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

Dementia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887601
• Other study ID #: 3134-006
• Secondary ID: 2009_583
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2009
• Last updated: July 29, 2015
• Start date: August 2007
• Est. completion date: May 2008

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dementia

Intervention

Drug:
• MK3134
Single dose 25 mg (5 x 5 mg) MK3134 capsules in one of the four treatment periods.
• Comparator: Placebo
Placebo capsules only in one of the four treatment periods.
• Donepezil
Single dose 5 mg donepezil capsules in two of the four treatment periods.
• MK3134
Single doses of 1 mg, 5 mg, or 25 mg MK3134 capsules in the assigned treatment periods

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part I: Difference in number of voxels showing a positive response after treatment with donepezil and placebo		3.5 to 4.5 hours after study drug administration	No
Primary	Part I: Difference in number of voxels activated for both faces and scenes after treatment with donepezil and placebo		3.5 to 4.5 hours after study drug administration	No
Primary	Part II: Number of voxels showing a positive response after varying doses of MK3134 compared to placebo		3.5 to 4.5 hours after study drug administration	No
Primary	Part II: Number of voxels activated for both faces and scenes after varying doses of MK3134 compared to placebo		3.5 to 4.5 hours after study drug administration	No
Secondary	Part I: Difference in arterial transit time as measured by arterial spin labeling after treatment with donepezil and placebo		3.5 to 4.5 hours after study drug administration	No
Secondary	Part I: Difference in Pulsatility index after treatment with donepezil and placebo		5 hours after study drug administration	No
Secondary	Part I: Test-retest reproducibility of the BOLD fMRI and cerebral blood flow measurements in donepezil treated subjects		1 to 5 weeks	No
Secondary	Part II: Change in arterial transit time after treatment with placebo and varying doses of MK3134		3.5 to 4.5 hours after study drug administration	No
Secondary	Part II: Change in Pulsatility index after treatment with placebo and varying doses of MK3134		5 hours after study drug administration	No