2024
Adverse effects of methylphenidate for apathy in patients with Alzheimer's disease (ADMET2 trial)
Zeng L, Perin J, Gross A, Shade D, Lanctôt K, Lerner A, Mintzer J, Brawman‐Mintzer O, Padala P, van Dyck C, Porsteinsson A, Craft S, Levey A, Herrmann N, Rosenberg P. Adverse effects of methylphenidate for apathy in patients with Alzheimer's disease (ADMET2 trial). International Journal Of Geriatric Psychiatry 2024, 39: e6108. PMID: 38858522, PMCID: PMC11265565, DOI: 10.1002/gps.6108.Peer-Reviewed Original ResearchConceptsMethylphenidate groupTreating apathyPlacebo-controlled trial of methylphenidateTreatment of apathyAssociated with methylphenidateEffects of methylphenidateTrial of methylphenidateAlzheimer's diseaseFollow-upNo treatment group differencesAdverse effects of methylphenidateDiastolic blood pressureSymptom ChecklistAdverse eventsTreatment group differencesMonitoring weightMethylphenidate useMethylphenidate treatmentMedical comorbiditiesPlacebo groupParticipantsMethylphenidateGroup differencesPlacebo-controlled trialMonthly visitsUpdated safety results from phase 3 lecanemab study in early Alzheimer’s disease
Honig L, Sabbagh M, van Dyck C, Sperling R, Hersch S, Matta A, Giorgi L, Gee M, Kanekiyo M, Li D, Purcell D, Dhadda S, Irizarry M, Kramer L. Updated safety results from phase 3 lecanemab study in early Alzheimer’s disease. Alzheimer's Research & Therapy 2024, 16: 105. PMID: 38730496, PMCID: PMC11084061, DOI: 10.1186/s13195-024-01441-8.Peer-Reviewed Original ResearchConceptsOpen-label extensionInfusion-related reactionsIntracerebral hemorrhageAdverse eventsAmyloid-related imaging abnormalitiesARIA-HParallel-group studyClinical laboratory parametersMonths of treatmentMild-to-moderateMagnetic resonance imagingHomozygous participantsAPOE e4 carriersDouble-blindPlacebo-controlledLaboratory parametersStudy treatmentARIA-E.Imaging abnormalitiesOptimal patient carePhysical examinationSafety resultsClinical trialsHemosiderin depositionResonance imaging
2022
Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer’s Disease
Budd Haeberlein S, Aisen P, Barkhof F, Chalkias S, Chen T, Cohen S, Dent G, Hansson O, Harrison K, von Hehn C, Iwatsubo T, Mallinckrodt C, Mummery C, Muralidharan K, Nestorov I, Nisenbaum L, Rajagovindan R, Skordos L, Tian Y, van Dyck C, Vellas B, Wu S, Zhu Y, Sandrock A. Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer’s Disease. The Journal Of Prevention Of Alzheimer's Disease 2022, 9: 197-210. PMID: 35542991, DOI: 10.14283/jpad.2022.30.Peer-Reviewed Original ResearchConceptsEarly Alzheimer's diseasePhase 3 studyAlzheimer's diseaseDisease dementiaAmyloid betaDisease pathophysiologyRandomized phase 3 studyClinical Dementia Rating SumCommon adverse eventsSecondary clinical endpointsPrimary outcome measureDose-dependent reductionAlzheimer's disease pathophysiologyAlzheimer's disease dementiaHuman monoclonal antibodyMild cognitive impairmentMild Alzheimer's disease dementiaPrimary endpointSecondary endpointsWeek 78Adverse eventsBiomarker substudyClinical outcomesEfficacy analysisBackgroundAlzheimer’s disease
2021
Apathy in Dementia Methylphenidate Trial 2 (ADMET2): Results of a phase III, placebo‐controlled, double‐blind, 6‐month, multi‐center, randomized clinical trial
Mintzer J, Scherer R, Drye L, Lanctôt K, Rosenberg P, Herrmann N, Padala P, Brawman‐Mintzer O, Lerner A, Levey A, Porsteinsson A, van Dyck C. Apathy in Dementia Methylphenidate Trial 2 (ADMET2): Results of a phase III, placebo‐controlled, double‐blind, 6‐month, multi‐center, randomized clinical trial. Alzheimer's & Dementia 2021, 17 DOI: 10.1002/alz.051489.Peer-Reviewed Original ResearchAlzheimer's diseasePlacebo groupMethylphenidate groupClinical trialsAD Cooperative Study-Clinical Global ImpressionPhase IIITreatment of apathyClinical Global ImpressionRatings of improvementADCS-CGICAdverse eventsSecondary outcomesMonth 6Primary outcomeNeuropsychiatric symptomsSafety profileGlobal ImpressionSmall studyViable treatmentStudy participantsMean differenceMonthsMethylphenidatePrevious trialsTrials
2019
Effect of AZD0530 on Cerebral Metabolic Decline in Alzheimer Disease
van Dyck CH, Nygaard HB, Chen K, Donohue MC, Raman R, Rissman RA, Brewer JB, Koeppe RA, Chow TW, Rafii MS, Gessert D, Choi J, Turner RS, Kaye JA, Gale SA, Reiman EM, Aisen PS, Strittmatter SM. Effect of AZD0530 on Cerebral Metabolic Decline in Alzheimer Disease. JAMA Neurology 2019, 76: 1219-1229. PMID: 31329216, PMCID: PMC6646979, DOI: 10.1001/jamaneurol.2019.2050.Peer-Reviewed Original ResearchAZD0530 treatmentAdverse eventsPrimary outcomeTreatment groupsAlzheimer's Disease Cooperative Study-ActivitiesAlzheimer's diseasePositron emission tomography evidenceMini-Mental State Examination scoreAlzheimer's Disease Assessment Scale-cognitive subscaleCerebral metabolic declineFrequent adverse eventsSecondary end pointsCerebral metabolic rateMild Alzheimer's dementiaState Examination scorePlasma drug levelsClinical Dementia RatingVolumetric magnetic resonanceEffect of AZD0530Neuronal cell surfaceModified intentionTreat populationSecondary outcomesNeuropsychiatric InventoryEfficacy analysis
2018
Guanfacine treatment for prefrontal cognitive dysfunction in older participants: a randomized clinical trial
Barcelos NM, Van Ness PH, Wagner AF, MacAvoy MG, Mecca AP, Anderson GM, Trentalange M, Hawkins KA, Sano M, Arnsten AFT, van Dyck CH. Guanfacine treatment for prefrontal cognitive dysfunction in older participants: a randomized clinical trial. Neurobiology Of Aging 2018, 70: 117-124. PMID: 30007160, PMCID: PMC6503670, DOI: 10.1016/j.neurobiolaging.2018.05.033.Peer-Reviewed Original ResearchConceptsDose of guanfacineQuality of lifeZ-scoreCognitive functionPrefrontal cognitive dysfunctionCommon adverse eventsPrimary outcome measureRandomized clinical trialsGlobal functionOlder participantsHealthy older participantsPrefrontal cognitive functionDry mouthAdverse eventsAgonist guanfacineClinical trialsGuanfacine treatmentCognitive dysfunctionMean changeOutcome measuresPlaceboGuanfacineOlder individualsWeeksDose
2012
Safety and biomarker effects of solanezumab in patients with Alzheimer's disease
Farlow M, Arnold SE, van Dyck C, Aisen PS, Snider BJ, Porsteinsson AP, Friedrich S, Dean RA, Gonzales C, Sethuraman G, DeMattos RB, Mohs R, Paul SM, Siemers ER. Safety and biomarker effects of solanezumab in patients with Alzheimer's disease. Alzheimer's & Dementia 2012, 8: 261-271. PMID: 22672770, DOI: 10.1016/j.jalz.2011.09.224.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAlzheimer DiseaseAmyloid beta-PeptidesAntibodies, Monoclonal, HumanizedCognition DisordersDose-Response Relationship, DrugDouble-Blind MethodElectroencephalographyEnzyme-Linked Immunosorbent AssayFemaleFollow-Up StudiesHumansMaleMiddle AgedNeuropsychological TestsPeptide FragmentsPsychiatric Status Rating ScalesPyridinesTomography, Emission-Computed, Single-PhotonTreatment OutcomeConceptsAlzheimer's Disease Assessment Scale-cognitive portionAntibody administrationDose-dependent mannerAlzheimer's diseaseAntibody treatmentAnti-β-amyloid antibodiesPlacebo-controlled clinical trialMagnetic resonance imaging (MRI) scansCerebrospinal fluid examinationClinical laboratory valuesActive treatment periodCSF cell countResonance imaging scansModerate Alzheimer's diseaseDose-dependent increaseMagnetic resonance imagingWeekly infusionsAdverse eventsFluid examinationImaging scansClinical trialsLaboratory valuesTreatment periodAmyloid plaquesCell count