grant

FDA approved IND 29644: Multicenter Phase 1 Trial to Evaluate Safety and Immunogenicity of Preventive Tau Vaccine, AV-1980R/A, in cognitively unimpaired preclinical AD participants.

Organization INSTITUTE FOR MOLECULAR MEDICINELocation HUNTINGTON BEACH, UNITED STATESPosted 1 Aug 2025Deadline 31 Jul 2030
NIHUS FederalResearch GrantFY2025A β-42A β42A-beta 42A-beta42AD dementiaAb responseAbeta-42Abeta42Active Follow-upActive ImmunotherapyAdjuvantAlzheimer Type DementiaAlzheimer beta-ProteinAlzheimer disease dementiaAlzheimer risk factorAlzheimer sclerosisAlzheimer syndromeAlzheimer'sAlzheimer's Amyloid beta-ProteinAlzheimer's DiseaseAlzheimer's amyloidAlzheimer's disease patientAlzheimer's disease riskAlzheimer's disease therapyAlzheimer's patientAlzheimer's therapyAlzheimers DementiaAmentiaAmyloidAmyloid Alzheimer's Dementia Amyloid ProteinAmyloid Beta-PeptideAmyloid Protein A4Amyloid SubstanceAmyloid beta-42Amyloid beta-ProteinAmyloid beta42Amyloid βAmyloid β oligomerAmyloid β-42Amyloid β-PeptideAmyloid β-ProteinAmyloid β42Amyloidβ-42Amyloidβ42AntibodiesAntibody FormationAntibody ProductionAntigenic DeterminantsAstroproteinAβ-42Aβ42AβOBinding DeterminantsBiologicalBiological MarkersBlood PlasmaBrainBrain Nervous SystemCell BodyCellsClass II GenesClinicalClinical Treatment MoabClinical TrialsCognitiveCognitive DisturbanceCognitive ImpairmentCognitive declineCognitive function abnormalCollaborationsCollecting CellComplexDementiaDevelopmentDiagnosisDiseaseDisease ProgressionDisorderDisturbance in cognitionDoseDouble-Blind MethodDouble-Blind StudyDouble-BlindedDouble-Masked MethodDouble-Masked StudyECGEKGELISAELISPOTElderlyElectrocardiogramElectrocardiographyEncephalonEngineeringEnvironmental FactorEnvironmental Risk FactorEnzyme-Linked Immunosorbent AssayEpitopesEvaluationFDA approvedFlow CytofluorometriesFlow CytofluorometryFlow CytometryFlow MicrofluorimetryFlow MicrofluorometryFrequenciesFutureGFA-ProteinGFAPGenetic PolymorphismGenetic predisposing factorGlial Fibrillary Acid ProteinGlial Fibrillary Acidic ProteinGlial Intermediate Filament ProteinGroups at riskGuidelinesHLA Class II GenesHumanImageImmune mediated therapyImmune responseImmunizationImmunologically Directed TherapyImmunotherapeutic agentImmunotherapyImpaired cognitionIndividualInflammationIntramuscular InjectionsLaboratoriesLightMHC Class IIMHC Class II GenesMR ImagingMR TomographyMRIMRIsMT-bound tauMagnetic Resonance ImagingMeasuresMedical Imaging, Magnetic Resonance / Nuclear Magnetic ResonanceMemoryMemory DeficitMemory impairmentModern ManModernizationMonitorMonoclonal AntibodiesNIAAANMR ImagingNMR TomographyNational Institute on Alcohol Abuse and AlcoholismNerve DegenerationNeurofibrillary TanglesNeuron DegenerationNuclear Magnetic Resonance ImagingOlder PopulationOutcomeOxidative StressPBMCPETPET ScanPET imagingPET positivityPETSCANPETTParticipantPassive ImmunotherapyPathologicPathologic ProcessesPathological ProcessesPathologyPeople at riskPeripheral Blood Mononuclear CellPersonsPersons at riskPhasePhase 2/3 trialPhase II/III TrialPhosphatasesPhosphohydrolasesPhosphomonoesterasesPhosphoric Monoester HydrolasesPhotoradiationPlacebo ControlPlacebosPlasmaPlasma SerumPopulations at RiskPositionPositioning AttributePositron Emission Tomography Medical ImagingPositron Emission Tomography ScanPositron-Emission TomographyPreventative ImmunizationPreventative vaccinationPreventative vaccinePreventionPreventivePreventive ImmunizationPreventive vaccinationPreventive vaccinePrimary Senile Degenerative DementiaProbabilityProphylactic immunizationProphylactic vaccinationProphylactic vaccineRad.