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Drugs Fut 2022, 47(4): 239
ISSN 0377-8282
e-ISSN 2013-0368
Copyright 2022 Clarivate
CCC: 0377-8282
DOI: 10.1358/dof.2022.47.4.3389009
Donanemab. Monoclonal antibody targeting N3pG beta-amyloid, Treatment of early Alzheimer's disease
Buxbaum, J.N.
Donanemab (LY-3002813; Lilly), a humanized monoclonal antibody specific for the fibrillar plaques characteristic of Alzheimer's disease (AD), was administered intravenously to 132 patients with early-stage AD who had beta-amyloid (Abeta) and tau visualized by positron emission tomography (PET) in the TRAILBLAZER-ALZ study. A matched group of 126 subjects received placebo (72 weeks). The primary outcome measure was modification of deterioration in performance on the Integrated Alzheimer's Disease Rating Scale (iADRS). Secondary measures included changes in other functional assays and changes in the volume of Abeta and tau deposits by Abeta- and tau-specific PET. Both groups continued to show reductions in their iADRS scores from baseline. The decline was statistically significantly less in the antibody-treated group (P = 0.04) but the difference was considered to be clinically marginal and the rate of deterioration in the donanemab-treated patients reverted to that seen in those treated with placebo. Hence, the major reduction in amyloid plaque lev¡el seen in the antibody recipients was not associated with a commensurate improvement in clinical status. These data are similar to those recently reported with aducanumab, another anti-Abeta antibody, with respect to plaque clearance, marginal clinical responses and frequency of ARIA (antibody-related imaging abnormalities). This review discusses the TRAILBLAZER-ALZ study, along with the development and future of donanemab for the treatment of AD.

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