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

• Status: Active, not recruiting
• Trial end date: 2023-04-27
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, rollover study 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 will be eligible to participate in this study. Participants will continue receiving open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies.

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

Details

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

Criteria

Inclusion Criteria:

• Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745

• 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

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