Intranasal Glutathione in Parkinson's Disease

What Was Tested

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

Excessive free radical formation and depletion of the brain's primary antioxidant, glutathione, are established components of Parkinson's disease (PD) pathophysiology.

It had four arms (groups): one (active comparator), one (active comparator), Saline intranasal delivery (placebo comparator) and Watchful waiting (no intervention).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 34 actual participants took part.

It was open to people of any sex aged from 21 years up to 100 years.

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

Examples of who could join: Diagnosis of Parkinson's Disease made by neurologist within previous 10 years. Modified Hoehn and Yahr Stage \<3. Subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16. Diet, exercise and supplementation must be kept constant throughout participation in study. Ability to read and speak English.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: dementia as evidenced by montreal cognitive assessment (moca) \<24; diseases with features common to parkinson's disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy); history of stroke, cva.

How the Study Was Run

Design: randomized, single-group and quadruple-blind.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Glutathione study, the assignments were hidden from both participants and investigators until the end.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-07 with completion listed for 2016-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Determination of Safety (time frame: 12 weeks). Determination of Tolerability (time frame: 12 weeks).

It also tracked 1 secondary outcome, for example Description of systemic absorption characteristics.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glutathione in 34 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.