NCT00940589

Efficacy of Circadin® 2 mg in Patients With Mild to Moderate Alzheimer Disease Treated With AChE Inhibitor

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Neurim Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease
• Sleep Disorder

Interventions

Type	Name	Description
DRUG	Circadin	Prolonged Release melatonin (Circadin) 2mg tablets
DRUG	Placebo	Matched placebo tablets, with identical features to the Circadin tablets

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2009-07-16
• Last updated: 2018-06-01
• Results posted: 2018-06-01

Locations

6 sites across 3 countries: United States, Israel, United Kingdom