[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605160":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":57,"locations":65,"responsibleParty":114,"collaborators":116,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":36,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":85,"whyStopped":36,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Institute for Molecular Medicine","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"AV-1980R 20 µg Arm","EXPERIMENTAL","Participants receive 20 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.",[13],"Biological: AV-1980R 20 µg",{"label":15,"type":10,"description":16,"interventionNames":17},"AV-1980R 60 µg Arm","Participants receive 60 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.",[18],"Biological: AV-1980R 60 µg",{"label":20,"type":10,"description":21,"interventionNames":22},"AV-1980R 180 µg Arm","Participants receive 180 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.",[23],"Biological: AV-1980R 180 µg",{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo Arm","PLACEBO_COMPARATOR","Participants receive placebo injections (10 mM phosphate buffer with the adjuvant, no antigen) at Weeks 0, 4, 12, and 36.",[29],"Other: Placebo",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","AV-1980R 20 µg","MultiTEP-based investigational tau vaccine formulated with the adjuvant. The vaccine is designed to elicit anti-tau antibodies in participants with preclinical Alzheimer's disease.",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"AV-1980R 60 µg","MultiTEP-based tau vaccine formulated with the adjuvant, 60 µg per dose; intramuscular injections at Weeks 0, 4, 12, and 36; secondary-prevention immunotherapy in preclinical AD.",[15],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"AV-1980R 180 µg","MultiTEP-based tau vaccine formulated with the adjuvant, 180 µg per dose; intramuscular injections at Weeks 0, 4, 12, and 36; secondary-prevention immunotherapy in preclinical AD.",[20],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Placebo","10 mM phosphate buffer formulated with the adjuvant; intramuscular injections at Weeks 0, 4, 12, and 36; no active antigen.",[25],[50,54],{"name":51,"affiliation":52,"role":53},"Michael Agadjanyan, PhD","Institute MM","PRINCIPAL_INVESTIGATOR",{"name":55,"affiliation":52,"role":56},"Roman Kniazev","STUDY_DIRECTOR",[58,62],{"name":55,"role":59,"phone":60,"phoneExt":36,"email":61},"CONTACT","7145963981","rkniazev@immed.org",{"name":63,"role":59,"phone":60,"phoneExt":36,"email":64},"Anahit Ghochikyan","aghochikyan@immed.org",[66,83,98],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Comprehensive Center for Brain Health","NOT_YET_RECRUITING","Boca Raton","Florida","33433","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-80.0831,26.35869,{"lat":78,"lon":77},[81],{"name":82,"role":59,"phone":36,"phoneExt":36,"email":36},"Magdalena Dr. Tolea, PhD, MS, MA",{"facility":84,"status":85,"city":86,"state":70,"zip":87,"country":72,"countryCode":73,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Alzheimer's Research and Treatment Center (Stuart)","RECRUITING","Stuart","34996",{"type":75,"coordinates":89},[90,91],-80.25283,27.19755,{"lat":91,"lon":90},[94],{"name":95,"role":59,"phone":96,"phoneExt":36,"email":97},"Cristina Healy","772-675-0000","cchirino@researchalz.com",{"facility":99,"status":85,"city":100,"state":70,"zip":101,"country":72,"countryCode":73,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Alzheimer's Research and Treatment Center (Wellington)","Wellington","33414",{"type":75,"coordinates":103},[104,105],-80.24144,26.65868,{"lat":105,"lon":104},[108,112],{"name":109,"role":59,"phone":110,"phoneExt":36,"email":111},"Megan Moran","561-209-2400","mmoran@researchalz.com",{"name":113,"role":59,"phone":36,"phoneExt":36,"email":36},"Jasmine",{"type":115,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[117],{"name":118,"class":119},"National Institute on Aging (NIA)","NIH","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":132,"type":133},48,"ESTIMATED","INTERVENTIONAL",[136],"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.",[139,140],"Alzheimer Disease","Preclinical Alzheimer's Disease",[142,143,144,140,145,146,147,148],"Tau protein","Immunotherapy","Vaccine","Alzheimer's Disease","secondary prevention","Neurodegeneration","Preventive Alzheimer's","2026-06-24",{"date":151,"type":152},"2026-06-26","ACTUAL",{"date":154,"type":152},"2026-06-23",{"date":156,"type":133},"2029-10-15",{"name":5,"class":6},3]