{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,12]],"date-time":"2026-11-12T08:22:43Z","timestamp":1794471763535,"version":"4.9.1"},"reference-count":121,"publisher":"Elsevier BV","issue":"10","license":[{"start":{"date-parts":[[2022,12,1]],"date-time":"2022-12-01T00:00:00Z","timestamp":1669852800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,12,1]],"date-time":"2022-12-01T00:00:00Z","timestamp":1669852800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T00:00:00Z","timestamp":1663113600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["clinicalkey.fr","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Revue Neurologique"],"published-print":{"date-parts":[[2022,12]]},"DOI":"10.1016\/j.neurol.2022.06.012","type":"journal-article","created":{"date-parts":[[2022,9,29]],"date-time":"2022-09-29T08:27:16Z","timestamp":1664440036000},"page":"1011-1030","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":91,"title":["High-clearance anti-amyloid immunotherapies in Alzheimer's disease. Part 1: Meta-analysis and review of efficacy and safety data, and medico-economical aspects"],"prefix":"10.1016","volume":"178","author":[{"given":"N.","family":"Villain","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Planche","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Levy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.neurol.2022.06.012_bib0615","unstructured":"International Conference on Alzheimer's & Parkinson's Diseases 2011 | ALZFORUM n.d. https:\/\/www.alzforum.org\/print-series\/188576.(accessed January 18, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0620","first-page":"2576","article-title":"Differential in vitro and in vivo binding profiles of BIIB037 and other anti-abeta clinical antibody candidates","volume":"11","author":"Bussiere","year":"2013","journal-title":"Neurodegener Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0625","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1038\/nature19323","article-title":"The antibody aducanumab reduces A\u03b2 plaques in Alzheimer's disease","volume":"537","author":"Sevigny","year":"2016","journal-title":"Nature"},{"key":"10.1016\/j.neurol.2022.06.012_bib0630","doi-asserted-by":"crossref","first-page":"367","DOI":"10.1016\/j.jalz.2011.05.2351","article-title":"Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer's Association Research Roundtable Workgroup","volume":"7","author":"Sperling","year":"2011","journal-title":"Alzheimer Dement J Alzheimer Assoc"},{"key":"10.1016\/j.neurol.2022.06.012_bib0635","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1016\/j.trci.2016.06.002","article-title":"First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease","volume":"2","author":"Ferrero","year":"2016","journal-title":"Alzheimer Dement Transl Res Clin Interv"},{"key":"10.1016\/j.neurol.2022.06.012_bib0640","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1212\/WNL.0000000000001877","article-title":"Amyloid-\u03b2 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials","volume":"85","author":"Liu","year":"2015","journal-title":"Neurology"},{"key":"10.1016\/j.neurol.2022.06.012_bib0645","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1016\/j.jalz.2011.03.005","article-title":"The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease","volume":"7","author":"McKhann","year":"2011","journal-title":"Alzheimers Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib0650","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's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease","volume":"7","author":"Albert","year":"2011","journal-title":"Alzheimers Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib0655","doi-asserted-by":"crossref","first-page":"1409","DOI":"10.3233\/JAD-180675","article-title":"Clinical evaluation of amyloid-related imaging abnormalities in bapineuzumab phase III studies","volume":"66","author":"Brashear","year":"2018","journal-title":"J Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0660","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1038\/s41582-019-0281-2","article-title":"Cerebral amyloid angiopathy and Alzheimer disease\u00a0\u2013\u00a0one peptide, two pathways","volume":"16","author":"Greenberg","year":"2020","journal-title":"Nat Rev Neurol"},{"key":"10.1016\/j.neurol.2022.06.012_bib0665","first-page":"1","article-title":"Two randomized phase 3 studies of aducanumab in early Alzheimer's disease","volume":"2022","author":"Budd Haeberlein","year":"2022","journal-title":"J Prev Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0670","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1212\/WNL.0000000000012451","article-title":"Aducanumab, amyloid lowering, and slowing of Alzheimer disease","volume":"97","author":"Salloway","year":"2021","journal-title":"Neurology"},{"key":"10.1016\/j.neurol.2022.06.012_bib0675","doi-asserted-by":"crossref","DOI":"10.1002\/alz.12615","article-title":"A Bayesian perspective on Biogen's aducanumab trial","author":"Temp","year":"2022","journal-title":"Alzheimers Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib0680","first-page":"Preprint:1","article-title":"A Bayesian reanalysis of the phase III aducanumab (ADU) trial","author":"Costa","year":"2022","journal-title":"J Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0870","doi-asserted-by":"crossref","DOI":"10.1038\/s41582-021-00557-x","article-title":"Can we learn lessons from the FDA's approval of aducanumab?","author":"Liu","year":"2021","journal-title":"Nat Rev Neurol"},{"key":"10.1016\/j.neurol.2022.06.012_bib0685","doi-asserted-by":"crossref","first-page":"1e4","DOI":"10.1016\/j.jalz.2014.07.003","article-title":"The Centiloid project: standardizing quantitative amyloid plaque estimation by PET","volume":"11","author":"Klunk","year":"2015","journal-title":"Alzheimers Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib0690","article-title":"Amyloid-\u03b2 PET classification on cognitive aging stages using the centiloid scale","author":"de Souza","year":"2021","journal-title":"Mol Imaging Biol"},{"key":"10.1016\/j.neurol.2022.06.012_bib0695","doi-asserted-by":"crossref","DOI":"10.1007\/s00401-022-02433-4","article-title":"Alzheimer disease neuropathology in a patient previously treated with aducanumab","author":"Plowey","year":"2022","journal-title":"Acta Neuropathol"},{"key":"10.1016\/j.neurol.2022.06.012_bib0700","unstructured":"FDA Advisory Committee Throws Cold Water on Aducanumab Filing | ALZFORUM n.d. https:\/\/www.alzforum.org\/news\/community-news\/fda-advisory-committee-throws-cold-water-aducanumab-filing.(accessed November 26, 2021)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0705","unstructured":"FDA Grants Accelerated Approval for Alzheimer's Drug | FDA n.d. https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-grants-accelerated-approval-alzheimers-drug (accessed November 26, 2021)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0710","unstructured":"Update on the Phase 4 Confirmatory Study of ADUHELM\u00ae | Biogen n.d. https:\/\/investors.biogen.com\/news-releases\/news-release-details\/update-phase-4-confirmatory-study-aduhelmr.(accessed January 17, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0715","unstructured":"Biogen Submits Final Protocol for ADUHELM\u00ae (aducanumab-avwa) Phase 4 ENVISION Trial to FDA | Biogen n.d. https:\/\/investors.biogen.com\/news-releases\/news-release-details\/biogen-submits-final-protocol-aduhelmr-aducanumab-avwa-phase-4 (accessed April 4, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0720","unstructured":"Eisai Turns Over Majority of Aduhelm Rights to Biogen | BioSpace n.d. https:\/\/www.biospace.com\/article\/biogen-and-eisai-modify-deal-on-alzheimer-s-drug-aduhelmbiogen-and-eisai-modify-deal-on-alzheimer-s-drug-aduhelm\/.(accessed April 25, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0725","unstructured":"Aduhelm: Pending EC decision | European Medicines Agency n.d. https:\/\/www.ema.europa.eu\/en\/medicines\/human\/summaries-opinion\/aduhelm (accessed January 18, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0730","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1016\/j.phrs.2021.105754","article-title":"Aducanumab for Alzheimer's disease: a regulatory perspective","volume":"171","author":"Nistic\u00f2","year":"2021","journal-title":"Pharmacol Res"},{"key":"10.1016\/j.neurol.2022.06.012_bib0735","doi-asserted-by":"crossref","first-page":"1691","DOI":"10.1056\/NEJMoa2100708","article-title":"Donanemab in early Alzheimer's disease","volume":"384","author":"Mintun","year":"2021","journal-title":"N Engl J Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib0740","first-page":"227","article-title":"A combined measure of cognition and function for clinical trials: the integrated Alzheimer's Disease Rating Scale (iADRS)","volume":"2","author":"Wessels","year":"2015","journal-title":"J Prev Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0745","unstructured":"Lilly's donanemab receives U.S. FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease | Eli Lilly and Company n.d. https:\/\/investor.lilly.com\/news-releases\/news-release-details\/lillys-donanemab-receives-us-fdas-breakthrough-therapy.(accessed November 26, 2021)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0750","unstructured":"Eli Lilly Initiates Rolling Submission for Donanemab in Early Alzheimer Disease n.d. https:\/\/www.neurologylive.com\/view\/eli-lilly-initiates-rolling-submission-donanemab-early-alzheimer-disease.