Trials / Terminated
TerminatedNCT04339413
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gantenerumab | Gantenerumab was administered as SC injection Q4W. |
Timeline
- Start date
- 2020-05-22
- Primary completion
- 2023-01-04
- Completion
- 2023-01-04
- First posted
- 2020-04-09
- Last updated
- 2024-01-18
- Results posted
- 2024-01-18
Locations
56 sites across 17 countries: United States, Argentina, Australia, Canada, Chile, Denmark, Italy, Japan, Mexico, Netherlands, Poland, Russia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04339413. Inclusion in this directory is not an endorsement.