Assessment Of The Effects Of Single Doses Of An Investigational Drug, Given Alone Or With Donepezil, On Scopolamine-Induced Changes In Memory And Learning In Healthy Adults
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01345864
- Lead Sponsor
- Pfizer
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 88
- Healthy male or female volunteers; females must be of non-childbearing potential.
- Weight with normal limits for height.
- Willing to comply with study schedule and able to complete 2 practice sessions (pre-study) with computerized memory and learning/problem solving tests.
- Positive urine drug screen; concurrent use of prescription or over-the-counter (OTC) drugs or dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication.
- Use of medications with significant serotonergic, cholinergic or anticholinergic side effects [SSRIs, pyridostigmine, tricyclic antidepressants, meclizine, oxybutynin]) within 4 weeks of first dose of study drug.
- Glaucoma
- Abnormal electrocardiogram (ECG)
- Treatment with an investigational drug within 30 days of dosing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Scopolamine + Donepezil Placebo + PF-04995274 Placebo Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed. Cohort A Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed. Cohort A Scopolamine + Donepezil 5 mg + PF-04995274 Placebo Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed. Cohort A Scopolamine + Donepezil 10mg + PF-04995274 Placebo Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed. Cohort A Scopolamine + Donepezil Placebo + PF-04995274 15 mg Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.
- Primary Outcome Measures
Name Time Method Groton Maze Learning Test (Total Errors) Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States