Actively Recruiting
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Led by Gateway Institute for Brain Research · Updated on 2026-03-31
56
Participants Needed
2
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
CONDITIONS
Official Title
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented clinical diagnosis of idiopathic Parkinson's Disease
- Able to administer study drug or have a caregiver to assist throughout the study
- Willing to consistently continue baseline diet, exercise, and medications during the trial
- Stable dose of Parkinson's medications or nutraceuticals for at least 30 days before screening
- Stable dose of chronic antidepressant or anxiolytic for at least 90 days before screening
You will not qualify if you...
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Glycated hemoglobin (HbA1c) level 6.5% or higher
- History of symptomatic hypoglycemia or documented low plasma glucose with symptoms
- Mini-Mental State Exam score 24 or lower at screening
- Positive COVID-19 test at or within 30 days before screening
- Recent change or increase in dose of chronic cognitive-impairing therapies within 8 weeks before screening or during study
- Chronic nasal inflammation or history of recurrent nosebleeds or uncontrolled allergic rhinitis
- Poorly controlled respiratory diseases such as asthma or COPD
- History of significant neurological or psychiatric diseases other than Parkinson's Disease
- Current epilepsy diagnosis with recent seizures or unexplained loss of consciousness
- History of stroke with residual neurological deficits
- Unstable or uncontrolled heart disease posing safety risks
- Use of insulin or other anti-hyperglycemic agents except isolated gestational diabetes
- Use of glutathione supplements or medications that increase glutathione levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Institute for Neuroimmune Medicine
Davie, Florida, United States, 33314
Actively Recruiting
2
Las Mercedes Medical Research
Hialeah, Florida, United States, 33012
Actively Recruiting
Research Team
S
Susana Restrepo, PhD
CONTACT
V
Vanesa Javier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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