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Intranasal Glutathione in Parkinson's Disease
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.
Specific Aim of Part 1: Safety Sub 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:
- Participant interviews will be conducted inquiring about adverse events. (qualitative research)
- Nasal examinations and evaluation of patient reported nasal symptoms using the Sino-Nasal Outcome Test (SNOT-20) evaluation tool. (See Appendix) Any worsening of sino-nasal symptoms will be recorded as an adverse event.
- Anosmia will be evaluated at baseline and upon completion of the 3 month study using the Sensonics Brief Smell Identification test.
- Safety will be evaluated after two weeks administration of study medication via:
- Laboratory tests: CBC/D, ALT, AST, BUN, creatinine, uric acid, urinalysis
- Evaluation of PD symptoms compared to baseline: Unified Parkinson’s Disease Rating Scale (UPDRS), MoCA, Hoehn & Yahr.
- Review of systems standardized questionnaire: Monitoring of Side Effects System (MOSES). An increase of 2 or more points in any symptom will be reported as an adverse event.
Specific Aims for Part 2
- To determine the safety of intranasal glutathione in participants with Parkinson’s disease.
- 1a. Laboratory monitoring for adverse events will include CBC, ALT, AST, BUN, creatinine, uric acid, and urinalysis. Data will be collected throughout the 12-week intervention and at 1-mo following cessation of the study medication.
- 1b. Clinical adverse events will be measured using a daily patient diary and record score card specifically screening for sinus irritation. Monitoring of Side Effects System (MOSES) will be used to screen for systemic and generalized adverse events.
- 1c. Effect on PD symptoms will be measured by the UPDRS to screen for accelerated disease activity.
- To determine the tolerability of intranasal glutathione in participants with Parkinson’s disease.
- Participants will be asked to keep a daily log and unused study medication will be measured at each clinical visit. Tolerability will be measured by frequency and severity of reported adverse events and withdrawal from study.
- The goal will be to identify the maximum tolerated dose (MTD) which will be defined as the highest dose achieving adherence, as defined as 80% of the group taking the prescribed dose 80% of the time.
- 1. To describe systemic absorption characteristics of the intranasal delivery of glutathione in participants with Parkinson’s disease.
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.