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

• Status: Recruiting
• Trial end date: 2024-12-27
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early

• 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 methods with a failure rate of <1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab

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

• Any medical condition that 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

• Evidence of disseminated 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