Slightly less cognitive and functional decline seen with donanemab versus placebo at 76 weeks in phase 2 trial
TUESDAY, March 16, 2021 (HealthDay News) — For patients with early symptomatic Alzheimer disease, donanemab, which targets a modified form of deposited amyloid-ß, results in slightly less cognitive and functional decline than placebo, according to a study published online March 13 in the New England Journal of Medicine.
Mark A. Mintun, M.D., from Eli Lilly in Indianapolis, and colleagues conducted a phase 2 trial involving patients with early symptomatic Alzheimer disease who had tau and amyloid deposition on positron emission tomography. Participants were randomly assigned to receive either donanemab (700 mg for the first three doses; 1,400 mg thereafter) or placebo intravenously every four weeks for up to 72 weeks (131 and 126 patients, respectively).
The researchers found that the change from baseline in the Integrated Alzheimer’s Disease Rating Scale at 76 weeks was −6.86 and −10.04 with donanemab and placebo, respectively (difference, 3.20 [95 percent confidence interval, 0.12 to 6.27; P = 0.04]; lower scores indicate greater cognitive and functional impairment). For most secondary outcomes, the results showed no substantial difference. Compared with placebo, the reductions in the amyloid plaque level and global tau load were 85.06 centiloids and 0.01 greater, respectively, with donanemab at 76 weeks. The investigators observed amyloid-related cerebral edema or effusions (mostly asymptomatic) with donanemab.
“This randomized phase 2 trial showed that, in patients with early symptomatic Alzheimer’s disease, treatment with donanemab resulted in modestly less cognitive and functional decline than placebo; however, slowing disease progression by half (an assumption on which the power calculation was based) was not achieved,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly, which manufactures donanemab and funded the trial.
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