(accessed January 17, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0755","unstructured":"Eli Lilly pushes back timeline for Alzheimer's drug application | Reuters n.d. https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/eli-lilly-profit-falls-18-higher-costs-2022-02-03\/(accessed April 5, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0760","unstructured":"Alzheimer's drugmakers seek accelerated FDA review despite U.S. coverage decision | Reuters n.d. https:\/\/www.reuters.com\/world\/us\/eisai-seeking-accelerated-fda-review-alzheimers-drug-after-us-coverage-decision-2022-04-08\/.(accessed April 25, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0765","unstructured":"LY3372993 | ALZFORUM n.d. https:\/\/www.alzforum.org\/therapeutics\/ly3372993 (accessed July 17, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0770","first-page":"1","article-title":"Design of a Bayesian adaptive phase 2 proof-of-concept trial for BAN2401, a putative disease-modifying monoclonal antibody for the treatment of Alzheimer's disease","volume":"2","author":"Satlin","year":"2016","journal-title":"Alzheimers Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib0775","doi-asserted-by":"crossref","first-page":"993","DOI":"10.1136\/jnnp-2015-312383","article-title":"ADCOMS: a composite clinical outcome for prodromal Alzheimer's disease trials","volume":"87","author":"Wang","year":"2016","journal-title":"J Neurol Neurosurg Psychiatry"},{"key":"10.1016\/j.neurol.2022.06.012_bib0780","series-title":"Subjects with early Alzheimer's disease","article-title":"Preliminary assessment of the clinical effects of lecanemab following 18 months of treatment in the open-label extension of the phase 2 proof-of-concept study, BAN2401-G000-201","author":"Swanson","year":"2021"},{"key":"10.1016\/j.neurol.2022.06.012_bib0785","unstructured":"EISAI statement on the centers for medicare and medicaid services\u2019 national coverage determination with coverage with evidence development for monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease | News Release: 2022 | Eisai Co., Ltd. n.d. https:\/\/www.eisai.com\/news\/2022\/news202226.html.(accessed April 25, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0790","unstructured":"EISAI initiates rolling submission to the U.S. FDA for biologics license application of Lecanemab (BAN2401) for early Alzheimer's disease under the accelerated approval pathway | News Release: 2021 | Eisai Co., Ltd. n.d. https:\/\/www.eisai.com\/news\/2021\/news202177.html.(accessed November 26, 2021)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0795","doi-asserted-by":"crossref","DOI":"10.1038\/s41591-021-01369-8","article-title":"A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer's disease","author":"Salloway","year":"2021","journal-title":"Nat Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib0800","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s13195-019-0559-z","article-title":"Gantenerumab reduces amyloid-\u03b2 plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis","volume":"11","author":"Klein","year":"2019","journal-title":"Alzheimer's Res Ther"},{"key":"10.1016\/j.neurol.2022.06.012_bib0805","doi-asserted-by":"crossref","first-page":"3","DOI":"10.14283\/jpad.2020.68","article-title":"Thirty-six-month amyloid positron emission tomography results show continued reduction in amyloid burden with subcutaneous gantenerumab","volume":"8","author":"Klein","year":"2021","journal-title":"J Prev Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0810","unstructured":"Roche - [Ad hoc announcement pursuant to Art. 53 LR] Roche's anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer's disease n.d. https:\/\/www.roche.com\/media\/releases\/med-cor-2021-10-08.htm.(accessed January 20, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0815","unstructured":"Lilly and Roche learn from Biogen's mistakes | Evaluate n.d. https:\/\/www.evaluate.com\/vantage\/articles\/news\/corporate-strategy\/lilly-and-roche-learn-biogens-mistakes (accessed April 5, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib0820","doi-asserted-by":"crossref","first-page":"311","DOI":"10.1016\/j.biopsych.2017.08.010","article-title":"Anti-amyloid-\u03b2 monoclonal antibodies for Alzheimer's disease: pitfalls and promise","volume":"83","author":"van Dyck","year":"2018","journal-title":"Biol Psychiatry"},{"key":"10.1016\/j.neurol.2022.06.012_bib0825","doi-asserted-by":"crossref","first-page":"1051","DOI":"10.1002\/alz.12379","article-title":"Bayes analysis supports null hypothesis of anti-amyloid beta therapy