A randomized, double-blind phase I/IIa study of intranasal glutathione in Parkinson's disease

作者：Mischley Laurie K^*; Leverenz James B; Lau Richard C; Polissar Nayak L; Neradilek Moni B; Samii Ali; Standish Leanna J

来源：Movement Disorders, 2015, 30(12): 1696-1701.

DOI：10.1002/mds.26351

• glutathione
• antioxidant
• nutrition
• neuroprotection
• deficiency

BackgroundDepletion 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.
MethodsThirty 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.
ResultsAfter 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.
ConclusionsThese data support the safety and tolerability of intranasal glutathione in this population. Pharmacokinetic and dose-finding studies are warranted.

• 出版日期2015-10