Real-world study of donanemab in Alzheimer’s disease: a six-center Chinese cohort

Introduction Real-world safety data for donanemab in China remain limited, particularly during early treatment and progressive dose titration. Methods We analyzed 108 participants with symptomatic AD treated with donanemab at six Chinese centers using a 4-weekly progressive titration regimen. Safety assessments included infusion-related reactions (IRRs), amyloid-related imaging abnormalities (ARIA), and treatment adjustments. Longitudinal assessments included plasma biomarkers, amyloid PET, cognitive measures, and MRI findings. Results IRRs occurred in 14/108 participants (13.0%), with the highest infusion-specific rate at the second infusion (8.5%). ARIA occurred in 12/108 participants (11.1%), including one symptomatic case; one serious adverse event (0.9%) was recorded. Plasma phosphorylated tau 217 (p-tau217) and p-tau181 decreased at 3 and 6 months; at 6 months, p-tau231 and glial fibrillary acidic protein decreased, while the Aβ1–42/Aβ1–40 ratio increased. Amyloid PET negativity was observed in 9/37 participants (24.3%) at month 6 and 8/25 (32.0%) at month 12. Cognitive changes were not significant after correction. Conclusions Donanemab with progressive titration showed manageable short-term safety in this real-world Chinese cohort. Exploratory analyses showed early changes in plasma biomarkers and amyloid burden, while no significant cognitive changes were observed. Longer follow-up is needed to assess long-term safety and clinical outcomes.