AzTrials
AzTrials

Alzheimer DiseasePhase 3NCT04374253

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

A Phase 3 study testing Gantenerumab in people with Alzheimer Disease, run by Hoffmann-La Roche at 268 sites in 29 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Alzheimer Disease
What is being tested?
Gantenerumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,382 participants
Where
268 sitesin 29 countries
Study dates
26 Jan 2021to 6 Mar 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

268 sites in 29 countries.

268 sites in 29 countries

United States67 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • Emory University

    Atlanta, Georgia, 30329

  • JEM Research LLC

    Atlantis, Florida, 33462

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • American Health Network Institute, LLC

    Avon, Indiana, 46123

  • Missouri Memory Center

    Bolivar, Missouri, 65613

  • Brigham and Womens Hospital; Center for Alzheimer Research & Treatment

    Boston, Massachusetts, 02115

  • Accel Research Sites - CRU Tampa

    Bradenton, Florida, 34201

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • Behavioral Health Research

    Charlotte, North Carolina, 28211

  • University of Virginia

    Charlottesville, Virginia, 22906

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

    Cleveland, Ohio, 44195

  • Ohio State University; College of Medicine

    Columbus, Ohio, 43210

  • Kerwin Medical Center

    Dallas, Texas, 75231

  • Neurology Consultants of Dallas; Research Department

    Dallas, Texas, 75243

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Health Initiatives Research, PLLC

    Fayetteville, Arkansas, 72703

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501

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

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77054

  • Irvine Center for Clinical Research

    Irvine, California, 92614

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Neurological Associates of Long Island, PC

    Lake Success, New York, 11042

  • Cleveland Clinic Lou Ruvo; Center for Brain Research

    Las Vegas, Nevada, 89106

  • UW Wisconsin-Madison

    Madison, Wisconsin, 53705

  • ClinCloud, LLC

    Maitland, Florida, 32751

  • Alzheimer's Memory Center

    Matthews, North Carolina, 28105

  • Optimus U Corp

    Miami, Florida, 33125

  • Allied Biomedical Research Institute, Inc

    Miami, Florida, 33155

  • Yale University School Of Medicine

    New Haven, Connecticut, 06519

  • Columbia University Medical Center

    New York, New York, 10032

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Sentara Neurology Specialists

    Norfolk, Virginia, 23507

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34470

  • University of Nebraska Medical Center; Dept of Neurological Sciences

    Omaha, Nebraska, 68198-8440

  • Banner Alzheimer?s Institute

    Phoenix, Arizona, 85006

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Summit Research Network Inc.

    Portland, Oregon, 97210

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6520

  • Desert Valley Research

    Redlands, California, 92374

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia, 23294

  • AD-CARE, University of Rochester Medical Center

    Rochester, New York, 14620

  • Sutter Medical Group, Neurology

    Sacramento, California, 95816

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

  • California Neuroscience Research Medical Group, Inc

    Sherman Oaks, California, 91403

  • Southern California Research LLC

    Simi Valley, California, 93065

  • Southern Illinois University, School of Medicine

    Springfield, Illinois, 62702

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

  • Banner Sun Health Research Insitute

    Sun City, Arizona, 85351

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Alzheimer?s Research and Treatment Center

    Wellington, Florida, 33414

  • Via Christi Research

    Wichita, Kansas, 67214

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan34 sites

  • Yachiyo Hospital

    Aichi, 446-8510

  • Nagoya Ekisaikai Hospital

    Aichi, 454-8502

  • National Center for Geriatrics and Gerontology

    Aichi, 474-8511

  • Medical Corporation Hakuyokai Kashiwado Hospital

    Chiba, 260-8656

  • Tokyo Bay Advanced Medical and Makuhari Clinic

    Chiba, 261-0024

  • Inage Neurology and Memory Clinic

    Chiba, 263-0043

  • Juntendo University Urayasu Hospital

    Chiba, 279-0021

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Southern Tohoku Medical Clinic

