{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T19:05:56Z","timestamp":1790622356315,"version":"4.1.0"},"reference-count":41,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,6,20]],"date-time":"2021-06-20T00:00:00Z","timestamp":1624147200000},"content-version":"vor","delay-in-days":170,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"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":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>A phase 2b clinical trial, HEADWAY\u2010DLB, was performed to assess treatment with intepirdine, a serotonin receptor antagonist, in patients with dementia with Lewy bodies (DLB).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>HEADWAY\u2010DLB was a multinational, double\u2010blind, randomized, placebo\u2010controlled study. Two hundred sixty\u2010nine DLB patients were randomized to receive placebo, 70\u00a0mg\/day intepirdine, or 35\u00a0mg\/day intepirdine over 24\u00a0weeks. The primary endpoint was change from baseline to week 24 on the Unified Parkinson's Disease Rating Scale\u2013Part III (UPDRS\u2010III).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Both intepirdine groups did not demonstrate significant benefits over placebo at 24\u00a0weeks on the UPDRS\u2010III (35\u00a0mg\/day:\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a0.1580, 70\u00a0mg\/day:\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a0.6069). All other endpoints were not significant. Intepirdine was well tolerated, with a slightly higher incidence of gastrointestinal adverse events observed in the intepirdine groups versus placebo.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Intepirdine treatment did not lead to improvements over placebo in patients with DLB. As one of the largest DLB studies to date, HEADWAY\u2010DLB demonstrates that international trials for DLB are feasible within a reasonable timeframe.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/trc2.12171","type":"journal-article","created":{"date-parts":[[2021,6,20]],"date-time":"2021-06-20T23:20:31Z","timestamp":1624231231000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["An international, randomized, placebo\u2010controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY\u2010DLB)"],"prefix":"10.1002","volume":"7","author":[{"given":"Frederick M.","family":"Lang","sequence":"first","affiliation":[{"name":"Axovant Sciences  New York New York USA"},{"name":"Roivant Sciences Inc. 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