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

Phase 2
Recruiting
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

Summary

This trial will see if insulin and glutathione can help treat Parkinson's Disease better than a placebo.

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.Check my eligibility
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.See study design
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.
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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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Cognitive Function
Motor Function
Non-Motor Function
+2 more

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

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.

Find a Location

Who is running the clinical trial?

Gateway Institute for Brain ResearchLead Sponsor
1 Previous Clinical Trials
86 Total Patients Enrolled

Media Library

INS-GSH Clinical Trial Eligibility Overview. Trial Name: NCT05266417 — Phase 2
Parkinson's Disease Research Study Groups: Active, Control
Parkinson's Disease Clinical Trial 2023: INS-GSH Highlights & Side Effects. Trial Name: NCT05266417 — Phase 2
INS-GSH 2023 Treatment Timeline for Medical Study. Trial Name: NCT05266417 — Phase 2
~16 spots leftby Jul 2025