The Aducanumab Controversy – How Do Clinicians Proceed?

Aducanumab has been FDA-approved for mild cognitive impairment and mild dementia due to Alzheimer disease despite controversy over the research findings to date. Careful consideration of appropriate use is needed.

Alzheimer disease (AD) is a neurodegenerative process associated pathologically with β-amyloid plaques and neurofibrillary tangles. Until now, no available treatment has affected these pathological processes. Aducanumab is an antibody that targets β-amyloid, disrupts amyloid aggregation, and facilitates clearance of β-amyloid plaques, which may be associated with the prodromal stages of AD. But the recent FDA approval of aducanumab through an accelerated pathway has been mired in controversy.

Why is there controversy with aducanumab?

The clinical trials of aducanumab focused on those with mild cognitive impairment (MCI) or mild dementia due to AD with increased β-amyloid on positron emission tomography (PET) imaging. PRIME, a phase 1b, 12-m…

Author

Jennifer Rose V. Molano, MD

Disclosures

Grant/Research SupportNational Center for Advancing Translational Science – Cincinnati Center for Clinical and Translational Science and Training

Editorial BoardsBrain & Life

Jennifer Rose V. Molano, MD

Disclosures

Grant/Research SupportNational Center for Advancing Translational Science – Cincinnati Center for Clinical and Translational Science and Training

Editorial BoardsBrain & Life

The Aducanumab Controversy – How Do Clinicians Proceed?

Topics

Why is there controversy with aducanumab?

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