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

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Gantenerumab; Drug: Gantenerumab

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.

• Study Type: Interventional
• Enrollment (Actual): 1382
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1199ABB
    • Hospital Italiano
  • Caba, Argentina, C1405BCK
    • Universidad Maimonides
  • Capital Federal, Argentina, C1427CCP
    • Instituto Geriatrico Nuestra Señora de Las Nieves
  • Cordoba, Argentina, X5004FJF
    • CEN Centro Especializado en Neurociencias
  • Córdoba, Argentina, X5004AOA
    • Instituto Kremer
  • La Plata, Argentina, B1902AVF
    • Instituto de Neurociencias San Agustín S.A.
  • Mendoza, Argentina, M5500AYB
    • Fundación Scherbovsky; General Department
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney; Neurology
    • Erina, New South Wales, Australia, 2250
      • Central Coast Neurosciences Research
    • Kogarah, New South Wales, Australia, 2217
      • Southern Neurology
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital; Neurology
  • Victoria
    • Heidelberg West, Victoria, Australia, 3081
      • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Australian Alzheimer's Research Foundation
• Belgium
  • Dendermonde, Belgium, 9200
    • AZ Sint Blasius (Dendermonde)
  • Gent, Belgium, 9000
    • UZ Gent
  • Hasselt, Belgium, 3500
    • Jessa Zkh (Campus Virga Jesse)
• Brazil
  • PR
    • Curitiba, PR, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba
    • Curitiba, PR, Brazil, 80810-040
      • Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
    • Maringa, PR, Brazil, 87013-250
      • Clinica Clinilive ltda
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • Hospital das Clinicas - FMUSP_X; Neurologia
• Canada
  • Quebec, Canada, G3K 2P8
    • ALPHA Recherche Clinique
  • British Columbia
    • Vancouver, British Columbia, Canada, V7T 2Z3
      • The Medical Arts Health Research Group - West Vancouver
  • Ontario
    • London, Ontario, Canada, N6C 5J1
      • Parkwood Hospital; Geriatric Medicine
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M6A 2E1
      • Baycrest Health Sciences
    • Woodstock, Ontario, Canada, N4S 5P5
      • Devonshire Clinical Research
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Center for Diagnosis and Research on Alzheimer's disease
• Chile
  • Antofagasta, Chile, 1270244
    • Psicomed Estudios Medicos
  • Santiago, Chile, 7500710
    • Biomedica Research Group
  • Santiago, Chile, 7560356
    • Especialidades Medicas LYS
• China
  • Beijing City, China, 100071
    • Beijing Tian Tan Hospital,Capital Medical University
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken
  • København Ø, Denmark, 2100
    • Rigshospitalet, Hukommelsesklinikken
  • Svendborg, Denmark, 5700
    • Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn
• Finland
  • Helsinki, Finland, 00180
    • Terveystalo Ruoholahti
  • Kuopio, Finland, 70210
    • Itä-Suomen yliopisto, Kuopion kampus
• France
  • Amiens Cedex1, France, 80054
    • CHU Amiens Hopital Sud; Neurologie
  • Bobigny Cedex, France, 93009
    • Hôpital Avicenne; Centre de Recherche Clinique
  • Bron cedex, France, 69677
    • Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)
  • Marseille, France, 13005
    • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Paris, France, 75010
    • Hôpital Lariboisière
  • Poitiers, France, 86000
    • CHU Poitiers - Hôpital la Milétrie
  • Strasbourg, France, 67098
    • CHU Strasbourg Hôpital Hautepierre
  • Toulouse, France, 31059
    • Gerontopole; Centre de Recherche clinique
  • Villeurbanne, France, 69100
    • Hopital des Charpennes
• Germany
  • Berlin, Germany, 13125
    • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
  • Berlin, Germany, 12200
    • Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin
  • Köln, Germany, 50937
    • Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie
  • Leipzig, Germany, 04275
    • PANAKEIA - Arzneimittelforschung Leipzig GmbH
  • Mainz, Germany, 55131
    • Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
  • Münster, Germany, 48149
    • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
  • Rostock, Germany, 18147
    • Universitätsklinikum Rostock Zentrum für Nervenheilkunde
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm; Klinik für Neurologie
  • Westerstede, Germany, 26655
    • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
  • Witten, Germany, 58455
    • Forschungszentrum Ruhr
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis University; Department of Neurology
• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41126
      • Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
  • Lazio
    • Roma, Lazio, Italy, 00185
      • Umberto I Policlinico di Roma-Università di Roma La Sapienza
    • Roma, Lazio, Italy, 00186
      • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
    • Roma, Lazio, Italy, 00179
      • Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
  • Lombardia
    • Brescia, Lombardia, Italy, 25125
      • IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
    • Milano, Lombardia, Italy, 20132
      • IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
    • Monza, Lombardia, Italy, 20900
      • ASST DI MONZA; Neurologia
  • Molise
    • Pozzilli, Molise, Italy, 86077
      • IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
  • Sicilia
    • Palermo, Sicilia, Italy, 90127
      • Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
• Japan
  • Aichi, Japan, 446-8510
    • Yachiyo Hospital
  • Aichi, Japan, 454-8502
    • Nagoya Ekisaikai Hospital
  • Aichi, Japan, 474-8511
    • National Center for Geriatrics and Gerontology
  • Chiba, Japan, 260-8656
    • Medical Corporation Hakuyokai Kashiwado Hospital
  • Chiba, Japan, 261-0024
    • Tokyo Bay Advanced Medical and Makuhari Clinic
  • Chiba, Japan, 263-0043
    • Inage Neurology and Memory Clinic
  • Chiba, Japan, 279-0021
    • Juntendo University Urayasu Hospital
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Fukushima, Japan, 963-8052
    • Southern TOHOKU Medical Clinic
  • Hiroshima, Japan, 739-0696
    • National Hospital Organization Hiroshima-Nishi Medical Center
  • Hyogo, Japan, 650-0017
    • Kobe University Hospital
  • Hyogo, Japan, 670-8560
    • Hyogo Prefectural HarimaHimeji General Medical Center
  • Hyogo, Japan, 671-1227
    • Tsukazaki Hospital
  • Hyogo, Japan, 673-0891
    • Matsui Dietary and Dementia Clinic
  • Kagawa, Japan, 760-8557
    • Kagawa Prefectural Central Hospital
  • Kanagawa, Japan, 247-8533
    • Shonan Kamakura General Hospital
  • Kyoto, Japan, 607-8062
    • Rakuwakai Otowa Hospital
  • Kyoto, Japan, 611-0021
    • Uji Takeda Hospital
  • Okayama, Japan, 703-8265
    • Okayama Kyokuto Hospital
  • Okayama, Japan, 710-0813
    • Rijikai Medical Corporation Katayama Medical Clinic
  • Osaka, Japan, 560-0004
    • MI Clinic
  • Osaka, Japan, 596-0042
    • Kishiwada Tokushukai Hospital
  • Saga, Japan, 842-0192
    • National Hospital Organization Hizen Psychiatric Medical Center
  • Shizuoka, Japan, 420-8688
    • NHO Shizuoka Institute of Epilepsy and Neurological Disorders
  • Shizuoka, Japan, 424-0911
    • Shizuoka City Shimizu Hospital
  • Tochigi, Japan, 329-0403
    • Jichiidai Station Brain Clinic
  • Tokushima, Japan, 770-0852
    • Medical corporation Ichiekai Itsuki Hospital
  • Tokushima, Japan, 776-8585
    • Tokushima Hospital
  • Tokyo, Japan, 187-8551
    • National Center of Neurology and Psychiatry
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 113-8519
    • Tokyo Medical and Dental University Hospital
  • Tokyo, Japan, 181-0013
    • Nozomi Memory Clinic
  • Tokyo, Japan, 192-0071
    • P-One Clinic
  • Yamagata, Japan, 990-0834
    • Yamagata Tokusyukai Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Gyeonggi-do, Korea, Republic of, 10475
    • Myongji Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • Seoul St Mary's Hospital
  • Seoul, Korea, Republic of, 07804
    • Ewha Womans University Hospital (Seoul)
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santariskiu Clinics; Neurology
• Mexico
  • Mexico CITY (federal District)
    • Ciudad de México, Mexico CITY (federal District), Mexico, 03100
      • Mexico Centre for Clinical Research
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64710
      • AVIX Investigación Clínica S.C
    • Monterrey, Nuevo LEON, Mexico, 64460
      • Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
• Netherlands
  • Amsterdam, Netherlands, 1081 GN
    • Brain Research Center B.V
• Peru
  • Bellavista, Peru, Callao 2
    • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
  • Lima, Peru, 15001
    • Clinica Internacional; Unidad De Investigacion
  • Lima, Peru, 15003
    • Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
• Poland
  • ?cinawa, Poland, 59-330
    • O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
  • Bia?ystok, Poland, 15-756
    • Podlaskie Centrum Psychogeriatrii
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Katowice, Poland, 40-749
    • Neuro-Care sp. z o.o. sp. Komandytowa
  • Lublin, Poland, 20-362
    • KO-MED Centra Kliniczne Lublin II
  • Plewiska, Poland, 62-064
    • Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
  • Sopot, Poland, 81-855
    • Senior Sp. Z O.O. Poradnia Psychogeriatryczna
  • Warszawa, Poland, 01-684
    • mMED Maciej Czarnecki
  • Warszawa, Poland, 02-171
    • Pratia S.A.
  • Wroc?aw, Poland, 53-659
    • NZOZ WCA
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga; Servico de Neurologia
  • Coimbra, Portugal, 3000-075
    • HUC; Servico de Neurologia
  • Guimarães, Portugal
    • Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia
  • Porto, Portugal, 4099-001
    • Hospital Geral de Santo Antonio; Servico de Neurologia
• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Santa Cruz Behavioral PSC
  • San Juan, Puerto Rico, 00936
    • University of Puerto Rico - Medical Science Campus; Internal Medicine
• Russian Federation
  • Saratov, Russian Federation, 410028
    • MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric
  • Tomsk, Russian Federation, 634009
    • Nebbiolo Center for Clinical Trials
  • Krasnojarsk
    • Krasnoyarsk, Krasnojarsk, Russian Federation, 660037
      • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 121467
      • University ?linic of headaches
    • Moscow, Moskovskaja Oblast, Russian Federation, 125101
      • City Clin Hosp n.a. S.P.Botkin
    • Moskva, Moskovskaja Oblast, Russian Federation, 117556
      • City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow
  • Sankt Petersburg
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 194044
      • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420047
      • Vertebronevrologiya LLC
    • Kazan, Tatarstan, Russian Federation, 420101
      • State autonomous institution of healthcare Inter-regional clinical and diagnostic center
• Spain
  • Albacete, Spain
    • Hospital General Universitario de Albacete; Servicio de Neurología
  • Barcelona, Spain, 08003
    • Hospital del Mar; Servicio de Neurologia
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial; Servicio de Neurologia
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Barcelona, Spain, 08028
    • Fundación ACE; Servicio de Neurología
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron; Servicio de Neurología
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia; Servicio de Neurologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Neurologia
  • Madrid, Spain, 28006
    • Universitario de La Princesa; Servicio de Neurología
  • Madrid, Spain, 28034
    • Hospital Ruber Internacional; Servicio de Neurología
  • Salamanca, Spain, 37005
    • Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío; Servicio de Neurología
  • Sevilla, Spain
    • Hospital Victoria Eugenia; Servico Neurología
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe; Servicio de Neurologia
  • Zamora, Spain, 49021
    • Complejo Asistencial de Zamora; Servicio Psiquiatria
  • Zaragoza, Spain, 50012
    • Servicio de Neurología Hospital Viamed Montecanal.
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche; Servicio de Neurología
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge; Servicio de Neurologia
    • Sant Cugat del Valles, Barcelona, Spain, 8195
      • Hospital General De Catalunya; Servicio de Neurologia
    • Terrassa, Barcelona, Spain, 08222
      • Hospital Mutua De Terrasa; Servicio de Neurologia
  • Caceres
    • Plasencia, Caceres, Spain, 10600
      • Hospital Virgen del Puerto. Servicio de Neurología
  • Cantabria
    • SANtander, Cantabria, Spain, 39011
      • Hospital Universitario Marques de Valdecilla; Servicio de Neurología
  • Guipuzcoa
    • Donostia-san Sebastian, Guipuzcoa, Spain, 20014
      • Policlínica Guipuzcoa; Servicio de Neurología
  • LA Rioja
    • Logroño, LA Rioja, Spain, 26006
      • Hospital San Pedro; Servicio de Neurología
  • Lerida
    • Lleida, Lerida, Spain, 25198
      • Hospital Universitario de Santa Maria; Servicio de Neurología
  • Madrid
    • Móstoles, Madrid, Spain, 28938
      • HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron de Madrid; Servicio de Neurologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria De Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Neurología
  • Vizcaya
    • Getxo, Vizcaya, Spain, 48993
      • CAE OROITU; Servicio de Neurología
• Sweden
  • Malmö, Sweden, 211 46
    • Skånes Universitetssjukhus Malmö, Minneskliniken
  • Mölndal, Sweden, 431 41
    • Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
  • Stockholm, Sweden, 141 86
    • KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54
• Taiwan
  • Changhua County, Taiwan, 500
    • Changhua Christian Hospital; Neurology
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital; Neurology
  • Niaosong Dist., Taiwan, 83301
    • Chang Gung Memorial Foundation - Kaohsiung - Neurology
  • North Dist., Taiwan, 40447
    • China Medical University Hospital; Neurology
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital; Neurology
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Foundation - Linkou - Neurology
• Turkey
  • Samsun, Turkey, 55139
    • Ondokuz Mayis Univ. Med. Fac.; Neurology
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • The Rice Centre; Royal United Hospital
  • Birmingham, United Kingdom, B16 8QQ
    • Re:Cognition Health Birmingham
  • Cheltenham, United Kingdom, GL53 9DZ
    • The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
  • Chertsey, United Kingdom, KT16 9AU
    • Surrey and Borders NHS Foundation Trust; Research and Development Department
  • Dundee, United Kingdom, DD12 9SY
    • Ninewells Hospital
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital - PPDS
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, W1G 9RU
    • Re:Cognition Health London
  • London, United Kingdom, SW17 ORE
    • St George?s Hospital
  • Newcastle, United Kingdom, NE4 5PL
    • Campus for Ageing and Vitality
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust
  • Southampton, United Kingdom, SO166YD
