Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease.

ABSTRACT:

Importance

The EMERGE and ENGAGE phase 3 randomized clinical trials of aducanumab provide a robust data set to characterize amyloid-related imaging abnormalities (ARIA) that occur with treatment with aducanumab, an amyloid-β (Aβ)-targeting monoclonal antibody, in patients with mild cognitive impairment due to Alzheimer disease or mild Alzheimer disease dementia.

Objective

To describe the radiographic and clinical characteristics of ARIA that occurred in EMERGE and ENGAGE.

Design, setting, and participants

Secondary analysis of data from the EMERGE and ENGAGE trials, which were 2 double-blind, placebo-controlled, parallel-group, phase 3 randomized clinical trials that compared low-dose and high-dose aducanumab treatment with placebo among participants at 348 sites acro

SUBMITTER: Salloway S 

PROVIDER: S-EPMC8609465 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature