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

Phase 4

Completed

• Conditions: Alzheimer Disease; Sleep Apnea, Obstructive
• Interventions: Drug: Placebo; Drug: donepezil

• Registration Number: NCT00480870
• Lead Sponsor: Associacao Fundo de Incentivo a Psicofarmcologia

Brief 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.

Study Timeline

• Study Start: 1999-04
• Study Completion: 2005-01
• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Diagnosis of Alzheimer's disease based on the probability criteria of the Alzheimer's Disease and Related Disorders Association
• Rated 1 and 2 (mild to moderate level) on the Brazilian version of the Clinical Dementia Rating

Exclusion Criteria

• Other causes of dementia
• Other severe medical or psychiatric disease
• Clinical indication of psychoactive drugs other than experimental drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	Placebo treated Alzheimer patients
A	donepezil	Donepezil treated Alzheimer patients

Primary Outcome Measures

Name	Time	Method
Polysomnography parameters: sleep structure, respiratory, limb movements	onset, 3 and 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Brain magnetic resonance imaging	onset
laboratory tests: hematological evaluation, creatinine, vitamin B12-folic acid, thyroid hormones, GOT, GPT, GGT, bilirubin, fasting glycemia, venereal disease research test and urine sediment	onset
electroencephalogram	onset
Mini-mental state examination	onset
IDATE	onset
Frequency bands of scalp EEG areas: overall (average of all electrodes), frontal (F3, F4, F7, F8, Fz), temporal (T3, T4, T5, T6), parietal (P3, P4, Pz), central (C3, C4, Cz), and occipital (O1, O2, Oz).	onset, 3 and 6 months of treatment
ADAS-cog scores	onset, 3 and 6 months of treatment
Clinical Dementia Rating	onset
EEG slowing ratio	onset, 3 and 6 monthes of treatment

Trial Locations

Locations (1)

Instituto do Sono; 🇧🇷 Sao Paulo, Brazil