[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"synucleinopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:synucleinopathy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"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":21,"type":22},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.",[26,27,28,29,30],"Parkinson´s Disease","REM Sleep Behavior Disorder (iRBD)","Lewy Body Disease","Synucleinopathy","Synucleinopathies",[32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Early diagnosis","CSF","Plasma","PET","MRI","DAT PET","Smell test","synuclein seed amplification assays","MIBG","Polysomnography","α-synuclein","Motoric test","cognitive test","UPDRS","RECRUITING","2026-04-09",{"date":49,"type":50},"2026-04-16","ACTUAL",{"date":52,"type":50},"2021-10-01",{"date":54,"type":22},"2033-06",{"name":56,"class":57},"Skane University Hospital","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":58},"100551434","phase-2-tenapanor-in-synucleinopathy-related-constipation-100551434","NCT06460038","Tenapanor in Synucleinopathy-Related Constipation","Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation","Inclusion Criteria\n\n1. Age 50-89 years.\n2. Diagnosis of PD within Hoehn and Yahr stages 1-3, confirmed by a neurologist per International Parkinson and Movement Disorder Society criteria.\n3. Average weekly stool frequency of ≤5 spontaneous bowel movements (SBMs) and ≤2 complete spontaneous bowel movements (CSBMs) over the past 6 months. These criteria will be verified during a 2-week screening period.\n4. Stool consistency ≤3 on the Bristol Stool Form Scale (BSFS). This criterion will be verified during a 2-week screening period.\n5. Agreement to use contraception, if applicable.\n\nExclusion Criteria\n\n1. Functional diarrhea or IBS-D\u002FM based on Rome IV Criteria.\n2. Symptomatic structural GI abnormalities or inflammatory bowel disease.\n3. Significant hepatic (ALT or AST ≥ 2.5x the upper limit of normal) or renal (serum creatinine \\>2mg\u002Fdl) dysfunction.\n4. Pregnancy or lactation.\n5. Diagnosis of primary dyssynergic defecation by anorectal manometry.","89 Years",{"count":68,"type":22},30,"INTERVENTIONAL",[71],"PHASE2","Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation",[29,74],"Parkinson's Disease",[76,77,78,79],"tenapanor","synucleinopathy","Parkinson's disease","constipation","2025-02-06",{"date":82,"type":50},"2025-02-10",{"date":84,"type":50},"2025-01-01",{"date":86,"type":22},"2027-03",{"name":88,"class":57},"Cedar Valley Digestive Health Center"]