution of healthcare Inter-regional clinical and diagnostic center

Kazan', , Russia

Site Status

Institution of RAMS (Mental Health Research Center of RAMS)

Moscow, , Russia

Site Status

City Clinical Psychiatry Hospital #1

Nizhny Novgorod, , Russia

Site Status

St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy

Saint Petersburg, , Russia

Site Status

Nebbiolo Center for Clinical Trials

Tomsk, , Russia

Site Status

Clinic for Mental disorders Dr Laza Lazarevic

Belgrade, , Serbia

Site Status

Neurology clinic, Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Clinic for neurology, Clinical Center Kragujevac

Kragujevac, , Serbia

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Private Practice; the Osteoporosis Clinic

Johannesburg, , South Africa

Site Status

Dong-A University Hospital

Busan, , South Korea

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Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Hanyang University Seoul Hospital

Seoul, , South Korea

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Konkuk University Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

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Seoul St Mary's Hospital

Seoul, , South Korea

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Borame Medical Center

Seoul, , South Korea

Site Status

Hospital General Universitario de Elche; Servicio de Neurología

Elche, Alicante, Spain

Site Status

Fundació ACE

BArcelon, Barcelona, Spain

Site Status

Hospital General De Catalunya; Servicio de Neurologia

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Hospital Mutua De Terrasa; Servicio de Neurologia

Terrassa, Barcelona, Spain

Site Status

Hospital Virgen del Puerto. Servicio de Neurología

Plasencia, Caceres, Spain

Site Status

Hospital Universitario Marques de Valdecilla; Servicio de Neurología

Santander, Cantabria, Spain

Site Status

Hospital la Magdalena; Servicio de Neurologia

Castellon, Castellon, Spain

Site Status

Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies

Salt, Girona, Spain

Site Status

Policlínica Guipuzkoa; Servicio de Neurología

Donosti-San Sebastián, Guipuzcoa, Spain

Site Status

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia

Santiago de Compostela, LA Coruña, Spain

Site Status

Hospital San Pedro; Servicio de Neurología

Logroño, La Rioja, Spain

Site Status

Hospital Quiron de Madrid; Servicio de Neurologia

Pozuelo de Alarcón, Madrid, Spain

Site Status

Clinica Universitaria de Navarra; Servicio de Neurología

Pamplona, Navarre, Spain

Site Status

CAE Oroitu

Barakaldo, Vizcaya, Spain

Site Status

Hospital Perpetuo Socorro, Servicio de Geriatria

Albacete, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

Barcelona, , Spain

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Hospital Universitario de Burgos. Servicio de Neurología

Burgos, , Spain

Site Status

Hospital Universitario Reina Sofia; Servicio de Neurologia

Córdoba, , Spain

Site Status

Hospital Ramon y Cajal; Servicio de Neurologia

Madrid, , Spain

Site Status

Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla

Salamanca, , Spain

Site Status

Hospital Universitario Virgen Macarena; Servicio de Neurologia

Seville, , Spain

Site Status

Skånes Universitetssjukhus Malmö, Minneskliniken

Malmo, , Sweden

Site Status

Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

Mölndal, , Sweden

Site Status

Changhua Christian Hospital; Neurology

Changhua County, , Taiwan

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Kaohsiung Medical University Hospital; Neurology

Kaohsiung City, , Taiwan

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Taipei Medical University - Shuang Ho Hospital - Neurology

New Taipei City, , Taiwan

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National Taiwan University Hospital; Neurology

Taipei, , Taiwan

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Chang Gung Memorial Foundation - Linkou - Neurology

Taoyuan District, , Taiwan

Site Status

Hacettepe University Medical Faculty; Neurology

Ankara, , Turkey (Türkiye)

Site Status

Istanbul University Istanbul School of Medicine; Neurology

Istanbul, , Turkey (Türkiye)

Site Status

Ondokuz Mayis Univ. Med. Fac.; Neurology

Samsun, , Turkey (Türkiye)

Site Status

The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre

Cheltenham, , United Kingdom

Site Status

Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

Chertsey, , United Kingdom

Site Status

Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

Crowborough, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital

Edinburgh, , United Kingdom

Site Status

Queen Elizabeth University Hospital; Clinical Research Facility

Glasgow, , United Kingdom

Site Status

RE:Cognition Health

London, , United Kingdom

Site Status

Charing Cross Hospital; Imperial Memory Unit, Level 10 West

London, , United Kingdom

Site Status

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

University Southampton NHS Foundation Trust; Wessex Neurologica Centre

Southampton, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada China Denmark Estonia France Germany Israel Italy Japan Norway Peru Poland Portugal Russia Serbia South Africa South Korea Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

References

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Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.

Reference Type DERIVED
PMID: 40603145 (View on PubMed)

Teng E, Manser PT, Shah M, Pickthorn K, Hu N, Djakovic S, Swendsen H, Blendstrup M, Faccin G, Ostrowitzki S, Sink KM. The Use of Episodic Memory Tests for Screening in Clinical Trials for Early Alzheimer's Disease: A Comparison of the Free and Cued Selective Reminding Test (FCSRT) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). J Prev Alzheimers Dis. 2023;10(1):41-49. doi: 10.14283/jpad.2022.101.

Reference Type DERIVED
PMID: 36641609 (View on PubMed)

Ostrowitzki S, Bittner T, Sink KM, Mackey H, Rabe C, Honig LS, Cassetta E, Woodward M, Boada M, van Dyck CH, Grimmer T, Selkoe DJ, Schneider A, Blondeau K, Hu N, Quartino A, Clayton D, Dolton M, Dang Y, Ostaszewski B, Sanabria-Bohorquez SM, Rabbia M, Toth B, Eichenlaub U, Smith J, Honigberg LA, Doody RS. Evaluating the Safety and Efficacy of Crenezumab vs Placebo in Adults With Early Alzheimer Disease: Two Phase 3 Randomized Placebo-Controlled Trials. JAMA Neurol. 2022 Nov 1;79(11):1113-1121. doi: 10.1001/jamaneurol.2022.2909.

Reference Type DERIVED
PMID: 36121669 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-003288-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BN29553

Identifier Type: -

Identifier Source: org_study_id

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