Back to search results

Intranasal Insulin and Glutathione for Parkinson's Disease

This study is looking into whether a combination of INS-GSH (intranasal insulin and glutathione) given twice daily can be a safe and effective add-on treatment for people with Parkinson's disease. You might be able to join if you have been diagnosed with idiopathic Parkinson's disease and are able to administer the study drug yourself or have a caregiver help you. The study will compare INS-GSH to matched placebos (inactive substances that look like the study drug) to see if it improves verbal fluency (how easily you can find and use words) after 24 weeks. The current status of this study is unclear, and it plans to enroll 56 participants.

Study design
This is an interventional study planning to enroll 56 participants. It compares INS-GSH to matched placebos.
What's involved
You would need to administer the study drug (INS-GSH or placebo) twice daily. You would also need to continue your diet, exercise, and medications consistently throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, verbal fluency, is measured at 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05266417

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

Recruiting
PHASE2Ages 30+InterventionalTreatment
Gateway Institute for Brain Research
~56 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:INS-GSHMatched Placebos

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Verbal Fluency
Measured over 24 Weeks

Conditions

Parkinson Disease

Explore related trials

Parkinson Disease

NCT05266417

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Charter Research

    The Villages, Floridastudy coordinator listed

    Recruiting

  • Institute for Neuroimmune Medicine

    Davie, Floridastudy coordinator listed

    Recruiting

  • Las Mercedes Medical Research

    Hialeah, Floridastudy coordinator listed

    Recruiting

  • NextGen Research Group

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Susana Restrepo, PhD
[email protected]
786-216-5334
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Verbal Fluency24 Weeks

    F, A and S (FAS) words test