in Alzheimer's disease","volume":"17","author":"Richard","year":"2021","journal-title":"Alzheimer's Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib0830","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1056\/NEJMoa1705971","article-title":"Trial of solanezumab for mild dementia due to Alzheimer's disease","volume":"378","author":"Honig","year":"2018","journal-title":"N Engl J Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib0835","doi-asserted-by":"crossref","first-page":"2061","DOI":"10.1212\/WNL.0b013e3181c67808","article-title":"A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease","volume":"73","author":"Salloway","year":"2009","journal-title":"Neurology"},{"key":"10.1016\/j.neurol.2022.06.012_bib0840","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1212\/WNL.0000000000001877","article-title":"Amyloid-\u03b2 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials","volume":"85","author":"Liu","year":"2015","journal-title":"Neurology"},{"key":"10.1016\/j.neurol.2022.06.012_bib0845","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s13195-017-0318-y","article-title":"A phase III randomized trial of gantenerumab in prodromal Alzheimer's disease","volume":"9","author":"Ostrowitzki","year":"2017","journal-title":"Alzheimer's Res Ther"},{"key":"10.1016\/j.neurol.2022.06.012_bib0850","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1056\/NEJMoa1705971","article-title":"Trial of solanezumab for mild dementia due to Alzheimer's disease","volume":"378","author":"Honig","year":"2018","journal-title":"N Engl J Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib0855","doi-asserted-by":"crossref","DOI":"10.1038\/s41573-022-00391-w","article-title":"The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics","author":"Karran","year":"2022","journal-title":"Nat Rev Drug Discov"},{"key":"10.1016\/j.neurol.2022.06.012_bib0860","doi-asserted-by":"crossref","first-page":"856","DOI":"10.1056\/NEJMc2111960","article-title":"An appropriate use of accelerated approval\u00a0\u2013\u00a0aducanumab for Alzheimer's disease","volume":"385","author":"Dunn","year":"2021","journal-title":"N Engl J Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib0865","doi-asserted-by":"crossref","first-page":"1276","DOI":"10.1001\/jamainternmed.2021.4607","article-title":"Approval of aducanumab for Alzheimer disease\u00a0\u2013\u00a0the FDA's perspective","volume":"181","author":"Dunn","year":"2021","journal-title":"JAMA Intern Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib0875","doi-asserted-by":"crossref","first-page":"1013","DOI":"10.1016\/S2215-0366(21)00197-8","article-title":"The need to show minimum clinically important differences in Alzheimer's disease trials","volume":"8","author":"Liu","year":"2021","journal-title":"Lancet Psychiatry"},{"key":"10.1016\/j.neurol.2022.06.012_bib0960","doi-asserted-by":"crossref","first-page":"221","DOI":"10.14283\/jpad.2022.34","article-title":"Aducanumab: appropriate use recommendations update","volume":"9","author":"Cummings","year":"2022","journal-title":"J Prev Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0880","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1016\/j.trci.2019.06.005","article-title":"Disease severity and minimal clinically important differences in clinical outcome assessments for Alzheimer's disease clinical trials","volume":"5","author":"Andrews","year":"2019","journal-title":"Alzheimers Dement Transl Res Clin Interv"},{"key":"10.1016\/j.neurol.2022.06.012_bib0885","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","author":"Schrag","year":"2012","journal-title":"J Neurol Neurosurg Psychiatry"},{"key":"10.1016\/j.neurol.2022.06.012_bib0890","first-page":"CD001190","article-title":"Donepezil for dementia due to Alzheimer\u2019 s disease","volume":"6","author":"Birks","year":"2018","journal-title":"Cochrane Database Syst Rev"},{"key":"10.1016\/j.neurol.2022.06.012_bib0895","doi-asserted-by":"crossref","first-page":"e2673","DOI":"10.1212\/WNL.0000000000012022","article-title":"Finding treatment effects in Alzheimer trials in the face of disease progression heterogeneity","volume":"96","author":"Jutten","year":"2021","journal-title":"Neurology"},{"key":"10.1016\/j.neurol.2022.06.012_bib0900","series-title":"Aducanumab 48-month analyses from prime a phase 1b study in patients with early Alzheimer's disease","first-page":"S168","author":"Von Rosenstiel","year":"2018"},{"key":"10.1016\/j.neurol.2022.06.012_bib0905","doi-asserted-by":"crossref","first-page":"624","DOI":"10.1126\/science.abi6401","article-title":"Treatments for Alzheimer's disease