Status:
TERMINATED
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Alzheimer Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study...
Detailed Description
Participants who were in the active arm in the double blind part and those who have completed OLE part in the parent study, will continue receive open-label gantenerumab 510 mg sub-cutaneously (SC) ev...
Eligibility Criteria
Inclusion
- 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
- Availability of a person (referred to as 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
- 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
- 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
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
1382 Patients enrolled
Trial Details
Trial ID
NCT04374253
Start Date
January 26 2021
End Date
March 6 2023
Last Update
May 8 2024
Active Locations (268)
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1
Banner Alzheimer?s Institute
Phoenix, Arizona, United States, 85006
2
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
3
Banner Sun Health Research Insitute
Sun City, Arizona, United States, 85351
4
Health Initiatives Research, PLLC
Fayetteville, Arkansas, United States, 72703