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

Phase 1

• Conditions: Alzheimer's Disease; MedDRA version: 20.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10074616Term: Prodromal Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000766-42-FR
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-13
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1463

Inclusion Criteria

• Completed Study WN29922 or WN39658, either its double-blind part (participants have reached the 510 mg Q2W dose schedule by the time of completion) or OLE part (participants have received at least 3 doses of 510 mg Q4W), and did not discontinue study drug early
• Ability to comply with the study protocol
• Willingness and ability to complete all aspects of the study (including MRI and lumbar puncture [if applicable]).
• The participant should be capable of completing assessments either alone or with the help of the caregiver
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 16 weeks after the
final dose of gantenerumab

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 293
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1170

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, either its double-blind or OLE part, as applicable, or from study drug, for any reason
• Any medical condition that the investigator or Sponsor determines 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, as applicable
• Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified