A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
NCT ID: NCT00141661
Last Updated: 2009-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2005-10-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose Arm
PF-04494700 - Low Dose Arm
30 mg loading dose for 6 days, followed by 10 mg daily
High Dose Arm
PF-04494700 - High Dose Arm
60 mg loading dose for 6 days, followed by 20 mg daily
Placebo Control
Placebo Comparator
Matching placebo.
Interventions
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PF-04494700 - Low Dose Arm
30 mg loading dose for 6 days, followed by 10 mg daily
PF-04494700 - High Dose Arm
60 mg loading dose for 6 days, followed by 20 mg daily
Placebo Comparator
Matching placebo.
Eligibility Criteria
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Inclusion Criteria
* Mini Mental State Exam (MMSE) score between 12-26 at screening.
* Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.
Exclusion Criteria
* Living alone.
* Poorly controlled high blood pressure.
50 Years
ALL
No
Sponsors
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Trans Tech Pharmaceuticals
UNKNOWN
Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Sun City, Arizona, United States
Pfizer Investigational Site
Fresno, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, United States
Pfizer Investigational Site
Fort Myers, Florida, United States
Pfizer Investigational Site
Hallandale, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Largo, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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TTP488-201
Identifier Type: -
Identifier Source: secondary_id
B0341008
Identifier Type: -
Identifier Source: org_study_id
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