A Single Center Study To Examine Neural Correlates Of Cognition In Subjects With Mild Alzheimer's Disease After Three Months Of Open Label Donepezil HCl (Aricept® ) Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI)
研究概览
简要总结
The objective of this study was to identify neural correlates of cognitive improvement after 3 months of donepezil hydrochloride treatment using either or both of two functional magnetic resonance imaging (fMRI) measures - the functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion; in the Medial Temporal Lobe (MTL) network in subjects in the early stage of Alzheimer's Disease (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, aged 50 and older with mild Alzheimer's disease (MMSE scores of 20 to 30 are allowed).
- •Diagnostic evidence of Alzheimer's disease.
- •Previous use of cholinesterase inhibitors (other than Aricept) and memantine allowed.
排除标准
- •Prior use of Aricept, pacemakers and insulin dependent diabetes are not allowed.
研究组 & 干预措施
Donepezil hydrochloride
干预措施: Donepezil hydrochloride (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 12 Based on Hippocampus Connectivity Index (HCI)
时间窗: Week 12
All neuroimaging procedures were performed on a research-dedicated GE 3.0 Tesla whole-body Excite scanner with 8-channel phase-array head coil. Resting-state functional magnetic resonance imaging (fMRI) of the medial temporal lobe (MTL) was performed. The functional HCI was derived from the MTL network using a data driven approach corresponding voxel time courses from the fMR images were processed to extract low frequency fluctuations. Functional connectivity was quantified by calculating the cross-correlation of each voxel time course in the hippocampus to all voxel time courses of the whole brain and the mean of absolute cross-correlation coefficients between a hippocampus voxel to the whole-brain voxels. HCI was then calculated as the average of all hippocampus cross-correlation coefficients. Change from baseline (CFB) was calculated using the CBF-Perfusion Processing Method. A positive change from baseline for HCI indicates improved function.
次要结局
- Change From Baseline at Week 12 in Mini-Mental State Examination (MMSE) Score(Baseline and Week 12)
- Change From Baseline at Week 12 in the Instrumental Activities of Daily Living (IADL) Assessment Score(Baseline and Week 12)
- Change From Baseline at Week 12 in the Neuropsychiatric Inventory (NPI) Score(Baseline and Week 12)
- Change From Baseline at Week 12 in Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS)-Cog Score(Baseline and Week 12)