A clinical trial to look at the long-term effects of gantenerumab in people with Alzheimer’s disease

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

  • Neurodegenerative Disorder
  • Alzheimer's Disease (AD)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Cities
  • Amsterdam
  • Austin
  • Baggiovara
  • Barcelona
  • Basel
  • Brescia
  • Buenos Aires
  • Castellanza
  • Chiba
  • Chihuahua
  • Elche
  • Halifax
  • Incheon
  • İstanbul
  • ivanhoe
  • İzmir
  • Kalamazoo
  • København
  • Las Condes
  • Lombardia
  • London
  • Los Angeles
  • Madrid
  • matthews
  • Memphis
  • Monterrey
  • New York
  • Newcastle upon Tyne
  • Orlando
  • Otake
  • penarth
  • Peterborough
  • Poznań
  • Québec
  • Saint Petersburg
  • Samsun
  • Sankt-Peterburg
  • Seoul
  • Sun City
  • Tampa
  • Terrassa
  • The Villages
  • Toronto
  • Tulsa
  • Urayasu
  • València
  • warrington
  • Warszawa
  • Woodville South
Trial Identifier:

NCT04339413 WN41874

  • Banner Sun Health Research Insitute

    85351Sun CityUnited States
  • California Neuroscience Research Medical Group, Inc

    91403Los AngelesUnited States
  • Accelerated Enrollment Solutions

    32806OrlandoUnited States
  • University of South Florida

    33620TampaUnited States
  • Bioclinica The Villages

    32162The VillagesUnited States
  • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

    49007KalamazooUnited States
  • Richmond Behavioral Associates

    10314New YorkUnited States
  • Alzheimer's Memory Center

    28105matthewsUnited States
  • Central States Research

    74136TulsaUnited States
  • Neurology Clinic PC

    38018MemphisUnited States
  • Senior Adults Specialty Research

    78757AustinUnited States
  • Instituto Neurologia Bs As

    Buenos AiresArgentina
  • The Queen Elizabeth Hospital; Neurology

    5011Woodville SouthAustralia
  • Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

    3079ivanhoeAustralia
  • Centricity Research

    B3S 1L8HalifaxCanada
  • True North Clinical Research-Halifax

    B3S 1N2HalifaxCanada
  • Kawartha Centre - Redefining Healthy Aging

    K9H 2P4PeterboroughCanada
  • Toronto Memory Program

    M3B 2S7TorontoCanada
  • Alpha Recherche Clinique

    G3K 2P8QuébecCanada
  • Especialidades Medicas LYS

    7550329Las CondesChile
  • Rigshospitalet, Hukommelsesklinikken

    2100KøbenhavnDenmark
  • Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze

    41126BaggiovaraItaly
  • Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

    25123BresciaItaly
  • IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer

    25125BresciaItaly
  • Irccs Multimedica Santa Maria; Unita' Di Neurologia

    21053CastellanzaItaly
  • Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

    20132LombardiaItaly
  • Medical Corporation Hakuyokai Kashiwado Hospital

    260-0854ChibaJapan
  • Juntendo University Urayasu Hospital; Neurology

    279-0021UrayasuJapan
  • National Hospital Organization Hiroshima-Nishi Medical Center

    739-0696OtakeJapan
  • Inha University Hospital

    400-103IncheonSouth Korea
  • Seoul St Mary's Hospital

    06591SeoulSouth Korea
  • Ewha Womans University Hospital (Seoul)

    07985SeoulSouth Korea
  • Hospital Mexico Americano

    ChihuahuaMexico
  • Hospital Universitario; Dr. Jose E. Gonzalez

    64460MonterreyMexico
  • AVIX Investigación Clínica S.C

    64710MonterreyMexico
  • Brain Research Center B.V

    1081 GNAmsterdamNetherlands
  • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

    61-853PoznańPoland
  • Przychodnia Specjalistyczna PROSEN

    01-231WarszawaPoland
  • Centrum Medyczne NeuroProtect

    01-684WarszawaPoland
  • Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center

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

    194044Sankt-PeterburgRussia
  • Hospital General Universitario de Elche; Servicio de Neurología

    03203ElcheSpain
  • Hospital Mutua De Terrasa; Servicio de Neurologia

    08221TerrassaSpain
  • Hospital del Mar; Servicio de Neurologia

    08003BarcelonaSpain
  • Fundación ACE; Servicio de Neurología

    08028BarcelonaSpain
  • Hospital Universitario 12 de Octubre; Servicio de Neurologia

    28041MadridSpain
  • Hospital Universitario Dr. Peset; Servicio de Neurologia

    46017ValènciaSpain
  • Hospital Universitario la Fe; Servicio de Neurologia

    46026ValènciaSpain
  • Felix Platter-Spital Medizin Geriatrie

    BaselSwitzerland
  • Istanbul University Istanbul School of Medicine; Neurology

    34093İstanbulTürkiye
  • Dokuz Eylul University Medicine Faculty; Noroloji Departmani

    35220İzmirTürkiye
  • Ondokuz Mayis University School of Medicine; Neurology

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

    CF64 2XXpenarthUnited Kingdom
  • Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences

    W6 8RFLondonUnited Kingdom
  • Campus for Ageing & Vitality; Clincal Ageing Research Unit

    NE4 6BENewcastle upon TyneUnited Kingdom
  • Hollins Park Hospital

    WA2 8WAwarringtonUnited Kingdom
    Show trial locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Trial 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.

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT04339413, WN41874 Trial Identifier
    All Gender
    No Healthy Volunteers

    How does the Open RoAD clinical trial work?

    This clinical trial has recruited people who have a type of disease called Alzheimer’s disease. In order to take part, they must have already completed one of the previous gantenerumab clinical trials, which were called WN25203 (SCarlet RoAD) and WN28745 (Marguerite RoAD).

    The purpose of this clinical trial is to evaluate the effects, good or bad, of long-term treatment with gantenerumab in people with Alzheimer’s disease. In this clinical trial, you will be given gantenerumab only. 

     

    How do I take part in this clinical trial?

    To be able to take part in this clinical trial, you must have already completed one of the previous gantenerumab clinical trials: WN25203 (SCarlet RoAD) or WN28745 (Marguerite RoAD). You must also have a caregiver who you will have regular contact with throughout the clinical trial.

    You must not have left the previous trial before completion or stopped taking gantenerumab for any reason, and you cannot take part if you are pregnant.

    If you think this clinical trial may be suitable for you and would like to take part, please talk to your clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

    Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

    While taking part in the clinical trial, women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or use contraceptive methods for safety reasons. 

     

    What treatment will I be given if I join this clinical trial?

    This clinical trial has been extended for an additional two years, and has now been split into two parts.

    In Part 1, everyone who joined the clinical trial received gantenerumab, as an injection under the skin every four weeks for two years.     

    In Part 2, everyone who is still in the trial and completes Part 1 will be invited to continue their participation for an additional two years. In Part 2, you will continue to receive gantenerumab, as an injection under the skin every four weeks, for an additional two years. 

     

    How often will I be seen in follow-up appointments and for how long?

    In Part 1 of this clinical trial, you will have received gantenerumab every four weeks for two years. If you decide to continue your participation in Part 2 of the trial, you will be given gantenerumab every four weeks for an additional two years. You are free to stop this treatment at any time. If your treatment is stopped, you will be seen by the clinical trial doctor after four weeks. Information for this clinical trial will be collected from various assessments and tests that your doctor will carry out at each visit. 

    What happens if I am unable to take part in this clinical trial?

    If this clinical trial is not suitable for you, you will not be able to continue to take part. Your doctor may suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

    For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov

    Trial-identifier: NCT04339413     

    Trial 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.

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT04339413, WN41874 Trial Identifier
    Gantenerumab Treatments
    Alzheimer Disease Condition
    Official Title

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

    Eligibility Criteria

    All Gender
    No Healthy Volunteers
    Inclusion Criteria
    • Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or 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 eligible for Part 2 of the study
    • For Part 1 and Part 2:
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
    • Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
    • Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant
    Exclusion Criteria
    • Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason
    • Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
    • If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest
    • Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745
    • Pregnancy
    • Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
    • Evidence of intracerebral macrohemorrhage
    • Part 2: Participants who have been discontinued from Part 1 of the study

    About Clinical Research

    What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

    Find out now