NCT00887601

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

April 23, 2009

Last Update Submit

July 29, 2015

Conditions

Dementia

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (5)

  • 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

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

    5 hours after study drug administration

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

    1 to 5 weeks

  • 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

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

    5 hours after study drug administration

Study Arms (2)

Part I

EXPERIMENTAL

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

Drug: MK3134Drug: Comparator: PlaceboDrug: Donepezil

Part II

EXPERIMENTAL

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

Drug: Comparator: PlaceboDrug: MK3134

Interventions

MK3134DRUG

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

Part I
Comparator: PlaceboDRUG

Placebo capsules only in one of the four treatment periods.

Part IPart II
DonepezilDRUG

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

Also known as: Aricept
Part I

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is a nonsmoker
  • Subject is in generally good health
  • Subject has normal (or corrected to normal) vision and hearing
  • Subject is right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

August 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 30, 2015

Record last verified: 2015-07