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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dementia

Treatments: Drug: Comparator: Placebo; Drug: Donepezil; Drug: MK3134

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887601

2009_583

3134-006

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Part I

Experimental group

Description:

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

Treatment:

Drug: MK3134

Drug: MK3134

Drug: Donepezil

Drug: Comparator: Placebo

Part II

Experimental group

Description:

Subjects will receive placebo and three different doses of MK3134 (1 mg, 5 mg, and 25 mg) in one of four treatment sequences.

Treatment:

Drug: MK3134

Drug: MK3134

Drug: Comparator: Placebo