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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00887601 |
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.
Condition | Intervention | Phase |
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Dementia |
Drug: MK3134 Drug: Comparator: Placebo Drug: Donepezil |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
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) |
Enrollment: | 32 |
Study Start Date: | August 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Part I: Experimental
Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences.
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Drug: MK3134
Single dose 25 mg (5 x 5 mg) MK3134 capsules in one of the four treatment periods.
Drug: Comparator: Placebo
Placebo capsules only in one of the four treatment periods.
Drug: Donepezil
Single dose 5 mg donepezil capsules in two of the four treatment periods.
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Part II: Experimental
Subjects will receive placebo and three different doses of MK3134 (1 mg, 5 mg, and 25 mg) in one of four treatment sequences.
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Drug: Comparator: Placebo
Placebo capsules only in one of the four treatment periods.
Drug: MK3134
Single doses of 1 mg, 5 mg, or 25 mg MK3134 capsules in the assigned treatment periods
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2009_583, MK3134-006 |
Study First Received: | April 23, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00887601 History of Changes |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Cholinesterase Inhibitors Nootropic Agents Neurotransmitter Agents Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil |
Central Nervous System Diseases Cholinergic Agents Brain Diseases Dementia Cognition Disorders Delirium |
Nootropic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Brain Diseases |
Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Donepezil Dementia Central Nervous System Agents |