NCT03256539终止不适用
Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants Enrolled to the Study
研究概览
简要总结
This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥65 years old
- •Memory complaints verified by an informant
- •Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease
- •General cognitive performance sufficiently persevered such that a diagnosis of Alzheimer's disease cannot be made by the site physician
- •No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease
- •Adequate visual and auditory acuity to allow neuropsychological testing
- •Meets International Classification of Sleep Disorders-2nd edition (ICSD-2) criteria for insomnia or circadian rhythm disorders, or shows actigraphy evidence of sleep disturbances and excessive napping
排除标准
- •Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma
- •Any comorbid psychiatric conditions or severe personality disorder within the past 2 years (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), such as major depression, bipolar disorder, schizophrenia and other psychotic features
- •Any uncontrolled medical conditions or systemic illness that might lead to difficulty complying with the study protocol
- •History of alcohol or substance abuse within the past 2 years
- •Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association
结局指标
主要结局
Number of Participants Enrolled to the Study
时间窗: Up to 24 weeks following study initiation
Number of Participants That Complete the Study
时间窗: Through study completion, up to 34 weeks
次要结局
- Sleep as Assessed by Actigraphy(Through study completion, up to 34 weeks)
- Cognitive Function Assessed by Standard Neurocognitive Battery(Through study completion, up to 34 weeks)
研究者
研究点 (2)
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