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Intranasal Insulin in Parkinson's Disease (INI-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251585
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
This project will investigate exploratory outcomes related to the effect of intranasal insulin on cognition, mood, apathy and motor performance of subjects with Parkinson's disease over a 3 week period.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Regular Novolin R Drug: Placebo Phase 2

Detailed Description:

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's dementia and was originally described as a motor disease. The diagnosis of PD is still based on the core motor features of bradykinesia, resting tremor, and rigidity, primarily as a result of degeneration of nigrostriatal dopaminergic neurons. In addition to the classic motor symptoms, however, PD is increasingly recognized as a multisystem disorder. A variety of non-motor symptoms, including cognitive deficits and dementia, are commonly observed in patients with PD.

In this study, we aim to investigate which intranasal insulin dose out of three doses and placebo, administered at three different doses or placebo over a 21-day period, is the optimum dosage based on safety and tolerability in Parkinson's disease. A similar design was used in a trial investigating intranasal oxytocin in frontotemporal dementia. Dosing for the first two groups of this study is based on previously conducted intranasal insulin studies in Alzheimer's disease (AD) and mild cognitive impairment (MCI), using daily doses on 20 and 40 IU of intranasal insulin. Higher dose have been found to be safe in healthy adults. Prior studies performed have demonstrated favorable effects of this regimen in the MCI/AD population without peripheral hypoglycemia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomly assigned to one of 3 treatment groups or the placebo group.

  • 20 international units twice daily (n=7)
  • 40 international units twice daily (n=7)
  • 80 international units twice daily (n=9)
  • placebo (n=7)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All participants, care providers, investigators, and outcomes assessors are masked.
Primary Purpose: Other
Official Title: Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Insulin
Regular insulin (Novolin-R) 20 international units (10 units) in one nostril twice daily for 21 days, 100 µl volume.
Drug: Regular Novolin R
Intranasal insulin

Experimental: Medium Insulin
Regular insulin (Novolin-R) 40 international units (10 units) in each nostril twice daily for 21 days, 100 µl volume.
Drug: Regular Novolin R
Intranasal insulin

Experimental: High Insulin
Regular insulin (Novolin-R) 80 international units (10 units) in each nostril twice daily for 21 days, 200 µl volume.
Drug: Regular Novolin R
Intranasal insulin

Placebo Comparator: Placebo
0.9% sodium chloride in each nostril twice daily for 21 days, 100 µl volume.
Drug: Placebo
Intranasal placebo (0.9% saline)




Primary Outcome Measures :
  1. Safety measured by count of safety events [ Time Frame: 3 weeks ]
    Composite safety event - this is a count of either a reduction of fasting glucose to <70 mg/dL or an unintended reduction of weight >5%. A larger composite event count indicates a less safe treatment.

  2. Safety measured by fasting glucose [ Time Frame: 3 weeks ]
    Pre-post change in fasting glucose (mg/dL). A larger decrease in fasting glucose indicates a less safe treatment.

  3. Safety measured by body weight [ Time Frame: 3 weeks ]
    Pre-post change in body weight (lbs). An unintended decrease in body weight indicates a less safe treatment.

  4. Safety measured by the number of serious adverse events (SAE) and adverse events (AE) [ Time Frame: 3 weeks ]
    Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.


Secondary Outcome Measures :
  1. Cognitive function measured by the Montreal cognitive assessment (MoCA) [ Time Frame: 5 weeks ]
    Pre-post difference. Total sum of scores. Range: 0-30. Higher score indicates less memory loss

  2. Cognitive function measured by the Weschler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span [ Time Frame: 3 weeks ]
    Pre-post difference. Scaled score. Range: 1-19. Forward and backward. Lower score indicates more impairment.

  3. Cognitive function measured by the Trailmaking Test Part A Time [ Time Frame: 3 weeks ]
    Pre-post difference. T-score. Range: 0-25. Lower score indicates more impairment.

  4. Cognitive function measured by the Trailmaking Test Part B Time [ Time Frame: 3 weeks ]
    Pre-post difference. T-score. Range: 0-26. Lower score indicates more impairment.

  5. Cognitive function measured by the Trailmaking Test Parts A & B Errors [ Time Frame: 3 weeks ]
    Pre-post difference. Total number of errors. No range. More errors indicate more impairment.

  6. Cognitive function measured by the Judgement of Line Orientation [ Time Frame: 3 weeks ]
    Pre-post difference. Z-score. Range: 0-29. Lower score indicates more impairment.

