grant

IND enabling CMC/safety/toxicology studies, submission of IND and pilot Phase 1 clinical trial with PV-1950R vaccine for Lewy Body Dementia (LBD)

Organization INSTITUTE FOR MOLECULAR MEDICINELocation HUNTINGTON BEACH, UNITED STATESPosted 5 Jun 2024Deadline 31 May 2029
NIHUS FederalResearch GrantFY2025AD dementiaAD related dementiaADRDAcuteAdjuvantAffectAgeAge of OnsetAlzheimer Type DementiaAlzheimer beta-ProteinAlzheimer disease dementiaAlzheimer sclerosisAlzheimer syndromeAlzheimer'sAlzheimer's Amyloid beta-ProteinAlzheimer's DiseaseAlzheimer's amyloidAlzheimer's and related dementiasAlzheimer's dementia and related dementiaAlzheimer's dementia or related dementiaAlzheimer's disease and related dementiaAlzheimer's disease and related disordersAlzheimer's disease or a related dementiaAlzheimer's disease or a related disorderAlzheimer's disease or related dementiaAlzheimer's disease related dementiaAlzheimers DementiaAmentiaAmericanAmyloidAmyloid Alzheimer's Dementia Amyloid ProteinAmyloid Beta-PeptideAmyloid Protein A4Amyloid SubstanceAmyloid beta-ProteinAmyloid βAmyloid β-PeptideAmyloid β-ProteinAnimalsAntibodiesAntibody titer measurementAntigenic DeterminantsAssayB-Cell EpitopesB-Lymphocyte EpitopesBehavior DisordersBinding DeterminantsBioassayBiological AssayBrainBrain InflammationBrain Nervous SystemBrain StemBrainstemBurden on their caregiversCaregiver BurdenCell BodyCellsChronicClinicalClinical TrialsCognitiveComplexCountryCyclic GMPDataDegenerative Neurologic DisordersDementiaDementia with Lewy BodiesDermatologic biopsyDevelopmentDiagnosisDiseaseDisorderDomestic RabbitDoseDouble-Blind MethodDouble-Blind StudyDouble-BlindedDouble-Masked MethodDouble-Masked StudyDrugsDyskinesia SyndromesELISPOTEarly-Stage Clinical TrialsEncephalitisEncephalonEndopeptidase KEngineeringEpitopesFDA approvedFamilyFutureGoalsGuanosine Cyclic MonophosphateHelper CellsHelper T-CellsHelper T-LymphocytesHelper-Inducer T-CellsHelper-Inducer T-LymphocyteHumanImmune mediated therapyImmunologically Directed TherapyImmunotherapyIndividualInducer CellsInducer T-LymphocytesInvestigational DrugsInvestigational New DrugsLB dementiaLewy BodiesLewy Body DementiaLewy Body Type Senile DementiaLewy dementiaLewy neuritesLewy-related neuritesMT-bound tauMeasuresMedicationMetabolicMiceMice MammalsModern ManMonkeysMovement Disorder SyndromesMovement DisordersMurineMusNAC precursorNeocortexNerve CellsNerve DegenerationNerve UnitNervous System Degenerative DiseasesNeural CellNeural Degenerative DiseasesNeural degenerative DisordersNeurocyteNeurodegenerative DiseasesNeurodegenerative DisordersNeurologic Degenerative ConditionsNeuron DegenerationNeuronsOnset of illnessOryctolagus cuniculusPARK1 proteinPARK4 proteinPD with dementiaParkinson Disease dementiaParkinson's DementiaParkinson's disease with dementiaParticipantPathologicPathologyPatientsPeripheralPersonsPharmaceutical PreparationsPhasePhase 1 Clinical TrialsPhase 1a TrialPhase I Clinical TrialsPhase Ia TrialPhosphorylationPlacebo ControlPlasmidsPreparationPreventative vaccinePreventive vaccinePrimary PreventionPrimary Senile Degenerative DementiaProcessProphylactic vaccineProtease KProtein PhosphorylationProteinase KProteinsREM Behavior DisorderREM Sleep Behavior DisorderRabbitsRabbits MammalsRandomizedRapid Eye Movement Behavior DisorderRapid Eye Movement Sleep Behavior DisorderRecombinant ProteinsRenal functionResearchResistanceRiskRunningSNCASNCA proteinSafetyScientistSiteStructureSynapsesSynapticTechnologyTestingTherapeuticThyroid Function TestsThyroid Gland Function TestsToxic effectToxicitiesToxicologyTritirachium Alkaline ProteinaseUnited StatesVaccinationVaccinesVialVial devicea beta peptidea-syna-synucleinabetaagesalpha synucleinalpha synuclein genealphaSP22amyloid betaamyloid-b proteinantibody titeringasynbehavioral disorderbeta amyloid fibrilburden in caregiversburden of their caregiversburden on caregiverscGMPcell bankcostcutaneous biopsydegenerative diseases of motor and sensory neuronsdegenerative neurological diseasesdementia in PDdementia in Parkinson diseasedevelopmentaldisability burdendisease onsetdisorder onsetdrug/agentenzyme linked immunospot assayextracellularfirst in manfirst-in-humanfunctional disabilityhealthy volunteerhigh riskhomotypical cortexhuman studyimmune therapeutic approachimmune therapeutic interventionsimmune therapeutic regimensimmune therapeutic strategyimmune therapyimmune-based therapiesimmune-based treatmentsimmuno therapyimmunogenicimmunogenicityinnovateinnovationinnovativeinterestisocortexkidney functionliver functionmanufacturemicrotubule bound taumicrotubule-bound taumouse modelmurine modelneopalliumneural cell bodyneural degenerationneurodegenerationneurodegenerativeneurodegenerative illnessneurological degenerationneuronalneuronal cell bodyneuronal degenerationnon A-beta component of AD amyloidnon A4 component of amyloid precursornon-human primatenonhuman primatephase 1 trialphase 2 studyphase I protocolphase I trialphase II studyplacebo controlledpre-clinicalpreclinicalpreparationspresynapticpreventpreventingprimary degenerative dementiapublic health relevancerandomisationrandomizationrandomly assignedresistantresponsesafety studysafety testingsenile dementia of the Alzheimer typeskin biopsysoluble amyloid precursor proteinsomasynapsetautau Proteinstau factortechnology platformtechnology systemthyroid functionvaccination studyvaccination trialvaccine formulationvaccine studyvaccine trialvolunteerα synuclein geneα-synα-synucleinτ Proteins
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Project Summary
Lewy Body Dementia (LBD) affects 1.4 million people in the United States and is the second most prevalent type

of dementia in the country. LBD includes individuals who initially present with a cognitive-behavioral disorder

(dementia with Lewy bodies) and those who initially present with a movement disorder (Parkinson's disease…

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IND enabling CMC/safety/toxicology studies, submission of IND and pilot Phase 1 clinical trial with PV-1950R vaccine for | Dev Procure