[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538342":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":30,"locations":36,"responsibleParty":57,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prodromal and manifest (PD) participants","EXPERIMENTAL",null,[13],"Drug: [F-18]DPA714 administration IV",{"label":15,"type":10,"description":11,"interventionNames":16},"Healthy participants",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","[F-18]DPA714 administration IV","brain PET\u002FMRI imaging after \\[F-18\\]DPA-714 administration",[15,9],[24,27],{"name":25,"affiliation":5,"role":26},"Jonathan McConathy, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":5,"role":29},"David Standaert, MD, PhD","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Evan Hudson","CONTACT","205-934-6499","evanhusdon@uabmc.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"UAB","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-86.80249,33.52066,{"lat":49,"lon":48},[52,55],{"name":53,"role":33,"phone":34,"phoneExt":11,"email":54},"Evan Hudson, BS","evanhudson@uabmc.edu",{"name":56,"role":26,"phone":11,"phoneExt":11,"email":11},"Jonathan McConathy, MD,PhD",{"type":26,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Deepak Prabataram Kalbi","Assistant Professor",[61],{"name":62,"class":6},"Michael J. Fox Foundation for Parkinson's Research","100538342","early-phase-1-longitudinal-tspo-pet-imaging-with-18fdpa-714-in-ppmi-ppmi-dpa-714-pet-imaging-100538342",false,"NCT06289582","Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)","Inclusion Criteria:\n\n* A prodromal PD and Healthy participant enrolled in PPMI Clinical protocol\n* A PD participant enrolled in PPMI Clinical protocol who has not started symptomatic treatment at time of enrollment or in the first 2 years of participation.\n* Able to provide informed consent\n* Must have screening genetic testing documenting high binder at the at the known TSPO gene polymorphism (rs6971)\n* 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\\]DPA-714\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\n  * Females of childbearing potential must not be pregnant, breastfeeding or lactating.\n  * Includes a negative urine pregnancy test prior to injection of \\[18F\\]DPA-714 on day of PET scan.\n\nExclusion Criteria:\n\n* Exposure to a total effective dose equivalent of 50 millisievert (mSv) for the whole body, which is the annual limit established by the US Code of Federal Regulations , during the past year.\n* Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.",true,"ALL","18 Years","99 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","The overall goal of this protocol is to investigate \\[18F\\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \\[18F\\]DPA-714 binding in PD participants during a 24-month interval.\n\nPrimary Objectives\n\n* To compare \\[18F\\]DPA-714 binding in prodromal and manifest PD and healthy volunteers.\n* To determine the longitudinal change in \\[18F\\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.\n\nSecondary Objectives\n\n* To evaluate the correlation between baseline \\[18F\\]DPA-714 and PPMI clinical and biomarker outcomes.\n* To evaluate the correlation between the longitudinal change of \\[18F\\]DPA-714 and PPMI clinical and biomarker outcomes\n* To acquire safety data following injection of \\[18F\\]DPA-714",[81],"Parkinson Disease","2026-08-10",{"date":84,"type":85},"2026-08-12","ACTUAL",{"date":87,"type":85},"2024-08-14",{"date":89,"type":75},"2028-06",{"name":5,"class":6},1]