Does lanabecestat, a potent inhibitor of the beta-site amyloid precursor protein–cleaving enzyme 1 (BACE1), slow the progression of early Alzheimer disease (AD) and mild AD dementia?..
..Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women. Both studies were terminated early after futility analysis. There were no consistent, reproducible dose-related findings on primary or secondary efficacy measures. Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
Conclusions and Relevance Treatment with lanabecestat was well tolerated and did not slow cognitive or functional decline.