AMDA–The Society for Post-Acute and Long-Term Care Medicine is compelled to comment on the recent approval of the controversial parenteral Alzheimer's dementia (AD) medication, aducanumab. After considering the evidence, we conclude that the aducanumab trials did not adequately demonstrate safety or efficacy. Moreover, aducanumab has only been studied in individuals with mild cognitive impairment or early-stage dementia due to hyperamyloidosis (eg, AD) and has never been tested in a population representative of nursing home residents. We therefore cannot endorse recommending or prescribing aducanumab to post-acute and long-term care (PALTC) residents and patients.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to Journal of the American Medical Directors Association
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- Aducanumab and Alzheimer’s disease: IPA's position on controversial FDA approval.(Available at:)https://www.ipa-online.org/news-and-issues/ipa-statement-on-aducanumabDate accessed: July 2, 2021
- ICER issues statement on the FDA’s approval of aducanumab for Alzheimer’s disease.(Available at:)https://icer.org/news-insights/press-releases/icer-issues-statement-on-the-fdas-approval-of-aducanumab-for-alzheimers-diseaseDate accessed: July 7, 2021
- Letter to FDA Biogen drug for Alzheimer’s.(Available at:)https://www.americangeriatrics.org/sites/default/files/inline-files/American%20Geriatrics%20Society_Letter%20to%20FDA%20Biogen%20Drug%20for%20Alzheimer%27s%20%28June%202021%29%20FINAL%20%281%29.pdfDate accessed: June 2, 2021
- What a bad day science had.(Available at:)https://www.thehastingscenter.org/what-a-bad-day-science-had/Date accessed: July 7, 2021
- People want an Alzheimer’s drug. This isn’t the one.(Available at:)https://www.nytimes.com/2021/05/28/opinion/alzheimer-treatment-FDA-aducanumab.htmlDate accessed: July 7, 2021
- If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.(Available at:)https://www.statnews.com/2021/05/30/if-the-fda-approves-biogens-alzheimers-treatment-i-wont-prescribe-it/Date accessed: July 7, 2021
- Evaluation of aducanumab for Alzheimer Disease: Scientific evidence and regulatory review involving efficacy, safety, and futility.JAMA. 2021; 325: 1717-1718
© 2021 Published by Elsevier Inc. on behalf of AMDA - The Society for Post-Acute and Long-Term Care Medicine.