Conditions: Alzheimer's Disease Sleep Disorder
Keywords: Alzheimer's Disease Acetylcholinesterase inhibitor cognitive function Circadin Sleep disturbances
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 73
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Drug arm 2: drug

Interventions: intervention 1: Circadin intervention 2: Placebo
Intervention descriptions: intervention 1: Prolonged Release melatonin (Circadin) 2mg tablets intervention 2: Matched placebo tablets, with identical features to the Circadin tablets

Protocol document: