INS-GSH for Parkinson's (NOSE-PD, NCT05266417)
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)
- Study Acronym
- 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
Summary For Families
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
- NextGen Research Group, Miami, 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 3 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 4 years and 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.