ABBY: A phase 2 randomized trial of crenezumab in mild to moderate Alzheimer disease.

ABSTRACT:

Objective

To evaluate the safety and efficacy of crenezumab in patients with mild to moderate Alzheimer disease (AD).

Methods

In this phase 2 trial, 431 patients with mild to moderate AD 50 to 80 years of age were randomized 2:1 (crenezumab:placebo). Patients received low-dose subcutaneous crenezumab 300 mg or placebo every 2 weeks (n = 184) or high-dose intravenous crenezumab 15 mg/kg or placebo every 4 weeks (n = 247) for 68 weeks. Primary outcome measures were change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) and Clinical Dementia Rating-Sum of Boxes scores from baseline to week 73.

Results

The primary and secondary endpoints were not met. In an exploratory post hoc analysis, a reduction in decline on the ADAS-Cog12 was observed in the

SUBMITTER: Cummings JL 

PROVIDER: S-EPMC5962917 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature