[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656624":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":73,"studyPopulation":66,"armGroups":74,"interventions":87,"overallOfficials":96,"centralContacts":100,"locations":66,"responsibleParty":106,"collaborators":108,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":66,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":139,"whyStopped":66,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":66},{"fullName":5,"class":6},"Institute for Molecular Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":39},[9,13,17,20,24],{"measure":10,"description":11,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events (TEAEs)","Number and percentage of participants with treatment-emergent adverse events.","From first study intervention through Week 78",{"measure":14,"description":15,"timeFrame":16},"Incidence of ARIA-E and ARIA-H","Number and percentage of participants with MRI-detected amyloid-related imaging abnormalities, including ARIA-E and ARIA-H.","Through Week 78",{"measure":18,"description":19,"timeFrame":16},"Clinically Significant Changes in Safety Assessments","Number and percentage of participants with clinically significant changes in vital signs, ECG, laboratory assessments, physical examinations, or neurological examinations.",{"measure":21,"description":22,"timeFrame":23},"Change From Baseline in Columbia-Suicide Severity Rating Scale Suicidal Ideation Severity Score","Change from baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation severity score, comparing AV-1959R and placebo groups. The score ranges from 0 to 5, with higher scores indicating greater severity of suicidal ideation.","Baseline and Weeks 4, 44, and 78",{"measure":25,"description":26,"timeFrame":27},"Serum Anti-Amyloid-Beta Antibody Levels","Serum anti-amyloid-beta antibody levels following vaccination, comparing AV-1959R and placebo groups.","Baseline through Week 78",[29,32,36],{"measure":30,"description":31,"timeFrame":27},"T-cell responses to MultiTEP and amyloid-beta","Assessment of MultiTEP-specific T-cell responses and autoreactive anti-amyloid-beta T-cell responses, comparing AV-1959R and placebo groups.",{"measure":33,"description":34,"timeFrame":35},"Change From Baseline in Global Brain Amyloid Burden","Change from baseline in global brain amyloid burden measured by amyloid PET using the Centiloid scale, comparing the AV-1959R and placebo groups.","Baseline to Week 78",{"measure":37,"description":38,"timeFrame":27},"Change From Baseline in Plasma p-tau217\u002FAβ1-42 Ratio","Change from baseline in plasma Lumipulse p-tau217\u002FAβ1-42 ratio, comparing the AV-1959R and placebo groups.",[40,43,46,49,52,55,58],{"measure":41,"description":42,"timeFrame":35},"Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score","Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score, comparing AV-1959R and placebo groups. The total score ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment.",{"measure":44,"description":45,"timeFrame":27},"Change From Baseline in Plasma Amyloid Biomarkers","Change from baseline in plasma Aβ42, Aβ40, and Aβ42\u002FAβ40 ratio, comparing the AV-1959R and placebo groups.",{"measure":47,"description":48,"timeFrame":27},"Change From Baseline in Plasma Tau Biomarker Concentrations","Change from baseline in plasma concentrations of BD-tau, MTBR-tau243, total tau, p-tau181, p-tau231, and p-tau217.",{"measure":50,"description":51,"timeFrame":27},"Change From Baseline in Plasma Neurofilament Light Chain Concentration","Change from baseline in plasma neurofilament light chain (NfL) concentration.",{"measure":53,"description":54,"timeFrame":27},"Change From Baseline in Plasma Glial Fibrillary Acidic Protein Concentration","Change from baseline in plasma glial fibrillary acidic protein (GFAP) concentration.",{"measure":56,"description":57,"timeFrame":35},"Change From Baseline in Brain Tau Burden","Change from baseline in pathological tau accumulation measured by quantitative tau PET imaging, comparing the AV-1959R and placebo groups.",{"measure":59,"description":60,"timeFrame":27},"Changes in T-Cell and B-Cell Receptor Repertoires and Lineages","Exploratory analysis of changes in T-cell receptor and B-cell receptor repertoires and T-cell and B-cell lineages in response to vaccination.",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":66,"timePerspective":66,"maskingInfo":67},"RANDOMIZED","PARALLEL","Participants will be randomized 1:1 to AV-1959R or placebo","PREVENTION",null,{"masking":68,"maskingDescription":69,"whoMasked":70},"DOUBLE","Participants and investigators will remain blinded to treatment assignment.",[71,72],"PARTICIPANT","INVESTIGATOR","This Phase 2 study is designed to further evaluate AV-1959R in cognitively unimpaired individuals with preclinical Alzheimer's disease, with emphasis on safety, tolerability, immunogenicity, and surrogate efficacy based on changes in Alzheimer's disease-related biomarkers and amyloid