A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease

A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MABT5102A Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Mild to Moderate Alzheimer's Disease

This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will be conducted in the United States and consists of a single ascending-dose stage followed by a multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult patients between 50-85 years old who have mild to moderate Alzheimer's disease.

Inclusion Criteria:

• Diagnosis of probable AD according to the NINCDS-ADRDA Criteria
• Approved AD treatments (AchE inhibitors+/-memantine) must be stable for ≥ 3 months prior to screening
• Other prescription medications must be stable for ≥ 1 month prior to screening

Exclusion Criteria:

• Female patients with reproductive potential
• History or presence of any clinically significant CNS disease
• History of treatment with any protein therapeutic targeting Abeta