Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Documented clinical diagnosis of idiopathic PD
- * Modified HY stage \< 5
- * 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.
- * Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus
- * Glycated hemoglobin (HbA1c) level ≥ 6.5%
- * History of hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with or without 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
- * Chronic inflammation of nasal cavity 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
- * 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, and Beta Blockers
Ages Eligible for Study
30 Years to 85 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No