The P-III (TRAILBLAZER-ALZ 4) study evaluates donanemab vs aducanumab in 148 patients aged 50-85yrs. with early symptomatic AD treated with amyloid-targeting therapies
The trial met all 1EPs & 2EPs i.e., 37.9% vs 1.6% of patients achieved brain amyloid clearance (<24.1 Centiloids) while 38.5% vs 3.8% in the intermediate tau subpopulation, 65.2% vs 17.0% reduction in brain amyloid plaque levels over baseline @6mos., reduction in plasma P-tau217 @6mos. over baseline in an exploratory outcome
The safety profile was consistent with prior studies, the incidence of total ARIA was 26.1% vs 25.4% with 4.3% vs 2.8% being symptomatic. The therapy is being studied in an ongoing (TRAILBLAZER-ALZ 4) trial with 12 & 18mos. secondary analyses
Ref: Eli Lilly | Image: Eli Lilly
