A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

NCT ID: NCT04374253

Last Updated: 2024-05-08

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

1382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2023-03-06

Brief Summary

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This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

Detailed Description

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Participants who were in the active arm in the double blind part and those who have completed OLE part in the parent study, will continue receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W). Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme as in the parent study before receiving target dose of open label gantenerumab.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Participants, who completed the double-blind part and did not enter the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the Week 116 visit of Study WN29922 or WN39658. This will be considered the OLE baseline visit (OLE Day 1).

Group Type EXPERIMENTAL

Gantenerumab

Intervention Type DRUG

Group 1 participants who were in the active arm in the double blind part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W. Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme before receiving target dose of open label gantenerumab, 510 mg SC, Q2W.

Group 2

Participants, who completed the double-blind part and the OLE part of Study WN29922 or WN39658, will be enrolled and receive open-label gantenerumab approximately 2 weeks after the OLE Week 34 visit or the final dose visit in the Study WN29922 or WN39658 OLE.

Group Type EXPERIMENTAL

Gantenerumab

Intervention Type DRUG

Group 2 participants who have completed OLE part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W

Interventions

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Gantenerumab

Group 1 participants who were in the active arm in the double blind part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W. Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme before receiving target dose of open label gantenerumab, 510 mg SC, Q2W.

Intervention Type DRUG

Gantenerumab

Group 2 participants who have completed OLE part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg SC, Q2W

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
* The participant should be capable of completing assessments either alone or with the help of the caregiver
* Availability of a person (referred to as the "caregiver")
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of \<1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
* Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug

Exclusion Criteria

* Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
* Prematurely discontinued from Study WN29922 or WN39658
* Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
* Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
* Evidence of disseminated leptomeningeal hemosiderosis
* Evidence of intracerebral macrohemorrhage
* Use of prohibited medication
* Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part
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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Banner Alzheimer?s Institute

Phoenix, Arizona, United States

Site Status

Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Banner Sun Health Research Insitute

Sun City, Arizona, United States

Site Status

Health Initiatives Research, PLLC

Fayetteville, Arkansas, United States

Site Status

Fullerton Neurology and Headache Center

Fullerton, California, United States

Site Status

Neurology Center of North Orange County

Fullerton, California, United States

Site Status

Irvine Center for Clinical Research

Irvine, California, United States

Site Status

Desert Valley Research

Redlands, California, United States

Site Status

Sutter Medical Group, Neurology

Sacramento, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, United States

Site Status

Southern California Research LLC

Simi Valley, California, United States

Site Status

Yale University School Of Medicine

New Haven, Connecticut, United States

Site Status

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, United States

Site Status

Georgetown University Medical Center

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

Site Status

JEM Research LLC

Atlantis, Florida, United States

Site Status

Accel Research Sites - CRU Tampa

Bradenton, Florida, United States

Site Status

Bradenton Research Center

Bradenton, Florida, United States

Site Status

Brain Matters Research, Inc.

Delray Beach, Florida, United States

Site Status

ClinCloud, LLC

Maitland, Florida, United States

Site Status

Optimus U Corp

Miami, Florida, United States

Site Status

Allied Biomedical Research Institute, Inc

Miami, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Intercoastal Medical Group

Sarasota, Florida, United States

Site Status

Infinity Clinical Research, LLC

Sunrise, Florida, United States

Site Status

Axiom Clinical Research of Florida

Tampa, Florida, United States

Site Status

Alzheimer?s Research and Treatment Center

Wellington, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Center for Advanced Research & Education

Gainesville, Georgia, United States

Site Status

Southern Illinois University, School of Medicine

Springfield, Illinois, United States

Site Status

American Health Network Institute, LLC

Avon, Indiana, United States

Site Status

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Site Status

Via Christi Research

Wichita, Kansas, United States

Site Status

Brigham and Womens Hospital; Center for Alzheimer Research & Treatment

Boston, Massachusetts, United States

Site Status

Boston Center for Memory

Newton, Massachusetts, United States

Site Status

Precise Research Centers

Flowood, Mississippi, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Missouri Memory Center

