Alzheimer Disease, Sleep Apnea, Obstructive
Conditions
Keywords
Alzheimer, polysomnography, REM sleep, donepezil, sleep apnea, oxygen saturation
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.
Interventions
DRUGdonepezil
donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.
DRUGPlacebo
Placebo 1p / day for 1 month and 2 / day for 5 months on
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Associacao Fundo de Incentivo a Psicofarmcologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnography parameters: sleep structure, respiratory, limb movements | onset, 3 and 6 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Brain magnetic resonance imaging | onset |
| ADAS-cog scores | onset, 3 and 6 months of treatment |
| Clinical Dementia Rating | onset |
| EEG slowing ratio | onset, 3 and 6 monthes of treatment |
| 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 |
Countries
Brazil
Outcome results
None listed