Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
研究概览
简要总结
This study examines the sensitivity of functional MRI to detect brain changes caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for Alzheimer's Disease.
详细描述
This 24-week study will examine the sensitivity of functional MRI to detect brain changes caused by donepezil HCL (a cholinesterase inhibitor) in healthy older adults at genetic risk for Alzheimer's Disease. Participants with a family history of Alzheimer's Disease will be eligible for this study. Participants without a family history of AD will also be enrolled to serve as a control group.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal general cognitive function
- •High Risk Group Only: Family history (1st degree relative) of AD
- •Low Risk Group Only: No family history (1st or 2nd degree relative) of AD
- •Visual and auditory acuity adequate for neuropsychological testing
排除标准
- •Current or past history of
- •neurological illnesses/conditions
- •head trauma with significant loss of consciousness
- •medical illnesses/conditions that may affect brain function
- •severe psychiatric disorder
- •substance abuse
- •unstable or severe cardiovascular disease or asthmatic condition
- •history of stroke or transient ischemic attack
研究组 & 干预措施
Donepezil HCL
Participants will receive 5mg of donepezil HCL for 4 weeks and then 10mg of donepezil HCL for 20 weeks.
干预措施: donepezil HCL (Drug)
Placebo
Participants will receive placebo for 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Left Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
时间窗: Baseline and 24 Weeks
Left hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal.
Change in BOLD Response From Baseline to 24 Weeks During Functional Magnetic Resonance Imaging - Left Posterior Cingulate BOLD Signal at 24 Weeks, Adjusting for Baseline Left Posterior Cingulate BOLD
时间窗: Baseline and 24 Weeks
Changes from baseline to 24 weeks follow-up fMRI - Left posterior cingulate BOLD signal at 24 weeks, adjusting for baseline left posterior cingulate BOLD signal.
Right Hippocampus BOLD Signal at 24 Weeks, Adjusted for Baseline Left Hippocampus BOLD Signal
时间窗: Baseline and 24 Weeks
Right hippocampus BOLD signal at 24 weeks, adjusting for baseline left hippocampus BOLD signal.
次要结局
- Brief Visuospatial Memory Test (BVMT) Learning Scores at 24 Weeks, Adjusted for Baseline BVMT Learning Scores(Baseline and 24 Weeks)
- Processing Speed Test (PST) at 24 Weeks, Adjusted for Baseline PST Scores(Baseline and 24 Weeks)
- Neuropsychological Testing Scores - Rey Auditory Verbal Learning Test (RAVLT) Sum of Trials (1-5) at 24 Weeks, Adjusted for Baseline RAVLT Score(Baseline and 24 Weeks)
- Left Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Left Hippocampus Volume(Baseline and 24 Weeks)
- Right Hippocampus Volume (MRI) at 24 Weeks, Adjusted for Baseline Right Hippocampus Volume(Baseline and 24 Weeks)
研究者
Stephen Rao
Principal Investigator
The Cleveland Clinic