Back to results

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

Primary Purpose

Dementia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MK3134

Comparator: Placebo

Donepezil

MK3134

About this trial

This is an interventional diagnostic trial for Dementia

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part I

Part II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Part I: Difference in number of voxels activated for both faces and scenes after treatment with donepezil and placebo

Part II: Number of voxels showing a positive response after varying doses of MK3134 compared to placebo

Part II: Number of voxels activated for both faces and scenes after varying doses of MK3134 compared to placebo

Secondary Outcome Measures

Part I: Difference in arterial transit time as measured by arterial spin labeling after treatment with donepezil and placebo

Part I: Difference in Pulsatility index after treatment with donepezil and placebo

Part I: Test-retest reproducibility of the BOLD fMRI and cerebral blood flow measurements in donepezil treated subjects

Part II: Change in arterial transit time after treatment with placebo and varying doses of MK3134

Part II: Change in Pulsatility index after treatment with placebo and varying doses of MK3134

Full Information

NCT ID

NCT00887601

First Posted

April 23, 2009

Last Updated

July 29, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00887601

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part I

Arm Type

Experimental

Arm Description

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

Arm Title

Part II

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MK3134

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: Placebo

Intervention Description

Placebo capsules only in one of the four treatment periods.

Intervention Type

Drug

Intervention Name(s)

Donepezil

Other Intervention Name(s)

Aricept

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MK3134

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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 Outcome Measure Information:

Title

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

Title

Part I: Difference in Pulsatility index after treatment with donepezil and placebo

Time Frame

5 hours after study drug administration

Title

Part I: Test-retest reproducibility of the BOLD fMRI and cerebral blood flow measurements in donepezil treated subjects

Time Frame

1 to 5 weeks

Title

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

Title

Part II: Change in Pulsatility index after treatment with placebo and varying doses of MK3134

Time Frame

5 hours after study drug administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs