Overview

A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.