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NCT04339413 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 116
- Enrollment target
NCT04339413 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 116 participants.
The verdict
NCT04339413, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 116 participants
- Enrollment target
Study 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.
Interventions
- DRUG Gantenerumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2023-01-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04339413
The ClinicalTrials.gov registry entry for NCT04339413 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gantenerumab is the first listed.
NCT04339413 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04339413 about?
NCT04339413 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)". 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, participa...
What is the current status of trial NCT04339413?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 116 participants. The study started on 2020-05-22. Estimated completion is 2023-01-04.
What interventions are being tested in trial NCT04339413?
The interventions under investigation include: Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT04339413?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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