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NCT03114657 · ClinicalTrials.gov registry record · Phase 3
A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 806
- Enrollment target
NCT03114657 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 806 participants.
The verdict
NCT03114657, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 806 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).
Interventions
- DRUG Placebo
- DRUG Crenezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 806 participants |
| Start Date | 2017-03-29 |
| Est. Completion | 2019-06-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03114657
The ClinicalTrials.gov registry entry for NCT03114657 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 806 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.
NCT03114657 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03114657 about?
NCT03114657 is a clinical study titled "A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)". This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks...
What is the current status of trial NCT03114657?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 806 participants. The study started on 2017-03-29. Estimated completion is 2019-06-11.
What interventions are being tested in trial NCT03114657?
The interventions under investigation include: Placebo (DRUG), Crenezumab (DRUG).
Who is sponsoring clinical trial NCT03114657?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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