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

• Registration Number: EUCTR2020-000766-42-LT
• 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: 2020-10-22
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2032

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).
• Availability of a caregiver
• 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
• 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
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