Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
Abstract
Cognitive dysfunction is common and devastating to people with multiple sclerosis (MS). To date, multiple pharmacologic interventions have been tried for MS-related cognitive dysfunction with disappointing results. Hence, there is an urgent need to identify or develop novel therapies that can help improve cognitive function in MS. This clinical trial is designed to evaluate the safety, tolerability, and efficacy of intranasal insulin in cognitively impaired people with MS. The study will also evaluate the impact of intranasal insulin on measures of oxidative stress, axonal injury, cellular stress, and energy metabolism in MS. The design of this phase I/II, randomized, double-blind, placebo-controlled trial is as follows; 105participants will be randomized (1:1:1, stratified by relapsing versus progressive MS) to intranasal insulin 10 international units (IU) twice a day, 20 IU twice a day, or placebo for 24weeks. Insulin will be administered intranasally to allow direct delivery of the medication into the central nervous system.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2017
- Accession Number
- AD1047495
Entities
People
- Ama Avornu
- Ellen M Mowry
- Scott Newsome
Organizations
- Johns Hopkins University