CNS Uptake of Intranasal Glutathione

NCT02324426 | Completed Phase 1

• 1 other identifier: 48273-A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Reduced Glutathione; CNS; Glutathione; Uptake; Intranasal; (in)GSH

Outcome Measures

Primary Outcomes (1)

• The concentration of metabolites before and after (in)GSH will be compared (change in mean GSH concentration)

  Describe the change in mean GSH concentration following administration of (in)GSH. The data analysis will be ipsative- results will be reported as percent change from the individual's own baseline GSH concentration.

  15 minutes after administration

Secondary Outcomes (1)

• A ROC curve will be generated to compare MRS [glutathione] to peripheral measures of RBC glutathione.

  15 minutes after administration

Study Arms (1)

Reduced Glutathione

EXPERIMENTAL

The study medication is packaged in sterile 1 ml pre-filled syringes, each containing 200 mg/ ml of reduced glutathione (GSH), which will be delivered intranasally.

Drug: Reduced Glutathione

Interventions

Reduced Glutathione DRUG

200 mg GSH delivered in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.

Also known as: (in)GSH

Reduced Glutathione

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Washington: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (23)

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  RESULT

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MeSH Terms

Conditions

Parkinson Disease

Interventions

Glutathione

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kevin Conley, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Appointment

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 30, 2015

Record last verified: 2015-03

Locations

US (1)