pathology",[75,81],{"label":76,"type":77,"description":78,"interventionNames":79},"AV-1959R","EXPERIMENTAL","Participants will receive AV-1959R 100 micrograms with adjuvant by intramuscular injection at Weeks 0, 4, and 44.",[80],"Biological: AV-1959R",{"label":82,"type":83,"description":84,"interventionNames":85},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo with adjuvant by intramuscular injection at Weeks 0, 4, and 44.",[86],"Drug: Placebo",[88,92],{"type":89,"name":76,"description":90,"armGroupLabels":91,"otherNames":66},"BIOLOGICAL","Investigational amyloid-beta vaccine, AV-1959R, 100 micrograms, administered intramuscularly with adjuvant at Weeks 0, 4, and 44.",[76],{"type":93,"name":82,"description":94,"armGroupLabels":95,"otherNames":66},"DRUG","Placebo administered by intramuscular injection with adjuvant at Weeks 0, 4, and 44.",[82],[97],{"name":98,"affiliation":5,"role":99},"Michael Agadjanyan","PRINCIPAL_INVESTIGATOR",[101],{"name":102,"role":103,"phone":104,"phoneExt":66,"email":105},"Roman Kniazev","CONTACT","7145963981","rkniazev@immed.org",{"type":107,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR",[109],{"name":110,"class":111},"Nuravax, Inc.","INDUSTRY","100656624","phase-2-phase-2-study-of-av-1959r-in-individuals-with-preclinical-alzheimers-disease-100656624",false,"NCT07827768","AV-1959R Vaccine in Individuals With Preclinical Alzheimer's Disease","A Phase II, Randomized, Double-Blind Study to Evaluate Safety, Tolerability, Immunogenicity, and Amyloid-Lowering Effect of Amyloid-β Vaccine, AV-1959R, in Individuals With Preclinical Alzheimer's Disease.","SAGITTARIUS","Inclusion Criteria:\n\nMale or female participants 55 to 80 years of age, inclusive, at screening. Signed informed consent before initiation of study-related procedures.\n\nCognitively unimpaired participants with preclinical Alzheimer's disease meeting all of the following:\n\nCDR global score = 0 at screening. MMSE score ≥26 at screening, with education adjustment. Plasma p-tau217\u002FAβ1-42 ratio ≥0.00738. Vision and hearing sufficient to comply with study procedures, in the investigator's judgment.\n\nStable concomitant medications for management of existing medical conditions, as appropriate.\n\nWomen must be of non-childbearing potential as defined in the protocol. Men must meet protocol-defined contraception and sperm donation requirements. Ability, in the investigator's opinion, to understand the study and comply with study requirements.\n\nExclusion Criteria:\n\nScreening MRI showing clinically significant abnormalities, including protocol-defined infarcts, excessive microbleeds, leptomeningeal hemosiderosis, superficial siderosis, or ARIA-E.\n\nContraindication to MRI. Serious illness requiring systemic treatment and\u002For hospitalization within 4 weeks before study entry.\n\nClinically relevant cardiovascular, respiratory, gastrointestinal, endocrine, immunologic, hematologic, neurologic, or other systemic disease that could interfere with participation or follow-up.\n\nInsulin-dependent diabetes. Clinically significant ECG abnormalities, including protocol-defined conduction abnormalities or QTc abnormalities.\n\nPre-existing autoimmune disease. History of seizure disorder, except protocol-permitted use of certain antiepileptic medications for chronic pain.\n\nAny medical, psychological, or social condition that may interfere with participation, compliance, or 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 amyloid-beta or tau immunotherapy, including vaccine or monoclonal antibody, within 1 year before screening.\n\nRecent use of protocol-defined immunomodulatory or growth-stimulating agents. Chronic use of protocol-defined anticoagulants or antiplatelet agents; aspirin is permitted.\n\nParenteral use of immunoglobulin preparations, blood products, or plasma derivatives.\n\nHistory of severe local or systemic vaccine reactions or significant allergic reactions.\n\nClinically significant laboratory abnormalities at screening. Positive testing for HIV-1\u002F2, hepatitis B surface antigen, or hepatitis C virus.","ALL","55 Years","80 Years",{"count":124,"type":125},160,"ESTIMATED","INTERVENTIONAL",[128],"PHASE2","This Phase 2 study will evaluate the safety, tolerability, immunogenicity, and amyloid-lowering effect of AV-1959R in cognitively unimpaired adults with preclinical Alzheimer's disease. Approximately 160 participants will be randomized to receive AV-1959R or placebo and will be followed for 78 weeks. The study will assess safety, immune responses, brain amyloid, and Alzheimer's disease-related biomarkers.",[131,132],"Preclinical Alzheimer's Disease","Alzheimer Disease",[76,134,135,136,137,138],"Amyloid-beta","Alzheimer's Vaccine","Secondary Prevention of Alzheimer's Disease","Alzheimer's Disease Prevention","Active Immunotherapy for Alzheimer's Disease","NOT_YET_RECRUITING","2026-09-21",{"date":142,"type":143},"2026-09-24","ACTUAL",{"date":145,"type":125},"2027-03-01",{"date":147,"type":125},"2029-06-15",{"name":5,"class":6}]