[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633985":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":57,"centralContacts":62,"locations":70,"responsibleParty":86,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":10,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":10,"studyType":106,"phases":10,"briefSummary":107,"conditions":108,"keywords":114,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Skane University Hospital","OTHER",[8,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Idiopathic REM-sleep Behavior Disorder (iRBD)",null,"200 individuals with iRBD will be recruited through advertisement or due to being under clinical investigation for the condition at any clinic in the county of Skåne, Sweden.",[13,14,15,16,17,18],"Diagnostic Test: Dopamine transporter PET scan with [18F]FE-PE2I","Diagnostic Test: Magnetic resonance imaging (MRI)","Diagnostic Test: [123I] MIBG scintigraphy of the heart","Diagnostic Test: α-synuclein seeding amplification assays","Diagnostic Test: Polysomnography","Diagnostic Test: Smell test",{"label":20,"type":10,"description":21,"interventionNames":22},"Early Parkinson´s disease","200 patients with early Parkinson's disease will be recruited from the Neurology clinic at Skåne University Hospital and in addition other Neurology clinics in the county of Skåne, Sweden.",[13,14,15,16,17,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Healthy controls","250 healthy controls will be recruited through advertisement and by personal invitation by mail.",[13,14,15,16,17,18],[28,33,37,41,47,51],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"DIAGNOSTIC_TEST","Dopamine transporter PET scan with [18F]FE-PE2I","Positron emission tomography (PET) imaging of dopamine transporters (DAT-PET) to quantify dopamine terminal loss.",[20,24,9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Magnetic resonance imaging (MRI)","Different MRI sequences relevant for brain imaging and with focus on dopamine associated structures of the brain.",[20,24,9],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"[123I] MIBG scintigraphy of the heart","MIBG scintigraphy to quantify the loss noradrenaline terminals to the heart.",[20,24,9],{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"α-synuclein seeding amplification assays","synuclein seed amplification assays (SSAs) will be applied to cerebrospinal fluid (CSF) and skin samples to establish synuclein pathology status",[20,24,9],[46],"αSyn-SAA",{"type":29,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Polysomnography","Polysomnography to establish presence of REM-sleep behavior disorder",[20,24,9],{"type":29,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Smell test","Sniffin' Sticks test to quantify hyposmia or anosmia.",[20,24,9],[56],"Sniffin' Sticks test",[58],{"name":59,"affiliation":60,"role":61},"Erik Stomrud, MD, PhD","Skane University Hospital and Lund University","PRINCIPAL_INVESTIGATOR",[63,67],{"name":59,"role":64,"phone":65,"phoneExt":10,"email":66},"CONTACT","+46 40 33 10 00","erik.stomrud@med.lu.se",{"name":68,"role":64,"phone":65,"phoneExt":10,"email":69},"Adjmal Nahimi, MD, PhD","adjmal.nahimi@med.lu.se",[71],{"facility":5,"status":72,"city":73,"state":10,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"RECRUITING","Malmö","392 33","Sweden","SE",{"type":78,"coordinates":79},"Point",[80,81],13.00073,55.60587,{"lat":81,"lon":80},[84,85],{"name":68,"role":64,"phone":65,"phoneExt":10,"email":69},{"name":59,"role":64,"phone":65,"phoneExt":10,"email":66},{"type":61,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Erik Stomrud","Principal Investigator",[90],{"name":91,"class":6},"Lund University","100633985","the-swedish-biofinder-sleep-study-100633985",false,"NCT07533799","The Swedish BioFINDER Sleep Study","BioFINDER-Sleep: Idiopathic REM-sleep Behavior Disorder & Early Parkinson's Disease","Inclusion Criteria:\n\nIdiopathic RBD:\n\n* Polysomnography verified RBD according to AASM criteria.\n* Does not fulfill diagnostic criteria for idiopathic Parkinson´s disease.\n* Age range 50-100. Women who are \\\u003C55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.\n* Ability to give informed consent.\n* Speaks and understands Swedish to the extent that an interpreter is not necessary for the patient to fully understand the study information and cognitive tests.\n\nEarly Parkinson´s disease:\n\n* Fulfills the diagnostic criteria for idiopathic Parkinson´s disease.\n* The PD patients will be de novo (yet without any PD treatment) or with treatment for a maximum of 3 years.\n* Age range 50-100. Women who are \\\u003C55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.\n* Ability to give informed consent.\n* Speaks Swedish fluently as stated above. Healthy Controls\n* Age range 50-100. Women who are \\\u003C55 years of age will be required to take a pregnancy test before participation in the PET and scintigraphy part of the study if not post-menopausal.\n* No diagnosis of PD or another significant neurological disorder.\n* No diagnosis of RBD.\n* Ability to give informed consent.\n* Speaks Swedish fluently as stated above.\n\nExclusion Criteria:\n\nFor all groups:\n\n* Past history of severe or repeated concussive head injury or stroke or any significant systemic disease or unstable medical condition.\n* History of severe and unstable depression, schizophrenia, schizoaffective disorder or bipolar disorder.\n* Significant white matter microvascular disease.\n* Contraindication to MRI and PET.\n\nExclusion criteria specific for early Parkinson´s disease:\n\n* Normal dopamine transporter (\\[18F\\]FE-PE2I) scan.",true,"ALL","50 Years","100 Years",{"count":104,"type":105},650,"ESTIMATED","OBSERVATIONAL","BioFINDER-Sleep study was established in 2021 and will include patients with early Parkinson´s disease (PD) and persons with iRBD to provide essential insights into the underlying mechanisms of the progressive neurodegenerative processes in central and peripheral nervous systems. Briefly polysomnography will be used to establish the presence of RBD in both the early PD cohort and in the iRBD cohort. Then, state of the art multimodal imaging techniques will be used, including, magnetic resonance imaging (MRI), positron emission tomography (PET) of the dopamine transporters (DAT-PET) to quantify dopamine terminal loss, and \\[123I\\] MIBG scintigraphy of the heart will be performed to quantify the loss noradrenaline terminals to the heart. In addition to this, synuclein seed amplification assays (SSAs) will be applied to cerebrospinal fluid (CSF) and skin samples to establish synuclein pathology status. Further, CSF and blood biomarkers will be developed that can be used to as prognostic markers. These investigations will be done in parallel to clinical assessments of motor and non-motor symptoms as well as assessment of cognitive function in a longitudinal setting.",[109,110,111,112,113],"Parkinson´s Disease","REM Sleep Behavior Disorder (iRBD)","Lewy Body Disease","Synucleinopathy","Synucleinopathies",[115,116,117,118,119,120,52,121,122,48,123,124,125,126],"Early diagnosis","CSF","Plasma","PET","MRI","DAT PET","synuclein seed amplification assays","MIBG","α-synuclein","Motoric test","cognitive test","UPDRS","2026-04-09",{"date":129,"type":130},"2026-04-16","ACTUAL",{"date":132,"type":130},"2021-10-01",{"date":134,"type":105},"2033-06",{"name":5,"class":6},1]