Bolivar, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, 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

Springfield, New Jersey, United States

Site Status

Advanced Memory Research Institute of NJ

Toms River, New Jersey, United States

Site Status

Neurological Associates of Long Island, PC

Lake Success, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

AD-CARE, University of Rochester Medical Center

Rochester, New York, United States

Site Status

Richmond Behavioral Associates

Staten Island, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Behavioral Health Research

Charlotte, North Carolina, United States

Site Status

Alzheimer's Memory Center

Matthews, North Carolina, United States

Site Status

Raleigh Neurology Associates

Raleigh, North Carolina, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute

Cleveland, Ohio, United States

Site Status

Ohio State University; College of Medicine

Columbus, Ohio, United States

Site Status

Summit Research Network Inc.

Portland, Oregon, United States

Site Status

Abington Neurological Associates

Abington, Pennsylvania, United States

Site Status

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, United States

Site Status

Senior Adults Specialty Research

Austin, Texas, United States

Site Status

Kerwin Medical Center

Dallas, Texas, United States

Site Status

Neurology Consultants of Dallas; Research Department

Dallas, Texas, United States

Site Status

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

Houston, Texas, United States

Site Status

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Sentara Neurology Specialists

Norfolk, Virginia, United States

Site Status

National Clinical Research Inc.-Richmond

Richmond, Virginia, United States

Site Status

UW Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Hospital Italiano

CABA, , Argentina

Site Status

Universidad Maimonides

Caba, , Argentina

Site Status

Instituto Geriatrico Nuestra Señora de las Nieves

Capital Federal, , Argentina

Site Status

Instituto Kremer

Córdoba, , Argentina

Site Status

CEN Centro Especializado en Neurociencias

Córdoba, , Argentina

Site Status

Instituto de Neurociencias San Agustín S.A.

La Plata, , Argentina

Site Status

Fundación Scherbovsky; General Department

Mendoza, , Argentina

Site Status

St Vincent's Hospital Sydney; Neurology

Darlinghurst, New South Wales, Australia

Site Status

Central Coast Neurosciences Research

Erina, New South Wales, Australia

Site Status

Southern Neurology

Kogarah, New South Wales, Australia

Site Status

The Queen Elizabeth Hospital; Neurology

Woodville, South Australia, Australia

Site Status

Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

Heidelberg West, Victoria, Australia

Site Status

Australian Alzheimer's Research Foundation

Nedlands, Western Australia, Australia

Site Status

AZ Sint Blasius (Dendermonde)

Dendermonde, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

Jessa Zkh (Campus Virga Jesse)

Hasselt, , Belgium

Site Status

Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia

Curitiba, Paraná, Brazil

Site Status

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Site Status

Clinica Clinilive ltda

Maringá, Paraná, Brazil

Site Status

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital das Clinicas - FMUSP_X; Neurologia

São Paulo, São Paulo, Brazil

Site Status

The Medical Arts Health Research Group - West Vancouver

Vancouver, British Columbia, Canada

Site Status

Parkwood Hospital; Geriatric Medicine

London, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Baycrest Health Sciences

Toronto, Ontario, Canada

Site Status

Devonshire Clinical Research

Woodstock, Ontario, Canada

Site Status

Center for Diagnosis and Research on Alzheimer's disease

Greenfield Park, Quebec, Canada

Site Status

Alpha Recherche Clinique

Québec, , Canada

Site Status

Psicomed Estudios Médicos

Antofagasta, , Chile

Site Status

Biomedica Research Group

Santiago, , Chile

Site Status

Especialidades Medicas LYS

Santiago, , Chile

Site Status

Beijing Tian Tan Hospital,Capital Medical University

Beijing, , China

Site Status

Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken

Aarhus N, , Denmark

Site Status

Rigshospitalet, Hukommelsesklinikken

København Ø, , Denmark

Site Status

Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn

Svendborg, , Denmark

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Terveystalo Ruoholahti

Helsinki, , Finland

Site Status

Itä-Suomen yliopisto, Kuopion kampus

Kuopio, , Finland

Site Status

CHU Amiens Hopital Sud; Neurologie

Amiens Cedex1, , France

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Hôpital Avicenne; Centre de Recherche Clinique

