[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655126":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":34,"interventions":40,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":85,"collaborators":27,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":27,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":27,"enrollmentInfo":96,"targetDuration":27,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":27,"overallStatus":62,"whyStopped":27,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Michael J. Fox Foundation for Parkinson's Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Comparison of tracer uptake between two camera using Standardized Uptake Value ratio","To compare \\[18F\\]AV133 Standardized Uptake Value Ratio (SUVR) in striatal regions and additional relevant regions for images acquired with NX compared to Siemens Biograph in all participants","Up to 24 months",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Longitudinal comparison of quantitative signals (SUVR) between two PET cameras","To compare the longitudinal regional change in \\[18F\\]AV133 SUVR in images acquired with NX PET and Siemens Biograph PET","24 months",{"measure":19,"description":20,"timeFrame":17},"Correlation of AV133 longitudinal change to clinical motor change","Correlation between longitudinal change in \\[18F\\]AV133 with NX derived SUVR in different brain regions and change in MDS-UPDRS score reported as correlation coefficient.",{"measure":22,"description":23,"timeFrame":17},"Correlation of AV133 longitudinal change to clinical cognitive change","Correlation between longitudinal change in \\[18F\\]AV133 with NX derived SUVR in different brain regions and change in Montreal Cognitive Assessment (MoCA) score reported as correlation coefficient.",{"measure":25,"description":26,"timeFrame":17},"Correlation of AV133 Longitudinal change to CSF biomarker","Correlation between longitudinal change in \\[18F\\]AV133 with NX derived SUVR in different brain regions and change in cerebrospinal fluid (CSF)- seed amplification assay (SAA) level reported as correlation coefficient.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE",[35],{"label":36,"type":37,"description":27,"interventionNames":38},"Prodromal Parkinson's disease (PD)","EXPERIMENTAL",[39],"Drug: [18F] AV-133 PET Imaging",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":27},"DRUG","[18F] AV-133 PET Imaging","The study will compare the performance of \\[18F\\]AV133 on both NX and standard PET camera in study participants enrolled at the INDD site in PPMI 015.",[36],[47],{"name":48,"affiliation":49,"role":50},"Ken Marek, MD","Institute for Neurodegenerative Disorders","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":27,"email":56},"Lianne Ramia","CONTACT","203-590-5600","LRamia1@indd.org",{"name":58,"role":54,"phone":55,"phoneExt":27,"email":59},"Jessica Dimos","jdimos@indd.org",[61],{"facility":49,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","New Haven","Connecticut","06510","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-72.92816,41.30815,{"lat":72,"lon":71},[75,79,83],{"name":76,"role":54,"phone":77,"phoneExt":27,"email":78},"Mackenzee George Clinical Research Coordinator II","475-318-8248","mgeorge@xingimaging.com",{"name":80,"role":54,"phone":81,"phoneExt":27,"email":82},"Kristen Hagwell Clinical Research Nurse II, RN","475-318-8259","khagwell@xingimaging.com",{"name":84,"role":50,"phone":27,"phoneExt":27,"email":27},"Neha Prakash, MBBS",{"type":86,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100655126","phase-2-a-comparative-performance-study-between-high-and-standard-resolution-positron-emission-tomography-camera-using-18f-av-133-in-prodromal-parkinsons-disease-100655126",false,"NCT07809438","A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease","A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography (PET) Camera Using [18F]AV-133 in Prodromal Parkinson's Disease [Dual PET AV133 in Prodromal PD]","Inclusion Criteria:\n\n1. Prodromal participant enrolled in the PPMI 015 sub study.\n2. Able to provide consent.\n\nExclusion Criteria:\n\na) Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.","ALL","18 Years",{"count":97,"type":98},25,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","This study is a single-center, longitudinal study and will be conducted at the Institute for Neurodegenerative (INDD) Site in New Haven, CT. This study aims to recruit participants from the ongoing Parkinson's Progression Markers Initiative AV-133 Prodromal Imaging sub study \\[PPMI 015\\] to obtain a second comparison imaging scan. In addition to being imaged with the standard Positron Emission Tomography (PET) camera after the \\[18F\\]AV133 injection in the PPMI 015 sub study, participants agreeing to a second scan will be imaged with the NeuroEXPLORER (NX) PET camera per this protocol.\n\nThis study will enroll approximately 25 participants at the INDD site. The dual PET scans will be completed at baseline, 1-and 2- years follow up. Participants may be asked to undergo further longitudinal scans based on the acquired study data.\n\nAll participants will have longitudinal clinical, biomarker, and genetic data for correlation analyses to imaging data from the PPMI Clinical study.",[104],"Prodromal Parkinson's Disease","2026-09-02",{"date":107,"type":108},"2026-09-09","ACTUAL",{"date":110,"type":108},"2025-09-18",{"date":112,"type":98},"2027-12",{"name":5,"class":6},1]