In the 76-week, 1,736 patient, Phase III, TRAILBLAZER-ALZ 2 trial, treatment with donanemab resulted in a decline in the integrated Alzheimer's Disease Rating Scale (iADRS) score of 6.02 points in patients with low to medium levels of tau and 10.2 in the overall population compared to 9.27 and 13.1 point reductions in patients who received placebo in patients with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology based on positron emission tomography imaging. Amyloid-related imaging abnormalities of edema or effusion (ARIA-E) and amyloid-related imaging abnormalities with hemorrhage (ARIA-H) have been reported with donanemab. In the TRAILBLAZER-ALZ 2 trial, 24% of donanemab patients experienced ARIA-E with 6.9% experiencing symptomatic ARIA-E compared to 2.1% with placebo with none being symptomatic. ARIA-H was experienced by 31.4% of donanemab patients compared to 13.6% with placebo.
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