Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease (NOSE-PD)

Gateway Institute for Brain Research

Status and phase: Enrolling; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: INS-GSH; Drug: Matched Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT05266417

20-GTY-008-01

Details and patient eligibility

About

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

Enrollment: 56 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Insulin (Novolin R) and Glutathione (INS-GSH)

Treatment:

Drug: INS-GSH

Control

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Matched Placebos