Global phase III trials of lanabecestat in Alzheimers disease discontinued.- AstraZeneca + Eli Lilly.

AstraZeneca and Eli Lilly are discontinuing the global Phase III clinical trials of lanabecestat, for the treatment of Alzheimer�s disease. The decision is based on recommendations by an independent data monitoring committee (IDMC), which concluded that both the AMARANTH trial, in early Alzheimer�s disease, and the DAYBREAK-ALZ trial, in mild Alzheimer�s disease dementia, were not likely to meet their primary endpoints upon completion and therefore should be stopped for futility. As a result of this decision, the related AMARANTH extension trial will also be discontinued. The IDMC recommendation to stop the studies was not based on safety concerns.

The AMARANTH trial randomised patients with early Alzheimer�s disease to receive lanabecestat, 20mg or 50mg, or placebo orally once daily for 104 weeks. The primary endpoint of the trial was change from baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13). Early Alzheimer�s disease is defined as the continuum of patients with mild cognitive impairment due to Alzheimer�s disease and patients diagnosed with mild Alzheimer�s disease dementia. Patients who completed the AMARANTH trial were given the opportunity to enrol in the AMARANTH extension trial, where all patients received active treatment.

The DAYBREAK-ALZ trial randomised patients with mild Alzheimer�s disease dementia to receive either lanabecestat, 20mg or 50mg, or placebo orally once daily for 156 weeks. The primary endpoint of the trial was change from baseline on ADAS-Cog13.