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

Genentech

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: anti-Abeta; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736775

ABE4427g

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 50 to 86 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind