A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD)
Gateway Institute for Brain Research
Summary
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Eligibility
- Age range
- 30+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * 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 * If taking PD medications or any nutraceuticals, must be on a stable dose for at least 30 days prior to Screening Visit. Essential changes will be permitted. * If subject is taking chronic antidepressant or an anxiolytic, must be on a stable dose for at…
Interventions
- DrugINS-GSH
Intranasal INS-GSH Twice Daily
- DrugMatched Placebos
Intranasal Matched Placebos Twice Daily
Locations (2)
- Institute for Neuroimmune MedicineDavie, Florida
- Las Mercedes Medical ResearchHialeah, Florida