Bobigny, , France

Site Status

Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

Bron, , France

Site Status

CHU de la Timone - Hopital d Adultes; Service de Neurologie

Marseille, , France

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Hôpital Lariboisière

Paris, , France

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CHU Poitiers - Hopital La Miletrie

Poitiers, , France

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CHU Strasbourg Hôpital Hautepierre

Strasbourg, , France

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Gerontopole; Centre de Recherche clinique

Toulouse, , France

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Hopital des Charpennes

Villeurbanne, , France

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Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

Berlin, , Germany

Site Status

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

Berlin, , Germany

Site Status

Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie

Cologne, , Germany

Site Status

PANAKEIA - Arzneimittelforschung Leipzig GmbH

Leipzig, , Germany

Site Status

Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi

Mainz, , Germany

Site Status

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

München, , Germany

Site Status

Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

Münster, , Germany

Site Status

Universitätsklinikum Rostock Zentrum für Nervenheilkunde

Rostock, , Germany

Site Status

Universitätsklinikum Ulm; Klinik für Neurologie

Ulm, , Germany

Site Status

Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

Westerstede, , Germany

Site Status

Forschungszentrum Ruhr

Witten, , Germany

Site Status

Semmelweis University; Department of Neurology

Budapest, , Hungary

Site Status

Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze

Modena, Emilia-Romagna, Italy

Site Status

Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

Rome, Lazio, Italy

Site Status

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, Italy

Site Status

Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

Rome, Lazio, Italy

Site Status

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

Brescia, Lombardy, Italy

Site Status

IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

Milan, Lombardy, Italy

Site Status

ASST DI MONZA; Neurologia

Monza, 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

Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily, Italy

Site Status

Yachiyo Hospital

Aichi, , Japan

Site Status

Nagoya Ekisaikai Hospital

Aichi, , Japan

Site Status

National Center for Geriatrics and Gerontology

Aichi, , Japan

Site Status

Medical Corporation Hakuyokai Kashiwado Hospital

Chiba, , Japan

Site Status

Tokyo Bay Advanced Medical and Makuhari Clinic

Chiba, , Japan

Site Status

Inage Neurology and Memory Clinic

Chiba, , Japan

Site Status

Juntendo University Urayasu Hospital

Chiba, , Japan

Site Status

Fukuoka University Hospital

Fukuoka, , Japan

Site Status

Southern Tohoku Medical Clinic

Fukushima, , Japan

Site Status

National Hospital Organization Hiroshima-Nishi Medical Center

Hiroshima, , Japan

Site Status

Kobe University Hospital

Hyōgo, , Japan

Site Status

Hyogo Prefectural HarimaHimeji General Medical Center

Hyōgo, , Japan

Site Status

Tsukazaki Hospital

Hyōgo, , Japan

Site Status

Matsui Dietary and Dementia Clinic

Hyōgo, , Japan

Site Status

Kagawa Prefectural Central Hospital

Kagawa, , Japan

Site Status

Shonan Kamakura General Hospital

Kanagawa, , Japan

Site Status

Rakuwakai Otowa Hospital

Kyoto, , Japan

Site Status

Uji Takeda Hospital

Kyoto, , Japan

Site Status

Okayama Kyokuto Hospital

Okayama, , Japan

Site Status

Rijikai Medical Corporation Katayama Medical Clinic

Okayama, , Japan

Site Status

MI Clinic

Osaka, , Japan

Site Status

Kishiwada Tokushukai Hospital

Osaka, , Japan

Site Status

National Hospital Organization Hizen Psychiatric Medical Center

Saga, , Japan

Site Status

NHO Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, , Japan

Site Status

Shizuoka City Shimizu Hospital

Shizuoka, , Japan

Site Status

Jichiidai Station Brain Clinic

Tochigi, , Japan

Site Status

Medical corporation Ichiekai Itsuki Hospital

