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RecruitingPhase 2

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests insulin and glutathione given through the nose as an added treatment for people with Parkinson’s disease. It compares them with a placebo (a treatment with no active drug) to see how safe they are and how well they work.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of idiopathic Parkinson’s disease, meaning the cause is not known.
  • Be able to take the study drug yourself, or have a caregiver help throughout the study.
  • Keep your usual diet, exercise, and medicines the same during the study. Needed changes are allowed.
  • If you take Parkinson’s medicines or health supplements, have a steady dose for at least 30 days before screening. Needed changes are allowed.
  • If you regularly take medicine for depression or anxiety, have a steady dose for at least 90 days before screening. Needed changes are allowed.

Who can't join

  • Have type 1 or type 2 diabetes; an HbA1c blood sugar test result of 6.5% or higher; or a history of low blood sugar with symptoms, including a measured level of 50 mg/dL or lower.
  • Score 24 or lower on the MMSE, a test of memory and thinking, at screening.
  • Test positive for COVID-19 at screening or within the 30 days before screening.
  • Have a change or increase in a regular medicine that the study doctor thinks could harm thinking skills, within 8 weeks before screening or during the study.
  • Have ongoing swelling inside the nose, repeated nosebleeds, or uncontrolled nose, eye, or dust mite allergies that may block treatment absorption. Poorly controlled breathing disease, such as asthma or COPD, also rules you out.
  • Have a major brain, nerve, or mental health condition other than Parkinson’s; epilepsy with an adult seizure within the past year; recent unexplained fainting; a serious head injury with loss of consciousness; or certain strokes with lasting brain or nerve problems.
  • Have unstable or uncontrolled heart disease that could add safety risks.
  • Use insulin or other blood sugar-lowering medicines, except past use only for diabetes during pregnancy. Glutathione (GSH) supplements or medicines shown to raise glutathione also rule you out.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (4)

FL