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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:
ClinicalTrials.gov Identifier:
NCT01345864
First Posted: May 2, 2011
Last Update Posted: November 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01345864     History of Changes
Other Study ID Numbers: B1661006
First Submitted: April 28, 2011
First Posted: May 2, 2011
Last Update Posted: November 17, 2011
Last Verified: November 2011

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

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