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

Alzheimer Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Sleep Apnea, Obstructive

• NCT number: NCT00480870
• Study type: Interventional
• Source: Associacao Fundo de Incentivo a Psicofarmcologia
• Status: Completed
• Phase: Phase 4
• Start date: April 1999
• Completion date: January 2005