CompletedPhase 1

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

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)

Lead sponsor

Merck Sharp & Dohme LLC

Assets

Donepezil / MK3134

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criteria

•Age 18-45•Male

Primary endpoints

•Part I•Part II

Identifiers

Registered as

Secondary2009_583

Org study ID3134-006

NCT IDNCT00887601

Timeline

Milestones

Study start2007-08 (month precision)

Primary completion2008-05actual (month precision)

Study completion2008-05actual (month precision)

Study first posted2009-04-24estimated

Last update posted2015-07-30estimated

Assets

Drug assets

Donepezil MK3134

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

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

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Neuroimaging

1 endpoint

Secondary/protocol endpoint

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

Time frame:1 to 5 weeks

descriptive

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

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

event count, event

Primary/protocol endpoint/low confidence

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

event count, event

Primary/protocol endpoint/low confidence

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

event count, event

Primary/protocol endpoint/low confidence

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

event count, event

Secondary/protocol endpoint/low confidence

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

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:5 hours after study drug administration

descriptive

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:5 hours after study drug administration

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.