2019
Randomized phase I clinical trial of anti–α‐synuclein antibody BIIB054
Brys M, Fanning L, Hung S, Ellenbogen A, Penner N, Yang M, Welch M, Koenig E, David E, Fox T, Makh S, Aldred J, Goodman I, Pepinsky B, Liu Y, Graham D, Weihofen A, Cedarbaum JM. Randomized phase I clinical trial of anti–α‐synuclein antibody BIIB054. Movement Disorders 2019, 34: 1154-1163. PMID: 31211448, PMCID: PMC6771554, DOI: 10.1002/mds.27738.Peer-Reviewed Original ResearchConceptsParkinson's disease participantsΑ-synucleinHealthy volunteersParkinson's diseaseHuman-derived monoclonal antibodiesSingle-dose cohortsMost adverse eventsFurther clinical developmentImmunotherapy targetingStudy drugAdverse eventsFavorable safetySingle doseNeuronal dysfunctionSerum ratioDisease progressionCerebrospinal fluidClinical developmentPharmacokinetic parametersPharmacokinetic profileSerum exposureLaboratory assessmentMonoclonal antibodiesDiseaseDose range
2013
Pharmacokinetic Profile of Orally Administered Scyllo‐Inositol (Elnd005) in Plasma, Cerebrospinal Fluid and Brain, and Corresponding Effect on Amyloid‐Beta in Healthy Subjects
Liang E, Garzone P, Cedarbaum JM, Koller M, Tran T, Xu V, Ross B, Jhee SS, Ereshefsky L, Pastrak A, Abushakra S. Pharmacokinetic Profile of Orally Administered Scyllo‐Inositol (Elnd005) in Plasma, Cerebrospinal Fluid and Brain, and Corresponding Effect on Amyloid‐Beta in Healthy Subjects. Clinical Pharmacology In Drug Development 2013, 2: 186-194. PMID: 27121673, DOI: 10.1002/cpdd.14.Peer-Reviewed Original ResearchAverage trough concentrationCerebrospinal fluidAlzheimer's diseaseTrough concentrationsDay 8Magnetic resonance spectroscopy scansCSF drug levelsHealthy young subjectsPredetermined time pointsOral treatmentCSF levelsAmyloid-beta fragmentsCSF concentrationsPlasma levelsDrug levelsHealthy subjectsAmyloid betaCSF samplesPharmacokinetic profileYoung subjectsTransgenic modelBaseline levelsTime pointsWhite matter voxelsAβ fragments