Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease

• Status: Recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gateway Institute for Brain Research
• Treatments: Insulin

Criteria

Key Inclusion Criteria:

• Documented clinical diagnosis of idiopathic PD

• Modified HY stage < 5

• 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 hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with or without 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

• Chronic inflammation of nasal cavity 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

• 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, and Beta Blockers