Clinical trial NCT00887601: BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dementia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part I: Difference in number of voxels showing a positive response after treatment with donepezil and placebo
timeFrame: 3.5 to 4.5 hours after study drug administration
measure: Part I: Difference in number of voxels activated for both faces and scenes after treatment with donepezil and placebo
timeFrame: 3.5 to 4.5 hours after study drug administration
measure: Part II: Number of voxels showing a positive response after varying doses of MK3134 compared to placebo
timeFrame: 3.5 to 4.5 hours after study drug administration
measure: Part II: Number of voxels activated for both faces and scenes after varying doses of MK3134 compared to placebo
timeFrame: 3.5 to 4.5 hours after study drug administration
Secondary outcomes:
measure: Part I: Difference in arterial transit time as measured by arterial spin labeling after treatment with donepezil and placebo
timeFrame: 3.5 to 4.5 hours after study drug administration
measure: Part I: Difference in Pulsatility index after treatment with donepezil and placebo
timeFrame: 5 hours after study drug administration
measure: Part I: Test-retest reproducibility of the BOLD fMRI and cerebral blood flow measurements in donepezil treated subjects
timeFrame: 1 to 5 weeks
measure: Part II: Change in arterial transit time after treatment with placebo and varying doses of MK3134
timeFrame: 3.5 to 4.5 hours after study drug administration
measure: Part II: Change in Pulsatility index after treatment with placebo and varying doses of MK3134
timeFrame: 5 hours after study drug administration
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: