At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 371 enrolled
Drug / intervention
Piromelatine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of Piromelatine in Patients With Mild Dementia Due to Alzheimer's Disease
In Brief
A Phase 2 clinical trial evaluating Piromelatine and Placebo for Alzheimer's Disease. Completed, enrolled 371 participants across 56 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedNov 2015
Primary CompletionJun 2019
Study CompletionNov 2019
TodayJul 2026
First PostedNov 25, 2015
Enrollment StartNov 1, 2015
Primary CompletionJun 1, 2019
Study CompletionNov 19, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.6 years ago
Interventions
Piromelatinedrug
Placebodrug