[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605160":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":57,"locations":65,"responsibleParty":178,"collaborators":180,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":36,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":68,"whyStopped":36,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},{"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 of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.",[13],"Biological: AV-1980R 20 µg",{"label":15,"type":10,"description":16,"interventionNames":17},"AV-1980R 60 µg Arm","Participants receive 60 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.",[18],"Biological: AV-1980R 60 µg",{"label":20,"type":10,"description":21,"interventionNames":22},"AV-1980R 180 µg Arm","Participants receive 180 µg of AV-1980R formulated with Advax-CpG55.2 by intramuscular injection at Weeks 0, 4, and 38.",[23],"Biological: AV-1980R 180 µg",{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo Arm","PLACEBO_COMPARATOR","Participants receive 10 mM phosphate buffer without active AV-1980R, formulated with Advax-CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.",[29],"Other: Placebo",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","AV-1980R 20 µg","AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 20 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"AV-1980R 60 µg","AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 60 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.",[15],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"AV-1980R 180 µg","AV-1980R is an investigational recombinant protein tau vaccine based on the MultiTEP platform. Participants receive 180 µg of AV-1980R formulated with Advax-CpG55.2, consisting of Advax and CpG55.2, by intramuscular injection at Weeks 0, 4, and 38.",[20],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Placebo","The placebo consists of 10 mM phosphate buffer without active AV-1980R, formulated with Advax-CpG55.2, consisting of Advax and CpG55.2. It is administered by intramuscular injection at Weeks 0, 4, and 38.",[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",[66,89,107,124,142,159],{"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","RECRUITING","Boca Raton","Florida","33433","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-80.0831,26.35869,{"lat":78,"lon":77},[81,85],{"name":82,"role":59,"phone":83,"phoneExt":36,"email":84},"Shanell Disla","561-869-6825","sxd1210@med.miami.edu",{"name":86,"role":59,"phone":87,"phoneExt":36,"email":88},"Alyssa Gosling","561-869-6820","aeg364@med.miami.edu",{"facility":90,"status":68,"city":91,"state":70,"zip":92,"country":72,"countryCode":73,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Palm Springs Community Health Center","Miami Lakes","33014",{"type":75,"coordinates":94},[95,96],-80.30866,25.90871,{"lat":96,"lon":95},[99,103],{"name":100,"role":59,"phone":101,"phoneExt":36,"email":102},"Mailin Perez","305-431-7493","mperez@palmspringschc.com",{"name":104,"role":59,"phone":105,"phoneExt":36,"email":106},"Vivianne Gonzalez","786-334-6675","vgonzalez@palmspringschc.com",{"facility":108,"status":68,"city":109,"state":70,"zip":110,"country":72,"countryCode":73,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Alzheimer's Research and Treatment Center (Stuart)","Stuart","34996",{"type":75,"coordinates":112},[113,114],-80.25283,27.19755,{"lat":114,"lon":113},[117,121],{"name":118,"role":59,"phone":119,"phoneExt":36,"email":120},"Cristina Healy","772-675-0000","cchirino@researchalz.com",{"name":122,"role":59,"phone":119,"phoneExt":36,"email":123},"Emma LaVopa","elavopa@researchalz.com",{"facility":125,"status":68,"city":126,"state":70,"zip":127,"country":72,"countryCode":73,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"University of South Florida","Tampa","33613",{"type":75,"coordinates":129},[130,131],-82.45843,27.94752,{"lat":131,"lon":130},[134,138],{"name":135,"role":59,"phone":136,"phoneExt":36,"email":137},"Randa Abdulkarim","656-244-6936","randaa@usf.edu",{"name":139,"role":59,"phone":140,"phoneExt":36,"email":141},"Genesis Estremera","813-440-9452","gestremera@usf.edu",{"facility":143,"status":68,"city":144,"state":70,"zip":145,"country":72,"countryCode":73,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Alzheimer's Research and Treatment Center (Wellington)","Wellington","33414",{"type":75,"coordinates":147},[148,149],-80.24144,26.65868,{"lat":149,"lon":148},[152,156],{"name":153,"role":59,"phone":154,"phoneExt":36,"email":155},"Megan Moran","561-209-2400","mmoran@researchalz.com",{"name":157,"role":59,"phone":154,"phoneExt":36,"email":158},"Jasmine