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

Last updated: December 21, 2023
Sponsor: Hoffmann-La Roche
Overall Status: Terminated

Phase

3

Condition

N/A

Treatment

Gantenerumab

Clinical Study ID

NCT04339413
WN41874
  • All Genders

Study Summary

The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203or WN28745 will be eligible to participate in Part 1 of the study
  • Part 2: All participants who have completed Week 104 visit in Part 1 will be eligiblefor Part 2 of the study
  • For Part 1 and Part 2:
  • For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive methods that result in a failure rateof <1% per year during the treatment period and for at least 16 weeks after the lastdose of study drug
  • Agreement to not donate blood or blood products for transfusion for the duration ofthe study and for 1 year after final dose of study drug
  • Availability of a person ('caregiver') who in the investigator's judgement, hasfrequent and sufficient contact with the participant

Exclusion

Exclusion Criteria:

  • Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from studydrug for any reason
  • Any medical condition that may jeopardize the participant's safety if he or shecontinues to receive study treatment
  • If the participant is unlikely to benefit from gantenerumab therapy, based on diseaseprogression or other factors, or if study participation is otherwise not in theparticipant's best interest
  • Any investigational treatment other than gantenerumab during or since completion ofthe OLEs of studies WN25203 or WN28745
  • Pregnancy
  • Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focalleptomeningeal hemosiderosis)
  • Evidence of intracerebral macrohemorrhage
  • Part 2: Participants who have been discontinued from Part 1 of the study

Study Design

Total Participants: 116
Treatment Group(s): 1
Primary Treatment: Gantenerumab
Phase: 3
Study Start date:
May 22, 2020
Estimated Completion Date:
January 04, 2023

Connect with a study center

  • Instituto Neurologia Bs As

    Ciudad Autonoma Buenos Aires, C1426ANZ
    Argentina

    Site Not Available

  • Instituto Neurologia Bs As

    Ciudad Autonoma de Bs As, 1426
    Argentina

    Site Not Available

  • The Queen Elizabeth Hospital; Neurology

    Woodville, South Australia 5011
    Australia

    Site Not Available

  • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

    Heidelberg West, Victoria 3081
    Australia

    Site Not Available

  • UZ Leuven Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Centricity Research

    Halifax, Nova Scotia B3S 1N2
    Canada

    Site Not Available

  • True North Clinical Research-Halifax

    Halifax, Nova Scotia B3S 1N2
    Canada

    Site Not Available

  • True North Clinical Research Kentville

    Kentville, Nova Scotia B4N 5E3
    Canada

    Site Not Available

  • True North Clinical Research

    New Minas, Nova Scotia B4N 3R7
    Canada

    Site Not Available

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario K9H 2P4
    Canada

    Site Not Available

  • Toronto Memory Program

    Toronto, Ontario M3B 2S7
    Canada

    Site Not Available

  • Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus

    Quebec City, Quebec G1J 1Z4
    Canada

    Site Not Available

  • Alpha Recherche Clinique

    Quebec, G3K 2P8
    Canada

    Site Not Available

  • Especialidades Medicas LYS

    Santiago, 7560356
    Chile

    Site Not Available

  • Rigshospitalet, Hukommelsesklinikken

    Koebenhavn Oe, 2100
    Denmark

    Site Not Available

  • Rigshospitalet, Hukommelsesklinikken

    København Ø, 2100
    Denmark

    Site Not Available

  • Skejby Sygehus - Aarhus University Hospital

    Århus N, 8200
    Denmark

    Site Not Available

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

    Modena, Emilia-Romagna 41126
    Italy

    Site Not Available

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

    Modena, Emilia-Romagna 41126
    Italy

    Site Not Available

  • Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

    Brescia, Lombardia 25100
    Italy

    Site Not Available

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

    Brescia, Lombardia 25125
    Italy

    Site Not Available

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

    Brescia, Lombardia 25125
    Italy

    Site Not Available

  • Irccs Multimedica Santa Maria; Unita' Di Neurologia

    Castellanza, Lombardia 21053
    Italy

    Site Not Available

  • Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Juntendo University Urayasu Hospital; Neurology

    Chiba, 279-0021
    Japan

    Site Not Available

  • Medical Corporation Hakuyokai Kashiwado Hospital

    Chiba, 260-8656
    Japan

    Site Not Available

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Hiroshima, 739-0696
    Japan