  7. Cognitive function measured by the Logical Memory Scaled Scores [ Time Frame: 3 weeks ]
    Pre-post difference. Scaled score. Range: 1-19. Logical memory immediate, delayed and recognition. Lower score indicates more impairment.

  8. Cognitive function measured by the Logical Memory Recognition [ Time Frame: 3 weeks ]
    Pre-post difference. No range. Lower score indicates more impairment.

  9. Cognitive function measured by the Hopkins Verbal Learning Test - Revised (HVLT) [ Time Frame: 3 weeks ]
    Pre-post difference. T-score. Range: 0-12. Immediate recall, delayed recall, and recognition. Lower score indicates more impairment.

  10. Cognitive function measured by the Visuospatial Memory Test - Revised (BVMT) [ Time Frame: 3 weeks ]
    Pre-post difference. T-score. Range: 0-6. Immediate recall, delayed recall, and recognition. Lower score indicates more impairment.

  11. Cognitive function measured by the Stroop Color Word Test (CWT) [ Time Frame: 3 weeks ]
    Pre-post difference. T-score. Range: 0-25. Word reading, color naming, color-word, and interference. Lower score indicates more impairment.

  12. Cognitive function measured by Fluency [ Time Frame: 3 weeks ]
    Pre-post difference. T-score. No range. Letter fluency and category fluency. Lower score indicates more impairment.

  13. Mood measured by the Beck Depression Inventory - Second Edition [ Time Frame: 3 weeks ]
    Pre-post difference. Raw score. Range: 0-63. Higher score indicates more symptomatic.

  14. Apathy measured by the Apathy scale [ Time Frame: 3 weeks ]
    Pre-post difference. Raw score. Range: 0-42. Higher score indicates more symptomatic.

  15. Mood measured by the Columbia Suicide Severity Rating (C-SSRS) [ Time Frame: 3 weeks ]
    Pre-post difference. Raw score. Range:1 or 0. 1 score - more symptomatic, 0 score - no symptoms.

  16. Motor function as measured by the United Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 3 weeks ]
    Pre-post difference. Raw score. Range: 0-72. Higher score indicates more symptomatic.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   41 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to Movement disorder society (MDS) clinical diagnostic criteria for Parkinson's disease confirmed by a fellowship trained movements disorder specialist
  • Subject is Hoehn & Yahr stage less than or equal to 3
  • Subject has a MOCA score ≥10.
  • Subject is > 40 and <90 years of age.
  • Female subjects are post-menopausal or have a negative pregnancy test
  • The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing of cognitive function, memory and physiology.
  • Subject has provided informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative.
  • Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian agents and is willing to remain on this dose for the duration of the study. If the subject is on a cholinesterase inhibitor, a stable dose without changes for 1 month is also required.
  • Subject has undergone a brain CT or MRI prior to the study as part of their previous diagnostic workup for PD to rule out underlying structural lesions, as determined clinically significant by the investigator

Exclusion Criteria:

  • Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, neuroleptics), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
  • Subject has medical history and/or clinically determined disorders: chronic sinusitis, untreated thyroid disease, or significant head trauma.
  • Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, condition known to affect absorption, distribution, metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal disease or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator.
  • Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
  • Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
  • Subject is currently taking sedative medications that are clinically contraindicated as determined by investigator.
  • Subject has undergone a recent change (<1 month) in their anti-parkinsonian medication, cholinesterase inhibitor or anti-depressant medication.
  • Subject has current or recent drug or alcohol abuse or dependence as defined by Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV TR).
  • Screening laboratory results that are medically relevant, in which inclusion would pose a safety risk to the subject as determined by investigator.
  • Subject has participated in a clinical trial investigation within 3 months of this study.
  • Subject has an insulin allergy.
  • Subject has Insulin-dependent diabetes

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): NCT04251585


Contacts
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Contact: Sharon Hwee 651-495-6363 Sharon.X.Hwee@HealthPartners.com
Contact: Maria Pyle 651-495-6363 Maria.X.Pyle@HealthPartners.com

Locations
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United States, Minnesota
HealthPartners Neuroscience Center Recruiting
Saint Paul, Minnesota, United States, 55130
Contact: Sharon Hwee    651-495-6363    Sharon.x.Hwee@HealthPartners.com   
Contact: Maria Pyle    651-495-6363    Maria.X.Pyle@HealthPartners.com   
Principal Investigator: Julia C Johnson, MD         
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: Julia C Johnson, MD HealthPartners Neurology
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT04251585    
Other Study ID Numbers: A19-214
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
intranasal
insulin
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs