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

NCT01345864 | Terminated Phase 1

• 1 other identifier: B1661006
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

attention cognition memory problem solving scopolamine challenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Cohort A

OTHER

Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.

Drug: Scopolamine + Donepezil Placebo + PF-04995274 Placebo; Drug: Scopolamine + Donepezil 5 mg + PF-04995274 Placebo; Drug: Scopolamine + Donepezil 10mg + PF-04995274 Placebo; Drug: Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg; Drug: Scopolamine + Donepezil Placebo + PF-04995274 15 mg

Interventions

Scopolamine + Donepezil Placebo + PF-04995274 Placebo DRUG

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

Cohort A

Scopolamine + Donepezil 5 mg + PF-04995274 Placebo DRUG

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

Cohort A

Scopolamine + Donepezil 10mg + PF-04995274 Placebo DRUG

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

Cohort A

Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg DRUG

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

Cohort A

Scopolamine + Donepezil Placebo + PF-04995274 15 mg DRUG

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

Cohort A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Scopolamine; Donepezil

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 2, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

US (1)