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

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)

Overview

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

Interventions

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

Primary outcome measures

• Verbal Fluency [Time frame: 24 Weeks]

Secondary outcome measures (10)

• Verbal Fluency [Time frame: 28 Weeks]
• Motor Function [Time frame: 24 Weeks]
• Motor Function [Time frame: 24 Weeks]
• Motor Function [Time frame: 24 Weeks]
• Motor Function [Time frame: Week 24]
• Motor Function [Time frame: Week 24]
• Cognitive Function [Time frame: Week 24]
• Non-Motor Function [Time frame: Week 24]
• Patient Reported Outcome [Time frame: Week 24]
• Patient Reported Outcome [Time frame: Week 24]

Eligibility criteria

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Institute for Neuroimmune Medicine — Davie
• Las Mercedes Medical Research — Hialeah
• NextGen Research Group — Miami
• Charter Research — The Villages

Identifiers

NCT: NCT05266417 · 20-GTY-008-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