{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T09:56:56Z","timestamp":1777888616484,"version":"3.51.4"},"reference-count":36,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2022,9,2]],"date-time":"2022-09-02T00:00:00Z","timestamp":1662076800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JPD"],"published-print":{"date-parts":[[2022,9,2]]},"abstract":"<jats:p>Background: PRESENCE was a Phase 2 trial assessing mevidalen for symptomatic treatment of Lewy body dementia (LBD). Participants received daily doses (10, 30, or 75\u200amg) of mevidalen (LY3154207) or placebo for 12 weeks. Objective: To evaluate if frequent cognitive and motor tests using an iPad app and wrist-worn actigraphy to track activity and sleep could detect mevidalen treatment effects in LBD. Methods: Of 340 participants enrolled in PRESENCE, 238 wore actigraphy for three 2-week periods: pre-, during, and post-intervention. A subset of participants (n\u200a=\u200a160) enrolled in a sub-study using an iPad trial app with 3 tests: digital symbol substitution (DSST), spatial working memory (SWM), and finger-tapping. Compliance was defined as daily test completion or watch-wearing \u226523\u200ah\/day. Change from baseline to week 12 (app) or week 8 (actigraphy) was used to assess treatment effects using Mixed Model Repeated Measures analysis. Pearson correlations between sensor-derived features and clinical endpoints were assessed. Results: Actigraphy and trial app compliance was &gt;\u200a90% and &gt;\u200a60%, respectively. At baseline, daytime sleep positively correlated with Epworth Sleepiness Scale score (p\u200a&lt;\u200a0.01). Physical activity correlated with improvement on Movement Disorder Society \u2013Unified Parkinson Disease Rating Scale (MDS-UPDRS) part II (p\u200a&lt;\u200a0.001). Better scores of DSST and SWM correlated with lower Alzheimer Disease Assessment Scale \u2013Cognitive 13-Item Scale (ADAS-Cog13) (p\u200a&lt;\u200a0.001). Mevidalen treatment (30\u200amg) improved SWM (p\u200a&lt;\u200a0.01), while dose-dependent decreases in daytime sleep (10\u200amg: p\u200a&lt;\u200a0.01, 30\u200amg: p\u200a&lt;\u200a0.05, 75\u200amg: p\u200a&lt;\u200a0.001), and an increase in walking minutes (75\u200amg dose: p\u200a&lt;\u200a0.001) were observed, returning to baseline post-intervention. Conclusion: Devices used in the LBD population achieved adequate compliance and digital metrics detected statistically significant treatment effects.<\/jats:p>","DOI":"10.3233\/jpd-213126","type":"journal-article","created":{"date-parts":[[2022,6,7]],"date-time":"2022-06-07T12:42:24Z","timestamp":1654605744000},"page":"1991-2004","source":"Crossref","is-referenced-by-count":13,"title":["Evaluating the Use of Digital Biomarkers to Test Treatment Effects on Cognition and Movement in Patients with Lewy Body Dementia"],"prefix":"10.1177","volume":"12","author":[{"given":"Jian","family":"Wang","sequence":"first","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chakib","family":"Battioui","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, IN, 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