NCT05266417 · Gateway Institute for Brain Research
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
(NOSE-PD)
What this study is about
This study will be evaluating the safety and effectiveness of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
View original scientific description
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Interventions
DRUG
INS-GSH
Intranasal INS-GSH Twice Daily
DRUG
Matched Placebos
Intranasal Matched Placebos Twice Daily
Primary outcome measures
Verbal Fluency
Time frame: 24 Weeks
F, A and S (FAS) words test
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Davie, Florida
- Hialeah, Florida
- Miami, Florida
- The Villages, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2026 · Source of record for eligibility and locations