    Site Not Available

  • Kurashiki Heisei Hospital; Neurology

    Okayama, 710-0826
    Japan

    Site Not Available

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Hospital (Seoul)

    Seoul, 07804
    Korea, Republic of

    Site Not Available

  • Seoul St Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Hospital Mexico Americano

    Guadalajara, Mexico CITY (federal District) 44610
    Mexico

    Site Not Available

  • AVIX Investigación Clínica S.C

    Monterrey, Nuevo LEON 64710
    Mexico

    Site Not Available

  • Hospital Universitario; Dr. Jose E. Gonzalez

    Monterrey, Nuevo LEON 64460
    Mexico

    Site Not Available

  • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

    Culiacan, 80020
    Mexico

    Site Not Available

  • Brain Research Center B.V

    Amsterdam, 1081 GN
    Netherlands

    Site Not Available

  • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

    Pozna?, 61-853
    Poland

    Site Not Available

  • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

    Poznań, 61-853
    Poland

    Site Not Available

  • Centrum Medyczne NeuroProtect

    Warszawa, 01-684
    Poland

    Site Not Available

  • Przychodnia Specjalistyczna PROSEN

    Warszawa, 01-231
    Poland

    Site Not Available

  • Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center

    Saint Petersburg, Sankt Petersburg 190103
    Russian Federation

    Site Not Available

  • FSMEI HPE ?Military Medical Academy n.a. S.M.Kirov"of Minist

    Sankt-peterburg, Sankt Petersburg 194044
    Russian Federation

    Site Not Available

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

    Kazan, 420101
    Russian Federation

    Site Not Available

  • Kirov State Medical Academy

    Kirov, 610027
    Russian Federation

    Site Not Available

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow, 119991
    Russian Federation

    Site Not Available

  • FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Minist

    St. Petersburg, 194044
    Russian Federation

    Site Not Available

  • Hospital General Universitario de Elche; Servicio de Neurología

    Elche, Alicante 03203
    Spain

    Site Not Available

  • Hospital Mutua De Terrasa; Servicio de Neurologia

    Terrassa, Barcelona 08222
    Spain

    Site Not Available

  • Fundación ACE; Servicio de Neurología

    Barcelona, 08028
    Spain

    Site Not Available

  • Hospital del Mar; Servicio de Neurologia

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre; Servicio de Neurologia

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Dr. Peset; Servicio de Neurologia

    Valencia, 46017
    Spain

    Site Not Available

  • Hospital Universitario la Fe; Servicio de Neurologia

    Valencia, 46026
    Spain

    Site Not Available

  • Felix Platter-Spital Medizin Geriatrie

    Basel, 4002
    Switzerland

    Site Not Available

  • Istanbul University Istanbul School of Medicine; Neurology

    Istanbul, 34093
    Turkey

    Site Not Available

  • Dokuz Eylul University Medicine Faculty; Noroloji Departmani

    Izmir, 35340
    Turkey

    Site Not Available

  • Ondokuz Mayis University School of Medicine; Neurology

    Samsun, 55139
    Turkey

    Site Not Available

  • Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building

    Cardiff, CF64 2XX
    United Kingdom

    Site Not Available

  • Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences

    London, W6 8RF
    United Kingdom

    Site Not Available

  • Campus for Ageing & Vitality; Clincal Ageing Research Unit

    Newcastle, NE4 5PL
    United Kingdom

    Site Not Available

  • Hollins Park Hospital

    Warrington, WA2 8WA
    United Kingdom

    Site Not Available

  • Banner Sun Health Research Insitute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Pacific Research Network - PRN

    San Diego, California 92103
    United States

    Site Not Available

  • California Neuroscience Research Medical Group, Inc

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Miami Jewish Health Systems; Clinical Research

    Miami, Florida 33137
    United States

    Site Not Available

  • Accelerated Enrollment Solutions

    Orlando, Florida 32806
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Bioclinica The Villages

    The Villages, Florida 32162
    United States

    Site Not Available

  • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

    Kalamazoo, Michigan 49008
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island, New York 10314
    United States

    Site Not Available

  • Alzheimer's Memory Center

    Charlotte, North Carolina 28270
    United States

    Site Not Available

  • Alzheimer's Memory Center

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • Central States Research

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Neurology Clinic PC

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Senior Adults Specialty Research

    Austin, Texas 78757
    United States

    Site Not Available

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