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

F. Hoffmann-La Roche Ltd0 个研究点目标入组 2,032 人开始时间: 2021年2月4日最近更新: 2024年7月31日

适应症

试验速览

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•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

•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

发起方