    • University Southampton NHS Foundation Trust; Wessex Neurologica Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer?s Institute
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Insitute
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Health Initiatives Research, PLLC
  • California
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Fullerton, California, United States, 92835
      • Fullerton Neurology and Headache Center
    • Irvine, California, United States, 92614
      • Irvine Center for Clinical Research
    • Redlands, California, United States, 92374
      • Desert Valley Research
    • Sacramento, California, United States, 95816
      • Sutter Medical Group, Neurology
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc
    • Simi Valley, California, United States, 93065
      • Southern California Research LLC
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Medicine
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies, Inc.
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research LLC
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center
    • Bradenton, Florida, United States, 34201
      • Accel Research Sites - CRU Tampa
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research, Inc.
    • Maitland, Florida, United States, 32751
      • ClinCloud, LLC
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research Institute, Inc
    • Miami, Florida, United States, 33125
      • Optimus U Corp
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Sarasota, Florida, United States, 34239
      • Intercoastal Medical Group
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research, LLC
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • Wellington, Florida, United States, 33414
      • Alzheimer?s Research and Treatment Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University, School of Medicine
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network Institute, LLC
    • Fort Wayne, Indiana, United States, 46805
      • Fort Wayne Neurological Center
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Via Christi Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital; Center for Alzheimer Research & Treatment
    • Newton, Massachusetts, United States, 02459
      • Boston Center for Memory
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Missouri Memory Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198-8440
      • University of Nebraska Medical Center; Dept of Neurological Sciences
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo; Center for Brain Research
  • New Jersey
    • Springfield, New Jersey, United States, 07081
      • The Cognitive and Research Center of New Jersey
    • Toms River, New Jersey, United States, 08755
      • Advanced Memory Research Institute of NJ
  • New York
    • Lake Success, New York, United States, 11042
      • Neurological Associates of Long Island, PC
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Rochester, New York, United States, 14620
      • AD-CARE, University of Rochester Medical Center
    • Staten Island, New York, United States, 10314
      • Richmond Behavioral Associates
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Behavioral Health Research
    • Matthews, North Carolina, United States, 28105
      • Alzheimer's Memory Center
    • Raleigh, North Carolina, United States, 27607-6520
      • Raleigh Neurology Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute
    • Columbus, Ohio, United States, 43210
      • Ohio State University; College of Medicine
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network Inc.
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Neurological Associates
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research
    • Dallas, Texas, United States, 75231
      • Kerwin Medical Center
    • Dallas, Texas, United States, 75243
      • Neurology Consultants of Dallas; Research Department
    • Houston, Texas, United States, 77054
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77030
      • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research, LLC
  • Virginia
    • Charlottesville, Virginia, United States, 22906
      • University of Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Neurology Specialists
    • Richmond, Virginia, United States, 23294
      • National Clinical Research Inc.-Richmond
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • UW Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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.; 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
Experimental: 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.	Drug: 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
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).	From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
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).	From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
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).	From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
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).	From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
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).	From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
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).	From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	Baseline (OLE Day 1), Weeks 24, 36, 52, 76 and 104
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).	From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Gantenerumab Administered SC	Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.	From Baseline (OLE Day 1) to Week 208

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: WN42171; 2020-000766-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No