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 study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Terminated

This study 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
Study Identifier:

NCT04339413 WN41874

      Show study 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 study 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

      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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04339413, WN41874 Study 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

      For the latest version of this information please go to www.forpatients.roche.com

       

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