BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs - Full Text View

Purpose

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
Dementia	Drug: MK3134 Drug: Comparator: Placebo Drug: Donepezil	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
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)

Resource links provided by NLM:

MedlinePlus related topics: Dementia MRI Scans

Drug Information available for: Donepezil hydrochloride Donepezil

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Part I: Difference in number of voxels showing a positive response after treatment with donepezil and placebo [ Time Frame: 3.5 to 4.5 hours after study drug administration ] [ Designated as safety issue: No ]
Part I: Difference in number of voxels activated for both faces and scenes after treatment with donepezil and placebo [ Time Frame: 3.5 to 4.5 hours after study drug administration ] [ Designated as safety issue: No ]
Part II: Number of voxels showing a positive response after varying doses of MK3134 compared to placebo [ Time Frame: 3.5 to 4.5 hours after study drug administration ] [ Designated as safety issue: No ]
Part II: Number of voxels activated for both faces and scenes after varying doses of MK3134 compared to placebo [ Time Frame: 3.5 to 4.5 hours after study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Part I: Difference in arterial transit time as measured by arterial spin labeling after treatment with donepezil and placebo [ Time Frame: 3.5 to 4.5 hours after study drug administration ] [ Designated as safety issue: No ]
Part I: Difference in Pulsatility index after treatment with donepezil and placebo [ Time Frame: 5 hours after study drug administration ] [ Designated as safety issue: No ]
Part I: Test-retest reproducibility of the BOLD fMRI and cerebral blood flow measurements in donepezil treated subjects [ Time Frame: 1 to 5 weeks ] [ Designated as safety issue: No ]
Part II: Change in arterial transit time after treatment with placebo and varying doses of MK3134 [ Time Frame: 3.5 to 4.5 hours after study drug administration ] [ Designated as safety issue: No ]
Part II: Change in Pulsatility index after treatment with placebo and varying doses of MK3134 [ Time Frame: 5 hours after study drug administration ] [ Designated as safety issue: No ]

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
Experimental: Part I Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences.	Drug: MK3134 Single dose 25 mg (5 x 5 mg) MK3134 capsules in one of the four treatment periods. Other Name: MK3134 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. Other Name: Aricept
Experimental: 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.	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 Other Name: MK3134

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887601

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00887601 History of Changes
Other Study ID Numbers:	2009_583, MK3134-006
Study First Received:	April 23, 2009
Last Updated:	September 23, 2009
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Nootropic Agents
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013