NCT05266417RecruitingPhase 2
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)
Gateway Institute for Brain Research6 sites in 1 country56 target enrollmentStarted: February 7, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 56
- Locations
- 6
- Primary Endpoint
- Verbal Fluency
Study Overview
Brief Summary
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
Arms & Interventions
Active
Experimental
Insulin (Novolin R) and Glutathione (INS-GSH)
Intervention: INS-GSH (Drug)
Control
Placebo Comparator
Placebo
Intervention: Matched Placebos (Drug)
Outcomes
Primary Outcomes
Verbal Fluency
Time Frame: 24 Weeks
F, A and S (FAS) words test
Secondary Outcomes
- Verbal Fluency(28 Weeks)
- Cognitive Function(Week 24)
- Non-Motor Function(Week 24)
- Motor Function(Week 24)
- Patient Reported Outcome(Week 24)
Investigators
Study Sites (6)
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