{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T20:31:41Z","timestamp":1791232301795,"version":"4.1.0"},"reference-count":70,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T00:00:00Z","timestamp":1706745600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Recent phase 3 randomised controlled trials of amyloid-targeting monoclonal antibodies in people with pre-clinical or early Alzheimer disease have reported positive results, raising hope of finally having disease-modifying drugs. Given their far-reaching implications for clinical practice, the methods and findings of these trials, and the disease causation theory underpinning the mechanism of drug action, need to be critically appraised. Key considerations are the representativeness of trial populations; balance of prognostic factors at baseline; psychometric properties and minimal clinically important differences of the primary efficacy outcome measures; level of study fidelity; consistency of subgroup analyses; replication of findings in similar trials; sponsor role and potential conflicts of interest; consistency of results with disease causation theory; cost and resource estimates; and alternative prevention and treatment strategies. In this commentary, we show shortcomings in each of these areas and conclude that monoclonal antibody treatment for early Alzheimer disease is lacking high-quality evidence of clinically meaningful impacts at an affordable cost.<\/jats:p>","DOI":"10.1093\/ageing\/afae023","type":"journal-article","created":{"date-parts":[[2024,2,27]],"date-time":"2024-02-27T13:48:27Z","timestamp":1709041707000},"source":"Crossref","is-referenced-by-count":11,"title":["Monoclonal antibodies for treating early Alzheimer disease\u2014a commentary on recent \u2018positive\u2019 trials"],"prefix":"10.1093","volume":"53","author":[{"given":"Ian A","family":"Scott","sequence":"first","affiliation":[{"name":"Centre for Health Services Research, University of Queensland , Brisbane, QLD , Australia"},{"name":"Department of Internal Medicine and Clinical Epidemiology, Princess Alexandra Hospital , Brisbane, QLD , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,2,26]]},"reference":[{"key":"2024022713482312000_ref1","volume-title":"World Alzheimer Report 2018","author":"Patterson","year":"2018"},{"key":"2024022713482312000_ref2","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1038\/nrneurol.2017.63","article-title":"The changing prevalence and incidence of dementia over time - current evidence","volume":"13","author":"Wu","year":"2017","journal-title":"Nat Rev Neurol"},{"key":"2024022713482312000_ref3","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1093\/ageing\/afaa228","article-title":"Mild cognitive impairment: the Manchester consensus","volume":"50","author":"Dunne","year":"2021","journal-title":"Age Aging"},{"key":"2024022713482312000_ref4","doi-asserted-by":"crossref","first-page":"320","DOI":"10.1159\/000354370","article-title":"Rate of conversion from prodromal Alzheimer\u2019s disease to Alzheimer\u2019s dementia: a systematic review of the literature","volume":"3","author":"Ward","year":"2013","journal-title":"Dement Geriatr Cogn Dis Extra"},{"key":"2024022713482312000_ref5","doi-asserted-by":"crossref","first-page":"270","DOI":"10.1016\/j.jalz.2011.03.008","article-title":"The diagnosis of mild cognitive impairment due to Alzheimer\u2019s disease: recommendations from the National Institute on Aging-Alzheimer\u2019s Association workgroups on diagnostic guidelines for Alzheimer\u2019s disease","volume":"7","author":"Albert","year":"2011","journal-title":"Alzheimers Dement"},{"key":"2024022713482312000_ref6","doi-asserted-by":"crossref","first-page":"1594","DOI":"10.1212\/01.WNL.0000034176.07159.F8","article-title":"Incidence and outcome of mild cognitive impairment in a population-based prospective cohort","volume":"59","author":"Larrieu","year":"2002","journal-title":"Neurology"},{"key":"2024022713482312000_ref7","first-page":"197","article-title":"Two randomised phase 3 studies of aducanumab in early Alzheimer\u2019s disease","volume":"2","author":"Budd Haeberlein","year":"2022","journal-title":"J Prev Alzheimers Dis"},{"key":"2024022713482312000_ref8","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1056\/NEJMoa2212948","article-title":"Lecanemab in early Alzheimer\u2019s disease","volume":"388","author":"Dyck","year":"2023","journal-title":"N Engl J Med"},{"key":"2024022713482312000_ref9","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1001\/jama.2023.13239","article-title":"Donanemab in early symptomatic Alzheimer disease. 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