Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Part of paid clinical trials in Davie, Florida.
- Sponsor
- Gateway Institute for Brain Research
- Study ID
- NCT05266417
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- INS-GSH — DRUGIntranasal INS-GSH Twice Daily
- Matched Placebos — DRUGIntranasal Matched Placebos Twice Daily
Study Details
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Key Dates
- Start date
- Feb 7, 2022
- Status verified
- May 2026
- Primary completion
- Jan 1, 2027
- Completion
- Jul 30, 2027
Study Design
- Enrollment
- 56 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ActiveInsulin (Novolin R) and Glutathione (INS-GSH)
- Placebo Comparator: ControlPlacebo
Primary Outcome Measure
Verbal Fluency [ Time Frame: 24 Weeks ]
Central Contacts
- Susana Restrepo, PhD786-216-5334
- Vanesa Javier954-636-2166
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Institute for Neuroimmune Medicine | Davie | Florida | 33314 | Irina Rozenfeld, DPN, APRN (PRINCIPAL_INVESTIGATOR) |
| Las Mercedes Medical Research | Hialeah | Florida | 33012 | Frank Alvarez, MD (PRINCIPAL_INVESTIGATOR) |
| NextGen Research Group | Miami | Florida | 33165 |
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