Status:
TERMINATED
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Alzheimer Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 extens...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04339413
Start Date
May 22 2020
End Date
January 4 2023
Last Update
January 18 2024
Active Locations (56)
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1
Banner Sun Health Research Insitute
Sun City, Arizona, United States, 85351
2
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, United States, 91403
3
Accelerated Enrollment Solutions
Orlando, Florida, United States, 32806
4
University of South Florida
Tampa, Florida, United States, 33612