2011
A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease
Salloway S, Sperling R, Keren R, Porsteinsson AP, van Dyck CH, Tariot PN, Gilman S, Arnold D, Abushakra S, Hernandez C, Crans G, Liang E, Quinn G, Bairu M, Pastrak A, Cedarbaum JM. A phase 2 randomized trial of ELND005, scyllo-inositol, in mild to moderate Alzheimer disease. Neurology 2011, 77: 1253-1262. PMID: 21917766, PMCID: PMC3179648, DOI: 10.1212/wnl.0b013e3182309fa5.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAlzheimer DiseaseAmyloid beta-PeptidesApolipoprotein E4Dose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansInositolMagnetic Resonance ImagingMaleMental Status ScheduleMiddle AgedPeptide FragmentsPlatelet Aggregation InhibitorsTime FactorsTreatment OutcomeConceptsNeuropsychological test batteryAlzheimer's diseaseDose-ranging phase 2 studyAlzheimer's Disease Cooperative Study-ActivitiesClass II trialsClinical efficacy outcomesCSF biomarker resultsScyllo-inositol concentrationsPhase 2 studyPrimary efficacy analysisHigh-dose groupDaily Living ScaleBrain ventricular volumeCoprimary endpointsEarly discontinuationEfficacy outcomesII trialADCS-ADLDose groupEfficacy analysisAcceptable safetyAβx-42Living ScaleOptimal doseTreatment groups
2006
A Phase I Trial of an IV-Administered Vascular Endothelial Growth Factor Trap for Treatment in Patients with Choroidal Neovascularization due to Age-Related Macular Degeneration
Nguyen QD, Shah SM, Hafiz G, Quinlan E, Sung J, Chu K, Cedarbaum JM, Campochiaro PA, Group C. A Phase I Trial of an IV-Administered Vascular Endothelial Growth Factor Trap for Treatment in Patients with Choroidal Neovascularization due to Age-Related Macular Degeneration. Ophthalmology 2006, 113: 1522.e1-1522.e14. PMID: 16876249, DOI: 10.1016/j.ophtha.2006.05.055.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overChoroidal NeovascularizationDose-Response Relationship, DrugFemaleFluorescein AngiographyHumansInfusions, IntravenousMacular DegenerationMaleMaximum Tolerated DoseMiddle AgedReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsRetinaTomography, Optical CoherenceVisual AcuityConceptsVascular endothelial growth factor trapAge-related macular degenerationVEGF TrapRetinal thicknessVisual acuityMacular degenerationEarly Treatment Diabetic Retinopathy Study protocolNeovascular age-related macular degenerationDiabetic Retinopathy Study protocolPlacebo-controlled clinical trialDoses 2 weeksDose-limiting toxicityPhase I trialMean percent changeVEGF receptor 1Optical coherence tomographyAdverse eventsI trialDose groupChoroidal neovascularizationStudy protocolClinical trialsStudy populationMultiple administrationsTherapeutic window