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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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01345864
First received: April 28, 2011
Last updated: November 16, 2011
Last verified: November 2011
History of Changes

April 28, 2011
November 16, 2011
May 2011
July 2011   (final data collection date for primary outcome measure)
Groton Maze Learning Test (Total Errors) [ Time Frame: Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01345864 on ClinicalTrials.gov Archive Site
  • Detection Task (Speed; included in CogState test battery) [ Time Frame: Day 1 of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing ] [ Designated as safety issue: No ]
  • Identification Task (Speed; included in CogState test battery) [ Time Frame: Day of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing ] [ Designated as safety issue: No ]
  • One Card Learning Task (Accuracy of Performance; included in CogState test battery) [ Time Frame: Day 1 of each period at 8 time points from 1-12 hrs postdose relative to scopolamine dosing ] [ Designated as safety issue: No ]
  • Bond-Lader Visual Analogue Scales [ Time Frame: Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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).

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
  • Drug: 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
  • Drug: 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
  • Drug: 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
  • Drug: 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
Cohort A
Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
88
August 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01345864
B1661006
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP