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NCT02615002 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)
A Phase 2 study, sponsored by Neurim Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 371
- Enrollment target
NCT02615002: Completed Phase 2 study, sponsored by Neurim Pharmaceuticals.
NCT02615002 is a Phase 2 study that has completed, run by Neurim Pharmaceuticals. The registered enrollment target is 371 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (179% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02615002, a Phase 2 study, has completed, sponsored by Neurim Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 371 participants
- Enrollment target
Study Summary
This study is a Phase 2, randomized, placebo-controlled, dose-ranging study of piromelatine (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on efficacy (cognitive performance), safety, and tolerability in patients with mild dementia due to Alzheimer's Disease (AD).
Primary Outcome
The global composite score of the cNTB combines the International Shopping List Test (ISLT), One Card Learning (OCL), Identification (IDN), Detection (DET), One Back Card (OBK), Controlled Oral Word Association Test (COWAT), and the Categorical Fluency Test (CFT). For each test, a z-score relative to the study baseline is calculated. The cNTB global composite score is the mean of all z-scores from the tests listed above. The scale range is from -3 to 3. Zero Z-score means no cognitive change.
Interventions
- DRUG Placebo
- DRUG Piromelatine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2015-11 |
| Est. Completion | 2019-11-19 |
| Phase | Phase 2 |
What the finished NCT02615002 record still lists
NCT02615002 is an interventional study that assigns participants to a tested intervention. The registered 371 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (179% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02615002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02615002 about?
NCT02615002 is a clinical study titled "Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)". This study is a Phase 2, randomized, placebo-controlled, dose-ranging study of piromelatine (5, 20, and 50 mg daily for 6 months) versus placebo to determine an effective dose based on efficacy (cognitive performance), safety, and tolerability in patients with mild dementia due to Alzheimer's Diseas...
What is the current status of trial NCT02615002?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 371 participants. The study started on 2015-11. Estimated completion is 2019-11-19.
What interventions are being tested in trial NCT02615002?
The interventions under investigation include: Placebo (DRUG), Piromelatine (DRUG).
Who is sponsoring clinical trial NCT02615002?
This trial is sponsored by Neurim Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02615002's enrollment target sits among peer trials
371 120th of 2000 higher than 1,881 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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