RECRUITING

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

Conditions

Parkinson Disease Insulin Glutathione Intranasal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2022-02-07

Study Completion:2027-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05266417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * Willing to continue diet, exercise and medications reported at baseline consistently throughout participation in the trial. Essential changes are permitted * 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.	* Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus * Glycated hemoglobin (HbA1c) level ≥ 6.5% * History of hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with or without symptoms of hypoglycemia * Mini-Mental State Exam (MMSE) score of ≤ 24 at Screening * Positive COVID-19 test at Screening and/or within 30 days of Screening * Change in or escalation of dose of a chronic therapeutic agent that has the potential to impair cognitive functioning * Chronic inflammation of nasal cavity that may prevent absorption of study treatments * Insufficiently controlled respiratory disease (i.e., asthma, COPD). * History of any significant neurologic or psychiatric disease other than PD * Current diagnosis of epilepsy and had a history of seizures as an adult within 1 year of Screening, or unexplained recent loss of consciousness, or history of significant head trauma with loss of consciousness * History of non-lacunar ischemic and/or hemorrhagic stroke * Unstable or uncontrolled cardiac disease that could expose the subject to additional safety risks * Use of the following medications: Insulin or any other anti-hyperglycemic agent(s) except if used during isolated gestational diabetes, Supplementation with GSH or any medication shown to increase glutathione, and Beta Blockers

Inclusion Criteria

Exclusion Criteria

* 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
* Willing to continue diet, exercise and medications reported at baseline consistently throughout participation in the trial. Essential changes are permitted
* 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.

* Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus
* Glycated hemoglobin (HbA1c) level ≥ 6.5%
* History of hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with or without symptoms of hypoglycemia
* Mini-Mental State Exam (MMSE) score of ≤ 24 at Screening
* Positive COVID-19 test at Screening and/or within 30 days of Screening
* Change in or escalation of dose of a chronic therapeutic agent that has the potential to impair cognitive functioning
* Chronic inflammation of nasal cavity that may prevent absorption of study treatments
* Insufficiently controlled respiratory disease (i.e., asthma, COPD).
* History of any significant neurologic or psychiatric disease other than PD
* Current diagnosis of epilepsy and had a history of seizures as an adult within 1 year of Screening, or unexplained recent loss of consciousness, or history of significant head trauma with loss of consciousness
* History of non-lacunar ischemic and/or hemorrhagic stroke
* Unstable or uncontrolled cardiac disease that could expose the subject to additional safety risks
* Use of the following medications: Insulin or any other anti-hyperglycemic agent(s) except if used during isolated gestational diabetes, Supplementation with GSH or any medication shown to increase glutathione, and Beta Blockers

Contacts and Locations

Study Contact

Susana Restrepo, PhD

CONTACT

786-216-5334

srestrepo@gifbr.com

Vanesa Javier

CONTACT

954-636-2166

vaday@gifbr.com

Study Locations (Sites)

Institute for Neuroimmune Medicine

Davie, Florida, 33314

United States

Las Mercedes Medical Research

Hialeah, Florida, 33012

United States

Collaborators and Investigators

Sponsor: Gateway Institute for Brain Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-07

Study Completion Date2027-01-30

Study Record Updates

Study Start Date2022-02-07

Study Completion Date2027-01-30

Terms related to this study

Keywords Provided by Researchers

Insulin
Glutathione
Intranasal

Additional Relevant MeSH Terms

Parkinson Disease