[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643681":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":71,"collaborators":36,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":36,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":36,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":94,"whyStopped":36,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Alnylam Pharmaceuticals","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Mivelsiran (Treatment Group A)","EXPERIMENTAL","Participants will be administered multiple low doses of mivelsiran.",[13],"Drug: Mivelsiran",{"label":15,"type":10,"description":16,"interventionNames":17},"Mivelsiran (Treatment Group B)","Participants will be administered multiple high doses of mivelsiran.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo (Treatment Group C)","PLACEBO_COMPARATOR","Participants will be administered multiple doses of placebo.",[23],"Drug: Placebo",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Mivelsiran","Mivelsiran will be administered intrathecally",[9,15],[31],"ALN-APP",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Placebo","Placebo will be administered intrathecally",[19],null,[38],{"name":39,"affiliation":5,"role":40},"Medical Director","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},"Alnylam Clinical Trial Information Line","CONTACT","1-877-ALNYLAM","clinicaltrials@alnylam.com",{"name":43,"role":44,"phone":48,"phoneExt":36,"email":46},"1-877-256-9526",[50,63],{"facility":51,"status":36,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":36},"Clinical Study Site","Maitland","Florida","32751","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-81.36312,28.62778,{"lat":61,"lon":60},{"facility":51,"status":36,"city":64,"state":53,"zip":65,"country":55,"countryCode":56,"cosmosGeoPoint":66,"geoPoint":70,"contacts":36},"Naples","34105",{"type":58,"coordinates":67},[68,69],-81.79596,26.14234,{"lat":69,"lon":68},{"type":72,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100643681","phase-2-a-study-to-evaluate-mivelsiran-in-adult-participants-with-early-stage-down-syndrome-associated-alzheimers-disease-ds-ad-100643681",false,"NCT07636811","A Study to Evaluate Mivelsiran in Adult Participants With Early-Stage Down Syndrome-Associated Alzheimer's Disease (DS-AD)","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study, to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered Mivelsiran in Adult Participants With Early-Stage Down Syndrome-Associated Alzheimer's Disease (DS-AD)","Inclusion Criteria:\n\n* Clinical diagnosis of Down-Syndrome (DS) associated with trisomy 21\n* Positive amyloid PET scan\n* Cognitively stable in the opinion of the investigator\n* Seizures must be well controlled with no occurrence of seizures in the 6 months prior to screening\n\nExclusion Criteria:\n\n* Has severe intellectual disability (ID)\n* Has a history of DS regression disorder\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2×upper limit of normal (ULN) at Screening\n* Has estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m\\^2 at Screening\n* Has recently received an investigational agent\n* Has had treatment with amyloid-targeting antibody\n* Comorbidities such as obstructive sleep apnea and hypothyroidism that are not well controlled\n\nNote: other protocol defined inclusion \u002F exclusion criteria apply","ALL","40 Years","55 Years",{"count":84,"type":85},58,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","The purpose of the study is to evaluate the effect of mivelsiran in adult participants with early-stage DS-AD and to characterize the safety, tolerability, and pharmacodynamics (PD) of mivelsiran. The study will be conducted over 2 periods: a 24-month double-blind period and an optional 12-month open-label treatment extension (OLE) period. The estimated duration of study participation, inclusive of screening, treatment, and additional safety follow-up, is up to 39 months.",[91],"Down Syndrome-Associated Alzheimer's Disease (DS-AD)",[93],"Alzheimer's; DS-AD; Down Syndrome; ALZ","NOT_YET_RECRUITING","2026-06-04",{"date":97,"type":98},"2026-06-09","ACTUAL",{"date":100,"type":85},"2026-07-01",{"date":102,"type":85},"2031-07-23",{"name":5,"class":6},2]