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It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive impairments in healthy adults subjects.
Proof of mechanism
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | placebo, plus scopolamine 0.5 mg |
|
| PF-05212377 5 mg, plus scopolamine 0.5 mg; | Experimental |
| |
| PF-05212377 20 mg, plus scopolamine 0.5 mg; | Experimental |
| |
| PF-05212377 60 mg, plus scopolamine 0.5 mg; | Experimental |
| |
| donepezil 10 mg, plus scopolamine 0.5 mg. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Capsule, single dose, oral, 1 day |
| |
| Scopolamine |
| Measure | Description | Time Frame |
|---|---|---|
| Groton Maze Learning Task (Total Errors); included in CogState Battery of Tests. | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Task (Speed; included in CogState Test Battery) | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period | |
| One Card Learning Task (Accuracy of performance; included in CogState Test Battery) | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Rennes | 35000 | France |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D012601 | Scopolamine |
| C000633777 | SAM-760 |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Drug |
injectable subcutaneous formulation, single dose, 1 day |
|
| PF-05212377 | Drug | 5 mg, PF-05212377, capsule, single dose, 1 day |
|
| Scopolamine | Drug | injectable subcutaneous formulation, single dose, 1 day |
|
| PF-05212377 | Drug | 20 mg, capsule PF-05212377, single dose, 1 day |
|
| scopolamine | Drug | injectable subcutaneous formulation, single dose, 1 day |
|
| PF-05212377 | Drug | 60 mg PF-05212377, capsule, single dose, 1 day |
|
| scopolamine | Drug | injectable sub cutaneous formulation, single dose, 1 day |
|
| Donepezil | Drug | Tablet, 10mg, single dose, 1 day |
|
| Scopolamine | Drug | injectable sub cutaneous formulation, single dose, 1 day |
|
| Continuous Paired Associate Learning Task (Number of errors; included in CogState Test Battery) | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period |
| Bond-Lader Visual Analog Scales (included in CogState Test Battery) | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period |
| Identification Task (Speed; included in CogState Test Battery) | Day 1 at 0, 5, 6, 7, 8, 10 and 12 hours of each period |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011083 | Polycyclic Compounds |