NCT05266417

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
15mo left

Started Feb 2022

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Feb 2022Jul 2027

Study Start

First participant enrolled

February 7, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

February 23, 2022

Last Update Submit

March 30, 2026

Conditions

Parkinson Disease

Keywords

InsulinGlutathioneIntranasal

Outcome Measures

Primary Outcomes (1)

  • Verbal Fluency

    F, A and S (FAS) words test

    24 Weeks

Secondary Outcomes (10)

  • Verbal Fluency

    28 Weeks

  • Motor Function

    24 Weeks

  • Motor Function

    24 Weeks

  • Motor Function

    24 Weeks

  • Motor Function

    Week 24

  • +5 more secondary outcomes

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: INS-GSH

Control

PLACEBO COMPARATOR

Placebo

Drug: Matched Placebos

Interventions

INS-GSHDRUG

Intranasal INS-GSH Twice Daily

Active
Matched PlacebosDRUG

Intranasal Matched Placebos Twice Daily

Also known as: Insulin Matched Placebo and Glutathione Matched Placebo
Control

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute for Neuroimmune Medicine

Davie, Florida, 33314, United States

RECRUITING

Las Mercedes Medical Research

Hialeah, Florida, 33012, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseInsulin Resistance

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Susana Restrepo, PhD

CONTACT

786-216-5334srestrepo@gifbr.com

Vanesa Javier

CONTACT

954-636-2166vaday@gifbr.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 4, 2022

Study Start

February 7, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

US(2)