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.
Multiple System Atrophy
Drug: Intranasal Insulin
|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|
- BVMT-R (Brief Visuospatial Memory Test-Revised) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Changes in BMVT-R compared to baseline
- 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.
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
40 IU of intranasal insulin daily
Drug: Intranasal Insulin
Other Name: Novolin R
Placebo Comparator: Placebo
Placebo arm using intranasal normal saline
Please refer to this study by its ClinicalTrials.gov identifier: NCT02064166
|Contact: Peter Novak, MDfirstname.lastname@example.org|
|Contact: Paula Ravin, MDemail@example.com|
|United States, Massachusetts|
|University of Massachusetts Medical School||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Peter Novak, MD,PhD 508-334-2527 firstname.lastname@example.org|
|Contact: Paula Ravin, MD 508-334-2527 email@example.com|
|Principal Investigator:||Peter Novak`, MD,PhD||Associate Professor|