{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T16:35:25Z","timestamp":1780331725427,"version":"3.54.1"},"reference-count":10,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,6,2]],"date-time":"2024-06-02T00:00:00Z","timestamp":1717286400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alzheimer's &amp;amp; Dementia"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>INTRODUCTION<\/jats:title><jats:p>Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>A modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Overall, the recommendations support the delivery of decentralized trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations are presented, spanning aspects of decentralized clinical trials, including safety, dispensing, outcome assessment, and data collection.<\/jats:p><\/jats:sec><jats:sec><jats:title>DISCUSSION<\/jats:title><jats:p>These recommendations provide an accessible, pragmatic guide for the design and conduct of remote medication trials for dementia prevention.<\/jats:p><\/jats:sec><jats:sec><jats:title>Highlights<\/jats:title><jats:p><jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>Clinical trials of medication have begun adopting decentralized approaches.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Researchers in the field lack guidance on what would be appropriate circumstances and frameworks for what would be appropriate circumstances and frameworks for the use of decentralized trial methods in dementia prevention.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>The present report provides consensus\u2010based expert recommendations for decentralized clinical trials for dementia prevention.<\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><\/jats:sec>","DOI":"10.1002\/alz.13891","type":"journal-article","created":{"date-parts":[[2024,6,2]],"date-time":"2024-06-02T14:04:28Z","timestamp":1717337068000},"page":"4625-4634","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Decentralized clinical trials for medications to reduce the risk of dementia: Consensus report and guidance"],"prefix":"10.1002","volume":"20","author":[{"given":"Leanne","family":"Howard","sequence":"first","affiliation":[{"name":"Brain Health The George Institute for Global Health  Sydney New South Wales Australia"},{"name":"School of Population Health University of New South Wales  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Abdelnour","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurological Sciences Stanford University School of Medicine  Stanford USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin L.","family":"Abner","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Environmental Health University of Kentucky  Lexington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo F.","family":"Allegri","sequence":"additional","affiliation":[{"name":"Departament of Cognitive Neurology, Neuropsychology, and Neuropsychiatry Instituto de Investigaciones Neurologicas Fleni  Buenos Aires Argentina"},{"name":"Department of Neurosciences Universidad de la Costa  Barranquilla Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroko H.","family":"Dodge","sequence":"additional","affiliation":[{"name":"Department of Neurology Massachusetts General Hospital and Harvard Medical School  Boston USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Serge","family":"Gauthier","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurosurgery McGill University  Montr\u00e9al Qu\u00e9bec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilla M.","family":"Hoyos","sequence":"additional","affiliation":[{"name":"Medicine, Human and Health Sciences Macquarie University  Sydney NSW Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory A.","family":"Jicha","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Environmental Health University of Kentucky  Lexington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick G.","family":"Kehoe","sequence":"additional","affiliation":[{"name":"Translational Health Sciences Bristol Medical School University of Bristol  Bristol UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine J.","family":"Mummery","sequence":"additional","affiliation":[{"name":"Neurodegenerative Diseases University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adesola","family":"Ogunniyi","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Ibadan  Ibadan Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolaos","family":"Scarmeas","sequence":"additional","affiliation":[{"name":"1st Department of Neurology Aiginition Hospital Medical School National and Kapodistrian University of Athens  Athens Greece"},{"name":"Department of Neurology Columbia University  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoying","family":"Chen","sequence":"additional","affiliation":[{"name":"Brain Health The George Institute for Global Health  Sydney New South Wales Australia"},{"name":"School of Population Health University of New South Wales  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jodie R.","family":"Titiner","sequence":"additional","affiliation":[{"name":"International Society to Advance Alzheimer's Research and Treatment Alzheimer's Association  Chicago USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher R.","family":"Weber","sequence":"additional","affiliation":[{"name":"International Society to Advance Alzheimer's Research and Treatment Alzheimer's Association  Chicago USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Clinical Trial Methodology Working review group members","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0148-3617","authenticated-orcid":false,"given":"Ruth","family":"Peters","sequence":"additional","affiliation":[{"name":"Brain Health The George Institute for Global Health  Sydney New South Wales Australia"},{"name":"School of Population Health University of New South Wales  Sydney New South Wales Australia"},{"name":"School of Public Health Imperial College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,6,2]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurol.2013.07.017"},{"key":"e_1_2_9_3_1","unstructured":"The Association of Clinical Research Organisations.Template for Risk Assessment Considerations. Bringing the Trial to the Patient: A Quality By\u2010Design Manual for Decentralized Trials and Template for Risk Assessment Considerations. ACRO. Accessed August 24 2023.https:\/\/www.acrohealth.org\/dctqbdmanual\/"},{"key":"e_1_2_9_4_1","unstructured":"European Medicines Agency.Recommendation paper on decentralised elements in clinical trials.2022. Accessed May 14 2024https:\/\/health.ec.europa.eu\/document\/download\/2ccc46bf\u20102739\u20104b9a\u2010ab6b\u20106f425db78c61_en?filename=mp_decentralised\u2010elements_clinical\u2010trials_rec_en.pdf"},{"key":"e_1_2_9_5_1","unstructured":"U.S. Food and Drug Administration.Decentralized Clinical Trials for Drugs Biological Products and Devices. Guidance for Industry Investigators and Other Stakeholders DRAFT GUIDANCE.U.S. Department of Health and Human Services Food and Drug Administration.2023. Accessed May 14 2024.https:\/\/www.fda.gov\/media\/167696\/download"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.070941"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-022-00603-y"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arr.2022.101777"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-073535"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12461"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2016.10.007"}],"container-title":["Alzheimer's &amp; Dementia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/alz.13891","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T13:55:49Z","timestamp":1759931749000},"score":1,"resource":{"primary":{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/10.1002\/alz.13891"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,2]]},"references-count":10,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2024,7]]}},"alternative-id":["10.1002\/alz.13891"],"URL":"https:\/\/doi.org\/10.1002\/alz.13891","archive":["Portico"],"relation":{},"ISSN":["1552-5260","1552-5279"],"issn-type":[{"value":"1552-5260","type":"print"},{"value":"1552-5279","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,2]]},"assertion":[{"value":"2024-01-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}