Intranasal Insulin and Glutathione for Parkinson's Disease
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Recruiting
Phase 2Interventional Study
Parkinson Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
56 (estimated)
Sponsor
Gateway Institute for Brain Research · Industry
Who this trial is looking for
This trial is looking for people with Parkinson's Disease to test the safety and effectiveness of a new treatment involving insulin and glutathione. Participants will need to take part in the study for some time and will continue their usual diet and medications.
Are You a Good Fit for This Trial?
Must not be takingInsulinGlutathione supplementation
Rules you outEpilepsyRecent seizuresSignificant head traumaHistory of strokeRespiratory disease
You may be able to join if
I have been diagnosed with Parkinson's Disease.
I can take the study drug myself or have someone help me.
I am willing to keep my diet, exercise, and medications the same during the study.
I have been on a stable dose of Parkinson's medications for at least 30 days.
I have been on a stable dose of antidepressants or anxiolytics for at least 90 days.
You may not be able to join if
I have been diagnosed with Type 1 or Type 2 Diabetes.
My HbA1c level is 6.5% or higher.
I have a history of low blood sugar events.
I scored 24 or lower on the Mini-Mental State Exam.
I tested positive for COVID-19 in the last 30 days.
I have had a recent medication change that affects my thinking.
I have chronic nasal inflammation or significant allergies.
I have unstable or uncontrolled heart disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Trial Locations
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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 i…
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
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