Recruiting
Phase 2

Insulin & Glutathione

Sponsor:

Gateway Institute for Brain Research

Code:

NCT05266417

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

INS-GSH

Matched Placebos

Study Details

Brief summary:

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

Conditions

Parkinson Disease

Study ID

NCT05266417

Start date

Feb 7, 2022

Status verified date

Jul, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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 Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active

Insulin (Novolin R) and Glutathione (INS-GSH)

placebo comparator: Control

Placebo

Interventions

INS-GSH

Intranasal INS-GSH Twice Daily

Matched Placebos

Intranasal Matched Placebos Twice Daily

Primary outcome measure

  • Verbal Fluency [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

Susana Restrepo, PhD

786-216-5334srestrepo@gifbr.com

Vanesa Javier

954-636-2166vaday@gifbr.com

Locations

Institute for Neuroimmune Medicine

Recruiting

Davie, Florida, United States, 33314

Contacts

Rafael Iglesias

954-262-2876ri73@nova.edu

Principal Investigator:

Irina Rozenfeld, DPN, APRN

Las Mercedes Medical Research

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Elivra Grana

786-577-5977elvira.grana@lmmresearch.com

Millie Silberberg

786-577-5977millie.munoz@lmmresearch.com

Principal Investigator:

Frank Alvarez, MD

NextGen Research Group

Recruiting

Miami, Florida, United States, 33165

Contacts

Dayana Rojas, PhD, MPH

786-427-9659dayana.rojas@nextgenresearchgroup.com

Luis Rodriguez

(645) 229-4543luis.rodriguez@nextgenresearchgroup.com

Charter Research

Recruiting

The Villages, Florida, United States, 32162

Contacts

Alessandra Cuevas

352-441-2000Alessandra.Cuevas@charterresearch.com

Principal Investigator:

Jeffrey Norton, MD

More Information

Sponsor

Gateway Institute for Brain Research

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Insulin
  • Glutathione
  • Intranasal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Gateway Institute for Brain Research on 2026-07-22.