BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006)
- Registration Number
- NCT00887601
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
- Subject is a nonsmoker
- Subject is in generally good health
- Subject has normal (or corrected to normal) vision and hearing
- Subject is right-handed
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part I Donepezil Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences. Part I MK3134 Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences. Part II MK3134 Subjects will receive placebo and three different doses of MK3134 (1 mg, 5 mg, and 25 mg) in one of four treatment sequences.
- Primary Outcome Measures
Name Time Method Part I: Difference in number of voxels activated for both faces and scenes after treatment with donepezil and placebo 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 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 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 3.5 to 4.5 hours after study drug administration
- Secondary Outcome Measures
Name Time Method 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