RecruitingRecruiting
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