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

Phase 1

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00736775
• Lead Sponsor: Genentech, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Primary Completion: 2010-05
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single and multiple doses of MABT5102A	Through study completion or early study discontinuation

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of MABT5102A after single and multiple doses	Through study completion or early study discontinuation
Immunogenicity of MABT5102A after single and multiple doses	Through study completion or early study discontinuation