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NCT05266417 | RECRUITING | Parkinson Disease

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

Gateway Institute for Brain Research

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

Parkinson Disease

Intervention/treatment

INS-GSH

Matched Placebos

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 56 participants
Masking : TRIPLE
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 : 2022-02-07
Estimated Primary Completion Date : 2027-01-01
Estimated Study Completion Date : 2027-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key 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.
  • Key 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
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease

Location Details

NCT05266417

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Institute for Neuroimmune Medicine

Davie, florida, United States, 33314

RECRUITING

United States, Florida

Las Mercedes Medical Research

Hialeah, florida, United States, 33012