[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03623672":3,"trial-entities:NCT03623672":156,"trial-summary:NCT03623672":160},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":37,"interventions":40,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":35,"healthy_volunteers":14,"eligibility_criteria":49,"std_ages":56,"locations":59,"central_contacts":140,"overall_officials":141,"references":147,"see_also_links":155},"NCT03623672","201712025","North American Prodromal Synucleinopathy Consortium","ENROLLING_BY_INVITATION","2026-07-31","2024-11","2024-11-06","2018-08-29","Washington University School of Medicine","OTHER",false,"This study will enroll participants with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD), for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.","REM sleep behavior disorder (RBD) is a rare disorder where people act out their dreams. People with RBD often, but not always, develop Parkinson's Disease, dementia with Lewy bodies, multiple system atrophy, or other neurodegenerative diseases of the synucleinopathy type. The North American Prodromal Synucleinopathy (NAPS) Consortium was formed with the purpose of enrolling participants with RBD, in anticipation of a future clinical trial of a neuroprotective treatment against synucleinopathies. The NAPS Consortium will collect standardized clinical assessments, biofluids, and other data in order to develop biomarkers for synucleinopathies in the prodromal (presymptomatic) stage as well as a trial-ready registry of participants. Participants procedures will include a \\~2-hour clinical assessment (medical history and physical exam), questionnaires, blood draw, and (at select sites) optional lumbar puncture.",[18,19,20,21,22,23],"REM Sleep Behavior Disorder","Parkinson Disease","Lewy Body Disease","Dementia With Lewy Bodies","Multiple System Atrophy","REM Sleep Parasomnias",[25,26,27,28,29,30,22,31,32,33],"sleep","REM","rapid eye movement","parkinson","lewy body disease","dementia with lewy bodies","parasomnia","synuclein","synucleinopathy","OBSERVATIONAL",null,[],{"count":38,"type":39},500,"ESTIMATED",[],[42],{"measure":43,"description":44,"timeFrame":45},"Prodromal Synucleinopathy Rating Scale","Rating scale combining neurocognitive battery, motor, autonomic, olfaction, color vision functions. Global score range 0-3, with higher score indicating greater symptoms of synucleinopathy.","2 years",[],"ALL","18 Years",{"inclusion":50,"exclusion":52,"raw_text":55},[51],"Idiopathic REM sleep behavior disorder",[53,54],"REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)","Other neurological disorder","Inclusion Criteria:\n\n* Idiopathic REM sleep behavior disorder\n\nExclusion Criteria:\n\n* REM sleep behavior disorder secondary to another cause (ex: narcolepsy, dementia, Parkinson's Disease, etc)\n* Other neurological disorder",[57,58],"ADULT","OLDER_ADULT",[60,69,77,84,92,100,108,115,123,131],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"Banner Sun Health Research Institute","Sun City","Arizona","85351","United States",{"lat":67,"lon":68},33.59754,-112.27182,{"facility":70,"city":71,"state":72,"zip":73,"country":65,"geoPoint":74},"University of California Los Angeles","Los Angeles","California","90095",{"lat":75,"lon":76},34.05223,-118.24368,{"facility":78,"city":79,"state":72,"zip":80,"country":65,"geoPoint":81},"Stanford University","Redwood City","94063",{"lat":82,"lon":83},37.48522,-122.23635,{"facility":85,"city":86,"state":87,"zip":88,"country":65,"geoPoint":89},"Emory University","Atlanta","Georgia","30322",{"lat":90,"lon":91},33.749,-84.38798,{"facility":93,"city":94,"state":95,"zip":96,"country":65,"geoPoint":97},"Massachusetts General Hospital","Boston","Massachusetts","02145",{"lat":98,"lon":99},42.35843,-71.05977,{"facility":101,"city":102,"state":103,"zip":104,"country":65,"geoPoint":105},"University of Minnesota","Minneapolis","Minnesota","55455",{"lat":106,"lon":107},44.97997,-93.26384,{"facility":109,"city":110,"state":103,"zip":111,"country":65,"geoPoint":112},"Mayo Clinic","Rochester","55905",{"lat":113,"lon":114},44.02163,-92.4699,{"facility":116,"city":117,"state":118,"zip":119,"country":65,"geoPoint":120},"Washington University","St Louis","Missouri","63110",{"lat":121,"lon":122},38.62727,-90.19789,{"facility":124,"city":125,"state":126,"zip":127,"country":65,"geoPoint":128},"Portland VA Medical Center","Portland","Oregon","97239",{"lat":129,"lon":130},45.52345,-122.67621,{"facility":132,"city":133,"state":134,"zip":135,"country":136,"geoPoint":137},"McGill University","Montreal","Quebec","HGH 2R9","Canada",{"lat":138,"lon":139},45.50884,-73.58781,[],[142,145],{"name":143,"affiliation":12,"role":144},"Yo-El Ju, MD","PRINCIPAL_INVESTIGATOR",{"name":146,"affiliation":109,"role":144},"Bradley Boeve, MD",[148,152],{"pmid":149,"type":150,"citation":151},"39270144","DERIVED","Postuma R, Vorasoot N, St Louis EK, Pelletier A, Lim MM, Elliott J, Gagnon JF, Gan-Or Z, Forsberg LK, Fields JA, Ross OA, Singer W, Huddleston DE, Bliwise DL, Avidan AY, Howell M, Schenck CH, McLeland J, Davis AA, Criswell SR, Videnovic A, During EH, Miglis MG, Boeve BF, Ju YS, McKeon A; as the North American Prodromal Synucleinopathy (NAPS) Consortium. IGLON5 Frequency in Idiopathic REM Sleep Behavior Disorder: A Multicenter Study. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200311. doi: 10.1212\u002FNXI.0000000000200311. Epub 2024 Sep 13.",{"pmid":153,"type":150,"citation":154},"37857496","Elliott JE, Bryant-Ekstrand MD, Keil AT, Ligman BR, Lim MM, Zitser J, During EH, Gagnon JF, St Louis EK, Fields JA, Huddleston DE, Bliwise DL, Avidan AY, Schenck CH, McLeland J, Criswell SR, Davis AA, Videnovic A, Lee-Iannotti JK, Postuma R, Boeve BF, Ju YS, Miglis MG; for North American Prodromal Synucleinopathy (NAPS) Consortium. Frequency of Orthostatic Hypotension in Isolated REM Sleep Behavior Disorder. Neurology. 2023 Dec 12;101(24):e2545-e2559. doi: 10.1212\u002FWNL.0000000000207883. Epub 2023 Oct 19.",[],{"nct_id":4,"conditions":157,"biomarkers":159},[158],"REM sleep behavior disorder",[],{"nct_id":4,"found":14,"summary":35,"prompt_version":35}]