[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute for Molecular Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100605160","phase-1-av-1980r-tau-vaccine-in-preclinical-alzheimers-disease-taurus-1980-100605160",false,"NCT07158905","AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)","A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease","TAURUS-1980","Inclusion Criteria:\n\nMale or post-menopausal\u002Fsurgically sterile female, 65-80 years of age.\n\nCognitively unimpaired with preclinical Alzheimer's disease:\n\nCDR global score = 0. MMSE ≥ 26. WMS-R LM II ≥ 6. Amyloid Probability Score 2 (APS2) \\> 54 (PrecivityAD2™). Adequate vision\u002Fhearing to comply with study procedures. Stable concomitant medications if applicable. Signed informed consent.\n\nExclusion Criteria:\n\nMRI abnormalities: \\>1 large lacunar infarct, territorial infarct, \\>5 microbleeds, ARIA-E, or other significant pathology.\n\nContraindications to MRI (e.g., pacemaker, metallic implants, severe claustrophobia).\n\nSerious illness or hospitalization within 4 weeks prior to enrollment. Clinically significant cardiovascular, endocrine, hematologic, autoimmune, or neurological disease.\n\nInsulin-dependent diabetes, significant arrhythmias, or seizure disorder. Positive C-SSRS (score ≥ 3). Prior tau or amyloid-beta immunotherapy within 1 year. Immunosuppressive or anticoagulant use that could interfere with study safety. Clinically significant lab abnormalities or positive HIV, HBV, or HCV screening.","ALL","65 Years","80 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose-escalating trial to evaluate the safety, tolerability, and immune response of AV-1980R, an investigational vaccine targeting tau protein, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65-80 with biomarker evidence of early Alzheimer's disease will be enrolled into three ascending dose cohorts. The study is designed as a secondary prevention trial to test whether therapeutic immunization at the preclinical stage is safe, induces an immune response, and, exploratorily, may favorably affect biomarkers associated with disease progression.",[28,29],"Alzheimer Disease","Preclinical Alzheimer's Disease",[31,32,33,29,34,35,36,37],"Tau protein","Immunotherapy","Vaccine","Alzheimer's Disease","secondary prevention","Neurodegeneration","Preventive Alzheimer's","RECRUITING","2026-06-24",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":42},"2026-06-23",{"date":46,"type":22},"2029-10-15",{"name":48,"class":49},"Institute for Molecular Medicine","OTHER",3,""]