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BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006)

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ClinicalTrials.gov Identifier: NCT00887601
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Dementia Drug: MK3134 Drug: Comparator: Placebo Drug: Donepezil Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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)
Study Start Date : August 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Part I: Difference in Pulsatility index after treatment with donepezil and placebo [ Time Frame: 5 hours after study drug administration ]
  3. Part I: Test-retest reproducibility of the BOLD fMRI and cerebral blood flow measurements in donepezil treated subjects [ Time Frame: 1 to 5 weeks ]
  4. 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 ]
  5. Part II: Change in Pulsatility index after treatment with placebo and varying doses of MK3134 [ Time Frame: 5 hours after study drug administration ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887601


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00887601     History of Changes
Other Study ID Numbers: 3134-006
2009_583
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Nootropic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs