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Insulin + Glutathione for Parkinson's Disease (NOSE-PD Trial)

Q: If I qualify, may I take part in this research study?

This study is recruiting 56 people with <a href="https://www.withpower.com/clinical-trials/parkinson-disease">parkinson disease</a>. The following criteria must be met: Documented clinical diagnosis of idiopathic PD, Modified HY stage &#x3C; 5, Able to administer study drug or have a caregiver throughout the duration of the study to help administer drug, If taking PD medications or any nutraceuticals, must be on a stable dose for at least 30 days prior to Screening Visit. Essential changes will be permitted., If subject is taking chronic antidepressant or an anxiolytic, must be on a stable dose for at least 90 days prior to Screening. Essential changes will be permitted., Key

Q: What is the government's current stance on INS-GSH?

While there is some evidence backing INS-GSH's safety, it only received a 2 because efficacy has not been proven in any clinical trials.

Q: Would this experiment be appropriate for senior citizens?

The aim of this clinical study is to recruit individuals who are between 30 and 85 years old.

Q: Are investigators looking for new participants at this time?

That is correct. As of 4/21/2022, this clinical trial was actively recruiting 56 participants from 1 site, according to the listing on clinicaltrials.gov

Q: How many people are subjects in this clinical trial?

Yes, this information can be found on clinicaltrials.gov. This specific trial was posted on February 7th, 2022 and was updated most recently on April 21st of the same year. The study is looking for 56 patients at a single location.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

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 more

NOSE-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

0 / 1Eligibility criteria met

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

INS-GSH Clinical Trial Eligibility Overview. Trial Name: NCT05266417 — Phase 2

Parkinson's Disease Research Study Groups: Active, Control

Parkinson's Disease Clinical Trial 2023: INS-GSH Highlights & Side Effects. Trial Name: NCT05266417 — Phase 2

INS-GSH 2023 Treatment Timeline for Medical Study. Trial Name: NCT05266417 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If I qualify, may I take part in this research study?

"This study is recruiting 56 people with parkinson disease. The following criteria must be met: Documented clinical diagnosis of idiopathic PD, Modified HY stage < 5, Able to administer study drug or have a caregiver throughout the duration of the study to help administer drug, If taking PD medications or any nutraceuticals, must be on a stable dose for at least 30 days prior to Screening Visit. Essential changes will be permitted., If subject is taking chronic antidepressant or an anxiolytic, must be on a stable dose for at least 90 days prior to Screening. Essential changes will be permitted., Key"

Answered by AI

What is the government's current stance on INS-GSH?

"While there is some evidence backing INS-GSH's safety, it only received a 2 because efficacy has not been proven in any clinical trials."

Answered by AI

Would this experiment be appropriate for senior citizens?

"The aim of this clinical study is to recruit individuals who are between 30 and 85 years old."

Answered by AI

Are investigators looking for new participants at this time?

"That is correct. As of 4/21/2022, this clinical trial was actively recruiting 56 participants from 1 site, according to the listing on clinicaltrials.gov"

Answered by AI

How many people are subjects in this clinical trial?

"Yes, this information can be found on clinicaltrials.gov. This specific trial was posted on February 7th, 2022 and was updated most recently on April 21st of the same year. The study is looking for 56 patients at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05266417.

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