{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T09:21:59Z","timestamp":1778059319272,"version":"3.51.4"},"reference-count":20,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,2,8]],"date-time":"2023-02-08T00:00:00Z","timestamp":1675814400000},"content-version":"vor","delay-in-days":38,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["P30 AG072959"],"award-info":[{"award-number":["P30 AG072959"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["P20 AG068053"],"award-info":[{"award-number":["P20 AG068053"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01AG022304"],"award-info":[{"award-number":["R01AG022304"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01 AG057552"],"award-info":[{"award-number":["R01 AG057552"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01 AG070736"],"award-info":[{"award-number":["R01 AG070736"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R56 AG074001"],"award-info":[{"award-number":["R56 AG074001"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["RF1 AG071566"],"award-info":[{"award-number":["RF1 AG071566"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["U01 AG073323"],"award-info":[{"award-number":["U01 AG073323"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["U01 NS100610"],"award-info":[{"award-number":["U01 NS100610"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01 AG071514"],"award-info":[{"award-number":["R01 AG071514"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01 NS101483"],"award-info":[{"award-number":["R01 NS101483"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01 NS101483\u2010S1"],"award-info":[{"award-number":["R01 NS101483\u2010S1"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["P01 AG066584"],"award-info":[{"award-number":["P01 AG066584"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01 AG071643"],"award-info":[{"award-number":["R01 AG071643"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01 AG069765"],"award-info":[{"award-number":["R01 AG069765"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["R01 AG057681"],"award-info":[{"award-number":["R01 AG057681"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["P30 AG059295"],"award-info":[{"award-number":["P30 AG059295"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017312","name":"Lewy Body Dementia Association","doi-asserted-by":"publisher","award":["U19\u2010AG062418"],"award-info":[{"award-number":["U19\u2010AG062418"]}],"id":[{"id":"10.13039\/100017312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["NIH R01AG059008"],"award-info":[{"award-number":["NIH R01AG059008"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["NIH P30 AG072980"],"award-info":[{"award-number":["NIH P30 AG072980"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["NIH R01AG073212"],"award-info":[{"award-number":["NIH R01AG073212"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["A&amp;D Transl Res &amp; Clin Interv"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>The regulatory path for drug approval is increasingly well defined. Drugs for the treatment of Alzheimer disease (AD) need to show statistically significant benefit over placebo with respect to cognitive and functional measures, with the Clinical Dementia Rating scale and Alzheimer's Disease Assessment Scale\u2013Cognitive Subscale being among the most often used instruments in AD clinical trials. In contrast, there are no validated instruments for use in clinical trials of drugs for the treatment of dementia with Lewy bodies. This poses challenges for drug development because the regulatory pathway to drug approval requires demonstrable efficacy measures. In December 2021, the Lewy Body Dementia Association advisory group met with representatives from the US Food and Drug Administration to discuss the lack of approved drugs and treatments, discernment of efficacy measures, and identification of biomarkers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Highlights<\/jats:title>\n                    <jats:p>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>The Lewy Body with Dementia Association convened a listening session with the US Food and Drug Administration on dementia with Lewy bodies (DLB) and clinical trial design.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Gaps include DLB\u2010specific measures, alpha synuclein biomarkers, and coexisting pathologies.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>DLB clinical trial design should focus on clinical value and disease specificity.<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/trc2.12375","type":"journal-article","created":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T02:56:16Z","timestamp":1675911376000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Listening session with the US Food and Drug Administration, Lewy Body Dementia Association, and an expert panel"],"prefix":"10.1002","volume":"9","author":[{"given":"Marwan N.","family":"Sabbagh","sequence":"first","affiliation":[{"name":"Department of Neurology Alzheimer's and Memory Disorders Division Barrow Neurological Institute St. Joseph's Hospital and Medical Center  Phoenix Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Taylor","sequence":"additional","affiliation":[{"name":"Lewy Body Dementia Association  Lilburn Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas","family":"Galasko","sequence":"additional","affiliation":[{"name":"University of California San Diego Shiley\u2010Marcos Alzheimer's Disease Research Center and Department of Neurosciences University of California San Diego  La Jolla California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James E.","family":"Galvin","sequence":"additional","affiliation":[{"name":"Comprehensive Center for Brain Health Department of Neurology University of Miami Miller School of Medicine  Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer G.","family":"Goldman","sequence":"additional","affiliation":[{"name":"Parkinson's and Movement Disorders Shirley Ryan Ability Lab and Departments of Physical Medicine and Rehabilitation and Neurology Northwestern University Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James B.","family":"Leverenz","sequence":"additional","affiliation":[{"name":"Cleveland Alzheimer's Disease Research Center and Cleveland Clinic Center for Brain Health  Cleveland Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathleen L.","family":"Poston","sequence":"additional","affiliation":[{"name":"Department of Neurology Stanford University  Palo Alto California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bradley F.","family":"Boeve","sequence":"additional","affiliation":[{"name":"Mayo Alzheimer's Disease Research Center and Department of Neurology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David J.","family":"Irwin","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Pennsylvania Perelman School of Medicine  Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph F.","family":"Quinn","sequence":"additional","affiliation":[{"name":"Department of Neurology Oregon Health Sciences University  Portland Oregon USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,2,8]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/alzrt274"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1353\u20108020(13)70017\u20108"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2013.3579"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1017\/cjn.2016.2"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2022.2059978"},{"key":"e_1_2_6_7_1","first-page":"69","article-title":"Lewy body dementia. The second highest cause of dementia is highly variable","author":"Galvin JE","year":"2019","journal-title":"Pract Neurol"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2019.03.015"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/dad2.12235"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.JGP.0000216177.08010.f4"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/gps.1738"},{"key":"e_1_2_6_12_1","unstructured":"National Institutes of Health.Dementia with Lewy bodies.2019. Accessed February 4 2019.https:\/\/www.ninds.nih.gov\/health\u2010information\/disorders\/dementia\u2010lewy\u2010bodies"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000004058"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(15)00462\u20106"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11940\u2010013\u20100261\u20106"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2018.1519548"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195\u2010020\u201000703\u20105"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/trc2.12171"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/mds.28879"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41467\u2010022\u201032944\u20103"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000009323"}],"container-title":["Alzheimer's &amp; Dementia: Translational Research &amp; Clinical Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/trc2.12375","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/trc2.12375","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/trc2.12375","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T13:02:18Z","timestamp":1761483738000},"score":1,"resource":{"primary":{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/10.1002\/trc2.12375"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1]]},"references-count":20,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,1]]}},"alternative-id":["10.1002\/trc2.12375"],"URL":"https:\/\/doi.org\/10.1002\/trc2.12375","archive":["Portico"],"relation":{},"ISSN":["2352-8737","2352-8737"],"issn-type":[{"value":"2352-8737","type":"print"},{"value":"2352-8737","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1]]},"assertion":[{"value":"2022-12-07","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-12-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-02-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e12375"}}