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Completed

NCT Number: NCT00887601

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK3134

Drug

Single dose 25 mg (5 x 5 mg) MK3134 capsules in one of the four treatment periods.

Comparator: placebo

Drug

Placebo capsules only in one of the four treatment periods.

Donepezil

Drug

Single dose 5 mg donepezil capsules in two of the four treatment periods.

Other names: Aricept

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 24, 2009
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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