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Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.

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ClinicalTrials.gov Identifier: NCT02064166
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Novak, University of Massachusetts, Worcester

Brief Summary:

Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative disorders characterized by abnormal accumulation of α-synuclein. There is no effective treatment that can slow down the disease progression and both disorders are associated with severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and memory in healthy and cognitively impaired non-diabetic adults.

The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322) has shown that a single 40 international units dose of intranasal insulin improves visuospatial memory in diabetes and control subjects.

This proposal includes randomized, double blinded, placebo-controlled trial of intranasal insulin (40 international units daily) in treatment of PD and MSA.

The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of the cognitive scale ratings.


Condition or disease Intervention/treatment Phase
Parkinson Disease Multiple System Atrophy Drug: Intranasal Insulin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy
Study Start Date : February 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: Insulin
40 IU of intranasal insulin daily
Drug: Intranasal Insulin
  1. treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
  2. placebo arm: normal saline, daily, intranasally, for 4 weeks.
Other Name: Novolin R

Placebo Comparator: Placebo
Placebo arm using intranasal normal saline
Drug: Intranasal Insulin
  1. treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
  2. placebo arm: normal saline, daily, intranasally, for 4 weeks.
Other Name: Novolin R




Primary Outcome Measures :
  1. Change in Verbal Fluency FAS (F, A or S Words) Total Score [ Time Frame: Baseline and post-treatment ]
    Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency.


Secondary Outcome Measures :
  1. Modified Hoehn and Yahr Scale [ Time Frame: Baseline and post-treatment ]
    The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson Disease and treatment response post treatment as compared to baseline. The scale ranges from 1 to 5. The lower score indicates better outcome, e.g. less severe parkinsonism.

  2. Cognitive Impairment Using Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline and post-treatment ]
    The Montreal Cognitive Assessment (MoCA) is a one-page 30-point test administered in approximately 10 minutes and is used to assess symptoms of cognitive impairment and their changes after treatment as compared to baseline. MoCA scores range between 0 and 30 with higher scores indicative of better cognitive performance. A score of 26 and above is considered to be normal.

  3. Beck Depression Inventory Score (BDI) [ Time Frame: Baseline and post-treatment ]
    Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression.


Other Outcome Measures:
  1. Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III) [ Time Frame: Baseline and post-treatment ]
    UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The total score for subscale 3 ranges from 0 to 108 (the sum of scores from 14 items with 27 observations). The higher the value, the more severe the symptoms. The outcomes reflect the UPDRS Part III score at baseline and 4 weeks post treatment with post treatment scores compared to baseline in the insulin and placebo groups.

  2. Gait Analysis (4-meter Test) [ Time Frame: Baseline and post-treatment ]
    Changes in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment.

  3. Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: Baseline and post-treatment ]
    Changes in Brief Visuospatial Memory Test-Revised (BMVT-R) compared to baseline. For BVMT, there were concerns about the test administration and validity of this test which relies on fine motor control in PD patients that have motor impairment which could affect the drawing precision. Therefore, BVMT was not included in the analyses, because these methodological concerns would have affected the calculation of the total score as the outcome measure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females older than 17 years.
  2. Clinical diagnosis of Parkinson disease or multiple system atrophy.
  3. Provide written informed consent to participate in the study.
  4. Understand that they may withdraw their consent at any time.

Exclusion Criteria:

  1. Women who are pregnant or lactating.
  2. In the investigator's opinion, have significant systemic, hepatic, cardiovascular, renal or other illness that can interfere based on investigator judgment with the trial.
  3. History of dementia.
  4. Unable to walk without help for at least 1 minute.
  5. History of allergic reaction to insulin.
  6. The presence of inflammation of nasal cavity that may prevents absorption of insulin.

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): NCT02064166


Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Peter Novak
Investigators
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Principal Investigator: Peter Novak`, MD,PhD Former Associate Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Novak, Former Faculty member, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02064166     History of Changes
Other Study ID Numbers: PN-1
First Posted: February 17, 2014    Key Record Dates
Results First Posted: November 22, 2018
Last Update Posted: November 22, 2018
Last Verified: November 2018

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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.: No

Keywords provided by Peter Novak, University of Massachusetts, Worcester:
Parkinson disease
Multiple system atrophy
Intranasal
Insulin

Additional relevant MeSH terms:
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Parkinson Disease
Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs