Status:
COMPLETED
A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients 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 to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzh...
Eligibility Criteria
Inclusion
- Japanese male or females of non-childbearing potential, ages 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) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
- 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 :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00607308
Start Date
February 1 2008
End Date
October 1 2010
Last Update
December 7 2010
Active Locations (9)
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1
Pfizer Investigational Site
Hirosaki, Aomori, Japan
2
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
3
Pfizer Investigational Site
Fukuyama, Hiroshima, Japan
4
Pfizer Investigational Site
Tsukuba, Ibaraki, Japan