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