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See termination reason in detailed description.
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This study is designed to look at the potential for an investigational drug (PF-04995274, under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to reverse changes in memory and learning/problem solving skills caused by co-administration of a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in memory and learning/problem solving skills that are similar to those seen in people with alzheimer's disease(AD).
Changes in sponsor's organizational strategy have led to the decision to terminate the study and therefore to not conduct the second cohort (Cohort B/arms 2 and 3) . This decision was not based on significant safety concerns. Date of termination (ie, the date the site was notified to stop study activities) was 12 Oct 2011.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Other | Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scopolamine + Donepezil Placebo + PF-04995274 Placebo | Drug | Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Groton Maze Learning Test (Total Errors) | Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Task (Speed; included in CogState test battery) | Day 1 of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing | |
| Identification Task (Speed; included in CogState test battery) | Day of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing |
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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 | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Scopolamine + Donepezil 5 mg + PF-04995274 Placebo | Drug | Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 5 mg tablet orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1 |
|
| Scopolamine + Donepezil 10mg + PF-04995274 Placebo | Drug | Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 10 mg (2 x 5 mg tablets) orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1 |
|
| Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg | Drug | Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 0.25 mg oral liquid x 1 dose on Day 1 |
|
| Scopolamine + Donepezil Placebo + PF-04995274 15 mg | Drug | Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 15 mg oral liquid x 1 dose on day 1 |
|
| One Card Learning Task (Accuracy of Performance; included in CogState test battery) | Day 1 of each period at 8 time points from 1-12 hrs postdose relative to scopolamine dosing |
| Bond-Lader Visual Analogue Scales | Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing |
| ID | Term |
|---|---|
| D012601 | Scopolamine |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| 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 |
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