emerge","volume":"373","author":"Selkoe","year":"2021","journal-title":"Science"},{"key":"10.1016\/j.neurol.2022.06.012_bib0910","doi-asserted-by":"crossref","first-page":"238","DOI":"10.14283\/jpad.2021.26","article-title":"New hope for Alzheimer's disease","volume":"8","author":"Vellas","year":"2021","journal-title":"J Prev Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0915","doi-asserted-by":"crossref","first-page":"821","DOI":"10.1007\/s12603-021-1657-8","article-title":"Editorial: the geriatrician, the primary care physician, aducanumab and the FDA decision: from frustration to new hope","volume":"25","author":"Vellas","year":"2021","journal-title":"J Nutr Health Aging"},{"key":"10.1016\/j.neurol.2022.06.012_bib0920","first-page":"13","article-title":"Aducanumab: appropriate use recommendations","author":"Cummings","year":"2021","journal-title":"Alzheimers Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib0925","doi-asserted-by":"crossref","first-page":"398","DOI":"10.14283\/jpad.2021.41","article-title":"Aducanumab: appropriate use recommendations","volume":"8","author":"Cummings","year":"2021","journal-title":"J Prev Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0930","doi-asserted-by":"crossref","first-page":"412","DOI":"10.14283\/jpad.2021.45","article-title":"Commentary: aducanumab: appropriate use recommendations","volume":"8","author":"Scheltens","year":"2021","journal-title":"J Prev Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0940","doi-asserted-by":"crossref","first-page":"322","DOI":"10.1056\/NEJMoa1304839","article-title":"Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease","volume":"370","author":"Salloway","year":"2014","journal-title":"N Engl J Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib0945","unstructured":"INDICATIONS AND USAGE ADUHELM is indicated for the treatment of Alzheimer\u2019 s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, effectiveness data on initiating treatment at 2021."},{"key":"10.1016\/j.neurol.2022.06.012_bib0950","doi-asserted-by":"crossref","first-page":"211","DOI":"10.14283\/jpad.2022.21","article-title":"Detection and management of amyloid-related imaging abnormalities in patients with Alzheimer's disease treated with anti-amyloid beta therapy","volume":"2","author":"Barakos","year":"2022","journal-title":"J Prev Alzheimer's Dis"},{"key":"10.1016\/j.neurol.2022.06.012_bib0955","doi-asserted-by":"crossref","DOI":"10.1001\/jamaneurol.2021.5205","article-title":"Amyloid-related imaging abnormalities and \u03b2-amyloid\u2013targeting antibodies: a systematic review","author":"Filippi","year":"2022","journal-title":"JAMA Neurol"},{"key":"10.1016\/j.neurol.2022.06.012_bib0965","doi-asserted-by":"crossref","first-page":"754","DOI":"10.1038\/375754a0","article-title":"Cloning of a gene bearing missense mutations in early-onset familial Alzheimer's disease","volume":"375","author":"Sherrington","year":"1995","journal-title":"Nature"},{"key":"10.1016\/j.neurol.2022.06.012_bib0970","doi-asserted-by":"crossref","first-page":"970","DOI":"10.1126\/science.7638621","article-title":"A familial Alzheimer's disease locus on chromosome 1","volume":"269","author":"Levy-Lahad","year":"1995","journal-title":"Science"},{"key":"10.1016\/j.neurol.2022.06.012_bib0975","doi-asserted-by":"crossref","first-page":"775","DOI":"10.1038\/376775a0","article-title":"Familial Alzheimer's disease in kindreds with missense mutations in a gene on chromosome 1 related to the Alzheimer's disease type 3 gene","volume":"376","author":"Rogaev","year":"1995","journal-title":"Nature"},{"key":"10.1016\/j.neurol.2022.06.012_bib0980","doi-asserted-by":"crossref","first-page":"985","DOI":"10.1093\/hmg\/5.7.985","article-title":"Alzheimer's disease associated with mutations in presenilin 2 is rare and variably penetrant","volume":"5","author":"Sherrington","year":"1996","journal-title":"Hum Mol Genet"},{"key":"10.1016\/j.neurol.2022.06.012_bib0985","doi-asserted-by":"crossref","first-page":"844","DOI":"10.1038\/353844a0","article-title":"Early-onset Alzheimer's disease caused by mutations at codon 717 of the \u03b2-amyloid precursor protein gene","volume":"353","author":"Chartier-Harlin","year":"1991","journal-title":"Nat"},{"key":"10.1016\/j.neurol.2022.06.012_bib0990","doi-asserted-by":"crossref","first-page":"704","DOI":"10.1038\/349704a0","article-title":"Segregation of a missense mutation in the amyloid precursor protein gene with familial Alzheimer's disease","volume":"349","author":"Goate","year":"1991","journal-title":"Nature"},{"key":"10.1016\/j.neurol.2022.06.012_bib0995","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1038\/ng1292-255","article-title":"More missense in amyloid gene","volume":"2","author":"Carter","year":"1992","journal-title":"Nat