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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part I

Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences.

Group Type EXPERIMENTAL

MK3134

Intervention Type DRUG

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

Comparator: Placebo

Intervention Type DRUG

Placebo capsules only in one of the four treatment periods.

Donepezil

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Comparator: Placebo

Intervention Type DRUG

Placebo capsules only in one of the four treatment periods.

MK3134

Intervention Type DRUG

Single doses of 1 mg, 5 mg, or 25 mg MK3134 capsules in the assigned treatment periods

Interventions

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MK3134

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

Intervention Type DRUG

Comparator: Placebo

Placebo capsules only in one of the four treatment periods.

Intervention Type DRUG

Donepezil

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

Intervention Type DRUG

MK3134

Single doses of 1 mg, 5 mg, or 25 mg MK3134 capsules in the assigned treatment periods

Intervention Type DRUG

Other Intervention Names

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Aricept

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes