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.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
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
Monkeypox Resource Center
Customize your JAMA Network experience by selecting one or more topics from the list below.