-PETRandomizedResearchReticuloendothelial System, Serum, PlasmaSafetySelf ToleranceSeverity of illnessSham TreatmentSymptomsSynapsesSynapticTarget PopulationsTauopathiesTestingTracerVaccinationVaccine ResearchVaccinesZeugmatographya beta peptideabetaabeta accumulationabeta aggregationabeta oligomerabnormally aggregated tau proteinactive followupadvanced ageagedalzheimer riskamyloid betaamyloid beta accumulationamyloid beta aggregationamyloid beta oligomeramyloid β accumulationamyloid β aggregationamyloid-b proteinantibody biosynthesisarmautoimmune reactivityautoreactivityaβ accumulationaβ aggregationaβ oligomerbeta amyloid associated pathologybeta amyloid fibrilbeta amyloid pathologybio-markersbiologicbiologic markerbiomarkerclinical research siteclinical siteclinical trial readinesscognitive abilitycognitive benefitscognitive dysfunctioncognitive losscohortcooperative studycostdesigndesigningdevelop therapydevelopmentaldisease preventiondisease severitydisorder preventionefficacy trialenvironmental riskenzyme linked immunoassayenzyme linked immunospot assayevaluate vaccinesfilamentous tau inclusionfirst in manfirst-in-humanflow cytophotometryfollow upfollow-upfollowed upfollowupfunctional outcomesgenetic risk factorgeriatrichost responseimagingimaging biomarkerimaging markerimaging-based biological markerimaging-based biomarkerimaging-based markerimmune drugsimmune senescenceimmune system responseimmune therapeutic approachimmune therapeutic interventionsimmune therapeutic regimensimmune therapeutic strategyimmune therapyimmune-based therapeuticsimmune-based therapiesimmune-based treatmentsimmunization strategyimmuno therapyimmunogenicimmunogenicityimmunoglobulin biosynthesisimmunologic therapeuticsimmunoresponseimmunosenescenceimmunotherapeuticsimmunotherapy agentimprovedinherited factorinnovateinnovationinnovativeinsightintervention developmentintramuscular drug administrationmAbsmemory dysfunctionmicrotubule associated protein tau aggregationmicrotubule associated protein tau depositmicrotubule bound taumicrotubule-bound taumonoclonal Absmultidisciplinarynerve cell deathnerve cell lossneural degenerationneurodegenerationneurodegenerativeneurofibrillary degenerationneurofibrillary lesionneurofibrillary pathologyneurofilamentneurological degenerationneuron cell deathneuron cell lossneuron deathneuron lossneuronal cell deathneuronal cell lossneuronal deathneuronal degenerationneuronal lossneuropathologic tauneuropathological taunoveloAβolder groupsolder individualsolder personoligomeric amyloid betaoligomeric amyloid-βp-taup-τpaired helical filament of taupassive antibodiespassive immune therapypassive immunotherapeuticspatient living with Alzheimer's diseasepatient suffering from Alzheimer's diseasepatient with Alzheimer'spatient with Alzheimer's diseasephase 1 trialphase I trialphospho-tauphospho-τphosphorylated tauplacebo controlledpolymorphismpositron emission tomographic (PET) imagingpositron emission tomographic imagingpositron emission tomography positivitypositron emitting tomographypost-translational modification of tauposttranslational modification of taupre-clinicalpreclinicalpreventpreventingprimary degenerative dementiaprimary outcomeprophylacticrandomisationrandomizationrandomly assignedresponsesecondary outcomeself-aggregate tausenile dementia of the Alzheimer typesenior citizensham therapysoluble amyloid precursor proteinsynapsetangletautau PHFtau Proteinstau accumulationtau aggregatetau aggregationtau associated neurodegenerationtau associated neurodegenerative processtau driven neurodegenerationtau factortau fibrillizationtau filamenttau induced degenerationtau induced neurodegenerationtau mediated neurodegenerationtau neurodegenerative diseasetau neurofibrillary tangletau neuropathologytau oligomertau paired helical filamenttau pathologytau pathophysiologytau phosphorylationtau polymerizationtau posttranslational modificationtau proteinopathytau related neurodegenerationtau-1tau-induced pathologytau-tau interactiontauopathic neurodegenerative disordertauopathytechnology platformtechnology systemtherapy developmenttreatment developmentvaccination strategyvaccine evaluationvaccine platformvaccine screeningvaccine strategyvaccine testingvaccine-related researchvolunteerβ-amyloid pathologyτ Proteinsτ aggregationτ phosphorylation
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Project Summary
Alzheimer's disease (AD) is the most common type of dementia characterized by memory impairment and

alteration of diverse cognitive abilities. It is a complex and multifactorial disease involving various genetic and

environmental risk factors that lead to the development of two hallmark pathologies: β-amyloid (Aβ)…

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