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

• Sponsor: Gateway Institute for Brain Research (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05266417
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.7
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: INS-GSH; Drug: Matched Placebos	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Feb 7, 2022
• Anticipated Primary Completion Date: Feb 28, 2024
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Insulin (Novolin R) and Glutathione (INS-GSH)	Drug: INS-GSH; Intranasal INS-GSH Twice Daily
Placebo Comparator: Control Placebo	Drug: Matched Placebos; Intranasal Matched Placebos Twice Daily; Other Names: Insulin Matched Placebo and Glutathione Matched Placebo

Outcome Measures

Primary Outcome Measures

1. Verbal Fluency [24 Weeks]

   F, A and S (FAS) words test

Secondary Outcome Measures

1. Verbal Fluency [28 Weeks]

   Change in verbal fluency as assessed by the FAS test

2. Motor Function [24 Weeks]

   Change in Timed Up and Go (TUG) test

3. Motor Function [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

4. Motor Function [24 Weeks]

   Change in the updated MDS-UPDRS total score

5. Motor Function [Week 24]

   Change in the Clinical Global Impression (CGI) score

6. Motor Function [Week 24]

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

7. Cognitive Function [Week 24]

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

8. Non-Motor Function [Week 24]

   Change in Hamilton Rating Scale for Depression total score

9. Patient Reported Outcome [Week 24]

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

10. Patient Reported Outcome [Week 24]

    Change in the Patient Global Impression (PGI) score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Neuroimmune Medicine	Davie	Florida	United States	33314

Sponsors and Collaborators

• Gateway Institute for Brain Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gateway Institute for Brain Research
• ClinicalTrials.gov Identifier: NCT05266417
• Other Study ID Numbers: 20-GTY-008-01
• First Posted: Mar 4, 2022
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• 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
• Keywords provided by Gateway Institute for Brain Research: Insulin; Glutathione; Intranasal
• Additional relevant MeSH terms: Parkinson Disease; Insulin

Study Results

No Results Posted as of Apr 22, 2022