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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00887601
First received: April 23, 2009
Last updated: August 16, 2013
Last verified: August 2013
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00887601     History of Changes
Other Study ID Numbers: 3134-006, 2009_583
Study First Received: April 23, 2009
Last Updated: August 16, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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 July 23, 2014