[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613362":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":187,"collaborators":20,"id":189,"slug":190,"hasResults":191,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":20,"eligibilityCriteria":195,"healthyVolunteers":191,"sex":196,"minAge":197,"maxAge":20,"enrollmentInfo":198,"targetDuration":20,"studyType":201,"phases":202,"briefSummary":204,"conditions":205,"keywords":20,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Michael J. Fox Foundation for Parkinson's Research","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prodromal Parkinson's disease (PD)","EXPERIMENTAL","Prodromal Parkinson's disease participants enrolled in the PPMI Clinical 002 study will receive 3 injections of \\[18F\\] AV-133 and imaging procedures over the course of 24 months.",[13],"Drug: [18F] AV-133 PET Imaging",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","[18F] AV-133 PET Imaging","Prodromal PD participants from the PPMI Clinical (002) study will be followed for up to 24 months. These participants will undergo imaging assessments with \\[18F\\]AV-133 under this protocol at baseline, 12-month and 24 months.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Ken Marek, MD","Institute for Neurodegenerative Disorders","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Lianne Ramia","CONTACT","203-590-5600","LRamia1@indd.org",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Jessica Dimos","jdimos@indd.org",[36,60,76,93,110,128,146,167],{"facility":24,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","New Haven","Connecticut","06510","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-72.92816,41.30815,{"lat":47,"lon":46},[50,54,58],{"name":51,"role":29,"phone":52,"phoneExt":20,"email":53},"Mackenzee George Clinical Research Coordinator II","475-318-8248","mgeorge@xingimaging.com",{"name":55,"role":29,"phone":56,"phoneExt":20,"email":57},"Amy Ruimerman Lead Clinical Research Nurse, LPN","475-318-8208","aruimerman@xingimaging.com",{"name":59,"role":25,"phone":20,"phoneExt":20,"email":20},"Neha Prakash, MBBS",{"facility":61,"status":37,"city":62,"state":63,"zip":64,"country":41,"countryCode":42,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"University of Pennsylvania","Philadelphia","Pennsylvania","19107",{"type":44,"coordinates":66},[67,68],-75.16362,39.95238,{"lat":68,"lon":67},[71,74],{"name":72,"role":29,"phone":73,"phoneExt":20,"email":20},"PPMI Call Center","877-525-7764",{"name":75,"role":25,"phone":20,"phoneExt":20,"email":20},"Nabila Dahodwala, MD",{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Toronto Western Hospital","NOT_YET_RECRUITING","Toronto","Ontario","M5T2S8","Canada","CA",{"type":44,"coordinates":85},[86,87],-79.39864,43.70643,{"lat":87,"lon":86},[90,91],{"name":72,"role":29,"phone":73,"phoneExt":20,"email":20},{"name":92,"role":25,"phone":20,"phoneExt":20,"email":20},"Connie Marras",{"facility":94,"status":78,"city":95,"state":20,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Philipps-University of Marburg","Hessen","35043","Germany","DE",{"type":44,"coordinates":100},[101,102],10.779,52.01702,{"lat":102,"lon":101},[105,108],{"name":106,"role":29,"phone":20,"phoneExt":20,"email":107},"Elisabeth Sittig","sittig@med.uni-marburg.de",{"name":109,"role":25,"phone":20,"phoneExt":20,"email":20},"Wolfgang Oertel",{"facility":111,"status":78,"city":112,"state":20,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Tel Aviv Sourasky Medical Center","Tel Aviv","64239","Israel","IL",{"type":44,"coordinates":117},[118,119],34.78057,32.08088,{"lat":119,"lon":118},[122,126],{"name":123,"role":29,"phone":124,"phoneExt":20,"email":125},"Anat Mirelman","Bsc972-3-697-3014","anatmi@tlvmc.gov.il",{"name":127,"role":25,"phone":20,"phoneExt":20,"email":20},"Roy Alcalay, MD",{"facility":129,"status":78,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Radboud University","Nijmegen","Gelderland","6525 GC","Netherlands","NL",{"type":44,"coordinates":136},[137,138],5.85278,51.8425,{"lat":138,"lon":137},[141,144],{"name":142,"role":29,"phone":20,"phoneExt":20,"email":143},"Yara Krasowski","info@onderzoek-parkinson.nl",{"name":145,"role":25,"phone":20,"phoneExt":20,"email":20},"Bastiaan Bloem, MD",{"facility":147,"status":37,"city":148,"state":149,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Queen Mary University of London","London","Britain","EC1M 6BQ","United Kingdom","UK",{"type":44,"coordinates":154},[155,156],-0.12574,51.50853,{"lat":156,"lon":155},[159,163,165],{"name":160,"role":29,"phone":161,"phoneExt":20,"email":162},"Cristina Simonet","44-02078823379","c.simonet@qmul.ac.uk",{"name":164,"role":25,"phone":20,"phoneExt":20,"email":20},"Cristina Simonet, MD",{"name":166,"role":25,"phone":20,"phoneExt":20,"email":20},"Alastair Noyce, MD",{"facility":168,"status":37,"city":169,"state":170,"zip":171,"country":151,"countryCode":152,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Newcastle University","Newcastle upon Tyne","Tyne and Wear","NE45PL",{"type":44,"coordinates":173},[174,175],-1.61396,54.97328,{"lat":175,"lon":174},[178,182,184],{"name":179,"role":29,"phone":180,"phoneExt":20,"email":181},"Victoria Foster","+441912081197","victoria.foster@ncl.ac.uk",{"name":183,"role":25,"phone":20,"phoneExt":20,"email":20},"Nicola Pavese",{"name":185,"role":186,"phone":20,"phoneExt":20,"email":20},"David Ledingham","SUB_INVESTIGATOR",{"type":188,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100613362","phase-2-early-longitudinal-imaging-in-the-parkinsons-progressive-marker-initiative-ppmi-using-18fav-133-ppmi-av-133-prodromal-imaging-100613362",false,"NCT07265596","Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)","Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)","Inclusion Criteria:\n\n1. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.\n2. Able to provide informed consent.\n3. Male or Female (females must meet additional criteria specified below as applicable)\n\n   * Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of 18F-AV-133\n\n     * Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).\n     * Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.\n   * Females of childbearing potential must not be pregnant, breastfeeding or lactating.\n\n     * Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of PET scan.\n\nExclusion Criteria:\n\n1. Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection.\n2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.","ALL","18 Years",{"count":199,"type":200},100,"ESTIMATED","INTERVENTIONAL",[203],"PHASE2","The study is a longitudinal, multi-center study to assess progression of \\[18F\\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \\[18F\\] AV-133 and clinical (motor, neuropsychiatric, cognitive and imaging and biomarker) assessments (conducted under the PPMI Clinical protocol).",[206],"Prodromal Parkinsons Disease","2025-11-24",{"date":209,"type":210},"2025-12-05","ACTUAL",{"date":212,"type":210},"2023-10-30",{"date":214,"type":200},"2027-12",{"name":5,"class":6},8]