A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease

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NCT00930059

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Study Location
Neurology Clinic, PC
Northport, Alabama, 35476, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Mild to moderate Alzheimer's disease (MMSE 14-26)

- Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)

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


- Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or
memantine within 12 weeks of the start of the study


- Significant cardiovascular disease in the past 6 months


- Illness other than Alzheimer's disease that could contribute to cognitive impairment


- History of stroke or seizure disorder

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Pfizer Clinical Trials Contact Center

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  10. Jacksonville, Florida
  11. Chicago, Illinois
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  20. Portland, Oregon
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE A PHASE 2 MULTICENTER, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF PF-04447943 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE
Brief Summary The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: PF-04447943
    tablets, 25 mg every 12 hours for 12 wks
  • Drug: Placebo
    matching placebo tablets, every 12 hours for 12 wks
Study Arms  ICMJE
  • Experimental: PF-04447943
    Intervention: Drug: PF-04447943
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2020)		191
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2009)		150
Actual Study Completion Date  ICMJE September 22, 2010
Actual Primary Completion Date September 22, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild to moderate Alzheimer's disease (MMSE 14-26)
  • Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)

Exclusion Criteria:

  • Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study
  • Significant cardiovascular disease in the past 6 months
  • Illness other than Alzheimer's disease that could contribute to cognitive impairment
  • History of stroke or seizure disorder
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Chile,   Czechia,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00930059
Other Study ID Numbers  ICMJE B0401005
2009-012179-82 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

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