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
  Purpose

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).


Condition Intervention Phase
Healthy
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
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 88
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort A
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
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

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345864

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01345864     History of Changes
Other Study ID Numbers: B1661006
Study First Received: April 28, 2011
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
attention cognition memory problem solving scopolamine challenge

Additional relevant MeSH terms:
Butylscopolammonium Bromide
Scopolamine Hydrobromide
Donepezil
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Mydriatics
Cholinesterase Inhibitors
Enzyme Inhibitors
Nootropic Agents

ClinicalTrials.gov processed this record on August 26, 2014