Flores","jflores@researchalz.com",{"facility":160,"status":68,"city":161,"state":162,"zip":163,"country":72,"countryCode":73,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Alzheimer's Research and Treatment Center (Columbus)","Columbus","Georgia","31904",{"type":75,"coordinates":165},[166,167],-84.98771,32.46098,{"lat":167,"lon":166},[170,174],{"name":171,"role":59,"phone":172,"phoneExt":36,"email":173},"Dawn Pitman","776-653-8455","dpitman@researchalz.com",{"name":175,"role":59,"phone":176,"phoneExt":36,"email":177},"Kylie Gilbert","706-653-8455","kgilbert@researchalz.com",{"type":179,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[181],{"name":182,"class":183},"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 postmenopausal or surgically sterile female, 65 to 80 years of age, inclusive.\n\nCognitively unimpaired participant with preclinical Alzheimer's disease who meets all of the following:\n\nClinical Dementia Rating global score of 0 at Screening. Mini-Mental State Examination score ≥26, with education adjustment at Screening.\n\nPlasma p-tau217\u002FAβ42 ratio ≥0.00738 measured using Lumipulse (Fujirebio). A prior positive result obtained within 12 months before Screening may be accepted but must be confirmed by the central laboratory.\n\nSight and hearing, including use of a hearing aid, sufficient to comply with study procedures.\n\nStable concomitant medications. Participants receiving fluctuating medication or treatment may be considered if the underlying condition is controlled.\n\nSigned informed consent before any study-related procedure. Ability, in the Investigator's opinion, to understand the study and comply with protocol requirements.\n\nExclusion Criteria:\n\nScreening MRI showing any of the following:\n\nMore than one noncortical lacunar infarct greater than 1.5 cm. Any territorial infarct greater than 1.5 cm. Combined microbleeds and areas of leptomeningeal hemosiderosis greater than 5, or disseminated leptomeningeal hemosiderosis.\n\nAny other significant cerebral abnormality, including ARIA-E. Contraindication to MRI, including non-MRI-safe implanted metallic devices or clinically significant claustrophobia.\n\nSerious illness requiring systemic treatment or hospitalization within 4 weeks before study entry.\n\nClinically relevant cardiovascular, respiratory, gastrointestinal, endocrine, immunologic, hematologic, systemic disease, or major surgery that could interfere with participation or follow-up.\n\nInsulin-dependent diabetes. Clinically relevant cardiac arrhythmia, palpitation, conduction abnormality, prolonged QT interval, or bundle branch block.\n\nPre-existing autoimmune disease. C-SSRS score of 3 or higher. History of seizure disorder, except permitted stable use of certain antiepileptic medications for chronic pain.\n\nAny medical, psychological, or social condition that could interfere with participation, compliance, or participant safety.\n\nParticipation in another investigational drug study or use of an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.\n\nPrior tau or amyloid-beta immunotherapy within 1 year before Screening. Use of specified immunomodulatory or growth-stimulating treatments within 30 days before study entry.\n\nChronic use for more than 3 months of warfarin, other coumarin derivatives, anticoagulants, or an antiplatelet agent such as clopidogrel.\n\nParenteral immunoglobulin preparations, blood products, or plasma derivatives. History of severe local or systemic vaccination reactions or significant allergic reactions.\n\nClinically significant laboratory abnormalities at Screening, including ALT or AST greater than 1.5 times the upper limit of normal.\n\nPositive testing for HIV-1 or HIV-2, hepatitis B surface antigen, or hepatitis C.","ALL","65 Years","80 Years",{"count":196,"type":197},48,"ESTIMATED","INTERVENTIONAL",[200],"PHASE1","This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose-escalation study evaluating the safety, tolerability, and immunogenicity of AV-1980R, an investigational vaccine targeting pathological tau, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65 to 80 years with biomarker evidence of preclinical Alzheimer's disease will be enrolled into three ascending-dose cohorts.",[203,204],"Alzheimer Disease","Preclinical Alzheimer's Disease",[206,207,208,204,209,210,211,212],"Tau protein","Immunotherapy","Vaccine","Alzheimer's Disease","secondary prevention","Neurodegeneration","Preventive Alzheimer's","2026-08-20",{"date":215,"type":216},"2026-08-21","ACTUAL",{"date":218,"type":216},"2026-06-23",{"date":220,"type":197},"2029-10-15",{"name":5,"class":6},6]