[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636495":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":80,"collaborators":82,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":11,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":11,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":106,"whyStopped":11,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AB-1005 infusion","EXPERIMENTAL",null,[13],"Drug: AB-1005",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","AB-1005","Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Bayer Clinical Trials Contact","CONTACT","18888422937","clinical-trials-contact@bayer.com",[27,40,46,56,66,71],{"facility":28,"status":11,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":11},"Nagoya Central Hospital - Neurosurgery","Nagoya","Aichi-ken","453-0801","Japan","JP",{"type":35,"coordinates":36},"Point",[37,38],136.90641,35.18147,{"lat":38,"lon":37},{"facility":41,"status":11,"city":29,"state":30,"zip":42,"country":32,"countryCode":33,"cosmosGeoPoint":43,"geoPoint":45,"contacts":11},"Nagoya University Hospital - Neurology","466-8560",{"type":35,"coordinates":44},[37,38],{"lat":38,"lon":37},{"facility":47,"status":11,"city":48,"state":49,"zip":50,"country":32,"countryCode":33,"cosmosGeoPoint":51,"geoPoint":55,"contacts":11},"Yokohama City University Medical Center - Neurology","Yokohama","Kanagawa","232-0024",{"type":35,"coordinates":52},[53,54],139.65,35.43333,{"lat":54,"lon":53},{"facility":57,"status":11,"city":58,"state":59,"zip":60,"country":32,"countryCode":33,"cosmosGeoPoint":61,"geoPoint":65,"contacts":11},"National Hospital Organization Osaka Toneyama Medical Center - Neurology","Toyonaka","Osaka","560-8552",{"type":35,"coordinates":62},[63,64],135.46932,34.78244,{"lat":64,"lon":63},{"facility":67,"status":11,"city":68,"state":69,"zip":70,"country":32,"countryCode":33,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Juntendo University Hospital - Neurology","Bunkyo-ku","Tokyo","113-8431",{"facility":72,"status":11,"city":73,"state":11,"zip":74,"country":32,"countryCode":33,"cosmosGeoPoint":75,"geoPoint":79,"contacts":11},"National Hospital Organization Utano National Hospital - Neurology","Kyoto","616-8255",{"type":35,"coordinates":76},[77,78],135.75385,35.02107,{"lat":78,"lon":77},{"type":81,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[83],{"name":84,"class":6},"AskBio Inc","100636495","phase-2-a-study-of-ab-1005-gene-therapy-in-japanese-adults-with-moderate-parkinsons-disease-j-regenerate-pd-100636495",false,"NCT07566429","A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease (J-REGENERATE-PD)","A Phase 2, Open-label, Single Group, Fixed-dose Study to Evaluate the Safety and Efficacy of a Single Bilateral Intraputaminal Administration of AB-1005 (AAV2-GDNF Gene Therapy) in Japanese Participants With Moderate Stage Parkinson's Disease","Inclusion Criteria:\n\n* Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent\n* Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) and currently meeting all the following criteria:\n\n  1. Presence of bradykinesia PLUS any of the following: rigidity, rest tremor, postural instability\n  2. Presence of motor fluctuations as measured by the PD Motor Diary\n  3. Stable anti-parkinsonian medication regimen for 4 weeks or more, prior to screening\n  4. Responsiveness to levodopa therapy\n\nExclusion Criteria:\n\n* Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis\n* Presence or history of significant vascular and\u002For cardiovascular disease\n* Presence of clinically significant cognitive impairment\n* Presence or history of psychosis or impulse control disorder\n* History of malignancy other than treated cutaneous squamous or basal cell carcinomas\n* Presence of clinically relevant conditions that could compromise surgical suitability and\u002For subject safety\n* Contraindication to magnetic resonance imaging and\u002For use gadolinium-based contrast agents\n* Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure\n* Chronic immunosuppressive therapy","ALL","45 Years","75 Years",{"count":96,"type":97},8,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","The objective of this Phase 2, open-label, single group, one-time, fixed-dose study is to assess the safety and efficacy of bilateral intraputaminal infusion of AB-1005 (AAV2-GDNF gene therapy) in Japanese patients with moderate Parkinson's Disease (PD).",[103],"Parkinson Disease",[105],"Gene therapy","NOT_YET_RECRUITING","2026-07-28",{"date":109,"type":110},"2026-07-29","ACTUAL",{"date":112,"type":97},"2027-01-25",{"date":114,"type":97},"2032-12-15",{"name":5,"class":6},6]