An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer’s Disease

Sponsor:

Brief 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.

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

Locations

Pacific Research Network – PRN, San Diego, California, United States, 92103
California Neuroscience Research Medical Group, Inc, Sherman Oaks, California, United States, 91403