Tokushima, , Japan

Site Status

Tokushima Hospital

Tokushima, , Japan

Site Status

Tokyo Medical and Dental University Hospital

Tokyo, , Japan

Site Status

Tokyo Medical University Hospital

Tokyo, , Japan

Site Status

Nozomi Memory Clinic

Tokyo, , Japan

Site Status

National Center of Neurology and Psychiatry

Tokyo, , Japan

Site Status

P-One Clinic

Tokyo, , Japan

Site Status

Yamagata Tokusyukai Hospital

Yamagata, , Japan

Site Status

Vilnius University Hospital Santariskiu Clinics; Neurology

Vilnius, , Lithuania

Site Status

Mexico Centre for Clinical Research

Mexico City, Mexico CITY (federal District), Mexico

Site Status

Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta

Monterrey, Nuevo León, Mexico

Site Status

AVIX Investigación Clínica S.C

Monterrey, Nuevo León, Mexico

Site Status

Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

Culiacán, Sinaloa, Mexico

Site Status

Brain Research Center B.V

Amsterdam, , Netherlands

Site Status

Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

Bellavista, , Peru

Site Status

Clinica Internacional; Unidad De Investigacion

Lima, , Peru

Site Status

Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

Lima, , Peru

Site Status

O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie

?cinawa, , Poland

Site Status

Podlaskie Centrum Psychogeriatrii

Bia?ystok, , Poland

Site Status

NZOZ Vitamed

Bydgoszcz, , Poland

Site Status

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Katowice, , Poland

Site Status

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

Site Status

Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

Plewiska, , Poland

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Senior Sp. Z O.O. Poradnia Psychogeriatryczna

Sopot, , Poland

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mMED Maciej Czarnecki

Warsaw, , Poland

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Pratia S.A.

Warsaw, , Poland

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NZOZ WCA

Wroc?aw, , Poland

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Hospital de Braga; Servico de Neurologia

Braga, , Portugal

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HUC; Servico de Neurologia

Coimbra, , Portugal

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Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia

Guimarães, , Portugal

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Hospital Geral de Santo Antonio; Servico de Neurologia

Porto, , Portugal

Site Status

Santa Cruz Behavioral PSC

Bayamón, , Puerto Rico

Site Status

University of Puerto Rico - Medical Science Campus; Internal Medicine

San Juan, , Puerto Rico

Site Status

FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

Krasnoyarsk, Krasnoyarsk Krai, Russia

Site Status

University ?linic of headaches

Moscow, Moscow Oblast, Russia

Site Status

City Clin Hosp n.a. S.P.Botkin

Moscow, Moscow Oblast, Russia

Site Status

City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow

Moskva, Moscow Oblast, Russia

Site Status

FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Vertebronevrologiya LLC

Kazan', Tatarstan Republic, Russia

Site Status

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

Kazan', Tatarstan Republic, Russia

Site Status

MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric

Saratov, , Russia

Site Status

Nebbiolo Center for Clinical Trials

Tomsk, , Russia

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Myongji Hospital

Gyeonggi-do, , South Korea

Site Status

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Hanyang University Seoul Hospital

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul St Mary's Hospital

Seoul, , South Korea

Site Status

Ewha Womans University Hospital (Seoul)

Seoul, , South Korea

Site Status

Hospital General Universitario de Elche; Servicio de Neurología

Elche, Alicante, Spain

Site Status

Hospital Universitari de Bellvitge; Servicio de Neurologia

L'Hospitalet de Llobregat, 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

Policlínica Guipuzcoa; Servicio de Neurología

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Hospital San Pedro; Servicio de Neurología

