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

WN41874

The main purpose of the study was 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 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.

2020-05-22

2023-01-04

2023-01-04

Terminated

Early phase I

116

Inclusion Criteria: * Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study * Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study * For Part 1 and Part 2: * 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 * Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug * Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant 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 * Part 2: Participants who have been discontinued from Part 1 of the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 116, 'type': 'ACTUAL'}}

2024-01-18