Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Phase 2
Recruiting
- Conditions
- Parkinson Disease
- Interventions
- Drug: INS-GSHDrug: Matched Placebos
- Registration Number
- NCT05266417
- Lead Sponsor
- Gateway Institute for Brain Research
- Brief Summary
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active INS-GSH Insulin (Novolin R) and Glutathione (INS-GSH) Control Matched Placebos Placebo
- Primary Outcome Measures
Name Time Method Verbal Fluency 24 Weeks F, A and S (FAS) words test
- Secondary Outcome Measures
Name Time Method Verbal Fluency 28 Weeks Change in verbal fluency as assessed by the FAS test
Motor Function Week 24 Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)
Cognitive Function Week 24 Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery
Non-Motor Function Week 24 Change in Hamilton Rating Scale for Depression total score
Patient Reported Outcome Week 24 Change in the Patient Global Impression (PGI) score
Trial Locations
- Locations (2)
Institute for Neuroimmune Medicine
🇺🇸Davie, Florida, United States
Las Mercedes Medical Research
🇺🇸Hialeah, Florida, United States