The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Polysomnography parameters: sleep structure, respiratory, limb movements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Other causes of dementia
- •Other severe medical or psychiatric disease
- •Clinical indication of psychoactive drugs other than experimental drug
研究组 & 干预措施
A
Donepezil treated Alzheimer patients
干预措施: donepezil (Drug)
B
Placebo treated Alzheimer patients
干预措施: Placebo (Drug)
结局指标
主要结局
Polysomnography parameters: sleep structure, respiratory, limb movements
时间窗: onset, 3 and 6 months of treatment
次要结局
- 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)