Parkinson Disease
Conditions
Keywords
Insulin, Glutathione, Intranasal
Brief summary
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Interventions
DRUGINS-GSH
Intranasal INS-GSH Twice Daily
DRUGMatched Placebos
Intranasal Matched Placebos Twice Daily
Sponsors
Gateway Institute for Brain Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Fluency | 24 Weeks | F, A and S (FAS) words test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Fluency | 28 Weeks | Change in verbal fluency as assessed by the FAS test |
| Motor Function | 24 Weeks | Change in Timed Up and Go (TUG) test |
| Cognitive Function | Week 24 | Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery |
| Non-Motor Function | Week 24 | Change in Hamilton Rating Scale for Depression total score |
| Patient Reported Outcome | Week 24 | Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment |
Countries
United States
Contacts
CONTACTSusana Restrepo, PhD
CONTACTVanesa Javier
Outcome results
None listed