[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06289582":3,"trial-entities:NCT06289582":93,"trial-summary:NCT06289582":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":20,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":59,"locations":62,"central_contacts":81,"overall_officials":85,"references":91,"see_also_links":92},"NCT06289582","IRB-300012051 R24-004","Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)","RECRUITING","2028-06","2026-08","2026-08-12","2024-08-14","University of Alabama at Birmingham","OTHER",null,"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",[17],"Parkinson Disease",[],"INTERVENTIONAL","DIAGNOSTIC",[22],"EARLY_PHASE1",{"count":24,"type":25},60,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DRUG","[F-18]DPA714 administration IV","brain PET\u002FMRI imaging after \\[F-18\\]DPA-714 administration",[32,33],"Healthy participants","Prodromal and manifest (PD) participants",[35],{"measure":36,"description":37,"timeFrame":38},"Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.","The changes over time in neuroinflammation based on TSPO will be assessed by comparing TSPO-PET imaging at baseline, 12 months and 24 months after enrollment.","24 months",[],"ALL","18 Years","99 Years",true,{"inclusion":45,"exclusion":55,"raw_text":58},[46,47,48,49,50,51,52,53,54],"A prodromal PD and Healthy participant enrolled in PPMI Clinical protocol","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.","Able to provide informed consent","Must have screening genetic testing documenting high binder at the at the known TSPO gene polymorphism (rs6971)","Male or Female (Females must meet additional criteria specified below, as applicable)","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).","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.","Females of childbearing potential must not be pregnant, breastfeeding or lactating.","Includes a negative urine pregnancy test prior to injection of \\[18F\\]DPA-714 on day of PET scan.",[56,57],"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.","Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.","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.",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":78},"UAB","Birmingham","Alabama","35294","United States",[70,75],{"name":71,"role":72,"phone":73,"email":74},"Evan Hudson, BS","CONTACT","205-934-6499","evanhudson@uabmc.edu",{"name":76,"role":77},"Jonathan McConathy, MD,PhD","PRINCIPAL_INVESTIGATOR",{"lat":79,"lon":80},33.52066,-86.80249,[82],{"name":83,"role":72,"phone":73,"email":84},"Evan Hudson","evanhusdon@uabmc.edu",[86,88],{"name":87,"affiliation":12,"role":77},"Jonathan McConathy, MD, PhD",{"name":89,"affiliation":12,"role":90},"David Standaert, MD, PhD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":94,"biomarkers":95},[17],[96],"TSPO Gene",{"nct_id":4,"found":43,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an interventional study planning to enroll 60 participants. It compares [18F]DPA-714 binding in different groups.","completed","Investigating Brain Changes in Parkinson's Disease with [18F]DPA-714","This study is looking at how a special imaging agent called [18F]DPA-714 binds in the brains of people with early Parkinson's disease (PD) and those who are at risk (prodromal PD), as well as healthy volunteers. [18F]DPA-714 is given through an IV, and then special brain scans (PET\u002FMRI) are done. The goal is to see if the amount of [18F]DPA-714 binding changes over 24 months in people with PD. You might be able to join if you are already part of the PPMI study as a healthy volunteer, or have prodromal PD or early PD and haven't started treatment. You'll also need specific genetic testing showing you are a \"high binder\" for a gene related to TSPO. The study aims to understand how this binding relates to PD progression. The current status of this study is unclear.","Participants will be followed for 24 months to measure changes in brain TSPO levels.",137,"You will receive an intravenous (IV) administration of [18F]DPA-714, followed by brain PET\u002FMRI imaging. This will be done at the beginning and again after 24 months.","Not stated in the trial record.",[],"v2"]