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NCT02670083 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo 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
- 813
- Enrollment target
NCT02670083: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02670083 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 813 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
NCT02670083, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 813 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 final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.
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 105 between Crenezumab and Placebo treated participants was estim
Interventions
- DRUG Placebo
- DRUG Crenezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 813 participants |
| Start Date | 2016-03-22 |
| Est. Completion | 2019-05-31 |
| Phase | Phase 3 |
Why NCT02670083 stopped before completion
NCT02670083 is an interventional study that assigns participants to a tested intervention. The registered 813 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.
NCT02670083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02670083 about?
NCT02670083 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo 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 NCT02670083?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 813 participants. The study started on 2016-03-22. Estimated completion is 2019-05-31.
What interventions are being tested in trial NCT02670083?
The interventions under investigation include: Placebo (DRUG), Crenezumab (DRUG).
Who is sponsoring clinical trial NCT02670083?
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 NCT02670083's enrollment target sits among peer trials
813 407th of 2000 higher than 1,593 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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