Light Treatment for Sleep/Wake Disturbances AD

描述（由申请人提供）：阿尔茨海默病（AD）是痴呆症的最常见原因。许多AD患者出现睡眠/觉醒周期障碍。我们建议进行随机对照临床试验，仔细评估非药物治疗这些问题的方法。我们的具体目标和假设是：1)功效。我们计划比较四种治疗方法对社区AD患者睡眠/觉醒周期障碍的短期疗效：1)早晨强光治疗（AM light）， 2)晚上强光治疗（PM light）， 3)早晚强光治疗（AM&PM light）和4)对照治疗，早晨弱光治疗（AM dim）。假设1：我们假设4周的AM LIGHT， PM LIGHT或AM&PM LIGHT治疗在巩固夜间睡眠方面比AM DIM治疗更有效。我们不期望看到AM LIGHT， PM LIGHT和AM&PM LIGHT之间疗效的总体差异。

DESCRIPTION (provided by applicant): Alzheimer's Disease (AD) is the most common cause of dementia. Many AD patients develop sleep/wake cycle disturbances. We propose a randomized controlled clinical trial to carefully evaluate a non-pharmacologic approach to these problems. Our specific aims and hypotheses are: 1) Efficacy. We plan to compare the short-term efficacy of four treatments for sleep/wake cycle disturbances in community-dwelling AD patients: 1) Morning bright light treatment (AM LIGHT), 2) Evening bright light treatment (PM LIGHT), 3) Morning and Evening bright light treatment (AM&PM LIGHT) and 4) a control treatment, morning dim light treatment (AM DIM). Hypothesis 1: We hypothesize that 4 weeks of either AM LIGHT, PM LIGHT or AM&PM LIGHT treatment will be more efficacious than the AM DIM treatment in consolidating nighttime sleep as assessed by actigraphy. We do not expect to see overall differences in efficacy between AM LIGHT, PM LIGHT and AM&PM LIGHT. 2) Individual Differences in Response (Moderators). We will conduct preliminary "moderator analyses" to determine in which patients which LIGHT treatment works best. Hypothesis 2: Primary Predictors of Response: Response to the LIGHT treatments will depend upon the initial MMSE score. Secondary Predictor Analyses: We expect that baseline sleep/wake and circadian parameters and age may predict response to AM LIGHT versus PM light. 3) Effectiveness and Quality of Life. We will determine if bright light therapy is effective in terms of improvement in quality of life. Hypothesis 3: We hypothesize that any of the three LIGHT treatments will be more effective than AM DIM in improving quality of life in patients and caregivers. These hypotheses will be tested in a parallel groups design study in community-dwelling AD patients with caregivers. Specifically, we propose to randomize 120 patient/caregiver dyads into four groups of 30 dyads each: AM LIGHT, PM LIGHT AM&PM LIGHT or AM DIM. After 4 weeks of treatment (Phase 1) all subjects will be given bright light for an additional 4 weeks (Phase 2). Outcome will be documented by objective circadian activity rhythm parameters and standard sleep/wake measures both assessed by actigraphy.