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

Associacao Fundo de Incentivo a Psicofarmcologia

Status and phase: Completed; Phase 4

Conditions: Alzheimer Disease; Sleep Apnea, Obstructive

Treatments: Drug: Placebo; Drug: donepezil

Study type: Interventional

Funder types: Other

Identifiers

NCT00480870

CEP nº051/99

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Donepezil treated Alzheimer patients

Treatment:

Drug: donepezil

B

Placebo Comparator group

Description:

Placebo treated Alzheimer patients

Treatment:

Drug: Placebo