A 4-Period, Placebo-Controlled, Crossover Study to Evaluate the Utility and Feasibility of BOLD fMRI and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (Donepezil and MK3134)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Part I: Difference in number of voxels activated for both faces and scenes after treatment with donepezil and placebo
研究概览
简要总结
This study will evaluate functional magnetic resonance imaging (fMRI) and methods for measuring drug induced changes in cerebral blood flow as biomarkers for attention-improving drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a nonsmoker
- •Subject is in generally good health
- •Subject has normal (or corrected to normal) vision and hearing
- •Subject is right-handed
排除标准
- •Subject has a history of any illness that would make participation unsafe or would make the study results difficult to interpret
- •Subject has a history of stroke, seizures, or major neurological disorders
- •Subject has a history of cancer
- •Subject has permanent cosmetic or metallic implants that would interfere with measurements
- •Subject has a history of sleep apnea
- •Subject has a history of head injury/trauma
研究组 & 干预措施
Part I
Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences.
干预措施: MK3134 (Drug)
Part I
Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences.
干预措施: Donepezil (Drug)
Part II
Subjects will receive placebo and three different doses of MK3134 (1 mg, 5 mg, and 25 mg) in one of four treatment sequences.
干预措施: MK3134 (Drug)
结局指标
主要结局
Part I: Difference in number of voxels activated for both faces and scenes after treatment with donepezil and placebo
时间窗: 3.5 to 4.5 hours after study drug administration
Part II: Number of voxels showing a positive response after varying doses of MK3134 compared to placebo
时间窗: 3.5 to 4.5 hours after study drug administration
Part I: Difference in number of voxels showing a positive response after treatment with donepezil and placebo
时间窗: 3.5 to 4.5 hours after study drug administration
Part II: Number of voxels activated for both faces and scenes after varying doses of MK3134 compared to placebo
时间窗: 3.5 to 4.5 hours after study drug administration
次要结局
- Part I: Test-retest reproducibility of the BOLD fMRI and cerebral blood flow measurements in donepezil treated subjects(1 to 5 weeks)
- Part II: Change in arterial transit time after treatment with placebo and varying doses of MK3134(3.5 to 4.5 hours after study drug administration)
- Part II: Change in Pulsatility index after treatment with placebo and varying doses of MK3134(5 hours after study drug administration)
- Part I: Difference in Pulsatility index after treatment with donepezil and placebo(5 hours after study drug administration)
- Part I: Difference in arterial transit time as measured by arterial spin labeling after treatment with donepezil and placebo(3.5 to 4.5 hours after study drug administration)