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

NCT05266417 · Gateway Institute for Brain Research
In plain English

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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)
About this study
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 * 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 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
Study design
Enrollment target: 56 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2022-02-07
Estimated completion: 2027-07-30
Last updated: 2026-05-28
Interventions
Drug: INS-GSHDrug: Matched Placebos
Primary outcomes
  • Verbal Fluency (24 Weeks)
Sponsor
Gateway Institute for Brain Research · industry
Contacts & investigators
ContactSusana Restrepo, PhD · contact · srestrepo@gifbr.com · 786-216-5334
ContactVanesa Javier · contact · vaday@gifbr.com · 954-636-2166
All locations (3)
Institute for Neuroimmune MedicineRecruiting
Davie, Florida, United States
Las Mercedes Medical ResearchRecruiting
Hialeah, Florida, United States
NextGen Research GroupRecruiting
Miami, Florida, United States
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease · TrialPath