Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease (NOSE-PD)

July 21, 2026 updated by: Gateway Institute for Brain Research

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Davie, Florida, United States, 33314
        • Recruiting
        • Institute for Neuroimmune Medicine
        • Contact:
          • Rafael Iglesias
          • Phone Number: 954-262-2876
          • Email: ri73@nova.edu
        • Principal Investigator:
          • Irina Rozenfeld, DPN, APRN
      • Hialeah, Florida, United States, 33012
      • Miami, Florida, United States, 33165
      • The Villages, Florida, United States, 32162

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Documented clinical diagnosis of idiopathic PD
  • 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.

Key Exclusion Criteria:

  • Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus
  • Glycated hemoglobin (HbA1c) level ≥ 6.5%
  • History of symptomatic hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with 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 per investigator within the last 8 weeks of Screening or during the study conduct.
  • Chronic inflammation of nasal cavity, history of recurrent epistaxis, and/or clinically significant medical history of uncontrolled allergic rhinitis, rhino-conjunctivitis, or house dust mite allergy at Screening 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 with residual neurologic deficits.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Placebo
Drug: Matched Placebos
Intranasal Matched Placebos Twice Daily
Other Names:
  • Insulin Matched Placebo and Glutathione Matched Placebo
Experimental: Active
Insulin (Novolin R) and Glutathione (INS-GSH)
Drug: INS-GSH
Intranasal INS-GSH Twice Daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Verbal Fluency
Time Frame: 24 Weeks
F, A and S (FAS) words test
24 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Verbal Fluency
Time Frame: 28 Weeks
Change in verbal fluency as assessed by the FAS test
28 Weeks
Motor Function
Time Frame: 24 Weeks
Change in Timed Up and Go (TUG) test
24 Weeks
Motor Function
Time Frame: 24 Weeks
Change in the updated Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score
24 Weeks
Motor Function
Time Frame: 24 Weeks
Change in the updated MDS-UPDRS total score
24 Weeks
Motor Function
Time Frame: Week 24
Change in the Clinical Global Impression (CGI) score
Week 24
Motor Function
Time Frame: Week 24
Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)
Week 24
Cognitive Function
Time Frame: Week 24
Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery
Week 24
Non-Motor Function
Time Frame: Week 24
Change in Hamilton Rating Scale for Depression total score
Week 24
Patient Reported Outcome
Time Frame: Week 24
Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment
Week 24
Patient Reported Outcome
Time Frame: Week 24
Change in the Patient Global Impression (PGI) score
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-GTY-008-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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