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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: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03114657 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 806 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estima
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 |
Why NCT03114657 stopped before completion
NCT03114657 is an interventional study that assigns participants to a tested intervention. The registered 806 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03114657 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03114657's enrollment target sits among peer trials
806 411th of 2000 higher than 1,590 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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