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

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

INS-GSH

Matched Placebos

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Insulin, Glutathione, Intranasal

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion 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.

Key Exclusion Criteria:

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

Sites / Locations

Institute for Neuroimmune MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Control

Arm Description

Insulin (Novolin R) and Glutathione (INS-GSH)

Placebo

Outcomes

Primary Outcome Measures

Verbal Fluency

F, A and S (FAS) words test

Secondary Outcome Measures

Verbal Fluency

Change in verbal fluency as assessed by the FAS test

Motor Function

Change in Timed Up and Go (TUG) test

Motor Function

Change in the updated Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score

Motor Function

Change in the updated MDS-UPDRS total score

Motor Function

Change in the Clinical Global Impression (CGI) score

Motor Function

Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)

Cognitive Function

Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery

Non-Motor Function

Change in Hamilton Rating Scale for Depression total score

Patient Reported Outcome

Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment

Patient Reported Outcome

Change in the Patient Global Impression (PGI) score

Full Information

NCT ID

NCT05266417

First Posted

February 23, 2022

Last Updated

April 21, 2022

Sponsor

Gateway Institute for Brain Research

1. Study Identification

Unique Protocol Identification Number

NCT05266417

Brief Title

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

Acronym

NOSE-PD

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 7, 2022 (Actual)

Primary Completion Date

February 28, 2024 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gateway Institute for Brain Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Insulin, Glutathione, Intranasal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

Insulin (Novolin R) and Glutathione (INS-GSH)

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

INS-GSH

Intervention Description

Intranasal INS-GSH Twice Daily

Intervention Type

Drug

Intervention Name(s)

Matched Placebos

Other Intervention Name(s)

Insulin Matched Placebo and Glutathione Matched Placebo

Intervention Description

Intranasal Matched Placebos Twice Daily

Primary Outcome Measure Information:

Title

Verbal Fluency

Description

F, A and S (FAS) words test

Time Frame

24 Weeks

Secondary Outcome Measure Information:

Title

Verbal Fluency

Description

Change in verbal fluency as assessed by the FAS test

Time Frame

28 Weeks

Title

Motor Function

Description

Change in Timed Up and Go (TUG) test

Time Frame

24 Weeks

Title

Motor Function

Description

Change in the updated Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score

Time Frame

24 Weeks

Title

Motor Function

Description

Change in the updated MDS-UPDRS total score

Time Frame

24 Weeks

Title

Motor Function

Description

Change in the Clinical Global Impression (CGI) score

Time Frame

Week 24

Title

Motor Function

Description

Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)

Time Frame

Week 24

Title

Cognitive Function

Description

Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery

Time Frame

Week 24

Title

Non-Motor Function

Description

Change in Hamilton Rating Scale for Depression total score

Time Frame

Week 24

Title

Patient Reported Outcome

Description

Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment

Time Frame

Week 24

Title

Patient Reported Outcome

Description

Change in the Patient Global Impression (PGI) score

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion 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. Key Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Freeman

Phone

(954) 636-2166

tfreeman@gifbr.com

First Name & Middle Initial & Last Name or Official Title & Degree

Vanesa Aday

Phone

(954) 636-2166

vaday@gifbr.com

Facility Information:

Facility Name

Institute for Neuroimmune Medicine

City

Davie

State/Province

Florida

ZIP/Postal Code

33314

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irina Rozenfeld, DN

12. IPD Sharing Statement

Learn more about this trial

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

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