What is the mechanism of action of this treatment?

The most common treatments for Parkinson's Disease (PD) include dopaminergic therapies such as levodopa, dopamine agonists, and monoamine oxidase B (MAO-B) inhibitors. Levodopa is converted to dopamine in the brain, replenishing the diminished levels of this neurotransmitter. Dopamine agonists mimic dopamine's effects, while MAO-B inhibitors prevent the breakdown of dopamine, prolonging its action. These treatments primarily address the symptomatic relief of motor symptoms in PD. Insulin and glutathione, being studied for their neuroprotective and antioxidant effects, respectively, offer a different approach by potentially slowing disease progression. Insulin may protect neurons from degeneration, while glutathione reduces oxidative stress, a key factor in PD pathogenesis. This matters for PD patients as it opens avenues for treatments that not only alleviate symptoms but also target underlying disease mechanisms.

What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa, can cause side effects including nausea, somnolence, dizziness, headache, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Levodopa may also lead to elevated homocysteine levels and sensorimotor peripheral neuropathy. Antioxidant treatments like vitamin E have been studied for their potential benefits, but they generally have a good safety profile with modest benefits. Neuroprotective treatments, such as those involving insulin and glutathione, are still under investigation, and their side effects are not yet well-documented.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease primarily focus on managing symptoms and include medications like Levodopa, which is often combined with Carbidopa to enhance its efficacy. Dopamine agonists such as Pramipexole and Ropinirole, and MAO-B inhibitors like Selegiline and Rasagiline, are also commonly used. These treatments aim to increase dopamine levels or mimic its action. While neuroprotective and antioxidant therapies are under investigation, specific FDA-approved drugs with mechanisms similar to insulin (neuroprotective) and glutathione (antioxidant) are not explicitly mentioned in the provided context.

What other types of research exist?

Promising novel alternatives for Parkinson's Disease treatment in 2024 include natural antioxidants such as Ginkgo biloba, Withania somnifera, curcumin, green tea, and Hypericum perforatum, as well as coenzyme Q10. These agents have shown potential neuroprotective and antioxidant effects in preclinical studies, though further clinical trials are needed to confirm their efficacy.

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Insulin + Glutathione for Parkinson's Disease (NOSE-PD Trial)

Phase 2

Waitlist Available

Research Sponsored by Gateway Institute for Brain Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented clinical diagnosis of idiopathic PD

Be older than 18 years old

Must not have

Insufficiently controlled respiratory disease (i.e., asthma, COPD)

Unstable or uncontrolled cardiac disease that could expose the subject to additional safety risks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 weeks

Awards & highlights

All Individual Drugs Already Approved

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include nasal irritation due to administration method and risks typically associated with insulin use such as low blood sugar levels. Other side effects could relate to changes in mood or cognition due to medication interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My asthma or COPD is not well-controlled.

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My heart condition is stable and under control.

Select...

I have epilepsy with seizures in the last year, or I've recently fainted without explanation, or had a serious head injury.

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I am not using insulin, anti-hyperglycemic agents (except for past gestational diabetes), GSH supplements, or beta blockers.

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I have Parkinson's Disease but no other major neurological or mental health conditions.

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I have had a stroke that was not a small-vessel type.

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I have had low blood sugar levels (≤ 50 mg/dL) with or without feeling symptoms.

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I have been diagnosed with Type 1 or Type 2 Diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Cognitive Function

Motor Function

Non-Motor Function

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

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

Group II: ControlPlacebo Group1 Intervention

Placebo

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) include dopaminergic therapies such as levodopa, dopamine agonists, and monoamine oxidase B (MAO-B) inhibitors. Levodopa is converted to dopamine in the brain, replenishing the diminished levels of this neurotransmitter. Dopamine agonists mimic dopamine's effects, while MAO-B inhibitors prevent the breakdown of dopamine, prolonging its action. These treatments primarily address the symptomatic relief of motor symptoms in PD. Insulin and glutathione, being studied for their neuroprotective and antioxidant effects, respectively, offer a different approach by potentially slowing disease progression. Insulin may protect neurons from degeneration, while glutathione reduces oxidative stress, a key factor in PD pathogenesis. This matters for PD patients as it opens avenues for treatments that not only alleviate symptoms but also target underlying disease mechanisms.

Nuclear factor erythroid 2-related factor 2 signaling in Parkinson disease: a promising multi therapeutic target against oxidative stress, neuroinflammation and cell death.