[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448558":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Exeter","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with MSA",null,"Patients with a diagnosis of MSA and either a clinical form MSA-C or MSA-P",[13],"Other: Study procedures for MSA patients",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients with Progressive Supranuclear Palsy","Patients with a diagnosis of PSP, either the clinical forms PSP-RS or PSP-P",[18],"Other: Study procedures for PSP patients",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Study procedures for MSA patients","The group of MSA patients will undergo a collection of demographic data, a neurological examination with administration of clinical scales relevant for MSA, and a collection of venous blood sample for routine and biomarker analyses.\n\nParticipants will undergo one PET scan with the tracer \\[11C\\]UCB-J, and one PET scan with the tracer \\[18F\\]FDG. All participants will also undergo one MRI scan.\n\nParticipants will also undergo one lumbar puncture (optional).\n\nAll procedures will be performed at baseline and after one-year follow-up.\n\nA subgroup of patients with MSA will also undergo, at one time point only, one PET scan with the tracer \\[18F\\]APN107.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Study procedures for PSP patients","The group of PSP patients will undergo a collection of demographic data, a neurological examination with administration of clinical scales relevant for PSP, and a collection of venous blood sample for routine and biomarker analyses. Participants will undergo one PET scan with the tracer \\[18F\\]APN107 and one MRI scan. All procedures will be performed at baseline and after one-year follow-up.",[15],[29],{"name":30,"affiliation":5,"role":31},"Marios Politis, MD MSc PhD","STUDY_CHAIR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Edoardo R. de Natale, MD MSc Ph.D","CONTACT","07503741242","e.de-natale@exeter.ac.uk",{"name":39,"role":35,"phone":10,"phoneExt":10,"email":40},"Heather Wilson, MSc Ph.D","h.wilson4@exeter.ac.uk",[42],{"facility":5,"status":43,"city":44,"state":10,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Exeter","SE16 7RJ","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-3.52751,50.7236,{"lat":52,"lon":51},[55],{"name":56,"role":35,"phone":36,"phoneExt":10,"email":37},"Edoardo R de Natale, MD MSc PhD",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100448558","synaptic-loss-in-multiple-system-atrophy-100448558",false,"NCT05121012","Synaptic Loss in Multiple System Atrophy","Molecular Imaging of Synaptic Loss in Multiple System Atrophy (MSA)","Inclusion Criteria\n\nMSA group:\n\nMale or female, aged 45-80 at the time of informed consent. Meet criteria for diagnosis of probable or possible MSA (Gilman et al., 2008) (Appendix 1).\n\nA female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b) of childbearing potential but not pregnant (as determined by urinary pregnancy test on screening and on each study day), is not lactating and is willing to use one of the contraception methods listed below:\n\n* Combined (estrogen and progesterone containing) hormonal contraception associated with initiation of ovulation( oral, intravaginal, or transdermal);\n* Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);\n* Intrauterine device;\n* Intrauterine hormone releasing system;\n* Bilateral tubal occlusion;\n* Vasectomized partner;\n* Sexual abstinence.\n\nMale subject with a female partner of child-bearing potential must use one of the following contraceptive methods for 90 days after each dose of radiotracer:\n\n* Condom plus partner use of a highly effective contraceptive (see point above) OR\n* Abstinence Subjects must understand the nature of the study and be able to provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. They must be able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.\n\nMust have anticipated survival of ≥3 years (in the opinion of the Investigator).\n\nMedical treatment of MSA and co-morbid medical conditions must be stable for at least 30 days prior to screening and between screening and baseline PET scan. Intermittently administered treatment may be considered stable if the dose and dosing frequency have been unchanged for the greater of 30 days or three dosing inbiomartervals (e.g. a treatment given once a month must be at a stable dose and dosing frequency for 3 months).\n\nFor inclusion in optional CSF sampling, written informed consent must be provided, either by separate signed and dated written informed consent or by specific written acknowledgement on the main study informed consent form, according to local procedure. Failure to participate in optional CSF sampling will have no influence on the subject's ability to participate in the main study.\n\nIn the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have high probability of completing the study.\n\nPSP Group:\n\nMale or female, aged 45-80 at the time of informed consent. Meet criteria for diagnosis of suggestive, probable or possible PSP - with preference for PSP-RS, PSP-OM, PSP-PI, PSP with gait freezing, and PSP-SL and PSP-P subtypes (Höglinger et al., 2017 (Appendix 2).\n\nA female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b) of childbearing potential but not pregnant (as determined by urinary pregnancy test on screening and on each study day), is not lactating and is willing to use one of the contraception methods listed below:\n\n* Combined (estrogen and progesterone containing) hormonal contraception associated with initiation of ovulation( oral, intravaginal, or transdermal);\n* Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);\n* Intrauterine device;\n* Intrauterine hormone releasing system;\n* Bilateral tubal occlusion;\n* Vasectomized partner; Sexual abstinence.