NCT00480870

The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Associacao Fundo de Incentivo a Psicofarmcologia · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.

Detailed description

Central acting cholinesterase inhibitors are the first primary pharmacological treatment approved for Alzheimer disease, of which donepezil is the most frequently used. Multicenter studies have found little toxicity, and its side effects (diarrhea, nausea, vomiting, nightmares, among others) are mild and transient. According to the literature, cholinergic active drugs may be expected to affect REM (rapid eye movement) sleep. Another possible effect is related to respiratory parameters in patients with Alzheimer disease and obstructive sleep apnea. In fact, cholinergic activity influences the upper airway opening via central and peripheral mechanisms. Intervention: Patients will be administered donepezil or placebo. The study has a randomized, double-blind placebo-controlled design. Complete polysomnography with REM sleep EEG spectral analysis and ADAS-cog scoring will be performed at baseline and after 3 and 6 months.

Conditions

• Alzheimer Disease
• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DRUG	donepezil	donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.
DRUG	Placebo	Placebo 1p / day for 1 month and 2 / day for 5 months on

Timeline

• Start date: 1999-04-01
• Completion: 2005-01-01
• First posted: 2007-05-31
• Last updated: 2007-12-04

Locations

1 site across 1 country: Brazil