[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604820":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":30,"collaborators":34,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":25,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"Hanyang University Seoul Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NS101 Treatment Group","ACTIVE_COMPARATOR","Participants will receive a two loading dose of NS101 15 mg\u002Fkg IV infusion, followed by biweekly dosing for 6 months during the double-blind phase. Those who complete the double-blind phase will be eligible to enter a 3-month open-label extension to receive active treatment.",[13],"Drug: NS101 IV infusion",{"label":15,"type":16,"description":11,"interventionNames":17},"NS101 Placebo Group","PLACEBO_COMPARATOR",[18],"Drug: Placebo IV Infusion",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","NS101 IV infusion","NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo IV Infusion","Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101",[15],{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Hee-Jin Kim","Professor, Department of Neurology, College of Medicine, Hanyang university",[35,37,39],{"name":36,"class":6},"Asan Medical Center",{"name":38,"class":6},"Gangnam Severance Hospital",{"name":40,"class":6},"Konkuk University Medical Center","100604820","phase-2-investigator-initiated-study-for-the-safety-and-efficacy-in-frontotemporal-dementia-100604820",false,"NCT07154485","Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia","A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Investigator-initiated Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics (PK\u002FPD), and Exploratory Efficacy of Multiple Doses of NS101 in Patients With Semantic Variant Primary Progressive Aphasia (svPPA), a Subtype of Frontotemporal Dementia (FTD)","Key Inclusion Criteria:\n\n* Participants diagnosed at screening with mild to moderate frontotemporal dementia, semantic variant (svFTD), defined by a CDR® Plus NACC FTLD Sum of Boxes (SOB) score between 4.5 and 15.5.\n* Participants confirmed to be amyloid-negative based on Amyloid PET scan or CSF results within the past 36 months.\n\nKey Exclusion Criteria:\n\n* Participants with other degenerative brain diseases as determined by the investigator\n* Participants with other neurological disorders and uncontrolled acute disease","ALL","55 Years","80 Years",{"count":52,"type":53},15,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics\u002Fpharmacodynamics (PK\u002FPD), immunogenicity, and efficacy of multiple intravenous administrations of the investigational drug NS101, compared to placebo, in patients with semantic variant primary progressive aphasia (svPPA), a subtype of frontotemporal dementia (FTD)",[59],"Dementia Frontotemporal",[61,62,63,64,65,66],"Frontotemporal Dementia","semantic variant","FTD","sv FTD","PPA","sv PPA","NOT_YET_RECRUITING","2025-09-03",{"date":70,"type":71},"2025-09-04","ACTUAL",{"date":73,"type":53},"2025-10-01",{"date":75,"type":53},"2028-08-01",{"name":32,"class":6}]