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

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05266417

NCT05266417 | Intranasal Insulin and Glutathione as an ...

This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo. Official Title. A ...

2.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/491695

Intranasal Insulin and Glutathione as an Add-On Therapy in ...

This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo. Fill out a short ...

3.

withpower.com

withpower.com/trial/phase-2-parkinson-disease-1-2022-dcc23

Insulin + Glutathione 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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7751460/

Potential use of glutathione as a treatment for Parkinson's ...

The present study demonstrated that GSH may mildly improve motor scores in PD, but not at the expense of increased adverse events.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28436395/

Phase IIb Study of Intranasal Glutathione in Parkinson's ...

Although predicted improvements in PD total and motor scores were observed, these data do not suggest (in)GSH is superior to placebo after a three month ...

6.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT05266417/

Trial | NCT05266417

This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo. Detailed ...