Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Insulin (Novolin R) and Glutathione (INS-GSH) |
|
| Control | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INS-GSH | Drug | Intranasal INS-GSH Twice Daily |
| |
| Matched Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Fluency | F, A and S (FAS) words test | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Fluency | Change in verbal fluency as assessed by the FAS test | 28 Weeks |
| Motor Function | Change in Timed Up and Go (TUG) test |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susana Restrepo, PhD | Contact | 786-216-5334 | srestrepo@gifbr.com | |
| Vanesa Javier | Contact | 954-636-2166 | vaday@gifbr.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Neuroimmune Medicine | Recruiting | Davie | Florida | 33314 | United States |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Intranasal Matched Placebos Twice Daily |
|
|
| 24 Weeks |
| Motor Function | Change in the updated Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score | 24 Weeks |
| Motor Function | Change in the updated MDS-UPDRS total score | 24 Weeks |
| Motor Function | Change in the Clinical Global Impression (CGI) score | Week 24 |
| Motor Function | Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD) | Week 24 |
| Cognitive Function | Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery | Week 24 |
| Non-Motor Function | Change in Hamilton Rating Scale for Depression total score | Week 24 |
| Patient Reported Outcome | Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment | Week 24 |
| Patient Reported Outcome | Change in the Patient Global Impression (PGI) score | Week 24 |
| Las Mercedes Medical Research | Recruiting | Hialeah | Florida | 33012 | United States |
|
| NextGen Research Group | Recruiting | Miami | Florida | 33165 | United States |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |