NCT05266417 Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
| NCT ID | NCT05266417 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Gateway Institute for Brain Research |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2022-02-07 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 56 participants in total. It began in 2022-02-07 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05266417 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05266417 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05266417 currently recruiting?
Yes, NCT05266417 is actively recruiting participants. Contact the research team at srestrepo@gifbr.com for enrollment information.
Where is the NCT05266417 trial being conducted?
This trial is being conducted at Davie, United States, Hialeah, United States, Miami, United States, The Villages, United States.
Who is sponsoring the NCT05266417 clinical trial?
NCT05266417 is sponsored by Gateway Institute for Brain Research. The trial plans to enroll 56 participants.
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