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

Parkinson Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266417
• Other study ID #: 20-GTY-008-01
• Status: Recruiting
• Phase: Phase 2
• Start date: February 7, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2022
• Source: Gateway Institute for Brain Research
• Contact: Thomas Freeman
• Phone: (954) 636-2166
• Email: tfreeman[@]gifbr.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• INS-GSH
Intranasal INS-GSH Twice Daily
• Matched Placebos
Intranasal Matched Placebos Twice Daily

Locations

Country	Name	City	State
United States	Institute for Neuroimmune Medicine	Davie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gateway Institute for Brain Research

Country where clinical trial is conducted

United States, 

Outcome

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