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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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