[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643681":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":11,"studyPopulation":11,"armGroups":36,"interventions":53,"overallOfficials":65,"centralContacts":69,"locations":77,"responsibleParty":99,"collaborators":11,"id":101,"slug":11,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":11,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":11,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":121,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Alnylam Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Double-Blind Period: Change from baseline in brain amyloid burden measured in centiloids (CLs)",null,"Up to 24 months",[14,16,18,20,22],{"measure":15,"description":11,"timeFrame":12},"Double-Blind Period: Change from baseline in APP protein concentration in cerebrospinal fluid (CSF)",{"measure":17,"description":11,"timeFrame":12},"Double-Blind Period: Change from baseline in the concentration of amyloid beta proteins in CSF",{"measure":19,"description":11,"timeFrame":12},"Double-Blind Period: Change from baseline in the concentration of tau proteins in plasma",{"measure":21,"description":11,"timeFrame":12},"Double-Blind Period: Change from baseline on a cognitive scale",{"measure":23,"description":11,"timeFrame":24},"Double-blind Period and Open-label Extension (OLE) Period: Frequency of adverse events (AEs)","Up to 36 months",{"allocation":26,"interventionModel":27,"interventionModelDescription":11,"primaryPurpose":28,"observationalModel":11,"timePerspective":11,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":11,"whoMasked":31},"QUADRUPLE",[32,33,34,35],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[37,43,47],{"label":38,"type":39,"description":40,"interventionNames":41},"Mivelsiran (Treatment Group A)","EXPERIMENTAL","Participants will be administered multiple low doses of mivelsiran.",[42],"Drug: Mivelsiran",{"label":44,"type":39,"description":45,"interventionNames":46},"Mivelsiran (Treatment Group B)","Participants will be administered multiple high doses of mivelsiran.",[42],{"label":48,"type":49,"description":50,"interventionNames":51},"Placebo (Treatment Group C)","PLACEBO_COMPARATOR","Participants will be administered multiple doses of placebo.",[52],"Drug: Placebo",[54,61],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"DRUG","Mivelsiran","Mivelsiran will be administered intrathecally",[38,44],[60],"ALN-APP",{"type":55,"name":62,"description":63,"armGroupLabels":64,"otherNames":11},"Placebo","Placebo will be administered intrathecally",[48],[66],{"name":67,"affiliation":5,"role":68},"Medical Director","STUDY_DIRECTOR",[70,75],{"name":71,"role":72,"phone":73,"phoneExt":11,"email":74},"Alnylam Clinical Trial Information Line","CONTACT","1-877-ALNYLAM","clinicaltrials@alnylam.com",{"name":71,"role":72,"phone":76,"phoneExt":11,"email":74},"1-877-256-9526",[78,91],{"facility":79,"status":11,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":11},"Clinical Study Site","Maitland","Florida","32751","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-81.36312,28.62778,{"lat":89,"lon":88},{"facility":79,"status":11,"city":92,"state":81,"zip":93,"country":83,"countryCode":84,"cosmosGeoPoint":94,"geoPoint":98,"contacts":11},"Naples","34105",{"type":86,"coordinates":95},[96,97],-81.79596,26.14234,{"lat":97,"lon":96},{"type":100,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":111,"type":112},58,"ESTIMATED","INTERVENTIONAL",[115],"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.",[118],"Down Syndrome-Associated Alzheimer's Disease (DS-AD)",[120],"Alzheimer's; DS-AD; Down Syndrome; ALZ","NOT_YET_RECRUITING","2026-06-04",{"date":124,"type":125},"2026-06-09","ACTUAL",{"date":127,"type":112},"2026-07-01",{"date":129,"type":112},"2031-07-23",{"name":5,"class":6},2]