    Fukushima, 963-8052

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Hiroshima, 739-0696

  • Kobe University Hospital

    Hyōgo, 650-0017

  • Hyogo Prefectural HarimaHimeji General Medical Center

    Hyōgo, 670-8560

  • Tsukazaki Hospital

    Hyōgo, 671-1227

  • Matsui Dietary and Dementia Clinic

    Hyōgo, 673-0891

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-8557

  • Shonan Kamakura General Hospital

    Kanagawa, 247-8533

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062

  • Uji Takeda Hospital

    Kyoto, 611-0021

  • Okayama Kyokuto Hospital

    Okayama, 703-8265

  • Rijikai Medical Corporation Katayama Medical Clinic

    Okayama, 710-0813

  • MI Clinic

    Osaka, 560-0004

  • Kishiwada Tokushukai Hospital

    Osaka, 596-0042

  • National Hospital Organization Hizen Psychiatric Medical Center

    Saga, 842-0192

  • NHO Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, 420-8688

  • Shizuoka City Shimizu Hospital

    Shizuoka, 424-0911

  • Jichiidai Station Brain Clinic

    Tochigi, 329-0403

  • Medical corporation Ichiekai Itsuki Hospital

    Tokushima, 770-0852

  • Tokushima Hospital

    Tokushima, 776-8585

  • Tokyo Medical and Dental University Hospital

    Tokyo, 113-8519

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Nozomi Memory Clinic

    Tokyo, 181-0013

  • National Center of Neurology and Psychiatry

    Tokyo, 187-8551

  • P-One Clinic

    Tokyo, 192-0071

  • Yamagata Tokusyukai Hospital

    Yamagata, 990-0834

Other trials in Japan

Spain32 sites

  • Hospital General Universitario de Albacete; Servicio de Neurología

    Albacete

  • Hospital del Mar; Servicio de Neurologia

    Barcelona, 08003

  • Fundación ACE; Servicio de Neurología

    Barcelona, 08028

  • Hospital Vall d'Hebron; Servicio de Neurología

    Barcelona, 08035

  • Hospital Clinic i Provincial; Servicio de Neurologia

    Barcelona, 08036

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

    Barcelona, 08041

  • Hospital Universitario Reina Sofia; Servicio de Neurologia

    Córdoba, 14004

  • Policlínica Guipuzcoa; Servicio de Neurología

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital General Universitario de Elche; Servicio de Neurología

    Elche, Alicante, 03203

  • CAE OROITU; Servicio de Neurología

    Getxo, Vizcaya, 48993

  • Hospital Universitari de Bellvitge; Servicio de Neurologia

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de Santa Maria; Servicio de Neurología

    Lleida, Lerida, 25198

  • Hospital San Pedro; Servicio de Neurología

    Logroño, La Rioja, 26006

  • Universitario de La Princesa; Servicio de Neurología

    Madrid, 28006

  • Hospital Ramon y Cajal; Servicio de Neurologia

    Madrid, 28034

  • Hospital Ruber Internacional; Servicio de Neurología

    Madrid, 28034

  • Hospital Universitario 12 de Octubre; Servicio de Neurologia

    Madrid, 28041

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

    Móstoles, Madrid, 28938

  • Clinica Universitaria de Navarra; Servicio de Neurología

    Pamplona, Navarre, 31008

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital Virgen del Puerto. Servicio de Neurología

    Plasencia, Caceres, 10600

  • Hospital Quiron de Madrid; Servicio de Neurologia

    Pozuelo de Alarcón, Madrid, 28223

  • Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

    Salamanca, 37005

  • Hospital General De Catalunya; Servicio de Neurologia

    Sant Cugat del Vallès, Barcelona, 8195

  • Hospital Universitario Marques de Valdecilla; Servicio de Neurología

    Santander, Cantabria, 39011

  • Hospital Virgen del Rocío; Servicio de Neurología

    Seville, 41013

  • Hospital Victoria Eugenia; Servico Neurología

    Seville

  • Hospital Mutua De Terrasa; Servicio de Neurologia

    Terrassa, Barcelona, 08222

  • Hospital Universitario Dr. Peset; Servicio de Neurologia

    Valencia, 46017

  • Hospital Universitario la Fe; Servicio de Neurologia

    Valencia, 46026

  • Complejo Asistencial de Zamora; Servicio Psiquiatria

    Zamora, 49021

  • Servicio de Neurología Hospital Viamed Montecanal.

