RecruitingPhase 2NCT05266417

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

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)

Sponsor

Gateway Institute for Brain Research

Enrollment

56 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

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

Eligibility

Min Age: 30 YearsMax Age: 85 Years

Inclusion Criteria6

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.

Exclusion Criteria13

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