Test intranasal insulin and glutathione
- Trial ID
- NCT05266417
- Official Title
- 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)
- Goal
- Test intranasal insulin and glutathione
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Gateway Institute for Brain Research
- Study Type
- INTERVENTIONAL
- Enrollment
- 56 participants
- Conditions
- Parkinson Disease
- Interventions
- INS-GSH, Matched Placebos
Plain-Language Summary
The goal is to see whether giving insulin and glutathione through the nose can protect dopamine-producing brain cells and improve or stabilize motor and cognitive symptoms in Parkinson's disease. The approach uses intranasal insulin to deliver insulin directly to the brain to boost neuronal energy and signaling, paired with glutathione as an antioxidant to reduce oxidative stress; both are tested as an add-on to, not a replacement for, usual Parkinson's medications like levodopa. Eligible participants are adults 30 to 85 with a clinical diagnosis of idiopathic PD under Hoehn and Yahr stage 5 who can self-administer or have a caregiver help and who have been on stable PD medications for at least 30 days. People with diabetes or recent hypoglycemia, significant cognitive impairment (MMSE 24 or less), current insulin or other anti-hyperglycemic use, or glutathione supplementation are excluded.
Locations
- Institute for Neuroimmune Medicine, Davie, Florida, United States
- Las Mercedes Medical Research, Hialeah, Florida, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying INS-GSH. The goal is to see whether giving insulin and glutathione through the nose can protect dopamine-producing brain cells and improve or stabilize motor and cognitive symptoms in Parkinson's disease. The approach uses intranasal insulin to deliver insulin directly to the brain to boost neuronal energy and signaling, paired with glutathione as an antioxidant to reduce oxidative stress; both are tested as an add-on to, not a replacement for, usual Parkinson's medications like levodopa. Eligible participants are adults 30 to 85 with a clinical diagnosis of idiopathic PD under Hoehn and Yahr stage 5 who can self-administer or have a caregiver help and who have been on stable PD medications for at least 30 days. People with diabetes or recent hypoglycemia, significant cognitive impairment (MMSE 24 or less), current insulin or other anti-hyperglycemic use, or glutathione supplementation are excluded.
- Who can participate?
- Participants must be at least 30 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 4 years and 11 months.