[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neuron23 Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100568408","phase-2-a-phase-2-study-and-open-label-extension-of-neu-411-in-companion-diagnostic-positive-participants-with-early-parkinsons-disease-100568408",false,"NCT06680830","A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (NEULARK)","NEULARK","Inclusion Criteria:\n\n1. Aged 40-80 years at time of screening, inclusive\n2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)\n3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)\n4. Modified Hoehn and Yahr (mH\\&Y) of 1 to 2.5\n\nExclusion Criteria:\n\n1. Secondary or atypical parkinsonian syndromes\n2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \\>8%\n3. Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)\n\nAdditional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.","ALL","40 Years","80 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the \"leucine-rich repeat kinase 2\" (\"LRRK2\" for short) pathway based on their genetic profile. A DNA test will be used to identify the \"LRRK2-driven\" population with predicted elevation in the LRRK2 pathway.",[28,29,30,31,32],"Parkinson Disease","Parkinson","Idiopathic Parkinson Disease","Early Parkinson Disease (Early PD)","Parkinson Disease, Idiopathic",[34,35,36,37,38,39,15,40,41,42,43],"Early PD","Parkinsons","Parkinsons Disease","Idiopathic Parkinsons Disease","leucine-rich repeat kinase 2","PD","LRRK2","PARK8","de novo Parkinsons disease","Parkinson's disease","RECRUITING","2026-06-29",{"date":47,"type":48},"2026-07-01","ACTUAL",{"date":50,"type":48},"2025-01-17",{"date":52,"type":22},"2028-06",{"name":54,"class":55},"Neuron23 Inc.","INDUSTRY",70,""]