Logroño, La Rioja, Spain

Site Status

Hospital Universitario de Santa Maria; Servicio de Neurología

Lleida, Lerida, Spain

Site Status

HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría

Móstoles, Madrid, 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

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

CAE OROITU; Servicio de Neurología

Getxo, Vizcaya, Spain

Site Status

Hospital General Universitario de Albacete; Servicio de Neurología

Albacete, , Spain

Site Status

Hospital del Mar; Servicio de Neurologia

Barcelona, , Spain

Site Status

Fundación ACE; Servicio de Neurología

Barcelona, , Spain

Site Status

Hospital Vall d'Hebron; Servicio de Neurología

Barcelona, , Spain

Site Status

Hospital Clinic i Provincial; Servicio de Neurologia

Barcelona, , Spain

Site Status

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

Barcelona, , Spain

Site Status

Hospital Universitario Reina Sofia; Servicio de Neurologia

Córdoba, , Spain

Site Status

Universitario de La Princesa; Servicio de Neurología

Madrid, , Spain

Site Status

Hospital Ramon y Cajal; Servicio de Neurologia

Madrid, , Spain

Site Status

Hospital Ruber Internacional; Servicio de Neurología

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre; Servicio de Neurologia

Madrid, , Spain

Site Status

Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

Salamanca, , Spain

Site Status

Hospital Virgen del Rocío; Servicio de Neurología

Seville, , Spain

Site Status

Hospital Victoria Eugenia; Servico Neurología

Seville, , Spain

Site Status

Hospital Universitario Dr. Peset; Servicio de Neurologia

Valencia, , Spain

Site Status

Hospital Universitario la Fe; Servicio de Neurologia

Valencia, , Spain

Site Status

Complejo Asistencial de Zamora; Servicio Psiquiatria

Zamora, , Spain

Site Status

Servicio de Neurología Hospital Viamed Montecanal.

Zaragoza, , 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

KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

Stockholm, , Sweden

Site Status

Changhua Christian Hospital; Neurology

Changhua County, , Taiwan

Site Status

Kaohsiung Medical University Hospital; Neurology

Kaohsiung City, , Taiwan

Site Status

Chang Gung Memorial Foundation - Kaohsiung - Neurology

Niaosong Dist., , Taiwan

Site Status

China Medical University Hospital; Neurology

North Dist., , Taiwan

Site Status

National Taiwan University Hospital; Neurology

Taipei, , Taiwan

Site Status

Chang Gung Memorial Foundation - Linkou - Neurology

Taoyuan District, , Taiwan

Site Status

Ondokuz Mayis Univ. Med. Fac.; Neurology

Samsun, , Turkey (Türkiye)

Site Status

The Rice Centre; Royal United Hospital

Bath, , United Kingdom

Site Status

Re:Cognition Health Birmingham

Birmingham, , United Kingdom

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; Research and Development Department

Chertsey, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

Queen Elizabeth University Hospital - PPDS

Glasgow, , United Kingdom

Site Status

St George?s Hospital

London, , United Kingdom

Site Status

Re:Cognition Health London

London, , United Kingdom

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Campus for Ageing and Vitality

Newcastle, , United Kingdom

Site Status

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , 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 Chile China Denmark Finland France Germany Hungary Italy Japan Lithuania Mexico Netherlands Peru Poland Portugal Puerto Rico Russia South Korea Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

References

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Salloway S, Wojtowicz J, Voyle N, Lane CA, Klein G, Lyons M, Rossomanno S, Mazzo F, Bullain S, Barkhof F, Bittner T, Schneider A, Grundman M, Aldea R, Boada M, Smith J, Doody R. Amyloid-Related Imaging Abnormalities (ARIA) in Clinical Trials of Gantenerumab in Early Alzheimer Disease. JAMA Neurol. 2025 Jan 1;82(1):19-29. doi: 10.1001/jamaneurol.2024.3937.

Reference Type DERIVED
PMID: 39556389 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-000766-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WN42171

Identifier Type: -

Identifier Source: org_study_id

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