Genet"},{"key":"10.1016\/j.neurol.2022.06.012_bib1000","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1038\/ng1718","article-title":"APP locus duplication causes autosomal dominant early-onset Alzheimer disease with cerebral amyloid angiopathy","volume":"38","author":"Rovelet-Lecrux","year":"2006","journal-title":"Nat Genet"},{"key":"10.1016\/j.neurol.2022.06.012_bib1005","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1126\/science.1566067","article-title":"Alzheimer's disease: the amyloid cascade hypothesis","volume":"256","author":"Hardy","year":"1992","journal-title":"Science"},{"key":"10.1016\/j.neurol.2022.06.012_bib1010","doi-asserted-by":"crossref","first-page":"595","DOI":"10.15252\/emmm.201606210","article-title":"The amyloid hypothesis of Alzheimer's disease at 25\u00a0years","volume":"8","author":"Selkoe","year":"2016","journal-title":"EMBO Mol Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib1015","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1016\/j.jalz.2018.02.018","article-title":"NIA-AA research framework: toward a biological definition of Alzheimer's disease","volume":"14","author":"Jack","year":"2018","journal-title":"Alzheimers Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib1020","doi-asserted-by":"crossref","first-page":"362","DOI":"10.1016\/S0197-4580(97)00047-X","article-title":"Prevalence, incidence and duration of Braak's stages in the general population: can we know?","volume":"18","author":"Duyckaerts","year":"1997","journal-title":"Neurobiol Aging"},{"key":"10.1016\/j.neurol.2022.06.012_bib1025","doi-asserted-by":"crossref","first-page":"484","DOI":"10.1016\/S1474-4422(21)00066-1","article-title":"Clinical diagnosis of Alzheimer's disease: recommendations of the International Working Group","volume":"20","author":"Dubois","year":"2021","journal-title":"Lancet Neurol"},{"key":"10.1016\/j.neurol.2022.06.012_bib1030","first-page":"23","article-title":"The probabilistic model of Alzheimer disease: the amyloid hypothesis revised","author":"Frisoni","year":"2022","journal-title":"Nat Rev Neurosci"},{"issue":"Suppl 2","key":"10.1016\/j.neurol.2022.06.012_bib1035","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1111\/jnc.13632","article-title":"The amyloid cascade hypothesis: are we poised for success or failure?","volume":"139","author":"Karran","year":"2016","journal-title":"J Neurochem"},{"key":"10.1016\/j.neurol.2022.06.012_bib1040","doi-asserted-by":"crossref","first-page":"431","DOI":"10.1002\/sim.4780080407","article-title":"Surrogate endpoints in clinical trials: definition and operational criteria","volume":"8","author":"Prentice","year":"1989","journal-title":"Stat Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib1045","doi-asserted-by":"crossref","first-page":"713","DOI":"10.1016\/j.mayocp.2016.02.012","article-title":"Strength of validation for surrogate end points used in the US food and drug administration's approval of oncology drugs","volume":"91","author":"Kim","year":"2016","journal-title":"Mayo Clin Proc"},{"key":"10.1016\/j.neurol.2022.06.012_bib1050","doi-asserted-by":"crossref","first-page":"2973","DOI":"10.1002\/sim.5403","article-title":"Biomarkers and surrogate endpoints in clinical trials","volume":"31","author":"Fleming","year":"2012","journal-title":"Stat Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib1055","doi-asserted-by":"crossref","first-page":"487","DOI":"10.1016\/j.jval.2016.10.011","article-title":"Time to review the role of surrogate end points in health policy: state of the art and the way forward","volume":"20","author":"Ciani","year":"2017","journal-title":"Value Health"},{"key":"10.1016\/j.neurol.2022.06.012_bib1060","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1056\/NEJMp2110468","article-title":"Revisiting FDA approval of aducanumab","volume":"385","author":"Alexander","year":"2021","journal-title":"N Engl J Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib1065","doi-asserted-by":"crossref","first-page":"1307","DOI":"10.1001\/jamaneurol.2021.3126","article-title":"US food and drug administration approval of aducanumab\u00a0\u2013\u00a0is amyloid load a valid surrogate end point for Alzheimer disease clinical trials?","volume":"78","author":"Planche","year":"2021","journal-title":"JAMA Neurol"},{"key":"10.1016\/j.neurol.2022.06.012_bib1070","series-title":"Combined FDA and Applicant PCNS Drugs Advisory Committee Briefing Document\u00a0\u2013\u00a0Aducanumab","year":"2020"},{"key":"10.1016\/j.neurol.2022.06.012_bib1075","doi-asserted-by":"crossref","first-page":"e057492","DOI":"10.1002\/alz.057492","article-title":"TRAILBLAZER-ALZ study: dynamics of amyloid reduction after donanemab treatment","volume":"17","author":"Shcherbinin","year":"2021","journal-title":"Alzheimers Dement"},{"key":"10.1016\/j.neurol.2022.06.012_bib1080","unstructured":"Alzheimer's Disease: Developing Drugs for Treatment Guidance for Industy | FDA n.d. