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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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.


Detailed Summary:
Sponsor: University of Massachusetts, Worcester

Current Primary Outcome: BVMT-R (Brief Visuospatial Memory Test-Revised) [ Time Frame: 4 weeks ]

Changes in BMVT-R compared to baseline


Original Primary Outcome: Changes in cognitive scales compared to baseline [ Time Frame: 4 weeks ]

The following scales will be used for outcome measures:

BVMT-R (Brief Visuospatial Memory Test-Revised) Unified Parkinson's Disease Rating scale (UPDRS Parts I, II, and III) Patient Global Impression - Improvement scale (PGI-I) Modified Hoehn and Yahr Scale Beck Depression Inventory Score (BDI) Montreal Cognitive Assessment (MoCA) Verbal Fluency FAS test Gait analysis (4-meter test)



Current Secondary Outcome:

  • Unified Parkinson's Disease Rating scale (UPDRS Parts I, II, and III) [ Time Frame: 4 weeks ]
    Changes in UPDRS compared to baseline
  • Patient Global Impression - Improvement scale (PGI-I) [ Time Frame: 4 weeks ]
    Changes in PGI-I compared to baseline
  • Modified Hoehn and Yahr Scale [ Time Frame: 4 weeks ]
    Changes in Hoehn and Yahr Scale compared to baseline
  • Beck Depression Inventory Score (BDI) [ Time Frame: 4 weeks ]
    Changes in BDI compared to baseline
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: 4 weeks ]
    Changes in MoCA compared to baseline
  • Verbal Fluency FAS test [ Time Frame: 4 weeks ]
    Changes in Verbal Fluency FAS test compared to baseline
  • Gait analysis (4-meter test) [ Time Frame: 4 weeks ]
    Changes in gait compared to baseline.


Original Secondary Outcome:

Information By: University of Massachusetts, Worcester

Dates:
Date Received: February 13, 2014
Date Started: February 2014
Date Completion:
Last Updated: January 5, 2017
Last Verified: February 2016