On 13 March, at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD 2021), and published simultaneously in the New England Journal of Medicine, pharmaceutical company Eli Lilly presented results from its Phase 2 TRAILBLAZER-ALZ trial for donanemab. The results expand on previously reported top-line data.
The phase II trial results found that donanemab slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease and also slowed the accumulation of tau across key brain regions in patients. Specifically, at 76 weeks compared to baseline, treatment with donanemab slowed decline by 32 percent compared to placebo as measured by the Integrated Alzheimer’s Disease Rating Scale (iADRS). In addition, 40 percent of participants treated with donanemab achieved amyloid negativity as early as six months after starting treatment and 68 percent achieved this target by 18 months.
The phase 2 study involved 257 participants, between the ages of 60-85, who were already displaying early clinical symptoms of Alzheimer’s disease.
TRAILBLAZER-ALZ is the first study to screen and enrol patients based on their tau pathology.
The TRAILBLAZER-ALZ2 trial is due in 2023.
ADI CEO Paola Barbarino said: “We are encouraged at the continued commitment to developing treatments for Alzheimer’s disease and other dementias and welcome this clinical trial update from Eli Lilly. The world continues to wait with bated breath for much needed treatment breakthroughs, and we look forward to the next steps and further trial updates for donanemab.“