RecruitingPhase 2NCT05266417

Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD)


Sponsor

Gateway Institute for Brain Research

Enrollment

56 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.


Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of intranasal (nose spray) insulin and glutathione (an antioxidant) can improve thinking, memory, and movement in people with Parkinson's disease. Both substances are delivered directly through the nose to reach the brain more effectively. **You may be eligible if...** - You have been diagnosed with idiopathic Parkinson's disease (not caused by another known condition) - Your Parkinson's is not yet at the most advanced stage - You have a caregiver or are able to self-administer the study medications - You are on stable doses of your Parkinson's medications (for at least 30 days before screening) **You may NOT be eligible if...** - You have been diagnosed with Type 1 or Type 2 diabetes - You have a high HbA1c (a blood sugar marker), which suggests poor blood sugar control - You have had a stroke or dementia diagnosis - You are pregnant or breastfeeding - You have had a recent major medication change Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINS-GSH

Intranasal INS-GSH Twice Daily

DRUGMatched Placebos

Intranasal Matched Placebos Twice Daily


Locations(2)

Institute for Neuroimmune Medicine

Davie, Florida, United States

Las Mercedes Medical Research

Hialeah, Florida, United States

View Full Details on ClinicalTrials.gov

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NCT05266417


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