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A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Mild-to-Moderate Dementia with Lewy Bodies (DLB)
NIHUS FederalResearch GrantFY2025AD dementiaAdmissionAdmission activityAdverse ExperienceAdverse eventAffectAggressionAggressive behaviorAgitationAlzheimer Type DementiaAlzheimer disease dementiaAlzheimer sclerosisAlzheimer syndromeAlzheimer'sAlzheimer's DiseaseAlzheimers DementiaAmentiaAmericanAnticholinesterase AgentsAnticholinesterase DrugsAnticholinesterasesAttentionBehavioral SymptomsBioavailabilityBiological AvailabilityBrainBrain Nervous SystemCSAID-Binding Protein 1CSAID-Binding Protein 2CSBP2Cessation of lifeCholinesterase InhibitorsClinicalClinical EvaluationClinical ResearchClinical StudyClinical TestingClinical TrialsClinical dementia rating scaleCognitionCognitiveCognitive ManifestationsCognitive SymptomsCollectionCytokine-Suppressive Antiinflammatory Drug-Binding Protein 1Cytokine-Suppressive Antiinflammatory Drug-Binding protein 2DeathDementiaDementia rating scaleDementia with Lewy BodiesDependenceDiagnosisDiseaseDisorderDoseDouble-Blind MethodDouble-Blind StudyDouble-BlindedDouble-Masked MethodDouble-Masked StudyDown SyndromeDrug usageDrugsDysfunctionEEGEffectivenessElectroencephalogramElectroencephalographyEncephalonEnzyme GeneEnzymesEquilibriumEquipment and supply inventoriesEyeEyeballFamilyFamily Care GiverFamily CaregiverFunctional disorderFutureGriefGrief reactionHallucinationsInventoryLaboratoriesLangdon Down syndromeLeannessMAPK14MAPK14 Mitogen-Activated Protein KinaseMAPK14 geneMDS-UPDRSMDS-Unified Parkinson's Disease Rating ScaleMeasuresMedicalMedicationMental DepressionMental disordersMental health disordersMitogen-Activated Protein Kinase 14ModelingMongolismMonitorMotorMovement Disorder Society Unified Parkinson's Disease Rating ScaleMxi2Nerve DegenerationNeurobehavioral ManifestationsNeurobehavioral Signs and SymptomsNeuron DegenerationNeuropsychologic TestsNeuropsychological TestsNursing HomesOralOutcomeOutcome MeasureParalysis AgitansParkinsonParkinson DiseasePathogenicityPatientsPharmaceutical PreparationsPharmacodynamicsPhasePhysiologic AvailabilityPhysiopathologyPlacebo ControlPlacebosPopulationPreclinical dataPrimary ParkinsonismPrimary Senile Degenerative DementiaProcessProgressive DiseasePsychiatric DiseasePsychiatric DisorderPsychomotor AgitationPsychomotor ExcitementPsychomotor HyperactivityPsychomotor RestlessnessQOLQuality of lifeRandomizedResearchRestRestlessnessRiskSAPK2ASafetySham TreatmentSleepStress-Activated Protein Kinase 2ASumSystemTestingThinnessTimeTransgenic MiceTrisomy 21UPDRSUnified Parkinson's Disease Rating ScaleVisualalleviate symptomameliorating symptombalancebalance functionbasal forebrainbasal forebrain cholinergic neuronsburden on familiesburden to familiescholinergicchromosome 21 trisomychromosome 21 trisomy syndromeclinical developmentclinical efficacyclinical relevanceclinical testclinically relevantcognitive assessmentcognitive testingcongenital acromicria syndromecooperative studydecrease symptomdepressiondesigndesigningdetermine efficacydrug usedrug/agentefficacy analysisefficacy assessmentefficacy determinationefficacy evaluationefficacy examinationevaluate efficacyexamine efficacyexecutive controlexecutive functionfall riskfamilial burdenfamily burdenfewer symptomsimpressionimprovedinhibitorinhibitor druginhibitor therapeuticinhibitor therapyinvestigator-initiated trialkinase inhibitormeasurable outcomemental illnessmorbus Downmotor symptomneural degenerationneurobehavioral symptomneurodegenerationneurodegenerativeneurodegenerative dementianeurological degenerationneuronal degenerationneuropsychiatricneuropsychiatrynursing homeoff-label applicationoff-label prescribingoff-label useoutcome measurementp38p38 MAP Kinasep38 MAPK Genep38 Mitogen Activated Protein Kinasep38 Protein Kinasep38 SAPKp38-Alphap38Alphapathophysiologypatient populationphase 2 studyphase 3 trialphase II studyphase III trialplacebo controlledpre-clinical studypreclinical findingspreclinical informationpreclinical studyprimary degenerative dementiaprimary end pointprimary endpointprimary outcomeprospectivepseudohypertrophic progressive muscular dystrophypsychiatric illnesspsychological disorderrandomisationrandomizationrandomly assignedreduce symptomsrelieves symptomsresearch clinical testingsecondary end pointsecondary endpointsenile dementia of the Alzheimer typesham therapysymptom alleviationsymptom reductionsymptom relieftherapeutic targettreatment effecttrisomy 21 syndromevisual learning
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Description preview
Dementia with Lewy bodies (DLB) is the second most common cause of neurodegenerative dementia after
Alzheimer’s disease (AD). DLB is a more rapidly progressive disease than AD, with a median time from diagnosis
to death or nursing home admission that is half that seen in AD and is associated with extensive burden on both
patients and family…
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