[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CHDI Foundation, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":38,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100564857","early-phase-1-imagemhtt-009--fih-evaluation-of-novel-mutant-huntingtin-pet-radioligand-11cchdi-00491009-100564857",false,"NCT06634628","iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009","First in Human Adaptive Study to Investigate the Kinetic Properties of the Novel PET Radioligand [11C]CHDI-00491009 and Its Suitability for Quantification of Aggregated Mutant Huntingtin in the Brains of People With Huntington's Disease","iMagemHTT-009","Inclusion Criteria:\n\nPwHD HD-ISS Stages 2 and 3 and HC participants who:\n\n1. Are female or male adults, age 18-64 years old, inclusive.\n2. Have body mass index (BMI) between 19 and 35, inclusive.\n3. Have capacity to give full informed consent in writing and have read and signed the informed consent form (ICF).\n4. Are able to comply with study procedures, including fasting and blood sampling.\n5. Are able and willing to travel to the imaging center in Leuven, Belgium.\n6. Are willing to comply with the use of adequate contraceptive measures.\n\n   HD-ISS Stage 2 participants who:\n7. Have a huntingtin gene CAG expansion between 40 and 50, inclusive; and\n8. Are classified within HD-ISS Stage 2 per the HD-ISS criteria using HD-ISS Modified Stage calculator.\n9. Have a PIN score of 0.47 to 1.84 \\[prognostic index normed for HD (PIN) where PIN = (PIHD - 883)\u002F1044 where PIHD = 51 x TMS + (-34) x SDMT + 7 x Age x (CAG - 34) (TMS is the UHDRS Total Motor Score, and SDMT is the UHDRS Symbol Digit Modalities Test)\\].\n\nHD-ISS Stage 2 participants who:\n\n7\\. Have a huntingtin gene CAG expansion between 40 and 50, inclusive; and 8. Are classified within HD-ISS Stage 2 per the HD-ISS criteria using HD-ISS Modified Stage calculator.\n\n9\\. Have a PIN score of 0.47 to 1.84 \\[prognostic index normed for HD (PIN) where PIN = (PIHD - 883)\u002F1044 where PIHD = 51 x TMS + (-34) x SDMT + 7 x Age x (CAG - 34) (TMS is the UHDRS Total Motor Score, and SDMT is the UHDRS Symbol Digit Modalities Test)\\].\n\nHC participants who:\n\n13\\. Have no known family history of HD; or 14. Have a known family history of HD and have been tested for the huntingtin gene CAG expansion and are not at genetic risk for HD (CAG \\\u003C 36).\n\n15\\. Age match (+\u002F- 5 years) and biological sex match to each HD participant in Cohort 2 and Cohort 3 (except for Cohort 1, no matching).\n\nExclusion Criteria:\n\nPwHD HD-ISS Stages 2 and 3 and HC participants who:\n\n1. Are currently participating in, or are less than 30 days after completing participation in, other therapeutic or imaging studies.\n2. Have previously participated in a PET imaging study in the past 12 months that, cumulatively with the current study, will exceed annual regulatory limits for radiation exposure.\n3. Have any disease, condition, or concomitant medication that significantly compromises the function of the body systems and that, in the opinion of the Investigator, might interfere with the conduct of the study or its interpretation.\n4. Are pregnant and breastfeeding females.\n5. Have concomitant use of antiplatelet or anticoagulant therapy (inclusive of acetylsalicylic acid).\n6. Have a bleeding disorder.\n7. Have a needle phobia.\n8. Have any metal objects present in the body that are incompatible with MRI.\n9. Have metal objects present in the body that are compatible with MRI and are located in the head or neck.\n10. Have any clinically significant results on safety laboratory tests that, in the opinion of the Investigator, would either put the participant at risk or interfere with the conduct of the study or interpretation of data. These tests include, but are not limited to:\n\n    * a. positive results for HBsAg, HepC, HIV-1 or HIV-2 (will also be reported as required by local\u002Fnational regulations),\n    * b. clinically significant, abnormal results for safety laboratory tests.\n\n    PwHD participants who:\n11. If they are using any antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD, the use of inappropriate (e.g., non-therapeutically high) or unstable dose within 30 days prior to participation.\n\n    HC participants who:\n12. Have a family history of HD and have not been tested for the huntingtin gene (CAG) expansion.",true,"ALL","18 Years","64 Years",{"count":22,"type":23},27,"ESTIMATED","INTERVENTIONAL",[26],"EARLY_PHASE1","This is a FIH (first-in-human) study to evaluate the clinical utility of the radioligand \\[11C\\]CHDI-00491009 as a PET tracer that binds specifically to mutant huntingtin (mHTT) aggregates in Huntington's disease (HD).\n\nThe study is divided into three cohorts defined by the Huntington's Disease Integrated Staging System (HD-ISS): Cohort 1 - initial tracer validation (3 healthy controls (HCs)); Cohort 2 - target validation and test-retest variability (6 HD-ISS Stage 3 participants and 6 age and biological sex-matched HCs); Cohort 3 - target sensitivity (6 HD-ISS Stage 2 participants and 6 age and biological sex-matched HCs). An interim analysis (IA) will be conducted after the completion of each cohort, followed by a final analysis for the study.\n\nIn addition to imaging, exploratory biomarkers, including somatic instability index, soluble mHTT and total huntingtin (HTT), will be assessed. All participants with HD (PwHD) will have an additional blood sample drawn at the screening visit to assess the somatic instability index and will also be invited to provide an optional cerebrospinal fluid (CSF) sample for measurement of soluble mHTT and total HTT.",[29,30,31,32,33,34,35,36,37],"Huntington Disease","HD","PET Tracer","Positron Emission Tomography","Radioligand","Imaging","mHTT","Huntington's","Huntington's Disease",[39,29,30,31,32,40,41,35,42,37],"iMagemHTT","radioligand","imaging","huntingtin","RECRUITING","2026-03-12",{"date":46,"type":47},"2026-03-13","ACTUAL",{"date":49,"type":47},"2026-02-24",{"date":51,"type":23},"2028-03",{"name":53,"class":54},"CHDI Foundation, Inc.","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":62,"targetDuration":64,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100176679","enroll--hd-a-prospective-registry-study-in-a-global-huntingtons-disease-cohort-100176679","NCT01574053","Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort","Inclusion Criteria:\n\n* Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.\n* Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation.\n\nThese two major categories can be further subdivided into six different subgroups of eligible individuals:\n\n* Manifest\u002FMotor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD.\n* Pre-Manifest\u002F-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.\n* Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status.\n* Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation.\n* Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers).\n* Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies.\n\nParticipant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification.\n\nExclusion Criteria:\n\n* Individuals who do not meet inclusion criteria,\n* Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.\n* For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.).\n\nParticipants under 18 may be eligible to participate (if they have juvenile-onset HD).",{"count":63,"type":23},35000,"1 Year","OBSERVATIONAL","Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org\u002Ffor-researchers\u002Faccess-data\u002F to learn more.",[37],[37,29,69,70,71,72],"Juvenile Huntington's Disease","Registry","Cohort","CHDI","2024-02-26",{"date":75,"type":47},"2024-02-28",{"date":77,"type":47},"2012-07",{"date":79,"type":23},"2062-01",{"name":53,"class":54},183,""]