2025
Safety, pharmacokinetics, and efficacy of HY-072808 ointment, a novel PDE4 inhibitor, in adolescent and adult patients with mild-to-moderate AD
Yao F, He M, Wang J, Li Y, Zhang Q, Yang J, Wu J, Zhang Q, Zhou R, Zhang M, Meng L, Wu L, Chu Z, Hu W. Safety, pharmacokinetics, and efficacy of HY-072808 ointment, a novel PDE4 inhibitor, in adolescent and adult patients with mild-to-moderate AD. Expert Opinion On Investigational Drugs 2025, 34: 435-447. PMID: 40411316, DOI: 10.1080/13543784.2025.2510671.Peer-Reviewed Original ResearchConceptsMild to moderate ADAnti-atopic dermatitisAdult patientsHealthy subjectsPDE4 inhibitorsPhase I clinical trialWell-tolerated treatmentOpen-label trialDouble-blindPlacebo-ControlledSafety profileAdverse eventsEASI scoreClinical developmentPharmacokinetic analysisAtopic dermatitisHealthy individualsPatientsPharmacokineticsDrug concentrationsEczema severityQuality of lifeEfficacyTrialsOintmentPrognostic value of plasma biomarkers for informing clinical trial design in mild-to-moderate Alzheimer’s disease
Qiu Y, Jacobs D, Messer K, Salmon D, Wellington C, Stukas S, Revta C, Brewer J, Léger G, Askew B, Donahue L, Kaplita S, Coric V, Qureshi I, Feldman H. Prognostic value of plasma biomarkers for informing clinical trial design in mild-to-moderate Alzheimer’s disease. Alzheimer's Research & Therapy 2025, 17: 97. PMID: 40317057, PMCID: PMC12046789, DOI: 10.1186/s13195-025-01745-3.Peer-Reviewed Original ResearchConceptsMild to moderate ADADAS-cog11CDR-SBBaseline plasma NfLAlzheimer's diseasePlasma biomarkersMild-to-moderate Alzheimer's diseasePrognostic valueClinical trialsBaseline NfLPlasma NfLPlacebo-controlled trialCortical volumeConcentrations of plasma biomarkersMethodsPost hoc analysisDesign of clinical trialsClinical outcome dataIncreased ventricular volumeTrial participantsVolumetric MRIBaseline concentrationsEarly disease stagesClinical trial designTrial entry criteriaAD trialsTime saved in activities of daily living and whole‐brain volume: Post hoc analysis of a randomized feasibility trial of gamma oscillation treatment in participants with mild or moderate Alzheimer's disease
Kern R, Haaland B, Nicodemus‐Johnson J, Dickson S, Morgan M, Christensen J, Sabbagh M, Lee L, Hajós M, Riddle J, Seshagiri C, Howell C, Mallinckrodt C, Hendrix S. Time saved in activities of daily living and whole‐brain volume: Post hoc analysis of a randomized feasibility trial of gamma oscillation treatment in participants with mild or moderate Alzheimer's disease. Alzheimer's & Dementia: Translational Research & Clinical Interventions 2025, 11: e70118. PMID: 40501511, PMCID: PMC12152371, DOI: 10.1002/trc2.70118.Peer-Reviewed Original ResearchWhole-brain volumeMini-Mental State ExaminationOpen-label extensionMild to moderate ADEvoked gamma oscillationsGamma oscillationsADCS-ADLActivities of daily livingWhole-brain atrophyPost Hoc AnalysisMeasures of whole-brain volumeMini-MentalState ExaminationAlzheimer's Disease Cooperative Study-ActivitiesAlzheimer's diseaseMonths of active treatmentDaily livingActive treatmentRandomized controlled trial phaseOpen-label extension phaseModerate Alzheimer's diseaseWhole-brain volume changesEffect of active treatmentMonths of progressionMemory consolidation
2024
Correlation between changes in apathy and cognition in Alzheimer’s disease associated apathy: analysis of the Apathy in Dementia Methylphenidate Trial 2 (ADMET 2)
Sankhe K, Tumati S, Perin J, Rivet L, Vieira D, Rosenberg P, Herrmann N, Shade D, Lerner A, Padala P, Brawman‐Mintzer O, van Dyck C, Porsteinsson A, Craft S, Levey A, Mintzer J, Lanctôt K. Correlation between changes in apathy and cognition in Alzheimer’s disease associated apathy: analysis of the Apathy in Dementia Methylphenidate Trial 2 (ADMET 2). Alzheimer's & Dementia 2024, 20: e091793. PMCID: PMC11710533, DOI: 10.1002/alz.091793.Peer-Reviewed Original ResearchMini-Mental State ExamBoston Naming TestDigit Span ForwardCategory fluencyWorsening apathyNPI-aCognitive testsAlzheimer's diseaseCognitive change scoresAssociated with cognitive impairmentBaseline cognitive test scoresCognitive test scoresMild to moderate ADAssociated with performanceNaming TestVerbal fluencyExecutive functionMethylphenidate treatmentMethylphenidate groupTrail MakingCognitive domainsCognitive changesMethylphenidatePlacebo-controlled trialNPI-apathyCT1812 biomarker signature from a meta‐analysis of CSF proteomic findings from two Phase 2 clinical trials in Alzheimer's disease
Lizama B, Williams C, North H, Pandey K, Duong D, Di V, Mecca A, Blennow K, Zetterberg H, Levey A, Grundman M, van Dyck C, Caggiano A, Seyfried N, Hamby M. CT1812 biomarker signature from a meta‐analysis of CSF proteomic findings from two Phase 2 clinical trials in Alzheimer's disease. Alzheimer's & Dementia 2024, 20: 6860-6880. PMID: 39166791, PMCID: PMC11485314, DOI: 10.1002/alz.14152.Peer-Reviewed Original ResearchVolumetric magnetic resonance imagingMagnetic resonance imagingPharmacodynamic biomarkersMeta-analysisClinical developmentCerebrospinal fluidPhase 2 clinical trialResonance imagingAlzheimer's diseaseMechanism of actionClinical trialsTandem mass tag-mass spectrometryClinical cohortMild to moderate ADCandidate biomarkersCT1812CohortBiomarker signaturesBiomarkersProteomic findingsUnbiased analysisNetwork analysisAmyloid-betaSynaptic biologyBiological impactRelationships between plasma biomarkers, tau PET, FDG PET, and volumetric MRI in mild to moderate Alzheimer's disease patients
Matthews D, Kinney J, Ritter A, Andrews R, Strom E, Lukic A, Koenig L, Revta C, Fillit H, Zhong K, Tousi B, Leverenz J, Feldman H, Cummings J. Relationships between plasma biomarkers, tau PET, FDG PET, and volumetric MRI in mild to moderate Alzheimer's disease patients. Alzheimer's & Dementia: Translational Research & Clinical Interventions 2024, 10: e12490. PMID: 38988416, PMCID: PMC11233274, DOI: 10.1002/trc2.12490.Peer-Reviewed Original ResearchFluorodeoxyglucose positron emission tomographyGlial fibrillary acidic proteinPositron emission tomographyMagnetic resonance imagingPlasma biomarkersVolumetric magnetic resonance imagingMild to moderate ADFDG positron emission tomographyPhase 2 clinical trialNeurofilament light chainGlial fibrillary acidic protein concentrationFibrillary acidic proteinInflammation-related proteinsTemporal cortexLeft inferior temporal cortexModerate ADCognitive endpointsFluorodeoxyglucosePET uptakeInflammation biomarkersBaseline MMSEMild-to-moderate Alzheimer's disease patientsImaging biomarkersBiomarker heterogeneityEmission tomographySafety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer’s disease
Hajós M, Boasso A, Hempel E, Shpokayte M, Konisky A, Seshagiri C, Fomenko V, Kwan K, Nicodemus-Johnson J, Hendrix S, Vaughan B, Kern R, Megerian J, Malchano Z. Safety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer’s disease. Frontiers In Neurology 2024, 15: 1343588. PMID: 38515445, PMCID: PMC10957179, DOI: 10.3389/fneur.2024.1343588.Peer-Reviewed Original ResearchAssessment of adverse eventsMild to moderate ADGamma oscillationsModerate ADAmyloid-related imaging abnormalitiesAlzheimer's diseaseMild-to-moderate Alzheimer's diseaseSecondary clinical outcome measuresTherapy systemPrimary outcome measureHigher adherence ratesWhole-brain volumeClinical outcome measuresSecondary outcome measuresModerate Alzheimer's diseaseDisease-modifying effectsBaseline MMSE scoreStudy discontinuationExperimental AD modelsWell-toleratedEfficacy outcomesClinical benefitAdverse eventsDaily treatmentClinical criteria
2021
Impact of 40 Hz Transcranial Alternating Current Stimulation on Cerebral Tau Burden in Patients with Alzheimer’s Disease: A Case Series1
Dhaynaut M, Sprugnoli G, Cappon D, Macone J, Sanchez J, Normandin M, Guehl N, Koch G, Paciorek R, Connor A, Press D, Johnson K, Pascual-Leone A, Fakhri G, Santarnecchi E. Impact of 40 Hz Transcranial Alternating Current Stimulation on Cerebral Tau Burden in Patients with Alzheimer’s Disease: A Case Series1. Journal Of Alzheimer’s Disease 2021, 85: 1667-1676. PMID: 34958021, PMCID: PMC9023125, DOI: 10.3233/jad-215072.Peer-Reviewed Original ResearchConceptsMicroglia activationGamma spectral powerDecrease of microglia activationNo adverse eventsTranscranial alternating current stimulationSlow disease progressionPlacebo-controlled conditionsPreclinical dataCase seriesAdverse eventsGamma oscillationsElectrophysiological assessmentP-tauMouse modelDisease progressionMesial regionMild to moderate ADAnimal modelsPatientsPET imagingAlzheimer's diseaseSpectral powerAD mouse modelAD patientsProtein clearance
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