Clinical trial NCT01345864: 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
Official title: A Randomized, Double-Blind, Sponsor Unblinded, Placebo- And Positive- Controlled Study To Evaluate The Effects Of Single Oral Administrations Of PF-04995274, Alone Or In Combination With Donepezil, On Scopolamine-Induced Deficits In Psychomotor And Cognitive Function In Healthy Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: attention cognition memory problem solving scopolamine challenge
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Groton Maze Learning Test (Total Errors)
timeFrame: Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing
Secondary outcomes:
measure: Detection Task (Speed; included in CogState test battery)
timeFrame: Day 1 of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing
measure: Identification Task (Speed; included in CogState test battery)
timeFrame: Day of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing
measure: One Card Learning Task (Accuracy of Performance; included in CogState test battery)
timeFrame: Day 1 of each period at 8 time points from 1-12 hrs postdose relative to scopolamine dosing
measure: Bond-Lader Visual Analogue Scales
timeFrame: Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: