The independent data monitoring committee (IDMC) concluded that the 2 trials (AMARANTH and DAYBREAK-ALZ) investigating the treatment in mild Alzheimer’s disease dementia, were not likely to meet their primary endpoints of change from baseline on the 13-item Alzheimer’s Disease Assessment Scale – Cognitive Subscale. It is upon the IDMC’s recommendation that the Companies decided to discontinue these trials and a related extension trial.
“We are committed to ensuring our findings can be used to inform further research in the Alzheimer’s community, given the importance of finding a treatment for this disease,” said Menelas Pangalos, PhD, EVP of IMED Biotech Unit at AstraZeneca.
The AMARANTH trial enrolled 2202 individuals with early Alzheimer’s disease who were randomized to 20mg or 50mg lanabecestat or placebo for 104 weeks. The DAYBREAK-ALZ trial enrolled 1899 individuals with early Alzheimer’s disease who were also randomized to 20mg or 50mg lanabecestat or placebo, but for 156 weeks.
Lanabecestat is an oral beta-secretase cleaving enzyme (BACE) inhibitor. In May 2018, Janssen also announced they would no longer continue studying their investigational BACE inhibitor atabecestat after study participants who received the treatment developed elevated liver enzymes. The recommendation to stop the lanabecestat trials, however, was not based on safety concerns.