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Trial record 1 of 2 for:    gateway institute for brain research
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Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease (NOSE-PD)

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ClinicalTrials.gov Identifier: NCT05266417
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Gateway Institute for Brain Research

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: INS-GSH Drug: Matched Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 7, 2022
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Insulin (Novolin R) and Glutathione (INS-GSH)
Drug: INS-GSH
Intranasal INS-GSH Twice Daily

Placebo Comparator: Control
Placebo
Drug: Matched Placebos
Intranasal Matched Placebos Twice Daily
Other Name: Insulin Matched Placebo and Glutathione Matched Placebo




Primary Outcome Measures :
  1. Verbal Fluency [ Time Frame: 24 Weeks ]
    F, A and S (FAS) words test


Secondary Outcome Measures :
  1. Verbal Fluency [ Time Frame: 28 Weeks ]
    Change in verbal fluency as assessed by the FAS test

  2. Motor Function [ Time Frame: 24 Weeks ]
    Change in Timed Up and Go (TUG) test

  3. Motor Function [ Time Frame: 24 Weeks ]
    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 ]
    Change in the updated MDS-UPDRS total score

  5. Motor Function [ Time Frame: Week 24 ]
    Change in the Clinical Global Impression (CGI) score

  6. Motor Function [ Time Frame: Week 24 ]
    Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)

  7. Cognitive Function [ Time Frame: Week 24 ]
    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 ]
    Change in Hamilton Rating Scale for Depression total score

  9. Patient Reported Outcome [ Time Frame: Week 24 ]
    Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment

  10. Patient Reported Outcome [ Time Frame: Week 24 ]
    Change in the Patient Global Impression (PGI) score



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Documented clinical diagnosis of idiopathic PD
  • Modified HY stage < 5
  • 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 hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with or without 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
  • Chronic inflammation of nasal cavity 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
  • 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, and Beta Blockers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05266417


Contacts
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Contact: Thomas Freeman (954) 636-2166 tfreeman@gifbr.com
Contact: Vanesa Aday (954) 636-2166 vaday@gifbr.com

Locations
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United States, Florida
Institute for Neuroimmune Medicine Recruiting
Davie, Florida, United States, 33314
Contact: Irina Rozenfeld, DN         
Sponsors and Collaborators
Gateway Institute for Brain Research
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Responsible Party: Gateway Institute for Brain Research
ClinicalTrials.gov Identifier: NCT05266417    
Other Study ID Numbers: 20-GTY-008-01
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Gateway Institute for Brain Research:
Insulin
Glutathione
Intranasal
Additional relevant MeSH terms:
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Brain Diseases
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs