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NCT03443973 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 975
- Enrollment target
NCT03443973 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 975 participants.
The verdict
NCT03443973, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 975 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.
Interventions
- DRUG Placebo
- DRUG Gantenerumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 975 participants |
| Start Date | 2018-08-22 |
| Est. Completion | 2022-11-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03443973
The ClinicalTrials.gov registry entry for NCT03443973 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 975 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 2 interventions - of which Placebo is the first listed.
NCT03443973 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03443973 about?
NCT03443973 is a clinical study titled "Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)". This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 ...
What is the current status of trial NCT03443973?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 975 participants. The study started on 2018-08-22. Estimated completion is 2022-11-28.
What interventions are being tested in trial NCT03443973?
The interventions under investigation include: Placebo (DRUG), Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT03443973?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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