    Zaragoza, 50012

Other trials in Spain

United Kingdom12 sites

  • The Rice Centre; Royal United Hospital

    Bath, BA1 3NG

  • Re:Cognition Health Birmingham

    Birmingham, B16 8QQ

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

    Cheltenham, GL53 9DZ

  • Surrey and Borders NHS Foundation Trust; Research and Development Department

    Chertsey, KT16 9AU

  • Ninewells Hospital

    Dundee, DD12 9SY

  • Queen Elizabeth University Hospital - PPDS

    Glasgow, G51 4TF

  • St George?s Hospital

    London, SW17 ORE

  • Re:Cognition Health London

    London, W1G 9RU

  • Charing Cross Hospital

    London, W6 8RF

  • Campus for Ageing and Vitality

    Newcastle, NE4 5PL

  • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2JF

  • University Southampton NHS Foundation Trust; Wessex Neurologica Centre

    Southampton, SO166YD

Other trials in United Kingdom

Germany11 sites

  • Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

    Berlin, 12200

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

    Berlin, 13125

  • Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie

    Cologne, 50937

  • PANAKEIA - Arzneimittelforschung Leipzig GmbH

    Leipzig, 04275

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

    Mainz, 55131

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

    München, 81675

  • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

    Münster, 48149

  • Universitätsklinikum Rostock Zentrum für Nervenheilkunde

    Rostock, 18147

  • Universitätsklinikum Ulm; Klinik für Neurologie

    Ulm, 89081

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655

  • Forschungszentrum Ruhr

    Witten, 58455

Other trials in Germany

South Korea11 sites

  • Dong-A University Hospital

    Busan, 49201

  • Myongji Hospital

    Gyeonggi-do, 10475

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St Mary's Hospital

    Seoul, 06591

  • Ewha Womans University Hospital (Seoul)

    Seoul, 07804

Other trials in South Korea

Italy10 sites

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

    Brescia, Lombardy, 25125

  • IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

    Milan, Lombardy, 20132

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

    Modena, Emilia-Romagna, 41126

  • ASST DI MONZA; Neurologia

    Monza, Lombardy, 20900

  • Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

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

    Pozzilli, Molise, 86077

  • Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

    Rome, Lazio, 00179

  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio, 00185

  • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

    Rome, Lazio, 00186

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

    Turin, Piedmont, 10126

Other trials in Italy

Poland10 sites

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

    ?cinawa, 59-330

  • Podlaskie Centrum Psychogeriatrii

    Bia?ystok, 15-756

  • NZOZ Vitamed

    Bydgoszcz, 85-079

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

    Katowice, 40-749

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

  • Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

    Plewiska, 62-064

  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna

    Sopot, 81-855

  • mMED Maciej Czarnecki

    Warsaw, 01-684

  • Pratia S.A.

    Warsaw, 02-171

  • NZOZ WCA

    Wroc?aw, 53-659

Other trials in Poland

France9 sites

  • CHU Amiens Hopital Sud; Neurologie

    Amiens Cedex1, 80054

  • Hôpital Avicenne; Centre de Recherche Clinique

    Bobigny, 93009

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

    Bron, 69677

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

    Marseille, 13005

  • Hôpital Lariboisière

    Paris, 75010

  • CHU Poitiers - Hopital La Miletrie

    Poitiers, 86000

  • CHU Strasbourg Hôpital Hautepierre

    Strasbourg, 67098

  • Gerontopole; Centre de Recherche clinique

    Toulouse, 31059

  • Hopital des Charpennes

    Villeurbanne, 69100

Other trials in France

Russia9 sites

  • Vertebronevrologiya LLC

    Kazan', Tatarstan Republic, 420047

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

    Kazan', Tatarstan Republic, 420101

  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

    Krasnoyarsk, Krasnoyarsk Krai, 660037

  • University ?linic of headaches

    Moscow, Moscow Oblast, 121467

  • City Clin Hosp n.a. S.P.Botkin

    Moscow, Moscow Oblast, 125101

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

    Moskva, Moscow Oblast, 117556

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

    Saint Petersburg, Sankt-Peterburg, 194044

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

    Saratov, 410028

  • Nebbiolo Center for Clinical Trials

    Tomsk, 634009

Other trials in Russia

Argentina7 sites

  • Universidad Maimonides

    Caba, C1405BCK

  • Hospital Italiano

    CABA, C1199ABB

  • Instituto Geriatrico Nuestra Señora de las Nieves

    Capital Federal, C1427CCP

  • Instituto Kremer

    Córdoba, X5004AOA

  • CEN Centro Especializado en Neurociencias

    Córdoba, X5004FJF

  • Instituto de Neurociencias San Agustín S.A.

