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Trial · Interventional

RecruitingPhase 2Registry data

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

Short name NOSE-PD

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
56 participants (estimated)
Sponsor
Gateway Institute for Brain Research · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
7 Feb 2022
Primary completion
1 Sept 2027 (estimated)
Completion
30 Nov 2027 (estimated)
First posted
4 Mar 2022
Last update posted
22 Jul 2026
Conditions
Parkinson Disease

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025202620272028
  1. Ph 2

    NOSE-PD

    NCT05266417

    7 Feb 2022 to est. 30 Nov 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • INS-GSHDrug
  • Matched PlacebosDrug

Arms2

  • Experimental

    Active

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

  • Placebo comparator

    Control

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Verbal Fluency

    Time frame · 24 Weeks

    Registry description

    F, A and S (FAS) words test

Secondary outcomes(10)
  1. Verbal Fluency

    Time frame · 28 Weeks

    Registry description

    Change in verbal fluency as assessed by the FAS test

  2. Motor Function

    Time frame · 24 Weeks

    Registry description

    Change in Timed Up and Go (TUG) test

  3. Motor Function

    Time frame · 24 Weeks

    Registry description

    Change in the updated Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score

  4. Motor Function

    Time frame · 24 Weeks

    Registry description

    Change in the updated MDS-UPDRS total score

  5. Motor Function

    Time frame · Week 24

    Registry description

    Change in the Clinical Global Impression (CGI) score

  6. Motor Function

    Time frame · Week 24

    Registry description

    Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)

  7. Cognitive Function

    Time frame · Week 24

    Registry description

    Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery

  8. Non-Motor Function

    Time frame · Week 24

    Registry description

    Change in Hamilton Rating Scale for Depression total score

  9. Patient Reported Outcome

    Time frame · Week 24

    Registry description

    Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment

  10. Patient Reported Outcome

    Time frame · Week 24

    Registry description

    Change in the Patient Global Impression (PGI) score

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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