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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
88
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
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 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 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 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
Pfizer Investigational Site
New Haven, Connecticut, United States
Groton Maze Learning Test (Total Errors)
Time frame: Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing
Detection Task (Speed; included in CogState test battery)
Time frame: 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)
Time frame: Day of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing
One Card Learning Task (Accuracy of Performance; included in CogState test battery)
Time frame: Day 1 of each period at 8 time points from 1-12 hrs postdose relative to scopolamine dosing
Bond-Lader Visual Analogue Scales
Time frame: Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing
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