---
title: Test intranasal insulin and glutathione
nct_id: NCT05266417
phase: PHASE2
status: RECRUITING
sponsor: Gateway Institute for Brain Research
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05266417"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05266417"
last_fetched: "2026-05-10T14:06:39.545Z"
source: "Parkinson's Pathways (curated)"
---
# Test intranasal insulin and glutathione

**Goal (in five words):** Test intranasal insulin and glutathione

**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)

**Trial ID:** [NCT05266417](https://clinicaltrials.gov/study/NCT05266417)

## Key Facts

- **Phase:** PHASE2
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Gateway Institute for Brain Research
- **Target Enrollment:** 56 participants
- **Start Date:** 2022-02-07
- **Completion Date:** 2027-01-01
- **Conditions:** Parkinson Disease
- **Interventions:** INS-GSH, Matched Placebos
- **Intervention Types:** DRUG

## Summary For Families

The goal is to see whether giving insulin and glutathione through the nose can protect dopamine-producing brain cells and improve or stabilize motor and cognitive symptoms in Parkinson's disease. The approach uses intranasal insulin to deliver insulin directly to the brain to boost neuronal energy and signaling, paired with glutathione as an antioxidant to reduce oxidative stress; both are tested as an add-on to, not a replacement for, usual Parkinson's medications like levodopa. Eligible participants are adults 30 to 85 with a clinical diagnosis of idiopathic PD under Hoehn and Yahr stage 5 who can self-administer or have a caregiver help and who have been on stable PD medications for at least 30 days. People with diabetes or recent hypoglycemia, significant cognitive impairment (MMSE 24 or less), current insulin or other anti-hyperglycemic use, or glutathione supplementation are excluded.

## Eligibility

- **Minimum age:** 30 Years
- **Sex:** ALL

### Full 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
```

## Locations (2)

- Institute for Neuroimmune Medicine, Davie, Florida, United States _(26.0629, -80.2331)_
  - Rafael Iglesias — (CONTACT) — 954-262-2876 — ri73@nova.edu
  - Irina Rozenfeld, DPN, APRN — (PRINCIPAL_INVESTIGATOR)
- Las Mercedes Medical Research, Hialeah, Florida, United States _(25.8576, -80.2781)_
  - Ariadna Zarzuela, RN, BSN — (CONTACT) — 786-577-5977 — ariadna.zarzuela@lmmresearch.com
  - Frank Alvarez, MD — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Susana Restrepo, PhD — (CONTACT) — 786-216-5334 — srestrepo@gifbr.com
- Vanesa Javier — (CONTACT) — 954-636-2166 — vaday@gifbr.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT05266417*  
*HTML version: https://parkinsonspathways.com/trial/NCT05266417*  
*Source data: https://clinicaltrials.gov/study/NCT05266417*