NCT02000583已完成不适用
Effect of Aerobic Exercise on Pathophysiology of PreClinical Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Amyloid Burden
研究概览
简要总结
The purpose of this study is to learn about the possible benefits of aerobic exercise in controlling or reducing the amount of amyloid present in the brain, reducing changes in brain structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in individuals that have amyloid deposits and are at risk to develop AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Clinical Dementia Rating 0 (nondemented)
- •Age 65 or older
- •Florbetapir PET evidence of cerebral amyloidosis
- •Sedentary or underactive by the Telephone Assessment of Physical Activity
- •Stable doses of medications for 30 days.
- •Clinician judgment regarding subject's health status and likelihood to successfully complete the 1-year exercise intervention
排除标准
- •Clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to standard criteria or significant psychiatric symptoms that could impair the completion of the study
- •Clinically-significant systemic illness that may affect safety or completion of the study
- •History of clinically-evident stroke
- •Clinically-significant infection within the last 30 days
- •Active cardiac condition (e.g. angina, myocardial infarction, atrial fibrillation) or pulmonary condition in the past 2 years that, in the investigator's opinion, could pose a safety risk to the participant-unless cleared for exercise by the participant's primary care physician or cardiologist.
- •Uncontrolled hypertension within the last 6 months
- •History of cancer in the last 5 years (except non-metastatic basal or squamous cell carcinoma)
- •History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
- •Insulin-dependent diabetes mellitus
- •Significant pain or musculoskeletal disorder prohibiting participation in an exercise program
- •Unwillingness to undergo or contraindication to brain MRI scan.
- •History within the last 5 years of primary or recurrent malignant disease with the exception of resected localized cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma, or prostate cancer.
结局指标
主要结局
Amyloid Burden
时间窗: Baseline to 52 weeks
Amyloid burden measure is mean Florbetapir cortical-to-cerebellar uptake ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus). Higher numbers mean more amyloid accumulation. There is no defined maximum value. Zero is the theoretical minimum value.
次要结局
- Executive Function(Baseline to Week 52)
- Whole Brain Volume(Baseline to 52 weeks)
研究者
研究点 (2)
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