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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
Last Update Posted : January 6, 2017
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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
Primary Completion Date : September 2015
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. BVMT-R (Brief Visuospatial Memory Test-Revised) [ Time Frame: 4 weeks ]
    Changes in BMVT-R compared to baseline

Secondary Outcome Measures :
  1. Unified Parkinson's Disease Rating scale (UPDRS Parts I, II, and III) [ Time Frame: 4 weeks ]
    Changes in UPDRS compared to baseline

  2. Patient Global Impression - Improvement scale (PGI-I) [ Time Frame: 4 weeks ]
    Changes in PGI-I compared to baseline

  3. Modified Hoehn and Yahr Scale [ Time Frame: 4 weeks ]
    Changes in Hoehn and Yahr Scale compared to baseline

  4. Beck Depression Inventory Score (BDI) [ Time Frame: 4 weeks ]
    Changes in BDI compared to baseline

  5. Montreal Cognitive Assessment (MoCA) [ Time Frame: 4 weeks ]
    Changes in MoCA compared to baseline

  6. Verbal Fluency FAS test [ Time Frame: 4 weeks ]
    Changes in Verbal Fluency FAS test compared to baseline

  7. Gait analysis (4-meter test) [ Time Frame: 4 weeks ]
    Changes in gait compared to baseline.

Information from the National Library of Medicine

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

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

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

Responsible Party: Peter Novak, Associate Professor of Neurology, 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
Last Update Posted: January 6, 2017
Last Verified: February 2016

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

Additional relevant MeSH terms:
Parkinson Disease
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
Vascular Diseases
Cardiovascular Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs