This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
56
Intranasal INS-GSH Twice Daily
Intranasal Matched Placebos Twice Daily
Institute for Neuroimmune Medicine
Davie, Florida, United States
RECRUITINGLas Mercedes Medical Research
Hialeah, Florida, United States
RECRUITINGVerbal Fluency
F, A and S (FAS) words test
Time frame: 24 Weeks
Verbal Fluency
Change in verbal fluency as assessed by the FAS test
Time frame: 28 Weeks
Motor Function
Change in Timed Up and Go (TUG) test
Time frame: 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
Time frame: 24 Weeks
Motor Function
Change in the updated MDS-UPDRS total score
Time frame: 24 Weeks
Motor Function
Change in the Clinical Global Impression (CGI) score
Time frame: Week 24
Motor Function
Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)
Time frame: 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
Time frame: Week 24
Non-Motor Function
Change in Hamilton Rating Scale for Depression total score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 24
Patient Reported Outcome
Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment
Time frame: Week 24
Patient Reported Outcome
Change in the Patient Global Impression (PGI) score
Time frame: Week 24