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NCT Number: NCT02064166

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

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.

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Key information

Conditions

Parkinson Disease Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Primary Dysautonomias Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intranasal insulin

Drug
  • treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
  • placebo arm: normal saline, daily, intranasally, for 4 weeks.

Other names: Novolin R

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peter Novak

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2014
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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