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/alzheimers-disease-developing-drugs-treatment-guidance-industy.(accessed January 21, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1085","series-title":"Guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease","author":"Committee for Medicinal Products for Human Use (CHMP)","year":"2018"},{"key":"10.1016\/j.neurol.2022.06.012_bib1090","doi-asserted-by":"crossref","first-page":"1367","DOI":"10.1001\/jama.2021.14861","article-title":"A middle ground for accelerated drug approval-lessons from aducanumab","volume":"326","author":"Emanuel","year":"2021","journal-title":"JAMA"},{"key":"10.1016\/j.neurol.2022.06.012_bib1095","doi-asserted-by":"crossref","first-page":"1275","DOI":"10.1001\/jamainternmed.2021.4604","article-title":"Fulfilling the mandate of the US food and drug administration's accelerated approval pathway: the need for reforms","volume":"181","author":"Gyawali","year":"2021","journal-title":"JAMA Intern Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib1100","first-page":"1","article-title":"The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: a cross-sectional study of products authorised 2011\u20132018","volume":"16","author":"Bruce","year":"2019","journal-title":"PLoS Med"},{"key":"10.1016\/j.neurol.2022.06.012_bib1105","unstructured":"Glossary | NICE n.d. https:\/\/www.nice.org.uk\/Glossary?letter=Q#Quality-adjusted life year.(accessed January 21, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1110","unstructured":"Methods Update: Value Assessment Framework - ICER n.d. https:\/\/icer.org\/assessment\/value-assessment-framework-2020\/#overview.(accessed January 21, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1115","doi-asserted-by":"crossref","DOI":"10.1007\/s40120-021-00273-0","article-title":"Predicted lifetime health outcomes for aducanumab in patients with early Alzheimer's disease","author":"Herring","year":"2021","journal-title":"Neurol Ther"},{"key":"10.1016\/j.neurol.2022.06.012_bib1120","series-title":"Cost-effectiveness and value-based pricing of aducanumab for patients with early Alzheimer disease","author":"Whittington","year":"2022"},{"key":"10.1016\/j.neurol.2022.06.012_bib1125","doi-asserted-by":"crossref","DOI":"10.1001\/jamaneurol.2022.0315","article-title":"Cost-effectiveness of aducanumab and donanemab for early Alzheimer disease in the US","author":"Ross","year":"2022","journal-title":"JAMA Neurol"},{"key":"10.1016\/j.neurol.2022.06.012_bib1130","series-title":"Aducanumab for Alzheimer's disease: effectiveness and value","author":"Institute for Clinical Economic Review","year":"2021"},{"key":"10.1016\/j.neurol.2022.06.012_bib1135","unstructured":"In Revised Evidence Report, ICER Confirms Judgment That Evidence is Insufficient to Demonstrate Net Health Benefit of Aducanumab for Patients with Alzheimer's Disease - ICER n.d. https:\/\/icer.org\/news-insights\/press-releases\/in-revised-evidence-report-icer-confirms-judgment-that-evidence-is-insufficient-to-demonstrate-net-health-benefit-of-aducanumab-for-patients-with-alzheimers-disease\/.(accessed January 24, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1140","unstructured":"Biogen Announces Reduced Price for ADUHELM\u00ae to Improve Access for Patients with Early Alzheimer's Disease | Biogen n.d. https:\/\/investors.biogen.com\/news-releases\/news-release-details\/biogen-announces-reduced-price-aduhelmr-improve-access-patients.(accessed January 19, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1145","doi-asserted-by":"crossref","first-page":"705","DOI":"10.3233\/ADR-210307","article-title":"Comparative value of cholinesterase inhibitors and memantine in persons with moderate-to-severe alzheimer's disease in the United States: a cost-effectiveness analysis","volume":"5","author":"Yunusa","year":"2021","journal-title":"J Alzheimers Dis Rep"},{"key":"10.1016\/j.neurol.2022.06.012_bib1150","unstructured":"The \u201cQALY\u201d shouldn\u2019t be used in drug cost-effectiveness reviews - STAT n.d. https:\/\/www.statnews.com\/2019\/02\/22\/qaly-drug-effectiveness-reviews\/.(accessed January 24, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1155","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/j.eururo.2018.03.006","article-title":"Cost-effectiveness of pembrolizumab in second-line advanced bladder cancer","volume":"74","author":"Sarfaty","year":"2018","journal-title":"Eur Urol"},{"key":"10.1016\/j.neurol.2022.06.012_bib1160","unstructured":"NCA - Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (CAG-00460N) - Decision Memo n.d. https:\/\/www.cms.gov\/medicare-coverage-database\/view\/ncacal-decision-memo.aspx?proposed=N&ncaid=305.