    La Plata, B1902AVF

  • Fundación Scherbovsky; General Department

    Mendoza, M5500AYB

Other trials in Argentina

Canada7 sites

  • Center for Diagnosis and Research on Alzheimer's disease

    Greenfield Park, Quebec, J4V 2J2

  • Parkwood Hospital; Geriatric Medicine

    London, Ontario, N6C 5J1

  • Alpha Recherche Clinique

    Québec, G3K 2P8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Baycrest Health Sciences

    Toronto, Ontario, M6A 2E1

  • The Medical Arts Health Research Group - West Vancouver

    Vancouver, British Columbia, V7T 2Z3

  • Devonshire Clinical Research

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

Australia6 sites

  • St Vincent's Hospital Sydney; Neurology

    Darlinghurst, New South Wales, 2010

  • Central Coast Neurosciences Research

    Erina, New South Wales, 2250

  • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

    Heidelberg West, Victoria, 3081

  • Southern Neurology

    Kogarah, New South Wales, 2217

  • Australian Alzheimer's Research Foundation

    Nedlands, Western Australia, 6009

  • The Queen Elizabeth Hospital; Neurology

    Woodville, South Australia, 5011

Other trials in Australia

Taiwan6 sites

  • Changhua Christian Hospital; Neurology

    Changhua County, 500

  • Kaohsiung Medical University Hospital; Neurology

    Kaohsiung City, 807

  • Chang Gung Memorial Foundation - Kaohsiung - Neurology

    Niaosong Dist., 83301

  • China Medical University Hospital; Neurology

    North Dist., 40447

  • National Taiwan University Hospital; Neurology

    Taipei, 100

  • Chang Gung Memorial Foundation - Linkou - Neurology

    Taoyuan, 333

Other trials in Taiwan

Brazil5 sites

  • Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia

    Curitiba, Paraná, 80810-040

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

  • Clinica Clinilive ltda

    Maringá, Paraná, 87013-250

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas - FMUSP_X; Neurologia

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Mexico4 sites

  • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

    Culiacán, Sinaloa, 80020

  • Mexico Centre for Clinical Research

    Mexico City, Mexico CITY (federal District), 03100

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

    Monterrey, Nuevo León, 64460

  • AVIX Investigación Clínica S.C

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Portugal4 sites

  • Hospital de Braga; Servico de Neurologia

    Braga, 4710-243

  • HUC; Servico de Neurologia

    Coimbra, 3000-075

  • Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia

    Guimarães

  • Hospital Geral de Santo Antonio; Servico de Neurologia

    Porto, 4099-001

Other trials in Portugal

Belgium3 sites

  • AZ Sint Blasius (Dendermonde)

