Insulin + Glutathione for Parkinson's Disease

(NOSE-PD Trial)

Recruiting at 1 trial location

Overseen By Vanesa Javier

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Gateway Institute for Brain Research

Must not be taking: Insulin, Anti-hyperglycemics, Glutathione, Beta blockers

Disqualifiers: Diabetes, Cognitive impairment, Respiratory disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

56 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug INS-GSH for Parkinson's disease?

Research suggests that insulin, a component of INS-GSH, may protect brain cells and improve movement in Parkinson's disease models, as seen in studies where intranasal insulin helped preserve neurons and reduce movement problems in rats. ^{1 2 3 4 5}

Is the combination of insulin and glutathione safe for humans?

Research on intranasal insulin in rats shows it is safe and does not affect body weight or blood sugar levels, suggesting it may be safe for humans. However, specific safety data for the combination of insulin and glutathione in humans is not available. ^{1 4 6 7 8}

How does the Insulin + Glutathione treatment for Parkinson's disease differ from other treatments?

This treatment is unique because it combines insulin with glutathione, an antioxidant that is depleted early in Parkinson's disease. Glutathione helps protect brain cells from oxidative stress, which is a key factor in the progression of Parkinson's disease, and its augmentation is a novel approach compared to traditional treatments. ^{9 10 11 12 13}

What is the purpose of this trial?

This trial is testing insulin and glutathione to see if they are safe and effective for people with Parkinson's Disease. Insulin helps control blood sugar, which can impact brain health, and glutathione protects brain cells from damage. The goal is to find out if these treatments can help improve symptoms or slow down the disease.

Eligibility Criteria

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

I can take the study drug myself or have someone to help me with it.

I have been on the same dose of my antidepressant or anxiety medication for at least 90 days.

I have been on the same dose of my Parkinson's or supplement medication for at least 30 days.

Exclusion Criteria

Your Mini-Mental State Exam (MMSE) score is 24 or lower at the screening.

I have long-term nasal inflammation that could affect medication absorption.

My asthma or COPD is not well-controlled.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intranasal insulin and glutathione or placebo

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INS-GSH

Trial Overview The study tests the safety and effectiveness of intranasal insulin combined with glutathione (INS-GSH) versus placebo in managing Parkinson's Disease symptoms. Participants will either receive the actual treatment or a matched placebo without knowing which one they are getting.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

Insulin (Novolin R) and Glutathione (INS-GSH)

Group II: Control Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Gateway Institute for Brain Research

Lead Sponsor

Trials

2

Recruited

140+

References

1. Austria pubmed.ncbi.nlm.nih.gov

Normal cerebrospinal fluid levels of insulin in patients with Parkinson's disease. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Impaired brain insulin signalling in Parkinson's disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Diabetes, insulin and new therapeutic strategies for Parkinson's disease: Focus on glucagon-like peptide-1 receptor agonists. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Intranasal insulin protects against substantia nigra dopaminergic neuronal loss and alleviates motor deficits induced by 6-OHDA in rats. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Glucose dysregulation in Parkinson's disease: Too much glucose or not enough insulin? [2019]

6. England pubmed.ncbi.nlm.nih.gov

Diabetes medications and risk of Parkinson's disease: a cohort study of patients with diabetes. [2021]

7. India pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide dual receptor agonist DA-CH5 is superior to exendin-4 in protecting neurons in the 6-hydroxydopamine rat Parkinson model. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

DA5-CH and Semaglutide Protect against Neurodegeneration and Reduce α-Synuclein Levels in the 6-OHDA Parkinson's Disease Rat Model. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Glutathione and Related Molecules in Parkinsonism. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Phase IIb Study of Intranasal Glutathione in Parkinson's Disease. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Characterization of intracellular elevation of glutathione (GSH) with glutathione monoethyl ester and GSH in brain and neuronal cultures: relevance to Parkinson's disease. [2018]

12. France pubmed.ncbi.nlm.nih.gov

Glutathione and Parkinson's disease: is this the elephant in the room? [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Plasma Glutathione and Prodromal Parkinson's Disease Probability. [2022]