Clinical Trials in the USA / NCT05266417
Recruiting
Phase 2
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
NCT05266417 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Parkinson Disease
Investigational drug(s) / intervention(s)
INS-GSHMatched Placebos
INS-GSH: Intranasal INS-GSH Twice Daily
Matched Placebos: Intranasal Matched Placebos Twice Daily
Study summary
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Eligibility
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
Primary outcome measure(s)
- Verbal Fluency — 24 Weeks
F, A and S (FAS) words test
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Institute for Neuroimmune Medicine | Davie | Florida | Recruiting |
| Las Mercedes Medical Research | Hialeah | Florida | Recruiting |
| NextGen Research Group | Miami | Florida | Recruiting |
| Charter Research | The Villages | Florida | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05266417 on ClinicalTrials.gov ↗ ← All trials in the USA