[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607383":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":37,"responsibleParty":52,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Parkinson's Disease (Brain-First phenotype)",null,"Patients with early-stage Parkinson's disease without REM sleep behavior disorder (RBD), consistent with a Brain-First phenotype. These patients typically show early central dopaminergic deficits followed by peripheral involvement.",[13,14],"Other: Clinical assessments","Other: Phenotypic classification",{"label":16,"type":10,"description":17,"interventionNames":18},"Early Parkinson's Disease (Body-First phenotype)","Patients with early-stage Parkinson's disease with REM sleep behavior disorder (RBD) before or at motor onset, consistent with a Body-First phenotype. These patients are expected to show early peripheral involvement (e.g., cardiac MIBG denervation) preceding central dopaminergic loss.",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"OTHER","Clinical assessments","standardized neurological examination, motor and non-motor symptom scales, cognitive testing, and autonomic symptom questionnaires.",[16,9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Phenotypic classification","patients will be stratified into Brain-First and Body-First phenotypes based on the presence of RBD and instrumental findings.",[16,9],[30,34],{"name":31,"role":32,"phone":10,"phoneExt":10,"email":33},"Francesco Cavallieri, MD","CONTACT","francesco.cavallieri@ausl.re.it",{"name":35,"role":32,"phone":10,"phoneExt":10,"email":36},"Stefania Croci, BSc","stefania.Croci@ausl.re.it",[38],{"facility":39,"status":40,"city":41,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Azienda USL IRCCS di Reggio Emilia","RECRUITING","Reggio Emilia","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],10.63125,44.69825,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":10,"phoneExt":10,"email":33},{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100607383","study-of-axial-and-cognitive-symptoms-and-biomarkers-of-neurodegeneration-in-brain-first-and-body-first-pd-100607383",false,"NCT07187843","Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD","Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes","BRABOAXPD","Inclusion Criteria:\n\n* Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy \\[123I-MIBG\\].\n* Free and informed consent expressed by the participant.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Inability to express free and informed consent.\n* Patient with a doubtful diagnosis.\n* Participant under 18 years of age.","ALL","18 Years",{"count":65,"type":66},150,"ESTIMATED","OBSERVATIONAL","This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed \"Brain-First\" and \"Body-First\" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability.\n\nFindings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.",[70,71,72,73,74],"Parkinson Disease","Parkinsonian Disorders","Brain Disease","Basal Ganglia Diseases","Synucleinopathies",[76,77,78,79,80,81,82,83],"Neurodegenerative Diseases","Nervous System Diseases","Movement Disorders","biomarker","neuroinflammation","brain-first","body-first","axial symptoms","2026-04-22",{"date":86,"type":87},"2026-04-23","ACTUAL",{"date":89,"type":87},"2024-09-04",{"date":91,"type":66},"2031-05",{"name":5,"class":6},1]