CNS Uptake of Intranasal Glutathione

Completed · Phase 1

Conditions studied: Parkinson's Disease

In brief

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, (in)GSH, is a novel method of glutathione augmentation. The aim of this study is to evaluate whether 200 mg of (in)GSH results in measurable changes in brain glutathione concentrations, as measured by magnetic resonance spectroscopy (MRS) in 15 individuals with PD.

Key facts

Study ID

NCT02324426

Run by

University of Washington

People needed

15

Starts

2014-12-01

Expected to finish

2015-03-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years.
• Ability to attend a 3 hour study visit in Seattle, WA.
• Ability to read and speak English.
• Have three or more of the required positive criteria for PD from Step 3 of the UK Brain Bank Diagnostic Criteria for Parkinson's Disease.
• A modified Hoehn \& Yahr Stage 2-3. (bilateral disease, not severely disabled.)

You may not qualify if…

• Any contra-indication to magnetic resonance imaging, including pacemaker, pacemaker wires, aneurysm clip, or any electronic implant, weight over 136 kg (300 lb), metal embedded in soft tissue or in the eye, prosthetic eye, claustrophobia, substance abuse, use of recreational drugs, pregnancy, or other medical contraindications.
• A history of epilepsy, stroke, brain surgery, or structural brain disease.
• The presence of other serious illnesses (discretion of study clinician, e.g. concurrent cancer treatment.)
• Pregnant.
• A history of sulfur sensitivity, e.g. reaction N-acetylcysteine, MSM, SAMe.
• A recent history of asthma.
• Supplementation with glutathione (oral, intravenous, intranasal, or nebulized) or the glutathione precursor, N-acetylcysteine, for six months prior to baseline study visit.
• History of sensitivity to sulfur containing medications/ supplements, i.e. NAC, MSM.
• Current drug or alcohol use or dependence.
• Inability/unwillingness to provide informed consent. (e.g. diagnosis of dementia, confusion about study goals or participation.)
• Acute infection (e.g. upper respiratory, dermal) in the previous 30 days.
• Diagnosis of any mental illness, ever. (Mental illness has been associated with glutathione depletion.)
• Diagnosis of any chronic disease, ever. (e.g. Hep C, autoimmune disease, etc.)
• Head tremor or head dyskinesia that cannot be comfortably controlled for 90 minutes.

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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