Mechanisms of Mindfulness for Cognition in Early-Stage Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Neuropsychological tests
研究概览
简要总结
The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are:
- How does mindfulness impact thinking and memory?
- How does mindfulness influence brain function and structure?
- How does mindfulness affect daily function and quality of life?
Researchers will compare all outcomes to one other groups. In one group, individuals will participate in a mindfulness class intervention; in the other group, individuals will not engage in any active interventions immediately, but will be placed on a waitlist for the mindfulness intervention. Researchers will compare all outcomes between the groups groups to determine whether the mindfulness interventions leads to greater improvement compared to no intervention (waitlist group).
Participants will:
- Be randomly assigned to participate in the mindfulness intervention, or no immediate intervention (waitlist)
- Complete paper-and-pencil cognitive testing, surveys, computerized tasks, and neuroimaging measures (EEG and MRI) before and after the intervention
Outcomes will be assess at baseline, 2 months, 4 months 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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy older adults will show cognitive performance within 1.0 SD for age & education adjusted norms on a neuropsychological test battery
- •Mild cognitive impairment (MCI) participants will show performance on delayed recall or one more or more other cognitive domains worse than 1.5 SD for age & education adjusted norms, an MMSE score between 25-30, and a MoCA score between 20-30.
排除标准
- •Participants without a computer, smart phone and internet access will be excluded
- •If they cannot understand the informed consent form or have moderate dementia.
- •Mood disorders (e.g., PTSD, depression, anxiety) or alcohol and drug use that either interferes with day-to-day life or required hospitalization within the past 5 years
- •Cerebrovascular disease
- •Any medical condition whose severity could significantly impair cognition (e.g., stroke, frontotermporal dementia, Parkinson's disease) are exclusionary
结局指标
主要结局
Neuropsychological tests
时间窗: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Paper-and-pencil tests measuring attention, processing speed, and memory.
Performance on computerized tasks
时间窗: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Reaction time and accuracy on computer tasks measuring attention and memory
Resting state and event-related electrophysiology
时间窗: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Electrophysiology measured while at rest and time-locked to performance on a computerized task measuring attention and memory
Brain function and structure
时间窗: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Blood-oxygen-level-dependent (BOLD) for functional magnetic resonance imaging. Voxel-based morphometry (VBM) and diffusion tensor imaging (DTI) for structural magnetic resonance imaging.
Survey outcomes
时间窗: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Surveys measuring mood, social isolation, sleep, and quality of life
次要结局
未报告次要终点
研究者
Katherine Turk
Behavioral Neurologist at VA Boston Memory Disorders Clinic; Assistant Professor of Neurology at Boston University Chobanian & Avedisian School of Medicine
VA Boston Healthcare System