Status:
COMPLETED
A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease
Lead Sponsor:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.
Eligibility Criteria
Inclusion
- Male or Females of non-childbearing potential, age 50-85
- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score of 16-26 inclusive
- Rosen-Modified Hachinski Ischemia Score \< or = 4
Exclusion
- Diagnosis or history of other dementia 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 :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00455000
Start Date
March 1 2007
End Date
September 1 2009
Last Update
October 14 2009
Active Locations (12)
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1
Pfizer Investigational Site
Heidelberg West, Victoria, Australia, 3081
2
Pfizer Investigational Site
Fremantle, Western Australia, Australia, 6160
3
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
4
Pfizer Investigational Site
London, Ontario, Canada, N6A 4G5