CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Circadin +1 moredrug
Likely dose
Circadin 2mgfrom 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.

Search/NCT00940589
NCT00940589Phase 2Completed
CompareCT.gov

A Double-blind, Parallel Group, Randomized, Placebo Controlled Study of the Efficacy of Circadin® 2mg in Patients With Mild to Moderate Alzheimer Disease (AD) Treated With Acetylcholinesterase (AChE) Inhibitor

Neurim Pharmaceuticals Ltd.·interventional·Posted Jul 16, 2009·Updated Jun 1, 2018

In Brief

A Phase 2 clinical trial evaluating Circadin and Placebo for Alzheimer's Disease and Sleep Disorder. Completed, enrolled 73 participants across 6 sites in 3 countries.

Detailed Summary

The aim of this exploratory randomized, placebo controlled study is to evaluate the efficacy of Circadin® 2mg in patients with mild to moderate Alzheimer Disease (AD) treated with the acetylcholinesterase (AChE) inhibitor. The effects of add-on Circadin® 2mg vs. placebo on the decline in cognitive skills and global functioning, as well as on daytime somnolence and will be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease, Sleep Disorder
CountriesIsrael, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2009
Enrollment StartSep 1, 2009
Primary CompletionFeb 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.0 years ago

Interventions

Circadindrug

Prolonged Release melatonin (Circadin) 2mg tablets

Placebodrug

Matched placebo tablets, with identical features to the Circadin tablets