\n\nMale subject with a female partner of child-bearing potential must use one of the following contraceptive methods for 90 days after each dose of radiotracer:\n\n• Condom plus partner use of a highly effective contraceptive (see point above) OR Abstinence Subjects must understand the nature of the study and be able to provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. They must be able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.\n\nExclusion criteria:\n\nMSA group:\n\nHistory of other neurological disorders or intracranial co-morbidities, such as stroke, haemorrhage, space-occupying lesions.\n\nPresence of supranuclear gaze palsy. Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgement of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results.\n\nSevere-to-complete dependence on caregivers (score \\>3 on UMSARS Part IV, Global Disability), severe impairment of swallowing (score ≥3 on UMSARS Part I, Question 2), or frequent falls (score ≥3 on UMSARS Part I, Question 8) at Screening.\n\nPresence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g. Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body. If the principal investigator considers the presence of any of the above not to be a contraindication to MRI in a given subject, the investigator may obtain approval from the MR operators based on a discussion of the case.Negative modified Allen test in both hands.\n\nHistory of claustrophobia or back pain that makes prolonged laying on the MRI or PET scanner intolerable.\n\nPregnancy, lactation, or, if female of childbearing potential, positive urine β-hCG at screening or prior to PET scan.\n\nUse of drugs acting on SV2A such as antiepileptics (e.g. levetiracetam or brivaracetam).\n\nHistory of brain surgery for parkinsonism or stem cell treatment. Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology.\n\nCurrent or recent history of alcohol or drug abuse \u002F dependence (except nicotine dependence).\n\nHistory of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin.\n\nHemoglobin A1c (HbA1c) ≥ 6.5% at screening. Uncontrolled\u002Fpoorly controlled diabetes mellitus.\n\nFor subjects participating in optional CSF sampling:\n\n* Any spinal malformation or other aspects (e.g. tattoos) \u002F clinical findings (e.g. papilledema) that may complicate or contraindicate lumbar puncture, as judged by the investigator.\n* Neoplasm or other space-occupying intracranial lesion on MRI. Any clinically important abnormality, as determined by the investigator, on physical examination or vital signs, ECG, or clinical laboratory test results other than abnormality due to a stable, well-controlled medical condition; or any abnormality that could be detrimental to the subject or could compromise the study.\n\nPSP group:\n\nHistory of other neurological disorders or intracranial co-morbidities, such as stroke, haemorrhage, space-occupying lesions.\n\nInclusion in any clinical trial with investigational drugs targeting tau. Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgement of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results.\n\nPresence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g. Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body. If the principal investigator considers the presence of any of the above not to be a contraindication to MRI in a given subject, the investigator may obtain approval from the MR operators based on a discussion of the case.\n\nAbnormal modified Allen test in both hands. History of claustrophobia or back pain that makes prolonged laying on the MRI or PET scanner intolerable.\n\nPregnancy, lactation, or, if female of childbearing potential, positive urine β-hCG at screening or prior to PET scan.\n\nHistory of brain surgery for parkinsonism or stem cell treatment. Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology.\n\nCurrent or recent history of alcohol or drug abuse \u002F dependence (except nicotine dependence).\n\nHistory of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin.\n\nFor subjects participating in optional CSF sampling:\n\n• Any spinal malformation or other aspects (e.g. tattoos) \u002F clinical findings (e.g. papilledema) that may complicate or contraindicate lumbar puncture, as judged by the investigator.\n\nNeoplasm or other space-occupying intracranial lesion on MRI. Any clinically important abnormality, as determined by the investigator, on physical examination or vital signs, ECG, or clinical laboratory test results other than abnormality due to a stable, well-controlled medical condition; or any abnormality that could be detrimental to the subject or could compromise the study.","ALL","45 Years","80 Years",{"count":70,"type":71},36,"ESTIMATED","OBSERVATIONAL","In this study the investigators would like to investigate the degree of damage of the synapses, an important part of the neurons vital for the communications between neurons, in Multiple System Atrophy (MSA), and pathology related to abnormal accumulation of a protein named tau, in Progressive Supranuclear Palsy (PSP).",[75,76],"Multiple System Atrophy","Progressive Supranuclear Palsy (PSP)",[78,79,75,80,81],"Neurodegeneration","Positron Emission Tomography","Biomarkers","Progressive Supranuclear Palsy","2026-02-06",{"date":84,"type":85},"2026-02-10","ACTUAL",{"date":87,"type":85},"2021-09-01",{"date":89,"type":71},"2027-03-31",{"name":5,"class":6},1]