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
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?
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.