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

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: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: INS-GSH; Drug: Matched Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Thomas Freeman; Phone Number: (954) 636-2166; Email: tfreeman@gifbr.com
• Study Contact Backup: Name: Vanesa Aday; Phone Number: (954) 636-2166; Email: vaday@gifbr.com

Study Locations

• United States
  • Florida
    • Davie, Florida, United States, 33314
      • Recruiting
      • Institute for Neuroimmune Medicine
      • Contact: Irina Rozenfeld, DN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Verbal Fluency	F, A and S (FAS) words test	24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Fluency	Change in verbal fluency as assessed by the FAS test	28 Weeks
Motor Function	Change in Timed Up and Go (TUG) test	24 Weeks
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	24 Weeks
Motor Function	Change in the updated MDS-UPDRS total score	24 Weeks
Motor Function	Change in the Clinical Global Impression (CGI) score	Week 24
Motor Function	Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)	Week 24
Cognitive Function	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	Change in Hamilton Rating Scale for Depression total score	Week 24
Patient Reported Outcome	Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment	Week 24
Patient Reported Outcome	Change in the Patient Global Impression (PGI) score	Week 24

Collaborators and Investigators

• Sponsor: Gateway Institute for Brain Research

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Insulin; Intranasal; Glutathione
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID 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