    Dendermonde, 9200

  • UZ Gent

    Ghent, 9000

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

Other trials in Belgium

Chile3 sites

  • Psicomed Estudios Médicos

    Antofagasta, 1270244

  • Biomedica Research Group

    Santiago, 7500710

  • Especialidades Medicas LYS

    Santiago, 7560356

Other trials in Chile

Denmark3 sites

  • Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken

    Aarhus N, 8200

  • Rigshospitalet, Hukommelsesklinikken

    København Ø, 2100

  • Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn

    Svendborg, 5700

Other trials in Denmark

Peru3 sites

  • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

    Bellavista, Callao 2

  • Clinica Internacional; Unidad De Investigacion

    Lima, 15001

  • Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

    Lima, 15003

Other trials in Peru

Sweden3 sites

  • Skånes Universitetssjukhus Malmö, Minneskliniken

    Malmö, 211 46

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

    Mölndal, 431 41

  • KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

    Stockholm, 141 86

Other trials in Sweden

Finland2 sites

  • Terveystalo Ruoholahti

    Helsinki, 00180

  • Itä-Suomen yliopisto, Kuopion kampus

    Kuopio, 70210

Other trials in Finland

Puerto Rico2 sites

  • Santa Cruz Behavioral PSC

    Bayamón, 00961

  • University of Puerto Rico - Medical Science Campus; Internal Medicine

    San Juan, 00936

Other trials in Puerto Rico

China1 site

  • Beijing Tian Tan Hospital,Capital Medical University

    Beijing, 100071

Other trials in China

Hungary1 site

  • Semmelweis University; Department of Neurology

    Budapest, 1083

Other trials in Hungary

Lithuania1 site

  • Vilnius University Hospital Santariskiu Clinics; Neurology

    Vilnius, 08661

Other trials in Lithuania

Netherlands1 site

  • Brain Research Center B.V

    Amsterdam, 1081 GN

Other trials in Netherlands

Turkey (Türkiye)1 site

  • Ondokuz Mayis Univ. Med. Fac.; Neurology

    Samsun, 55139

Other trials in Turkey (Türkiye)

About this study

Official title: An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease

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.

Read the detailed description

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.

Being tested
Gantenerumab
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GantenerumabDrug

    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.

  • GantenerumabDrug

    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

Study groups in NCT04374253
Study groupRoleWhat they receive
Group 1ExperimentalParticipants, 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).
Receives: Drug: Gantenerumab
Group 2ExperimentalParticipants, 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.
Receives: Drug: Gantenerumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE)

    An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. A SAE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug or a significant medical event in the investigator's judgment. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

  2. Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    C-SSRS= assesses lifetime suicidality of participant (at baseline) \& any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation (intensity of ideation, behavior, \& attempts with actual/potential lethality). Categories have yes/no responses, include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted/Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior= "yes" to any of listed categories. Score of 0= no suicide risk. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. First dosing visit in OLE (first dosing in current study or OLE period of parent GRADUATE studies)=baseline (OLE Day 1).

    Measured: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

  3. Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI

    ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

  4. Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI

    ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

  5. Number of Participants With Injection-Site Reactions (ISRs)

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, regardless of casual attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

  6. Number of Participants Who Discontinued the Study Due an AE

    An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

  7. Number of Participants With at Least One Adverse Event of Special Interest (AESI)

    An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. AEs that were considered to be of special interest for this study included cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law and suspected transmission of an infectious agent by the study drug. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

Secondary outcomes (10)

  1. Change From Baseline Over Time in Clinical Dementia Rating - Global Score (CDR-GS)

    CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=normal, 0.5=very mild dementia, 1=mild dementia, 2=moderate dementia, and 3= severe dementia. The score range for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  2. Change From Baseline Over Time in Clinical Dementia Rating (CDR) - Sum of Boxes (SB)

    CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  3. Change From Baseline Over Time in Mini-Mental State Examination (MMSE) Score

    MMSE is a rater-administered performance-based outcome (PerfO) that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  4. Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 11 (ADAS-Cog11) Score

    ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  5. Change From Baseline Over Time in Alzheimer Disease Assessment Scale-Cognition, Subscale 13 (ADAS-Cog13) Score

    The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall [DWR] score is 0-10 and for Number Cancellation [NC] is 0-5, thus the score is ADAS-cog 11[0-70] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  6. Change From Baseline Over Time in Verbal Fluency Task Score

    VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  7. Change From Baseline Over Time in Coding (Digit Symbol Substitution Test [DSST]) Subset

    Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  8. Change in Functional Activities Questionnaire (FAQ) Score

    FAQ is a rater-administered observer-reported outcome (ObsRO) (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  9. Change in Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) Score

    ADCS-ADL is a 23-item rater-administered, ObsRO that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104

  10. Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab

    The number of participants with positive results for ADA against gantenerumab at any of the post-baseline assessment time-points were reported. Evaluable participant during OLE was participant with an ADA assay result from at least one sample during OLE. Treatment Emergent ADA = A participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1).

    Measured: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start26 Jan 2021
  3. Primary completion6 Mar 2023
  4. Study completion6 Mar 2023

Why it stopped: Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04374253
Sponsor's protocol ID
WN42171
Other IDs
2020-000766-42
Status last verified
Apr 2024
First submitted
1 May 2020
Last updated
8 May 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Publications

  • 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.

    PubMed 39556389

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gantenerumab in people with Alzheimer Disease, run by Hoffmann-La Roche at 268 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 268 sites in United States, Japan, Spain, United Kingdom, Germany and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE) (time frame: From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04374253, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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