[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"down-syndrome-associated-alzheimers-disease-ds-ad\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:down-syndrome-associated-alzheimers-disease-ds-ad":27},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":20,"type":21},58,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Down Syndrome-Associated Alzheimer's Disease (DS-AD)",[29],"Alzheimer's; DS-AD; Down Syndrome; ALZ","NOT_YET_RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-09","ACTUAL",{"date":36,"type":21},"2026-07-01",{"date":38,"type":21},"2031-07-23",{"name":40,"class":41},"Alnylam Pharmaceuticals","INDUSTRY",2]