Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
NCT ID: NCT00733642
Last Updated: 2009-07-28
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
PHASE1
15 participants
INTERVENTIONAL
2008-08-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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PF-04360365 1 mg/kg
PF-04360365 1 mg/kg
PF-04360365 1 mg/kg infused as a single dose
PF-04360365 3 mg/kg
PF-04360365 3 mg/kg
PF-04360365 3 mg/kg infused as a single dose
PF-04360365 5 mg/kg
PF-04360365 5 mg/kg
PF-04360365 5 mg/kg infused as a single dose
PF-04360365 10 mg/kg
PF-04360365 10 mg/kg
PF-04360365 10 mg/kg infused as a single dose
Interventions
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PF-04360365 1 mg/kg
PF-04360365 1 mg/kg infused as a single dose
PF-04360365 3 mg/kg
PF-04360365 3 mg/kg infused as a single dose
PF-04360365 5 mg/kg
PF-04360365 5 mg/kg infused as a single dose
PF-04360365 10 mg/kg
PF-04360365 10 mg/kg infused as a single dose
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
* MMSE score of 16-26 inclusive.
* Rosen-Modified Hachinski Ischemia Score ≤4.
* On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.
Exclusion Criteria
* Diagnosis or history of clinically significant cerebrovascular disease.
* Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes.
* History of allergic or anaphylactic reactions.
50 Years
ALL
No
Sponsors
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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
Glendale, California, United States
Pfizer Investigational Site
Eatontown, New Jersey, United States
Pfizer Investigational Site
Oakhurst, New Jersey, 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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A9951008
Identifier Type: -
Identifier Source: org_study_id
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