[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609449":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":152,"collaborators":154,"id":157,"slug":25,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":25,"eligibilityCriteria":162,"healthyVolunteers":158,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":25,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Alnylam Pharmaceuticals","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ALN-5288","EXPERIMENTAL","Participants will be administered ALN-5288 in the Double-blind (DB) Period and Open-Label Extension (OLE) Period.",[13],"Drug: ALN-5288",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo + ALN-5288","PLACEBO_COMPARATOR","Participants will be administered placebo in the DB Period and ALN-5288 in the OLE Period.",[13,19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ALN-5288 will be administered IT.",[9,15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Placebo will be administered IT.",[15],[31],{"name":32,"affiliation":5,"role":33},"Medical Director","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Clinical Trial Information Line","CONTACT","1-877-ALNYLAM","clinicaltrials@alnylam.com",{"name":36,"role":37,"phone":41,"phoneExt":25,"email":39},"1-877-256-9526",[43,55,63,71,77,86,94,103,111,119,128,136,144],{"facility":44,"status":45,"city":46,"state":25,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":25},"Clinical Trial Site","RECRUITING","Montreal","H3G 1H9","Canada",{"type":50,"coordinates":51},"Point",[52,53],-73.58781,45.50884,{"lat":53,"lon":52},{"facility":44,"status":45,"city":56,"state":25,"zip":57,"country":48,"cosmosGeoPoint":58,"geoPoint":62,"contacts":25},"Ottawa","K1Z 1G3",{"type":50,"coordinates":59},[60,61],-75.69812,45.41117,{"lat":61,"lon":60},{"facility":44,"status":45,"city":64,"state":25,"zip":65,"country":48,"cosmosGeoPoint":66,"geoPoint":70,"contacts":25},"Toronto","M3B 2S7",{"type":50,"coordinates":67},[68,69],-79.39864,43.70643,{"lat":69,"lon":68},{"facility":44,"status":72,"city":64,"state":25,"zip":73,"country":48,"cosmosGeoPoint":74,"geoPoint":76,"contacts":25},"NOT_YET_RECRUITING","M5T 2S8",{"type":50,"coordinates":75},[68,69],{"lat":69,"lon":68},{"facility":44,"status":72,"city":78,"state":25,"zip":79,"country":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":25},"'s-Hertogenbosch","5223","Netherlands",{"type":50,"coordinates":82},[83,84],5.30417,51.69917,{"lat":84,"lon":83},{"facility":44,"status":72,"city":87,"state":25,"zip":88,"country":80,"cosmosGeoPoint":89,"geoPoint":93,"contacts":25},"Amsterdam","1081 GN",{"type":50,"coordinates":90},[91,92],4.88969,52.37403,{"lat":92,"lon":91},{"facility":44,"status":72,"city":95,"state":25,"zip":96,"country":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":25},"Barcelona","08036","Spain",{"type":50,"coordinates":99},[100,101],2.15899,41.38879,{"lat":101,"lon":100},{"facility":44,"status":45,"city":104,"state":25,"zip":105,"country":97,"cosmosGeoPoint":106,"geoPoint":110,"contacts":25},"Madrid","28040",{"type":50,"coordinates":107},[108,109],-3.70256,40.4165,{"lat":109,"lon":108},{"facility":44,"status":72,"city":112,"state":25,"zip":113,"country":97,"cosmosGeoPoint":114,"geoPoint":118,"contacts":25},"Sant Cugat del Vallès","08190",{"type":50,"coordinates":115},[116,117],2.08611,41.47063,{"lat":117,"lon":116},{"facility":44,"status":45,"city":120,"state":25,"zip":121,"country":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":25},"Glasgow","G51 4TF","United Kingdom",{"type":50,"coordinates":124},[125,126],-4.25763,55.86515,{"lat":126,"lon":125},{"facility":44,"status":45,"city":129,"state":25,"zip":130,"country":122,"cosmosGeoPoint":131,"geoPoint":135,"contacts":25},"London","WC1N 3BG",{"type":50,"coordinates":132},[133,134],-0.12574,51.50853,{"lat":134,"lon":133},{"facility":44,"status":72,"city":137,"state":25,"zip":138,"country":122,"cosmosGeoPoint":139,"geoPoint":143,"contacts":25},"Sheffield","S10 2JF",{"type":50,"coordinates":140},[141,142],-1.4659,53.38297,{"lat":142,"lon":141},{"facility":44,"status":45,"city":145,"state":25,"zip":146,"country":122,"cosmosGeoPoint":147,"geoPoint":151,"contacts":25},"Southampton","SO16 6YD",{"type":50,"coordinates":148},[149,150],-1.40428,50.90395,{"lat":150,"lon":149},{"type":153,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[155],{"name":156,"class":6},"Regeneron Pharmaceuticals","100609449",false,"NCT07214727","A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease","A Phase 1, Randomized, Placebo-controlled Study With a Double Blind Period With Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients With Alzheimer's Disease","Inclusion Criteria:\n\n* Is able and willing to meet all study requirements in the opinion of the Investigator\n* Has a diagnosis of Alzheimer's disease (AD) based on clinical findings supported by cerebrospinal fluid (CSF) biomarkers or positive positron emission tomography (PET) amyloid imaging within 7 years prior to screening\n* Has mild cognitive impairment (MCI) or dementia due to AD\n\nExclusion Criteria:\n\n* Has non-AD dementia\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2× upper limit of normal (ULN)\n* Has total bilirubin \\>1.5×ULN\n* Has known human immunodeficiency virus infection\n* Has history of hepatitis C virus or current hepatitis B virus infection\n* Has systolic blood pressure \\>160 mmHg and\u002For a diastolic blood pressure \\>100 mmHg after 10 minutes of rest at screening\n* Has an estimated glomerular filtration (eGFR) of \\\u003C45 mL\u002Fmin\u002F1.73 m\\^2 at screening\n* Has clinically significant ECG abnormalities at screening\n* Has uncontrolled psychiatric disease, including patients deemed by the Investigator to be at significant risk of suicide, major depressive episode, psychosis, confusional state, or violent behavior\n* Has history of bleeding diathesis or coagulopathy due to chronic conditions\n* Has a medical history of brain or spinal disease that would interfere with the IT injection and LP procedures\n* Has history of uncontrolled seizures within the last 6 months prior to Screening","ALL","40 Years","80 Years",{"count":167,"type":168},50,"ESTIMATED","INTERVENTIONAL",[171],"PHASE1","The purpose of this study is to:\n\n* Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD)\n* Evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ALN-5288 after dose administration",[174],"Alzheimer's Disease",[176,177],"AD","Dementia","2026-06-10",{"date":180,"type":181},"2026-06-12","ACTUAL",{"date":183,"type":181},"2025-10-15",{"date":185,"type":168},"2030-03-06",{"name":5,"class":6},13]