Status:
COMPLETED
A Multiple 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
The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients 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 criteria 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 :
August 6 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00945672
Start Date
August 6 2009
End Date
June 1 2011
Last Update
April 19 2024
Active Locations (4)
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1
Sahlgrenska Sjukhuset, CTC
Gothenburg, Sweden, 413 45
2
Malmo Sjukhus, Neuropsykiatriska Kliniken
Malmo, Sweden, 205 02
3
Sahlgrenska Universitetssjukhuset, Minnesmottagningen
Mölndal, Sweden, 431 41
4
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden, 141 86