[Skip to Navigation]
Views 4,532
Citations 0
October 4, 2021

What the Aducanumab Approval Reveals About Alzheimer Disease Research

Author Affiliations
  • 1Taub Institute for Research on Alzheimer’s Disease and the Aging Brain, Department of Neurology, Columbia University Irving Medical Center, New York, New York
  • 2Department of Epidemiology and Biostatistics, University of California, San Francisco
JAMA Neurol. Published online October 4, 2021. doi:10.1001/jamaneurol.2021.3404

The US Food and Drug Administration (FDA) recently provided accelerated approval for aducanumab to treat Alzheimer disease (AD). The decision was controversial within and outside the FDA because of inadequate evidence of medication efficacy. The Peripheral and Central Nervous System Drugs Advisory Committee voted against recommendation of aducanumab and several committee members resigned after approval. FDA approval was based on trials that were not inclusive of the people who bear a disproportionate burden of disease.1 Only 0.6% (ie, 19 individuals) of participants identified as Black, 3% as Hispanic, 0.03% (1 person) as American Indian or Alaska Native, and 0.03% as Native Hawaiian or Pacific Islander. Of the 9% identified as Asian, 94% were recruited in Asia.2 Older Black adults are estimated to have AD incidence up to double the rates in older White people. Despite this, Biogen reported that only 6 Black people were randomized to the treatment dose approved by the FDA.

Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

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.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    1 Comment for this article
    Early Diagnosis
    Paul Nelson, MS, MD | Family Health Care, PC retired
    Not to mention, that there is no early screening test that exists to accurately predict the eventual occurrence of advanced Senile Dementia. However, Parkinson's Law accurately predicts the cost of this therapy.