Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
Technical Report,30 Sep 2018,29 Sep 2019
Johns Hopkins University Baltimore United States
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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 III, randomized, double-blind, placebo-controlled trial is as follows 105 participants will be randomized 111, stratified by relapsing versus progressive MS to intranasal insulin 10 international units IU twice a day, 20 IU twice a day, or placebo for 24 weeks. Insulin will be administered intranasally to allow direct delivery of the medication into the central nervous system. Standardized cognitive assessments will occur at baseline and throughout the 24-week trial, as well as for a period of 24 weeks after discontinuation of the intervention, to evaluate the impact of insulin on cognitive performance as well as the longevity of the treatment response. If intranasal insulin does appear to be safe and shows some evidence of helping cognition in MS, we will pursue a larger clinical trial to confirm our results. Intranasal insulin may provide a safe way to improve cognition and, ultimately, overall disability in people with MS, leading to better quality of life for patients and their caregivers.
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