MONDAY, July 17, 2023 (HealthDay News) — Donanemab slows clinical progression among participants with early symptomatic Alzheimer disease and amyloid and tau pathology, according to a study published online July 17 in the Journal of the American Medical Association to coincide with the annual Alzheimer’s Association International Conference, held from July 16 to 20 in Amsterdam.
John R. Sims, M.D., from Eli Lilly and Company in Indianapolis, and colleagues examined the efficacy and adverse events of donanemab, an antibody designed to clear brain amyloid plaque, in a multicenter randomized 18-month trial involving 1,736 participants with early symptomatic Alzheimer disease with amyloid and low/medium or high tau pathology. Participants were randomly assigned to receive donanemab or placebo every four weeks for 72 weeks (860 and 876, participants, respectively); 76 percent completed the trial.
The researchers found that 23 of the 24 gated outcomes were statistically significant. The least-squares mean (LSM) change in the integrated Alzheimer Disease Rating Scale score at 76 weeks was −6.02 and −9.27, respectively, in the donanemab and placebo groups in the low-medium tau population, and −10.2 and −13.1, respectively, in the combined population. At 76 weeks, the LSM change in the sum of boxes of the Clinical Dementia Rating Scale score was 1.20 and 1.88, respectively, with donanemab and placebo in the low/medium tau population and 1.72 and 2.42, respectively, in the combined population.
“Among participants with early symptomatic Alzheimer disease and amyloid and tau pathology, donanemab significantly slowed clinical progression at 76 weeks in those with low/medium tau and in the combined low/medium and high tau pathology population,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including Eli Lilly, which manufactures donanemab and funded the study.
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