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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_583 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I | Experimental | Subjects will receive placebo, MK3134, and donepezil in one of four treatment sequences. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK3134 | Drug | Single dose 25 mg (5 x 5 mg) MK3134 capsules in one of the four treatment periods. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| Comparator: Placebo |
| Drug |
Placebo capsules only in one of the four treatment periods. |
|
| Donepezil | Drug | Single dose 5 mg donepezil capsules in two of the four treatment periods. |
|
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| MK3134 | Drug | Single doses of 1 mg, 5 mg, or 25 mg MK3134 capsules in the assigned treatment periods |
|
| 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 |
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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