Healthy
Conditions
Keywords
attention cognition memory problem solving scopolamine challenge
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.
Interventions
DRUGScopolamine + Donepezil Placebo + PF-04995274 Placebo
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
DRUGScopolamine + Donepezil 5 mg + PF-04995274 Placebo
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
DRUGScopolamine + Donepezil 10mg + PF-04995274 Placebo
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
DRUGScopolamine + Donepezil Placebo + PF-04995274 0.25 mg
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
DRUGScopolamine + Donepezil Placebo + PF-04995274 15 mg
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
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Outcome results
None listed