Abstract
Abstract
INTRODUCTION
Anti‐amyloid antibody clinical trials with a high proportion of participants reaching treatment‐related amyloid clearance (TRAC) had positive clinical outcomes. We evaluated the aducanumab phase 3 program to determine whether TRAC during the double‐blind period was likewise associated with clinical benefit.
METHODS
We pooled ENGAGE and EMERGE (E/E) aducanumab‐treated participants in the amyloid positron emission tomography substudy who continued into the long‐term extension ≤ 134 weeks (continuously treated population) and/or returned to the EMBARK redosing study 0.7 to 2.5 years after termination of E/E (treatment gap population). Clinical outcomes were stratified by week 78 TRAC status.
RESULTS
TRAC participants had less clinical decline at week 78, week 134, and EMBARK baseline than non‐TRAC participants. Post‐TRAC, clinical decline was heterogeneous; approximately two thirds of TRAC participants had annualized decline of
DISCUSSION
In these exploratory analyses, week 78 TRAC status was associated with better clinical outcomes.
CLINICAL TRIAL REGISTRATION
NCT02484547, NCT02477800, NCT04241068