title: A randomized, double-blind phase I/IIa study of intranasal glutathione in Parkinson's disease.
abstract: BACKGROUND
  Depletion of reduced glutathione is associated with PD and glutathione augmentation has been proposed as a disease-modifying strategy. The aim of this study was to determine the safety and tolerability of intranasal reduced glutathione in individuals with PD.
  
  
  METHODS
  Thirty individuals with PD were randomized to either placebo (saline), 300 mg/day, or 600 mg/day of intranasal glutathione in three divided daily doses. Follow-up visits included side effect screening of PD symptoms and cognition, blood chemistry, sinus irritation, and hyposmia. Tolerability was measured by frequency and severity of reported adverse events, compliance, and withdrawals from the study.
  
  
  RESULTS
  After 3 months, there were no substantial differences between groups in the number of adverse events reported or observed among all safety measures assessed. All groups met tolerability criteria.
  
  
  CONCLUSIONS
  These data support the safety and tolerability of intranasal glutathione in this population. Pharmacokinetic and dose-finding studies are warranted.
authors.affiliation: Bastyr University Research Institute, Kenmore, Washington, USA.|Department of Nutritional Sciences, University of Washington, Seattle, Washington, USA.
authors.forename: Laurie K
authors.initials: LK
authors.lastname: Mischley
authors.affiliation: Cleveland Lou Ruvo Center for Brain Health, Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: James B
authors.initials: JB
authors.lastname: Leverenz
authors.affiliation: Bastyr University Research Institute, Kenmore, Washington, USA.|School of Biological and Population Health Sciences, Oregon State University, Corvallis, Oregon, USA.
authors.forename: Richard C
authors.initials: RC
authors.lastname: Lau
authors.affiliation: The Mountain-Whisper Light, Seattle, Washington, USA.
authors.forename: Nayak L
authors.initials: NL
authors.lastname: Polissar
authors.affiliation: The Mountain-Whisper Light, Seattle, Washington, USA.
authors.forename: Moni B
authors.initials: MB
authors.lastname: Neradilek
authors.affiliation: Department of Neurology, University of Washington; Northwest PADRECC at the Seattle VA Medical Center, Washington, USA.
authors.forename: Ali
authors.initials: A
authors.lastname: Samii
authors.affiliation: Bastyr University Research Institute, Kenmore, Washington, USA.
authors.forename: Leanna J
authors.initials: LJ
authors.lastname: Standish
mesh_terms: D000281:Administration, Intranasal; D000977:Antiparasitic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005978:Glutathione / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010300:Parkinson Disease / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000977:Antiparasitic Agents; D005978:Glutathione
keywords: antioxidant; deficiency; glutathione; neuroprotection; nutrition