On July 8, 2020, Biogen submitted an application to the US Food and Drug Administration (FDA) for approval of aducanumab for the treatment of Alzheimer disease (AD) dementia. Aducanumab, a monoclonal antibody targeting aggregated amyloid-β, showed in a phase 3 clinical trial (but apparently not in another phase 3 trial) success in clearing amyloid plaques from the brain and slowing the rate of cognitive decline in some patients with mild AD dementia.1 While the aducanumab clinical trial data are complicated and the path to approval far from clear, approval is certainly possible, and other promising antibodies (such as Biogen’s BAN-2401 and Genentech’s gantenerumab) are just steps behind. Thus, the long-awaited advent of disease-modifying therapy for AD may be soon upon us, representing a major advance in the battle against AD and a beacon of much-needed hope for patients. However, the potential seismic effect of a disease-modifying therapy for AD requires serious consideration because it could present significant challenges for AD clinical practice and research, some of which are considered here.
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Musiek ES, Morris JC. Possible Consequences of the Approval of a Disease-Modifying Therapy for Alzheimer Disease. JAMA Neurol. 2021;78(2):141–142. doi:10.1001/jamaneurol.2020.4478
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