Eli Lilly reported positive results from its Phase II TRAILBLAZER-ALZ trial, which showed treatment with donanemab resulted in significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease compared to placebo. Results from the study will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal. Lilly plans to discuss these results with regulators to assess next steps for donanemab.
TRAILBLAZER-ALZ is a randomized, placebo-controlled, double-blind, multi-center study enrolled 272 patients who were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau imaging. Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer’s Disease Rating Scale (iADRS), slowing decline by 32 percent relative to placebo, which was statistically significant. The iADRS is a clinical composite tool combining the cognitive measure ADAS-Cog13 and functional measure ADCS-iADL, two commonly used measures in Alzheimer’s disease. Donanemab also showed consistent improvements in all prespecified secondary endpoints measuring cognition and function compared to placebo but did not reach nominal statistical significance on every secondary endpoint.
The safety, tolerability and efficacy of donanemab is also being evaluated in the ongoing randomized, placebo-controlled, double-blind, multi-center Phase 2 study TRAILBLAZER-ALZ 2.
Donanemab is an antibody that targets a modified form of beta amyloid called N3pG. By targeting N3pG beta amyloid, donanemab treatment has been shown to rapidly result in high levels of amyloid plaque clearance, as measured by amyloid imaging.
About Alzheimer’s Disease
Alzheimer’s disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. Dementia due to Alzheimer’s is the most common form of dementia, accounting for 60 to 80 percent of all cases. There are currently over 50 million people living with dementia around the world, with numbers expected to increase to nearly 152 million by 2050.