Clinical trial NCT05266417: Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Insulin
Glutathione
Intranasal
Lead sponsor: Gateway Institute for Brain Research
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Verbal Fluency
timeFrame: 24 Weeks
Secondary outcomes:
measure: Verbal Fluency
timeFrame: 28 Weeks
measure: Motor Function
timeFrame: 24 Weeks
measure: Motor Function
timeFrame: 24 Weeks
measure: Motor Function
timeFrame: 24 Weeks
measure: Motor Function
timeFrame: Week 24
measure: Motor Function
timeFrame: Week 24
measure: Cognitive Function
timeFrame: Week 24
measure: Non-Motor Function
timeFrame: Week 24
measure: Patient Reported Outcome
timeFrame: Week 24
measure: Patient Reported Outcome
timeFrame: Week 24
Other outcomes:
Locations:
city: Davie
country: United States
facility: Institute for Neuroimmune Medicine
state: Florida
city: Hialeah
country: United States
facility: Las Mercedes Medical Research
state: Florida
Study officials:
References: