Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease

What Was Tested

This registered phase 2 trial tested Glutathione for parkinson's disease.

It had two arms (groups): Active (experimental) and Control (placebo comparator).

Insulin (Novolin R) and Glutathione (INS-GSH).

Placebo.

The registry classes the interventions as drug.

Who Took Part

The registry lists 56 planned participants were the target.

It was open to people of any sex aged from 30 years with no upper age limit.

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

Examples of who could join: Documented clinical diagnosis of idiopathic PD. Able to administer study drug or have a caregiver throughout the duration of the study to help administer drug. Willing to continue diet, exercise and medications reported at baseline consistently throughout participation in the trial. Essential changes are permitted.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: clinical diagnosis of type 1 or type 2 diabetes mellitus; mini-mental state exam (mmse) score of ≤ 24 at screening; positive covid-19 test at screening and/or within 30 days of screening.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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.

Groups ran in parallel: each of the parkinson's disease participants stayed in one arm throughout.

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

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

It started in 2022-02-07 with completion listed for 2027-09-01.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Verbal Fluency (time frame: 24 Weeks).

It also tracked 10 secondary outcomes, for example Verbal Fluency, Motor Function, Motor Function, Motor Function, Motor Function and Motor Function.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 56 people with parkinson's disease.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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