Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
NCT ID: NCT05266417
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
56 participants
INTERVENTIONAL
2022-02-07
2027-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
Insulin (Novolin R) and Glutathione (INS-GSH)
INS-GSH
Intranasal INS-GSH Twice Daily
Control
Placebo
Matched Placebos
Intranasal Matched Placebos Twice Daily
Interventions
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INS-GSH
Intranasal INS-GSH Twice Daily
Matched Placebos
Intranasal Matched Placebos Twice Daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
30 Years
85 Years
ALL
No
Sponsors
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Gateway Institute for Brain Research
INDUSTRY
Responsible Party
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Locations
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Institute for Neuroimmune Medicine
Davie, Florida, United States
Las Mercedes Medical Research
Hialeah, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-GTY-008-01
Identifier Type: -
Identifier Source: org_study_id
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