Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease

Study Overview
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Brief Summary
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This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: INS-GSH
* Drug: Matched Placebos


Participation Criteria
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Eligibility Criteria
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Key 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Insulin (Novolin R) and Glutathione (INS-GSH) | Drug: INS-GSH<br>* Intranasal INS-GSH Twice Daily<br>|
| Placebo Comparator: Control<br>Placebo | Drug: Matched Placebos<br>* Intranasal Matched Placebos Twice Daily<br>* Other names: Insulin Matched Placebo and Glutathione Matched Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Fluency | F, A and S (FAS) words test | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Fluency | Change in verbal fluency as assessed by the FAS test | 28 Weeks | 
| Motor Function | Change in Timed Up and Go (TUG) test | 24 Weeks | 
| Motor Function | Change in the updated Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score | 24 Weeks | 
| Motor Function | Change in the updated MDS-UPDRS total score | 24 Weeks | 
| Motor Function | Change in the Clinical Global Impression (CGI) score | Week 24 | 
| Motor Function | Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD) | Week 24 | 
| Cognitive Function | Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery | Week 24 | 
| Non-Motor Function | Change in Hamilton Rating Scale for Depression total score | Week 24 | 
| Patient Reported Outcome | Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment | Week 24 | 
| Patient Reported Outcome | Change in the Patient Global Impression (PGI) score | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin, Glutathione, Intranasal