This is a Phase I study seeking to determine whether intranasal glutathione (nasal spray) is safe and tolerable. Participants will be asked to administer the nasal spray or placebo three times daily for three months.
Individuals must have been diagnosed with Parkinson's disease in the past 5 years, must not currently be using glutathione in any form, and must be able to come to Bastyr for 6-7 visits over four months. Study medication will be provided and participants will be reimbursed for transportation costs.
We are no longer recruiting for the Intranasal Glutathione study.
Excessive free radical formation and depletion of the brain’s primary antioxidant, glutathione, are established components of Parkinson’s disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles surrounding currently employed delivery methods have hindered the clinical utility of this therapy. Intranasal GSH is a novel method of delivery for this popular CAM therapy in patients with PD, and bypasses the obstacles associated with other delivery methods. It has been used in clinical practice since 2005. The aim of this study is to evaluate safety, tolerability, and preliminary absorption data of intranasally administered GSH, (in)GSH, in volunteers with Parkinson’s disease in a Phase I single ascending dose escalation study.
To evaluate safety of (in)GSH in a small (n=20) cohort of PD patients following short-term (2-week) administration.
In addition to all outcome measures identified in Part 2, participants will:
Outcome measures for Sub-Part 1:
Red blood cell (RBC) GSH levels will be measured at baseline, 4 weeks, and 12 weeks.
Additional funding is being sought for an add-on study that will address CNS absorption of (in)GSH in a sub-group, either via analysis of cerebrospinal fluid or spectroscopy.