How Will Aducanumab Approval Impact AD Research?

Abstract

The accelerated approval of aducanumab (AduhelmTM) by the US FDA is a momentous event. For the first time, a therapeutic agent that targets the neurobiology of Alzheimer’s disease (AD) is available for clinical use (1, 2). In addition to the FDA approval of aducanumab, the FDA has also provided “Breakthrough therapy designation” for Lilly’s Donanemab and Eisai’s Lecnemab which also are monoclonal antibodies that remove brain amyloid plaques and may slow cognitive decline. Aducanumab approval will impact clinical practice. The effects on AD clinical research will be profound in both positive and negative ways. This Editorial reflects the opinion of the leadership of the Alzheimer’s Disease Neuroimaging Initiative (ADNI), a large multisite longitudinal observational study with the goal of validating biomarkers for clinical trials. ADNI data have been used to help design and statistically power many AD clinical trials, including the aducanumab studies.