NL-OMON52334CompletedPhase 3
AN OPEN-LABEL, MULTICENTER, ROLLOVER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM GANTENERUMAB ADMINISTRATION IN PARTICIPANTS WITH ALZHEIMER'S DISEASE - WN42171 / Postgraduate
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Roche Nederland B.V.
- Enrollment
- 8
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Signed Informed Consent Form by the participant with AD and/or the legal
- •authorized representative as per local requirements
- •Completed WN39658 or WN29922 study, either its double-blind part
- •(participants have reached the 510 mg Q2W dose schedule by the time of
- •completion), or OLE part (participants have received at least 3 doses of 510
- •mg Q4W) and did not discontinue study drug early
- •Ability to comply with the study protocol
- •Willingness and ability to complete all aspects of the study (including
- •availability of a caregiver
- •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 as defined below:
- •Women must remain abstinent or use contraceptive methods with a failure rate of
- •1% per year during the treatment period and for at least 16 weeks after the
- •final dose of gantenerumab.
- •agreement not to donate blood or blood products for transfusion for the
- •duration of the study and for 1 year after final dose of study drug
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
- •Women of childbearing potential must have a negative urine pregnancy test at
- •the final visit of the parent study.
- •Prematurely discontinued from Study WN39658 or WN29922, its double-blind
- •part, or OLE part, from study drug, for any reason
- •Any medical condition that the investigator or Sponsor determines may
- •jeopardize the participant*s safety if he or she continues to receive study
- •Received any investigational treatment other than gantenerumab during or
- •since completion of Study WN39658 of WN29922, its double-blind part or OLE
- •Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three
- •focal leptomeningeal hemosiderosis)
- •Evidence of intracerebral macrohemorrhage
- •Use of prohibited medication
- •Evidence of ARIA-E on the last MRI scan report in Study WN39658 or WN29922,
- •its double-blind or OLE part
- •Participants should remain in the parent study, as governed by that protocol,
- •and may enroll in this study once the ARIA-E is resolved.
Investigators
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