[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479102":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":65,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":10,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Exeter","OTHER",[8,14,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"SNCA (Alpha-synuclein gene)",null,"PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology.",[13],"Other: Positron Emission Tomography (PET) scan using DASB tracer",{"label":15,"type":10,"description":16,"interventionNames":17},"Parkin (Parkin gene)","PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology",[13],{"label":19,"type":10,"description":16,"interventionNames":20},"PINK1 (Phosphatase and Tensin Homolog (PTEN)-Induced Kinase 1 gene)",[13],{"label":22,"type":10,"description":23,"interventionNames":10},"GBA1 (Glucosylceramidase beta gene)","Symptomatic and asymptomatic heterozygous carriers of risk variants to the GBA1 gene for Parkinson's disease",[25],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Positron Emission Tomography (PET) scan using DASB tracer","DASB is a highly selective PET radioligand for serotonin transporter and is a reliable tool to investigate serotonin terminals and neurons.\n\nThe included Magnetic Resonance Imaging (MRI) sequences serve to provide additional information plus complement PET data.\n\nTo quantify dopaminergic pathology with \\[123I\\]FP-CIT SPECT,",[19,15,9],[30,31,32],"FP-CIT Single-photon Emission Computed Tomography (SPECT) scan","Magnetic Resonance Imaging (MRI) Scan","Lumbar puncture",[34],{"name":35,"affiliation":36,"role":37},"Marios Politits, Professor","The University of Exeter","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Marios Politis, Professor","CONTACT","07503 741242","m.politis@exeter.ac.uk",{"name":45,"role":41,"phone":42,"phoneExt":10,"email":46},"Edoardo de Natale, Dr","e.de-natale@exeter.ac.uk",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Of Exeter","RECRUITING","Exeter","Devon","EX1 2LU","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-3.52751,50.7236,{"lat":60,"lon":59},[63,64],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},{"name":45,"role":41,"phone":42,"phoneExt":10,"email":46},{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100479102","molecular-and-functional-imaging-in-monogenic-pd-100479102",false,"NCT05518617","Molecular and Functional Imaging in Monogenic PD.","Molecular and Functional Imaging of Parkinson's Pathology in SNCA, Parkin and PINK1 Mutation Carriers","FOX_1","Inclusion Criteria:\n\n* All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.\n* All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.\n* All subjects must be able to travel to the research sites for the study procedures.\n* For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.\n* All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:\n\nOral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;\n\nOral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:\n\nIntrauterine device (IUD)\n\nIntrauterine hormone-releasing system (IUS)\n\nBilateral tubal occlusion\n\nVasectomised partner\n\nSexual abstinence\n\n* For sexually active male subjects, they must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. They must also agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands.\n\n  \\*\\*All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.\n* All subjects must have no use of medications with known interaction with serotonergic transmission (e.g. selective serotonin reuptake inhibitors, tricyclic antidepressant, triptans, etc).\n* For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.\n\nExclusion Criteria:\n\n* Subjects lacking capacity according to investigator judgement.\n* Subjects with a clinical diagnosis of dementia as determined by the investigator.\n* Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude safe completion of the lumbar puncture.\n* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n* Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.\n* Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).\n* History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.\n* Subjects with current or recent history of drug or alcohol abuse\u002Fdependence.\n* Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;\n* Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable.\n* Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n* Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.","ALL","25 Years","80 Years",{"count":79,"type":80},45,"ESTIMATED","OBSERVATIONAL","In this study, the investigators aim to find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of PD symptoms.",[84,85,86,87,88],"Parkinson Disease","Nervous System Disorder","Neurodegenerative Diseases","Neurodegenerative Disease, Hereditary","Parkinson's","2025-10-01",{"date":91,"type":92},"2025-10-07","ACTUAL",{"date":94,"type":92},"2022-07-01",{"date":96,"type":80},"2026-06-30",{"name":5,"class":6},1]