Status:
COMPLETED
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
Lead Sponsor:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.
Eligibility Criteria
Inclusion
- Males or females of non childbearing potential, age \> or = 50
- Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
- National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score of 16-26 inclusive
- Rosen-Modified Hachinski Ischemia Score of \< or = 4
Exclusion
- Diagnosis or history of other demential or neurodegenerative disorders
- Diagnosis or history of clinically significant cerebrovascular disease
- Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
- History of autoimmune disorders
- History of allergic or anaphylactic reactions
Key Trial Info
Start Date :
December 5 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2011
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00722046
Start Date
December 5 2008
End Date
August 16 2011
Last Update
November 7 2022
Active Locations (42)
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1
Pivotal Research Center
Peoria, Arizona, United States, 85381
2
Sun Radiology- for MRI
Peoria, Arizona, United States, 85381
3
Dedicated Phase 1
Phoenix, Arizona, United States, 85013
4
Neuroscience Consultants, LLC
Miami, Florida, United States, 33176