Rebecca Edelmayer, PhD, Alzheimer’s Association, discusses the recent announcement of the topline data from the Phase III TRAILBLAZER-ALZ 2 study (NCT04437511) of donanemab in patients with early Alzheimer’s disease. Donanemab is an anti-amyloid monoclonal antibody that targets the N-terminal of pyroglutamate Aβ, only found in aggregated amyloid plaques. The preliminary results from TRAILBLAZER-ALZ 2 show the strongest cognitive benefit of any anti-amyloid therapy to date, generating considerable anticipation for further insights to be shared at the upcoming Alzheimer’s Association International Conference in July. The trial successfully met all of its primary and secondary endpoints, demonstrating a 35% slowing of clinical decline (iADRS) and 40% less decline on the ability to perform activities of daily living (ADCS-iADL) at 18 months, with donanemab use compared to placebo. Given the concerns regarding the true clinical meaningfulness of the amyloid reductions seen with other anti-amyloid antibodies, it is encouraging to see that by targeting this hallmark protein, there is the potential to slow down the disease process and alter the course of cognitive and functional decline experienced by patients.
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