The investigational drug donanemab yielded greater amyloid clearance and amyloid plaque reduction than aducanumab in early, symptomatic Alzheimers disease results of a head-to-head study show. AAN2023 AANAM
April 27, 2023
Early results from the randomized phase 3 TRAILBLAZER-ALZ 4 trial of donanemab come just 3 months after the US Food and Drug Administration"This study shows that the drug with the quicker titration scheme, donanemab, produced more amyloid lowering and did it without having more ARIA," lead investigator Stephen P.
Aducanumab titration was slower, beginning at 1 mg/kg via IV monthly for 2 months, then 3 mg/kg for another 2 months, and 6 mg/kg for 2 more months before reaching the maximum dose of 10 mg/kg in the seventh month. Amyloid levels were 65.2% lower in donanemab patients, while levels in those receiving aducanumab were only reduced by 17.0% . Among those with intermediate tau, amyloid levels decreased with donanemab by 63.9% and 25.4% with aducanumab .Adverse events were similar between groups, with 62.0% of the donanemab group and 66.7% of aducanumab-treated participants reporting an adverse event.
There are three other Trailblazer trials of donanemab. Unlike in similar trials, participants in all three of these studies who received the trial drug could discontinue treatment once criteria for amyloid clearance were met. Both Snyder and Fillit noted that longer-term results are needed, along with studies of whether amyloid clearance offers a protective benefit against AD dementia. More results from Trailblazer 4 will be reported after 12 months and again at 18 months.
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