NEJM: Eli Lilly’s Phase II Aβ Antibody Clinical Results Announced: The primary endpoint was reached, the secondary endpoint was missed

On March 13, 2021, the Phase II clinical results of Eli Lilly’s Aβ antibody Donanemab were published in the New England Journal (clinical number: NCT03367403).

Eli Lilly conducted a Phase II trial of Donanemab in patients with early symptomatic Alzheimer's disease who had tau and amyloid deposits on positron emission tomography (PET).

The main result was the change from baseline in scores on the Alzheimer's Disease Comprehensive Rating Scale (iADRS; range, 0 to 144, lower scores indicate greater cognitive and functional impairment) at 76 weeks.

In the study, a total of 257 patients were enrolled; 131 were assigned to receive Donanemab treatment, and 126 received placebo.

However, there is no substantial difference in the statistics of most secondary results.

Therefore, in patients with early Alzheimer's disease, the comprehensive score of cognition and activities of daily living in the Donanemab treatment group at 76 weeks was better than that of the placebo group, but the secondary results were uneven.

Mark A.