{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T22:27:25Z","timestamp":1782858445580,"version":"3.54.5"},"reference-count":15,"publisher":"American Society of Consultant Pharmacists","issue":"8","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["sr care pharm"],"published-print":{"date-parts":[[2022,8,1]]},"abstract":"<jats:p><jats:bold>Objective<\/jats:bold> To review the data informing the US Food and Drug Administration (FDA) approval for aducanumab for mild cognitive impairment (MCI) and mild Alzheimer\u2019s disease (AD).  <jats:bold>Data Sources<\/jats:bold> At the time of writing there were no peer-reviewed published\n studies on aducanumab. All data presented are derived directly from the material Biogen submitted to the FDA for approval. The three studies that will be reviewed are: Multiple Dose Study of Aducanumab in Participants With Prodromal or Mild AD (PRIME), 221AD302 Phase 3 Study of Aducanumab\n in Early AD (EMERGE), 221AD301 Phase 3 Study of Aducanumab in Early AD (ENGAGE).  <jats:bold>Data Synthesis<\/jats:bold> PRIME, which was a phase 1 study, demonstrated the most common adverse drug reactions were amyloid-related imaging abnormalities (ARIA), which occurred at rates up to 47% (10\n mg\/kg group), headache (25%), urinary tract infection (16%), and upper respiratory tract infection (19%). EMERGE demonstrated that high-dose aducanumab was clinically significant at slowing down clinical decline. However, ENGAGE was terminated early based on a futility analysis. Prior to termination\n ENGAGE demonstrated no clinical difference between treatment and placebo regarding the primary endpoint of slowing clinical decline.  <jats:bold>Conclusion<\/jats:bold> Based on the data to date, it is difficult to accurately assess the role of aducanumab in patients with MCI or mild AD. EMERGE\n showed benefit with high-dose aducanumab slowing clinical decline. However, ENGAGE did not duplicate this benefit. With conflicting evidence of positive outcomes, future phase III studies are needed to confirm efficacy.<\/jats:p>","DOI":"10.4140\/tcp.n.2022.329","type":"journal-article","created":{"date-parts":[[2022,7,26]],"date-time":"2022-07-26T04:30:29Z","timestamp":1658809829000},"page":"329-334","source":"Crossref","is-referenced-by-count":15,"title":["Aducanumab for Alzheimer's Disease: Summarized Data From EMERGE, ENGAGE, and PRIME Studies"],"prefix":"10.4140","volume":"37","author":[{"given":"Jaylan M.","family":"Yuksel","sequence":"first","affiliation":[{"name":"Upstate University Hospital, Syracuse, New York."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Noviasky","sequence":"additional","affiliation":[{"name":"Upstate University Hospital, Syracuse, New York."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Britton","sequence":"additional","affiliation":[{"name":"Upstate University Hospital, Syracuse, New York."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2625","reference":[{"key":"ref1","volume-title":"761178Orig1s000.","year":"2020"},{"issue":"8","key":"ref2","first-page":"e17591","article-title":"Aducanumab as a novel treatment for Alzheimer\u2019s dsisease: a decade of hope, controversies, and the future.","volume":"13","year":"2021","journal-title":"Cureus."},{"key":"ref3","volume-title":"ADUHELM (Aducanumab) [prescribing information].","year":"2021"},{"issue":"1","key":"ref4","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1038\/jcbfm.2015.164","article-title":"The neuropathology and cerebrovascular mechanisms of dementia.","volume":"36","year":"2016","journal-title":"J Cereb Blood Flow Metab."},{"issue":"1","key":"ref5","first-page":"1","article-title":"Probable causes of Alzheimer\u2019s disease.","volume":"3","year":"2021","journal-title":"Sci."},{"issue":"1","key":"ref6","doi-asserted-by":"crossref","first-page":"1","DOI":"10.9758\/cpn.2017.15.1.1","article-title":"Mechanisms of Alzheimer\u2019s disease pathogenesis and prevention: the brain, neural pathology, N-methyl-D-aspartate receptors, Tau protein and other risk factors.","volume":"15","year":"2017","journal-title":"Clin Psychopharmacol Neurosci."},{"issue":"22","key":"ref7","doi-asserted-by":"crossref","first-page":"2017","DOI":"10.1056\/NEJMp2113679","article-title":"Why is aducanumab priced at $56,000 per patient? Lessons for drug-pricing reform.","volume":"385","year":"2021","journal-title":"N Engl J Med."},{"key":"ref8","volume-title":"NIA Statement on Proposed CMS Medicare Coverage Decision for Aducanumab to Treat Alzheimer\u2019s.","year":"2022"},{"issue":"8","key":"ref9","doi-asserted-by":"crossref","first-page":"703","DOI":"10.1007\/s12603-010-0102-1","article-title":"Functional evaluation distinguishes MCI patients from healthy elderly people\u2014the ADCS\/MCI\/ADL scale.","volume":"14","year":"2010","journal-title":"J Nutr Health Aging."},{"key":"ref10","first-page":"354","article-title":"Disease severity and minimal clinically important differences in clinical outcome assessments for Alzheimer\u2019s disease clinical trials.","volume":"5","year":"2019","journal-title":"Alzheimer\u2019s Dement."},{"issue":"2","key":"ref11","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1136\/jnnp-2011-300881","article-title":"What is the clinically relevant change on the ADAS-Cog?","volume":"83","year":"2012","journal-title":"J Neurol Neurosurg Psychiatry."},{"issue":"4","key":"ref12","doi-asserted-by":"crossref","first-page":"696","DOI":"10.1002\/alz.12213","article-title":"Failure to demonstrate efficacy of aducanumab: an analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019.","volume":"17","journal-title":"Alzheimers Dement."},{"issue":"4","key":"ref13","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1002\/alz.12286","article-title":"ENGAGE and EMERGE: truth and consequences?","volume":"17","year":"2021","journal-title":"Alzheimers Dement."},{"key":"ref14","article-title":"Re: Food and Drug Administration\u2019s Review of Biogen\u2019s Drug Aducanumab for Alzheimer\u2019s Disease."},{"key":"ref15","article-title":"Phase 3b open-label, multicenter, safety study of BIIB037 (Aducanumab) in subjects with Alzheimer\u2019s disease who had previously participated in the aducanumab studies 221AD103, 221AD301, 221AD302 and 221AD205. NCT04241068.","year":"2020"}],"container-title":["The Senior Care Pharmacist"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ingentaconnect.com\/content\/ascp\/tscp\/2022\/00000037\/00000008\/art00005","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,28]],"date-time":"2022-07-28T04:37:52Z","timestamp":1658983072000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ingentaconnect.com\/content\/10.4140\/TCP.n.2022.329"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,1]]},"references-count":15,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2022,8,1]]}},"alternative-id":["2639-9636(20220801)37:8L.329;1-"],"URL":"https:\/\/doi.org\/10.4140\/tcp.n.2022.329","relation":{},"ISSN":["2639-9636"],"issn-type":[{"value":"2639-9636","type":"print"}],"subject":[],"published":{"date-parts":[[2022,8,1]]}}}