{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T21:14:27Z","timestamp":1792185267292,"version":"4.4.0"},"reference-count":53,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2023,3,7]],"date-time":"2023-03-07T00:00:00Z","timestamp":1678147200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100005941","name":"an Edmond J","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005941","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000864","name":"Michael J. Fox Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000864","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The neurodegenerative synucleinopathies, including Parkinson\u2019s disease and dementia with Lewy bodies, are characterized by a typically lengthy prodromal period of progressive subclinical motor and non-motor manifestations. Among these, idiopathic REM sleep behaviour disorder is a powerful early predictor of eventual phenoconversion, and therefore represents a critical opportunity to intervene with neuroprotective therapy. To inform the design of randomized trials, it is essential to study the natural progression of clinical markers during the prodromal stages of disease in order to establish optimal clinical end points.<\/jats:p>\n                  <jats:p>In this study, we combined prospective follow-up data from 28 centres of the International REM Sleep Behavior Disorder Study Group representing 12 countries. Polysomnogram-confirmed REM sleep behaviour disorder subjects were assessed for prodromal Parkinson\u2019s disease using the Movement Disorder Society criteria and underwent periodic structured sleep, motor, cognitive, autonomic and olfactory testing. We used linear mixed-effect modelling to estimate annual rates of clinical marker progression stratified by disease subtype, including prodromal Parkinson\u2019s disease and prodromal dementia with Lewy bodies. In addition, we calculated sample size requirements to demonstrate slowing of progression under different anticipated treatment effects.<\/jats:p>\n                  <jats:p>Overall, 1160 subjects were followed over an average of 3.3 \u00b1 2.2 years. Among clinical variables assessed continuously, motor variables tended to progress faster and required the lowest sample sizes, ranging from 151 to 560 per group (at 50% drug efficacy and 2-year follow-up). By contrast, cognitive, olfactory and autonomic variables showed modest progression with higher variability, resulting in high sample sizes. The most efficient design was a time-to-event analysis using combined milestones of motor and cognitive decline, estimating 117 per group at 50% drug efficacy and 2-year trial duration. Finally, while phenoconverters showed overall greater progression than non-converters in motor, olfactory, cognitive and certain autonomic markers, the only robust difference in progression between Parkinson\u2019s disease and dementia with Lewy bodies phenoconverters was in cognitive testing.<\/jats:p>\n                  <jats:p>This large multicentre study demonstrates the evolution of motor and non-motor manifestations in prodromal synucleinopathy. These findings provide optimized clinical end points and sample size estimates to inform future neuroprotective trials.<\/jats:p>","DOI":"10.1093\/brain\/awad072","type":"journal-article","created":{"date-parts":[[2023,3,4]],"date-time":"2023-03-04T18:06:06Z","timestamp":1677953166000},"page":"3258-3272","source":"Crossref","is-referenced-by-count":130,"title":["Progression of clinical markers in prodromal Parkinson\u2019s disease and dementia with Lewy bodies: a multicentre study"],"prefix":"10.1093","volume":"146","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5598-4110","authenticated-orcid":false,"given":"Stephen","family":"Joza","sequence":"first","affiliation":[{"name":"Department of Neurology, Montreal Neurological Institute , Montreal, Quebec H3A 2B4 , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele T","family":"Hu","sequence":"additional","affiliation":[{"name":"Nuffield Department of Clinical Neurosciences, Division of Neurology and Oxford Parkinson\u2019s Disease Centre, University of Oxford , Oxford OX3 9DU , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5528-9081","authenticated-orcid":false,"given":"Ki-Young","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Neurology, Seoul National University College of Medicine, Seoul National University Hospital , 03080 Seoul , Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0430-5878","authenticated-orcid":false,"given":"Dieter","family":"Kunz","sequence":"additional","affiliation":[{"name":"Clinic for Sleep & Chronomedicine, St. Hedwig-Krankenhaus , 10115 Berlin , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4259-8824","authenticated-orcid":false,"given":"Ambra","family":"Stefani","sequence":"additional","affiliation":[{"name":"Medical University Innsbruck, Department of Neurology , 6020 Innsbruck , Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petr","family":"Du\u0161ek","sequence":"additional","affiliation":[{"name":"Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital , 116 36 Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9692-2218","authenticated-orcid":false,"given":"Michele","family":"Terzaghi","sequence":"additional","affiliation":[{"name":"Sleep Medicine and Epilepsy Unit, IRCCS Mondino Foundation , 27100 Pavia , Italy"},{"name":"Department of Brain and Behavioral Sciences, University of Pavia , 27100 Pavia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6823-6069","authenticated-orcid":false,"given":"Dario","family":"Arnaldi","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), Clinical Neurology, University of Genoa , 16132 Genoa , Italy"},{"name":"IRCCS Ospedale Policlinico San Martino , 16132 Genoa , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleksandar","family":"Videnovic","sequence":"additional","affiliation":[{"name":"Department of Neurology, Massachusetts General Hospital, Harvard Medical School , Boston, MA 02114 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mya C","family":"Schiess","sequence":"additional","affiliation":[{"name":"Department of Neurology, The University of Texas Health Science Center at Houston , Houston, TX 77030 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wiebke","family":"Hermann","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Rostock , 18147 Rostock , 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Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laur\u00e8ne","family":"Leclair-Visonneau","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurophysiology, CHU de Nantes , 44000 Nantes , France"},{"name":"Nantes Universit\u00e9, Inserm, TENS, The Enteric Nervous System in Gut and Brain Diseases , 44000 Nantes , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfgang H","family":"Oertel","sequence":"additional","affiliation":[{"name":"Department of Neurology and Section on Clinical Neuroscience, Philipps University Marburg , 35037 Marburg , Germany"},{"name":"Institute for Neurogenomics, Helmholtz Center for Health and Environment , 85764 M\u00fcnchen, Neuherberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Antelmi","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona , 37121 Verona , 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