Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT07158905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D009410', 'term': 'Nerve Degeneration'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants are randomized 3:1 within each cohort to AV-1980R or placebo. Arms reflect three dose levels (20, 60, 180 µg) and a pooled placebo; dosing at Weeks 0, 4, 12, and 36 with follow-up to Week 56.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized in a 3:1 ratio to receive AV-1980R or placebo across three ascending dose cohorts. Each participant gets one assigned intervention in parallel with others.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline in Plasma Biomarker Concentrations (pg/mL)', 'timeFrame': 'Baseline through Week 56', 'description': 'Change in plasma concentrations of Aβ42, Aβ40, pTau217, pTau181, pTau231, total tau (t-tau), neurofilament light (NfL), and glial fibrillary acidic protein (GFAP), reported in pg/mL.'}, {'measure': 'Change from Baseline in Immunoglobulin Isotypes and Subclasses (mg/dL)', 'timeFrame': 'Baseline through Week 56', 'description': 'Change in serum concentrations of IgM, total IgG, and IgG subclasses (IgG1, IgG2, IgG3, IgG4), reported in mg/dL'}, {'measure': 'Phenotyping of Activated T Cells', 'timeFrame': 'Baseline through Week 56', 'description': 'Characterization of activated T cell subsets by flow cytometry.'}, {'measure': 'T Cell Proliferative Response', 'timeFrame': 'Baseline through Week 56', 'description': 'Assessment of proliferative capacity of T cells following antigen stimulation.'}, {'measure': 'Polarization of Cellular Responses', 'timeFrame': 'Baseline through Week 56', 'description': 'Cytokine production by activated T cells to evaluate polarization of Th1/Th2/Th17 responses.'}, {'measure': 'Change from Baseline in Plasma Biomarker Ratios', 'timeFrame': 'Time Frame: Baseline through Week 56', 'description': 'Change in plasma biomarker ratios including Aβ42/40 ratio and Aβ42/tau ratios (unitless)'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline through Week 56', 'description': 'Frequency, severity, and relationship of TEAEs and SAEs; safety assessments include labs, vitals, ECGs, MRI, and neurological exams.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Clinically Significant Changes in Vital Signs', 'timeFrame': 'Baseline through Week 56', 'description': 'Number of participants with clinically significant abnormalities or changes in blood pressure, heart rate, respiratory rate, or body temperature.'}, {'measure': 'Number of Participants with Clinically Significant Changes in ECG Results', 'timeFrame': 'Baseline through Week 56', 'description': 'Number of participants with new or worsening clinically significant ECG abnormalities.'}, {'measure': 'Number of Participants with Clinically Significant Changes in Laboratory Tests', 'timeFrame': 'Baseline through Week 56', 'description': 'Number of participants with new or worsening abnormalities in hematology, serum chemistry, coagulation, or urinalysis results.'}, {'measure': 'Number of Participants with Clinically Significant Changes in Physical Examinations', 'timeFrame': 'Baseline through Week 56', 'description': 'Number of participants with new or worsening abnormal findings on physical examination.'}, {'measure': 'Number of Participants with Clinically Significant Changes in Neurological Examinations', 'timeFrame': 'Baseline through Week 56', 'description': 'Number of participants with new or worsening abnormal neurological findings.'}, {'measure': 'Incidence of Amyloid-Related Imaging Abnormalities (ARIA-E and ARIA-H)', 'timeFrame': 'Baseline through Week 56', 'description': 'Number of participants with vasogenic edema (ARIA-E), effusions, ischemic events, hemorrhagic events, or associated clinical symptoms detected on MRI.'}, {'measure': 'Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, Weeks 12, 36, 40, and 56', 'description': 'Change from baseline in suicidality assessment using the Columbia-Suicide Severity Rating Scale (C-SSRS; range: 0-25, with higher scores indicating greater severity of suicidal ideation and behavior).'}, {'measure': 'Change from Baseline in Serum Anti-Tau Antibody Concentrations', 'timeFrame': 'Baseline through Week 56', 'description': 'Quantification of anti-tau antibody titers induced by AV-1980R vaccination.'