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Insulin + Glutathione for Parkinson's Disease (NOSE-PD Trial)
Phase 2
Recruiting
Research Sponsored by Gateway Institute for Brain Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented clinical diagnosis of idiopathic PD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights
NOSE-PD Trial Summary
This trial will see if insulin and glutathione can help treat Parkinson's Disease better than a placebo.
Who is the study for?
This trial is for people with Parkinson's Disease who can self-administer the study drug or have someone to help them. They must be consistent with their diet, exercise, and current medications, which should be stable for at least 30 days (90 days for antidepressants or anxiolytics). They cannot join if they have nasal inflammation that affects drug absorption, other significant neurological/psychiatric diseases, recent seizures or loss of consciousness, uncontrolled heart disease, diabetes with HbA1c ≥ 6.5%, history of severe hypoglycemia, use certain disallowed medications like insulin or beta blockers.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of intranasal insulin combined with glutathione (INS-GSH) versus placebo in managing Parkinson's Disease symptoms. Participants will either receive the actual treatment or a matched placebo without knowing which one they are getting.See study design
What are the potential side effects?
Potential side effects may include nasal irritation due to administration method and risks typically associated with insulin use such as low blood sugar levels. Other side effects could relate to changes in mood or cognition due to medication interactions.
NOSE-PD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Parkinson's disease.
NOSE-PD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Cognitive Function
Motor Function
Non-Motor Function
+2 moreNOSE-PD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Insulin (Novolin R) and Glutathione (INS-GSH)
Group II: ControlPlacebo Group1 Intervention
Placebo
Find a Location
Who is running the clinical trial?
Gateway Institute for Brain ResearchLead Sponsor
1 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take the study drug myself or have someone to help me with it.Your Mini-Mental State Exam (MMSE) score is 24 or lower at the screening.I have long-term nasal inflammation that could affect medication absorption.My asthma or COPD is not well-controlled.My heart condition is stable and under control.I have been on the same dose of my antidepressant or anxiety medication for at least 90 days.I have epilepsy with seizures in the last year, or I've recently fainted without explanation, or had a serious head injury.I am not using insulin, anti-hyperglycemic agents (except for past gestational diabetes), GSH supplements, or beta blockers.I have been on the same dose of my Parkinson's or supplement medication for at least 30 days.I have Parkinson's Disease but no other major neurological or mental health conditions.I am willing to maintain my current lifestyle and medication regimen during the trial, with necessary adjustments allowed.I have had a stroke that was not a small-vessel type.You have tested positive for COVID-19 within 30 days before or during the screening.I have been diagnosed with Parkinson's disease.Your HbA1c level is higher than 6.5%.My medication dose that might affect my thinking was changed recently.I have had low blood sugar levels (≤ 50 mg/dL) with or without feeling symptoms.I have been diagnosed with Type 1 or Type 2 Diabetes.Your modified Hoehn and Yahr stage is less than 5.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Control
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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