Trial · Interventional
RecruitingPhase 2Registry dataIntranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
Short name NOSE-PD
Overview
- Status
- Recruiting
- Phase
- Phase 2
- Enrollment
- 56 participants (estimated)
- Sponsor
- Gateway Institute for Brain Research · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 7 Feb 2022
- Primary completion
- 1 Sept 2027 (estimated)
- Completion
- 30 Nov 2027 (estimated)
- First posted
- 4 Mar 2022
- Last update posted
- 22 Jul 2026
- Conditions
- Parkinson Disease
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Interventions
- INS-GSHDrug
- Matched PlacebosDrug
Arms2
Experimental
Active
Insulin (Novolin R) and Glutathione (INS-GSH)
Placebo comparator
Control
Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Verbal Fluency
Time frame · 24 Weeks
Registry description
F, A and S (FAS) words test
Secondary outcomes(10)
Verbal Fluency
Time frame · 28 Weeks
Registry description
Change in verbal fluency as assessed by the FAS test
Motor Function
Time frame · 24 Weeks
Registry description
Change in Timed Up and Go (TUG) test
Motor Function
Time frame · 24 Weeks
Registry description
Change in the updated Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score
Motor Function
Time frame · 24 Weeks
Registry description
Change in the updated MDS-UPDRS total score
Motor Function
Time frame · Week 24
Registry description
Change in the Clinical Global Impression (CGI) score
Motor Function
Time frame · Week 24
Registry description
Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)
Cognitive Function
Time frame · Week 24
Registry description
Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery
Non-Motor Function
Time frame · Week 24
Registry description
Change in Hamilton Rating Scale for Depression total score
Patient Reported Outcome
Time frame · Week 24
Registry description
Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment
Patient Reported Outcome
Time frame · Week 24
Registry description
Change in the Patient Global Impression (PGI) score
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 30 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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