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New treatment option for Parkinson Disease
Official title Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
ClinicalTrials.gov ID: NCT05266417
What this study is testing
What is INS-GSH?
INS-GSH is an investigational medicine, given as an once-daily, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Davie, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- The Villages, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Davie, Florida, United States; Hialeah, Florida, United States; Miami, Florida, United States; The Villages, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.