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

Merck Sharp & Dohme LLC32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Dementia

Interventions

MK3134DRUG

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

Comparator: PlaceboDRUG

Placebo capsules only in one of the four treatment periods.

DonepezilDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Part I: Difference in number of voxels showing a positive response after treatment with donepezil and placebo