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Search / Trial NCT02324426

CNS Uptake of Intranasal Glutathione

Launched by UNIVERSITY OF WASHINGTON · Dec 23, 2014

Trial Information

Current as of April 26, 2025

Completed

Keywords

Parkinson's Disease Reduced Glutathione Cns Glutathione Uptake Intranasal (In)gsh

ClinConnect Summary

Objectives

Primary Aim: To determine whether intranasal reduced glutathione, (in)GSH, is capable of augmenting CNS glutathione levels.

Hypothesis: Mean MRS glutathione concentration will rise from baseline following administration of 1 cc 200 mg/ml (in)GSH.

Design and Outcomes:

This pilot study seeks to obtain baseline data regarding the feasibility of MRS to detect a change in CNS glutathione concentration following administration of 200 mg (in)GSH. CNS glutathione levels will be measured using magnetic resonance spectroscopy (MRS), with the putamen as the region of interest. Baseline ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.)
  • Exclusion Criteria:
  • 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.

About University Of Washington

The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.

Locations

Seattle, Washington, United States

Patients applied

0 patients applied

Trial Officials

Kevin Conley, PhD

Principal Investigator

University of Washington

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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