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
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
2000
Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial
Mulnard R, Cotman C, Kawas C, van Dyck C, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Study L. Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial. Obstetrical & Gynecological Survey 2000, 55: 439-440. DOI: 10.1097/00006254-200007000-00021.Peer-Reviewed Original ResearchMini-Mental State ExaminationCognitive functionAlzheimer's diseaseMultiple Affect Adjective ChecklistMeasures of moodMMSE scoresSingle-blind placebo washout phaseVerbal learningLanguage measuresClinical Dementia Rating ScaleCategory fluencyPlacebo washout phaseDouble-blind trialLow-dose estrogenConjugated equine estrogensEstrogen replacement therapyDementia Rating ScaleTreatment of mildClinical Global ImpressionPrimary outcome measureHamilton Depression ScaleAdjective ChecklistModerate Alzheimer's diseaseOnset of diseaseGlobal functioningEstrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial
Mulnard R, Cotman C, Kawas C, van Dyck C, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Thal L, Study F. Estrogen Replacement Therapy for Treatment of Mild to Moderate Alzheimer Disease: A Randomized Controlled Trial. JAMA 2000, 283: 1007-1015. PMID: 10697060, DOI: 10.1001/jama.283.8.1007.Peer-Reviewed Original ResearchConceptsEstrogen replacement therapyModerate Alzheimer's diseaseSecondary outcome measuresReplacement therapyAlzheimer's diseaseOutcome measuresClinical trialsPlacebo-controlled clinical trialMini-Mental State Examination scoreAlzheimer's Disease Cooperative StudyPrevention of ADClinical Dementia Rating ScaleClinical Global ImpressionPrimary outcome measureTreatment of mildSmall clinical trialsRole of estrogenState Examination scoreDementia Rating ScaleCGIC scoresEstrogen groupPlacebo groupControlled TrialsFunctional outcomeGlobal Impression