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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01345864
• Other study ID #: B1661006
• Status: Terminated
• Phase: Phase 1
• First received: April 28, 2011
• Last updated: November 16, 2011
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Scopolamine + 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
• Scopolamine + 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
• Scopolamine + 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
• Scopolamine + 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
• Scopolamine + 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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Groton Maze Learning Test (Total Errors)		Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Bond-Lader Visual Analogue Scales		Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing	No

External Links

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