CNS Uptake of Intranasal Glutathione

What Was Tested

This registered phase 1 trial tested Glutathione for parkinson's disease.

Intranasal GSH, (in)GSH, is a novel method of glutathione augmentation.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

CNS glutathione levels will be measured using magnetic resonance spectroscopy (MRS), with the putamen as the region of interest.

Baseline brain GSH concentrations will be measured by MRS at approximately the same time each day in all individuals before and after administration of study medication.

Outcome Measure: 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.

Who Took Part

The registry lists 15 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age \> 18 years. Ability to attend a 3 hour study visit in Seattle, WA. Ability to read and speak English. A modified Hoehn \& Yahr Stage 2-3. (bilateral disease, not severely disabled.).

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: 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.); A history of sulfur sensitivity, e.g. reaction N-acetylcysteine, MSM, SAMe.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Glutathione study: the parkinson's disease participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-12 with completion listed for 2015-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The concentration of metabolites before and after (in)GSH will be compared (change in mean GSH concentration) (time frame: 15 minutes after administration).

It also tracked 1 secondary outcome, for example A ROC curve will be generated to compare MRS [glutathione] to peripheral measures of RBC glutathione.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Glutathione in 15 people with parkinson's disease.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, Parkinson's disease research.