[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652901":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":38,"centralContacts":41,"locations":49,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",[8,14,17,20,23,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Panel A1: BMS986446","EXPERIMENTAL",null,[13],"Drug: BMS-986446",{"label":15,"type":10,"description":11,"interventionNames":16},"Panel A2: BMS986446",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Panel A3: BMS986446",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Panel B1: BMS986446",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Panel B2: BMS986446",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"Panel C1: BMS986446",[13],[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","BMS-986446","Specified dose on specified days",[9,15,18,21,24,27],[36,37],"PRX005","Moponetug",[39],{"name":5,"affiliation":5,"role":40},"STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":48,"role":44,"phone":11,"phoneExt":11,"email":11},"First line of the email MUST contain NCT # and Site #.",[50],{"facility":51,"status":11,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Local Institution - 0001","Anaheim","California","92801","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-117.9145,33.83529,{"lat":61,"lon":60},[64],{"name":65,"role":44,"phone":11,"phoneExt":11,"email":11},"Site 0001",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100652901","phase-1-a-study-to-evaluate-the-drug-levels-absolute-bioavailability-safety-tolerability-and-immunogenicity-of-single-dose-of-bms-986446-in-healthy-adults-after-single-dose-administration-and-participants-with-early-alzheimers-disease-after-multiple-dose-administration-100652901",false,"NCT07780383","A Study to Evaluate the Drug Levels, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 in Healthy Adults After Single-dose Administration, and Participants With Early Alzheimer's Disease After Multiple Dose Administration","A Phase 1, Open-label, Multi-part Study to Evaluate Pharmacokinetics, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 Following Intravenous and Subcutaneous Administrations in Healthy Adults and Multiple Doses of BMS-986446 in Participants With Early Alzheimer's Disease.","Inclusion Criteria\n\n* Participants must have a BMI of 18.0 to 35.0 kg\u002Fm2.\n* For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations.\n* For Part C: Participants must meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.\n* For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).\n* For Part C: Participants must have evidence of positive plasma pTau217.\n\nExclusion Criteria\n\n* For Parts A and B: Participants must not have a general history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.\n* For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration.\n* For Part C: Participants must not have a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.\n* For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions).\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",true,"ALL","18 Years","80 Years",{"count":80,"type":81},84,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","The purpose of this study is to evaluate the drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration",[87,88],"Alzheimer's Disease","Healthy Participants",[88,90,32,91,92],"Early Alzheimer's Disease","Subcutaneous Administration","IV administration","NOT_YET_RECRUITING","2026-08-19",{"date":96,"type":97},"2026-08-21","ACTUAL",{"date":96,"type":81},{"date":100,"type":81},"2027-06-17",{"name":5,"class":6},1]