Using intranasal insulin and glutathione to treat Parkinson's disease

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD)

This study is testing if a combination of nasal insulin and glutathione can help improve symptoms or slow down the progression of Parkinson's disease in people who have it.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Gateway Institute for Brain Research (industry)
• Locations: 2 sites (Davie, Florida and 1 other locations)
• Trial ID: NCT05266417 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of intranasal insulin combined with glutathione as an add-on therapy for patients with Parkinson's Disease, comparing the effects to a placebo group. Participants must have a documented diagnosis of idiopathic Parkinson's Disease and be able to administer the study drug or have assistance. The trial aims to assess whether this combination therapy can improve symptoms or slow disease progression in affected individuals.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with idiopathic Parkinson's Disease who are in modified Hoehn and Yahr stage less than 5.

Not a fit: Patients with a clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus or those with significant cognitive impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for managing Parkinson's Disease symptoms.

How similar studies have performed: While the combination of intranasal insulin and glutathione is a novel approach, similar studies targeting neurodegenerative conditions have shown promise, suggesting potential for success.

Eligibility criteria

Key Inclusion Criteria:

* Documented clinical diagnosis of idiopathic PD
* Able to administer study drug or have a caregiver throughout the duration of the study to help administer drug
* Willing to continue diet, exercise and medications reported at baseline consistently throughout participation in the trial. Essential changes are permitted
* If taking PD medications or any nutraceuticals, must be on a stable dose for at least 30 days prior to Screening Visit. Essential changes will be permitted.
* If subject is taking chronic antidepressant or an anxiolytic, must be on a stable dose for at least 90 days prior to Screening. Essential changes will be permitted.

Key Exclusion Criteria:

* Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus
* Glycated hemoglobin (HbA1c) level ≥ 6.5%
* History of symptomatic hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with symptoms of hypoglycemia.
* Mini-Mental State Exam (MMSE) score of ≤ 24 at Screening
* Positive COVID-19 test at Screening and/or within 30 days of Screening
* Change in or escalation of dose of a chronic therapeutic agent that has the potential to impair cognitive functioning per investigator within the last 8 weeks of Screening or during the study conduct.
* Chronic inflammation of nasal cavity, history of recurrent epistaxis, and/or clinically significant medical history of uncontrolled allergic rhinitis, rhino-conjunctivitis, or house dust mite allergy at Screening that may prevent absorption of study treatments.
* Insufficiently controlled respiratory disease (i.e., asthma, COPD).
* History of any significant neurologic or psychiatric disease other than PD
* Current diagnosis of epilepsy and had a history of seizures as an adult within 1 year of Screening, or unexplained recent loss of consciousness, or history of significant head trauma with loss of consciousness
* History of non-lacunar ischemic and/or hemorrhagic stroke with residual neurologic deficits.
* Unstable or uncontrolled cardiac disease that could expose the subject to additional safety risks
* Use of the following medications: Insulin or any other anti-hyperglycemic agent(s) except if used during isolated gestational diabetes, Supplementation with GSH or any medication shown to increase glutathione

Where this trial is running

Davie, Florida and 1 other locations

• Institute for Neuroimmune Medicine — Davie, Florida, United States (RECRUITING)
• Las Mercedes Medical Research — Hialeah, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Susana Restrepo, PhD

Conditions: Parkinson Disease, Insulin, Glutathione, Intranasal