(accessed April 8, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1165","doi-asserted-by":"crossref","first-page":"1305","DOI":"10.1001\/jamaneurol.2021.3404","article-title":"What the aducanumab approval reveals about Alzheimer disease research","volume":"78","author":"Manly","year":"2021","journal-title":"JAMA Neurol"},{"key":"10.1016\/j.neurol.2022.06.012_bib1170","doi-asserted-by":"crossref","DOI":"10.1093\/aje\/kwac063","article-title":"Aduhelm, the newly approved medication for Alzheimer's disease: what epidemiologists can learn and what epidemiology can offer","author":"Glymour","year":"2022","journal-title":"Am J Epidemiol"},{"key":"10.1016\/j.neurol.2022.06.012_bib1175","unstructured":"Medicare finalizes its restrictions on new Alzheimer's drug - STAT n.d. https:\/\/www.statnews.com\/2022\/04\/07\/medicare-final-decision-alzheimers-coverage-biogen-aduhelm\/.(accessed April 8, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1180","unstructured":"Several private insurers won\u2019t cover Biogen's Alzheimer's drug n.d. https:\/\/www.statnews.com\/2021\/07\/14\/this-is-unprecedented-several-private-insurers-wont-cover-biogens-alzheimers-drug\/.(accessed January 24, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1185","unstructured":"Blue Cross of Massachusetts will not cover controversial Alzheimer's drug - The Boston Globe n.d. https:\/\/www.bostonglobe.com\/2021\/10\/07\/business\/blue-cross-massachusetts-will-not-cover-controversial-alzheimers-drug\/?p1=BGSearch_Advanced_Results (accessed January 24, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1190","doi-asserted-by":"crossref","first-page":"3690","DOI":"10.1111\/jgs.17462","article-title":"Instead of wasting money on aducanumab, pay for programs proven to help people living with dementia","volume":"69","author":"Hunt","year":"2021","journal-title":"J Am Geriatr Soc"},{"key":"10.1016\/j.neurol.2022.06.012_bib1195","unstructured":"News | Alzheimer's Association n.d. https:\/\/www.alz.org\/news\/2021\/next-steps-for-new-alzheimers-treatment.(accessed January 24, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1200","unstructured":"News | Alzheimer's Association n.d. https:\/\/www.alz.org\/news\/2022\/alzheimers-association-disappointed-by-medicare-co.(accessed April 25, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1205","unstructured":"With Aduhelm in limbo, Biogen starts laying off employees n.d. https:\/\/www.statnews.com\/2022\/03\/03\/with-aduhelm-in-limbo-biogen-starts-laying-off-employees\/(accessed April 8, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1210","unstructured":"UAE approves use of first, only drug to treat Alzheimer's - News | Khaleej Times n.d. https:\/\/www.khaleejtimes.com\/news\/20211003\/uae-approves-use-of-first-and-only-drug-to-treat-alzheimers.(accessed January 24, 2022)."},{"key":"10.1016\/j.neurol.2022.06.012_bib1215","series-title":"Key milestones in Alzheimer's disease","author":"Budd-Haeberlein","year":"2022"},{"key":"10.1016\/j.neurol.2022.06.012_bib1220","unstructured":"Japan delays decision on whether to OK new Alzheimer's drug | The Japan Times n.d. https:\/\/www.japantimes.co.jp\/news\/2021\/12\/23\/national\/science-health\/alzheimers-drug-japan-approval-delay\/.(accessed January 24, 2022)."}],"container-title":["Revue Neurologique"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S003537872200738X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S003537872200738X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T05:44:55Z","timestamp":1758519895000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S003537872200738X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12]]},"references-count":121,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["S003537872200738X"],"URL":"https:\/\/doi.org\/10.1016\/j.neurol.2022.06.012","relation":{},"ISSN":["0035-3787"],"issn-type":[{"value":"0035-3787","type":"print"}],"subject":[],"published":{"date-parts":[[2022,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"High-clearance anti-amyloid immunotherapies in Alzheimer's disease. Part 1: Meta-analysis and review of efficacy and safety data, and medico-economical aspects","name":"articletitle","label":"Article Title"},{"value":"Revue Neurologique","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.neurol.2022.06.012","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2022 The Author(s). Published by Elsevier Masson SAS.","name":"copyright","label":"Copyright"}]}}