Phase II Study of Intranasal Insulin and Glutathione as Additional Treatment for Parkinsons Disease Evaluating Safety and Effectiveness Compared to Placebo

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intranasal insulin combined with glutathione as an additional treatment for people with Parkinsons Disease. This phase II, randomized, double-blind, placebo-controlled study aims to compare these treatments against a placebo to better understand their impact on the condition. The study is sponsored by the Gateway Institute for Brain Research and seeks to explore new options for managing Parkinsons symptoms. Participants will be assigned to receive either the active drugsintranasal insulin Novolin R plus glutathioneor matching placebo treatments. These are administered twice daily as add-on therapies alongside participants usual medications. The study design includes a parallel group model where participants are monitored over a 24 to 28 week period to assess outcomes related to verbal fluency, motor function, cognitive function, non-motor symptoms, and patient-reported outcomes. During the study, participants will be closely monitored with evaluations of their verbal fluency at 24 weeks as the primary outcome measure. Secondary assessments include motor and cognitive function tests as well as reports on non-motor symptoms and overall patient well-being. Safety and tolerability of the treatments will also be carefully observed. Participants are expected to maintain consistent diets, exercise, and medication regimens throughout the trial. The total participation period extends up to approximately 28 weeks, with scheduled visits for assessments and monitoring.

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