Unblinded by the light: amyloid‐related imaging abnormalities in Alzheimer’s clinical trials
Andrew Gleason, Scott Ayton, Ashley I. Bush
Abstract
A disease modifying therapy for Alzheimer's disease is one of the highest priorities in medicine.Dozens of amyloid-modifying trials have failed to meet primary endpoints.Aducanumab, a monoclonal anti-amyloid antibody, lowers plaque burden.Early findings suggested a slowing of cognitive deterioration(1).However, phase 3 trials of aducanumab were ceased in March 2019 based on a futility analysis.A new analysis of a larger dataset from these trials, released in October 2019, showed a statistically significant benefit in the high dose arm on the primary endpoint, the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), and two secondary endpoints, the Alzheimer's Disease Cooperative Study-Activity of Daily Living Inventory (ADCS-ADL-MCI) and the Alzheimer's Disease