Status:
RECRUITING
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Lead Sponsor:
Gateway Institute for Brain Research
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-85 years
Phase:
PHASE2
Brief Summary
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05266417
Start Date
February 7 2022
End Date
January 30 2027
Last Update
April 30 2025
Active Locations (2)
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1
Institute for Neuroimmune Medicine
Davie, Florida, United States, 33314
2
Las Mercedes Medical Research
Hialeah, Florida, United States, 33012