{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T21:27:26Z","timestamp":1791840446970,"version":"4.3.4"},"reference-count":40,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,12,2]],"date-time":"2021-12-02T00:00:00Z","timestamp":1638403200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["movementdisorders.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Movement Disorders"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Mevidalen is a selective positive allosteric modulator (PAM) of the dopamine D1 receptor subtype.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the safety and efficacy of mevidalen for treatment of cognition in patients with Lewy body dementia (LBD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>PRESENCE was a phase 2, 12\u2010week study in participants with LBD (N\u00a0=\u00a0344) randomly assigned (1:1:1:1) to daily doses of mevidalen (10, 30, or 75\u2009mg) or placebo. The primary outcome measure was change from baseline on Cognitive Drug Research Continuity of Attention (CoA) composite score. Secondary outcomes included Alzheimer's Disease Assessment Scale\u2010Cognitive Subscale 13 (ADAS\u2010cog<jats:sub>13<\/jats:sub>), Movement Disorder Society\u2010Unified Parkinson's Disease Rating Scale (MDS\u2010UPDRS), and Alzheimer's Disease Cooperative Study\u2010Clinical Global Impression of Change (ADCS\u2010CGIC). Numerous safety measures were collected.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mevidalen failed to meet primary or secondary cognition endpoints. Mevidalen resulted in significant, dose\u2010dependent improvements of MDS\u2010UPDRS total score (sum of Parts I\u2212III, 10\u2009mg <jats:italic>P<\/jats:italic>\u00a0&lt;\u20090.05, 30\u2009mg <jats:italic>P<\/jats:italic>\u00a0&lt;\u20090.05, 75\u2009mg <jats:italic>P<\/jats:italic>\u00a0&lt;\u20090.01, compared to placebo). The 30\u2009mg and 75\u2009mg mevidalen doses significantly improved ADCS\u2010CGIC scores compared to placebo (minimal or better improvement: 30\u2009mg <jats:italic>P<\/jats:italic>\u00a0&lt;\u20090.01, 75\u2009mg <jats:italic>P<\/jats:italic>\u00a0&lt;\u20090.01; moderate or better improvement: 30\u2009mg <jats:italic>P<\/jats:italic>\u00a0&lt;\u20090.05, 75\u2009mg <jats:italic>P<\/jats:italic>\u00a0&lt;\u20090.001). Increases in blood pressure, adverse events, and cardiovascular serious adverse events were most pronounced at the 75\u2009mg dose.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Mevidalen harnesses a novel mechanism of action that improves motor symptoms associated with LBD on top of standard of care while improving or not worsening non\u2010motor symptoms associated with traditional dopaminergic therapy. \u00a9 2021 The Authors. <jats:italic>Movement Disorders<\/jats:italic> published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society<\/jats:p><\/jats:sec>","DOI":"10.1002\/mds.28879","type":"journal-article","created":{"date-parts":[[2021,12,3]],"date-time":"2021-12-03T02:59:30Z","timestamp":1638500370000},"page":"513-524","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Safety and Efficacy of Mevidalen in Lewy Body Dementia: A Phase 2, 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