}, {'measure': 'Detection of T Helper (Th) Cell Responses Specific to MultiTEP Platform', 'timeFrame': 'Baseline through Week 56', 'description': 'Presence of antigen-specific Th cell responses against the MultiTEP vaccine platform.'}, {'measure': 'Detection of Autoreactive Th-Cell Responses Specific to Tau', 'timeFrame': 'Baseline through Week 56', 'description': 'Presence of autoreactive Th cell responses directed against tau epitopes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tau protein', 'Immunotherapy', 'Vaccine', "Preclinical Alzheimer's Disease", "Alzheimer's Disease", 'secondary prevention', 'Neurodegeneration', "Preventive Alzheimer's"], 'conditions': ['Alzheimer Disease', "Preclinical Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "This first-in-human study investigates AV-1980R, a MultiTEP-based active immunotherapy formulated with the adjuvant, as a secondary prevention approach for Alzheimer's disease. The study will randomize up to 48 participants aged 65-80 years in a 3:1 ratio to AV-1980R or placebo across three ascending dose cohorts (20 μg, 60 μg, 180 μg). Participants will receive four intramuscular doses at Weeks 0, 4, 12, and 36, with follow-up through Week 56.\n\nPrimary objectives are to evaluate safety and tolerability, monitored by adverse events, labs, ECGs, MRI, and neurological assessments. Secondary objectives include immunogenicity measured by anti-tau antibody titers. Exploratory endpoints include plasma biomarker and tau-PET changes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nMale or post-menopausal/surgically 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/hearing 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."}, 'identificationModule': {'nctId': 'NCT07158905', 'acronym': 'TAURUS-1980', 'briefTitle': "AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)", 'organization': {'class': 'OTHER', 'fullName': 'Institute for Molecular Medicine'}, 'officialTitle': "A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'IMM-AV1980R-102'}, 'secondaryIdInfos': [{'id': '1R01AG092949-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG092949-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AV-1980R 20 µg Arm', 'description': 'Participants receive 20 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.', 'interventionNames': ['Biological: AV-1980R 20 µg']}, {'type': 'EXPERIMENTAL', 'label': 'AV-1980R 60 µg Arm', 'description': 'Participants receive 60 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.', 'interventionNames': ['Biological: AV-1980R 60 µg']}, {'type': 'EXPERIMENTAL', 'label': 'AV-1980R 180 µg Arm', 'description': 'Participants receive 180 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.', 'interventionNames': ['Biological: AV-1980R 180 µg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Participants receive placebo injections (10 mM phosphate buffer with the adjuvant, no antigen) at Weeks 0, 4, 12, and 36.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'AV-1980R 20 µg', 'type': 'BIOLOGICAL', 'description': "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.", 'armGroupLabels': ['AV-1980R 20 µg Arm']}, {'name': 'AV-1980R 60 µg', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['AV-1980R 60 µg Arm']}, {'name': 'AV-1980R 180 µg', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['AV-1980R 180 µg Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '10 mM phosphate buffer formulated with the adjuvant; intramuscular injections at Weeks 0, 4, 12, and 36; no active antigen.', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33433', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Magdalena Dr. Tolea, PhD, MS, MA', 'role': 'CONTACT'}], 'facility': 'Comprehensive Center for Brain Health', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}], 'centralContacts': [{'name': 'Roman Kniazev', 'role': 'CONTACT', 'email': 'rkniazev@immed.org', 'phone': '7145963981'}, {'name': 'Anahit Ghochikyan', 'role': 'CONTACT', 'email': 'aghochikyan@immed.org', 'phone': '7145963981'}], 'overallOfficials': [{'name': 'Michael Agadjanyan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute MM'}, {'name': 'Roman Kniazev', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute MM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Molecular Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}