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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

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NCT01345864

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01345864
Pfizer
Terminated
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

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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
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01345864
B1661006
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

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