Donanemab: A trailblazer for Alzheimer's disease treatment? BUmemoryloss JAMANetwork BrownMedicine IUMedSchool AlzheimersDisease disease Alzheimers medicine health
By Susha Cheriyedath, M.Sc.Jul 20 2023Reviewed by Sophia Coveney A recent study published in the journal JAMA evaluated the efficacy and side effects of donanemab. They aimed to use this antibody to clear brain amyloid plaque in randomized participants with early symptomatic Alzheimer disease with low/medium or high tau pathology.
In this study, researchers designed and investigated the use of donanemab, a monoclonal immunoglobulin G1 antibody, which targets an insoluble, mutated, and N-terminally shortened form of β-amyloid found in brain amyloid plaques. About the study The study conducted a randomized, double-blind, parallel, multicenter, placebo-controlled trial involving 277 locations across 8 countries. Participants of the 76-week trial ranged in age from 60 to 85 and had early-stage AD symptoms. Participants were considered eligible if they had a mini-mental state examination score of 20 to 28 and had undergone positron emission tomography and tau pathology analysis.
No unblinded data analysis was performed. The study changed its sample size and power calculations in light of the trial's key conclusions. Each sample was fitted to the natural cubic spline model with two degrees of freedom , with the power dependent on the low/medium tau population. Furthermore, compared to 29% of those getting placebo, 47% of those receiving donanemab exhibited no change in CDR-SB at one year. By one year, cerebral amyloid plaque had significantly decreased in 52% of low/medium tau participants, with 80% achieving amyloid clearance at 76 weeks.
These occurrences occasionally have the potential to be fatal and life-threatening. In the donanemab therapy group, 1.6% of patients had major side effects that required supportive care or hospitalization.
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