Phase 3 clinical trials for lanabecestat (Lilly, Indianapolis, IN and AstraZeneca, Wilmington, DE) for the treatment of patients with Alzheimer’s disease (AD) are being discontinued. An independent data monitoring committee concluded that both the DAYBREAK-ALX trial for treatment of patients with mild AD dementia and the AMARANTH trial for treatment of patients with early AD were unlikely to meet primary endpoints and recommended stopping both trials. The related AMARANTH extension trial is also being discontinued as a result. The decision to stop these trials was not based on safety concerns. The primary measures for both trials a change in patients’ baseline scores on the 13-item AD Assessment Scale—Cognitive Subscale (ADAS-Cog13).
"The complexity of AD poses one of the most difficult medical challenges of our time, and we are deeply disappointed for the millions suffering from this devastating disease," said Daniel Skovronsky, MD, PhD, president of Lilly. "We are grateful for the contributions of the study participants and their families and encourage them to consider other Alzheimer's disease clinical trials."
"We are saddened by this outcome as our researchers are working tirelessly to find a solution for the many people who are impacted by this devastating disease," said Menelas Pangalos, PhD, Executive Vice President, IMED Biotech Unit, AstraZeneca. "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."
Lanabecestat is an inhibitor of beta secretase cleaving enzyme (BACE), the enzyme that generates amyloid-ß, a known protein involved in the pathophysiology of AD.Next Story