Insulin + Glutathione for Parkinson's Disease
(NOSE-PD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of insulin and glutathione to determine its effectiveness for people with Parkinson's disease. Researchers aim to assess whether this treatment is safe and more effective than a placebo (a harmless pill without active medicine). Participants should have Parkinson's disease but not diabetes and must manage their medication consistently. Those who meet these criteria might find this trial suitable. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
You can continue taking your current medications as long as they are stable for at least 30 days before the trial for Parkinson's medications or 90 days for antidepressants or anxiolytics. However, you cannot use insulin, anti-hyperglycemic agents, glutathione supplements, or beta blockers.
Is there any evidence suggesting that insulin and glutathione are likely to be safe for humans?
Research has shown that using glutathione in treatments for Parkinson's Disease might slightly improve movement without adding more side effects, indicating it is generally well-tolerated. Insulin, a common medication for controlling blood sugar, has FDA approval for diabetes, so it is considered safe for use.
The study under consideration is in Phase 2. This phase confirms the treatment's safety for people and focuses on its effectiveness and any side effects. So far, evidence suggests that using insulin and glutathione together is safe, but further research is needed for confirmation.12345Why do researchers think this study treatment might be promising for Parkinson's Disease?
Unlike the standard treatments for Parkinson's Disease, which typically focus on dopamine replacement or modulation, the INS-GSH treatment combines insulin and glutathione to potentially target oxidative stress and improve cellular health. Researchers are excited about this treatment because glutathione is a powerful antioxidant that may protect neurons from damage, while insulin could enhance brain glucose metabolism, offering a novel pathway to address the disease. This combination could provide a dual-action approach that not only alleviates symptoms but also addresses underlying cellular dysfunction, setting it apart from current options.
What evidence suggests that insulin and glutathione might be an effective treatment for Parkinson's Disease?
Research suggests that insulin, a component of the INS-GSH treatment in this trial, may protect brain cells and improve movement in Parkinson's disease models. Studies on insulin indicate potential benefits for brain health, crucial for conditions like Parkinson's. Glutathione, the other component of the INS-GSH treatment, has shown slight improvement in movement scores for Parkinson's patients, although some studies found it not much better than a placebo. This trial examines the combined effects of insulin and glutathione on Parkinson's symptoms. Early evidence suggests insulin may protect the brain, while glutathione might slightly enhance movement.12346
Are You a Good Fit for This Trial?
This trial is for people with Parkinson's Disease who can self-administer the study drug or have someone to help them. They must be consistent with their diet, exercise, and current medications, which should be stable for at least 30 days (90 days for antidepressants or anxiolytics). They cannot join if they have nasal inflammation that affects drug absorption, other significant neurological/psychiatric diseases, recent seizures or loss of consciousness, uncontrolled heart disease, diabetes with HbA1c ≥ 6.5%, history of severe hypoglycemia, use certain disallowed medications like insulin or beta blockers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intranasal insulin and glutathione or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- INS-GSH
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gateway Institute for Brain Research
Lead Sponsor