Laurie K Mischley1,2, James B Leverenz3, Richard C Lau1,4, Nayak L Polissar5, Moni B Neradilek5, Ali Samii6, Leanna J Standish1. 1. Bastyr University Research Institute, Kenmore, Washington, USA. 2. Department of Nutritional Sciences, University of Washington, Seattle, Washington, USA. 3. Cleveland Lou Ruvo Center for Brain Health, Cleveland Clinic, Cleveland, Ohio, USA. 4. School of Biological and Population Health Sciences, Oregon State University, Corvallis, Oregon, USA. 5. The Mountain-Whisper Light, Seattle, Washington, USA. 6. Department of Neurology, University of Washington; Northwest PADRECC at the Seattle VA Medical Center, Washington, USA.
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.
RCT Entities:
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.
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