Falls: A Marker of Preclinical Alzheimer Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Change from baseline: Gait Speed
研究概览
简要总结
This longitudinal cohort study investigates cognitively normal participants with and without preclinical Alzheimer disease (AD) in order to examine: (1) the relationship between falls and functional mobility in preclinical stages of AD; and (2) a hypothesized model of central and peripheral mechanism(s) underlying falls and functional mobility in preclinical stages of AD.
详细描述
Alzheimer disease (AD) is a slowly progressive neurodegenerative disease. Conversion to symptomatic AD occurs slowly over years through a series of preclinical stages marked by changes in molecular biomarkers. It is unknown whether functional mobility and falls are preclinical markers of AD.
This longitudinal clinical study evaluates a cohort of cognitively normal individuals who are currently undergoing comprehensive clinical, neuropsychological, and biomarker evaluations at the Knight Alzheimer's Disease Research Center (Knight ADRC). They receive an annual in-home evaluation of fall risks and functional mobility and prospective ascertainment of falls. Comparisons of assessments of functional mobility will be performed with regard to measures of brain pathology (i.e., amyloidosis, tau, and neurodegeneration) to allow researchers to characterize when changes in falls and functional mobility occur during preclinical stages of AD.
This study also examines the central and peripheral system mechanism(s) underlying falls and functional mobility in preclinical AD using structural equation modeling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years of age or older
- •cognitively normal (Clinical Dementia Rating [CDR] score of 0)
- •A pilot sub-study collecting stool will also enroll a few individuals with CDR>0 for comparison.
- •have biomarkers (CSF), and/or neuroimaging (positron emission tomography [PET] and/or magnetic resonance imaging [MRI]) within 2 years of enrolling in this study.
排除标准
- •History of Parkinson's disease.
结局指标
主要结局
Change from baseline: Gait Speed
时间窗: 4 years post-enrollment
Gait speed will be collected using the Timed Up and Go (TUG) test.
Change from baseline: Dynamic balance and mobility
时间窗: 4 years post-enrollment
Dynamic balance and mobility will be assessed using the Performance Oriented Mobility Assessment (POMA), a task-oriented assessment.
Number and Severity of Falls
时间窗: Cumulative falls at 4 years post-enrollment
Prospective monthly fall reporting will be collected using an automated phone/email system. Severity of falls will be calculated using a previously published algorithm.
Change from baseline: Dual-task gait
时间窗: 4 years post-enrollment
Dual-task gait will be collected using the Timed Up and Go Cognitive (TUGcog) and Timed Up and Go Manual (TUGman)
Fall Severity
时间窗: Per 12 month time period
Prospective monthly fall reporting was collected using an automated phone/email system. Severity of falls was calculated using a previously published algorithm.
次要结局
- Fall Risk Composite Score(4 years post-enrollment)
- Change from baseline: Standing balance and vestibular function(4 years post-enrollment)
- Change from baseline: Falls behavior(4 years post-enrollment)
- Change from baseline: Depression(4 years post-enrollment)
- Change from baseline: Sensation(4 years post-enrollment)
- Change from baseline: Lower extremity strength(4 years post-enrollment)
- Change from baseline: Grip strength(4 years post-enrollment)
- Change from baseline: Vision(4 years post-enrollment)
- Change in baseline: Functional performance(4 years post-enrollment)
- Change from baseline: Olfaction(2 years post-enrollment)
- Change from baseline: Hearing(4 years post-enrollment)
研究者
Susan Stark
Associate Professor of Occupational Therapy, Neurology, and Social Work
Washington University School of Medicine