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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Massachusetts, Worcester
Sponsor:
Information provided by (Responsible Party):
Peter Novak, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT02064166
First received: February 13, 2014
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Parkinson Disease
Multiple System Atrophy
Drug: Intranasal Insulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • BVMT-R (Brief Visuospatial Memory Test-Revised) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in BMVT-R compared to baseline


Secondary Outcome Measures:
  • Unified Parkinson's Disease Rating scale (UPDRS Parts I, II, and III) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in UPDRS compared to baseline

  • Patient Global Impression - Improvement scale (PGI-I) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in PGI-I compared to baseline

  • Modified Hoehn and Yahr Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in Hoehn and Yahr Scale compared to baseline

  • Beck Depression Inventory Score (BDI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in BDI compared to baseline

  • Montreal Cognitive Assessment (MoCA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in MoCA compared to baseline

  • Verbal Fluency FAS test [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in Verbal Fluency FAS test compared to baseline

  • Gait analysis (4-meter test) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Changes in gait compared to baseline.


Estimated Enrollment: 44
Study Start Date: February 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064166

Contacts
Contact: Peter Novak, MD 508-334-2527 novakp@ummhc.org
Contact: Paula Ravin, MD 508-334-2527 ravinp@ummhc.org

Locations
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Peter Novak, MD,PhD    508-334-2527    novakp@ummhc.org   
Contact: Paula Ravin, MD    508-334-2527    ravinp@ummhc.org   
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Peter Novak`, MD,PhD Associate Professor
  More Information

No publications provided

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
Study First Received: February 13, 2014
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014