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

A PHASE 2 DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS/ PHARMACODYNAMICS OF PF-04360365 IN MILD TO MODERATE ALZHEIMER'S DISEASE PATIENTS

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.

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.