Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials.

ABSTRACT:

Background

Our objective was to evaluate the efficacy (clinical and biomarker) and safety of intravenous bapineuzumab in patients with mild to moderate Alzheimer's disease (AD).

Methods

Two of four phase 3, multicenter, randomized, double-blind, placebo-controlled, 18-month trials were conducted globally: one in apolipoprotein E ε4 carriers and another in noncarriers. Patients received bapineuzumab 0.5 mg/kg (both trials) or 1.0 mg/kg (noncarrier trial) or placebo every 13 weeks. Coprimary endpoints were change from baseline to week 78 on the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscale and the Disability Assessment for Dementia.

Results

A total of 683 and 329 patients completed the current carrier and noncarrier trials, respectively, which were ter

SUBMITTER: Vandenberghe R 

PROVIDER: S-EPMC4866415 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature