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DementiaPhase 1NCT00887601

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

A Phase 1 study testing MK3134 and Donepezil in people with Dementia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Dementia
What is being tested?
MK3134 and Donepezil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
No sites listed yet
Study dates
Aug 2007to May 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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)

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.

Conditions
Dementia
Being tested
MK3134, Comparator: Placebo, Donepezil
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK3134Drug

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

  • Comparator: PlaceboDrug

    Placebo capsules only in one of the four treatment periods.

  • DonepezilDrug

    Also called Aricept

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

  • MK3134Drug

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

Study groups in NCT00887601
Study groupRoleWhat they receive
Part IExperimentalSubjects will receive placebo, MK3134, and donepezil in one of four treatment sequences.
Receives: Drug: MK3134; Drug: Comparator: Placebo; Drug: Donepezil
Part IIExperimentalSubjects will receive placebo and three different doses of MK3134 (1 mg, 5 mg, and 25 mg) in one of four treatment sequences.
Receives: Drug: Comparator: Placebo; Drug: MK3134

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3.5 to 4.5 hours after study drug administration

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

    Measured: 3.5 to 4.5 hours after study drug administration

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

    Measured: 3.5 to 4.5 hours after study drug administration

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

    Measured: 3.5 to 4.5 hours after study drug administration

Secondary outcomes (5)

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

    Measured: 3.5 to 4.5 hours after study drug administration

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

    Measured: 5 hours after study drug administration

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

    Measured: 1 to 5 weeks

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

    Measured: 3.5 to 4.5 hours after study drug administration

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

    Measured: 5 hours after study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2009 (estimated)
  2. Study startAug 2007
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887601
Sponsor's protocol ID
3134-006
Other IDs
2009_583
Status last verified
Jul 2015
First submitted
23 Apr 2009
Last updated
30 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK3134 and Donepezil in people with Dementia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00887601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.

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