Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
Abstract
Multiple sclerosis (MS) is a chronic neurological disease of the central nervous system (CNS) that has widespread deleterious effects and is associated with an increased risk of long-term disability. It remains the most common cause of progressive neurologic disability in young adults and results in a reduced health-related quality of life due to its disabling symptoms. Cognitive impairment is extremely common in MS, affecting more than 60% of patients. Cognitive changes can appear at any time in an individual with MS, even early in the course and before an official MS diagnosis has been made. The psychosocial impact of cognitive impairment is pervasive and often catastrophic to an individual s quality of life. It remains a main cause of premature departure from the work force and negatively impacts everyday activities. Treatment of cognitive impairment in MS has been very disappointing, and no medication has been shown to improve this disabling problem. There is thus an urgent need to develop novel treatments that can help improve cognitive function. Insulin appears to be very important for keeping the nervous system healthy. It directly impacts processes associated with inflammation and also impacts the metabolism and damage repair mechanisms within the nervous system, which is important since brain and spinal cord damage in people with MS increase the risk of long-term disability and cognitive dysfunction. Inhaled (intranasal) insulin appeared to be safe in several small trials, and in people with early or established Alzheimer s disease, it also led to improvements in many aspects of cognition. In the proposed project, we will conduct a pilot clinical trial of intranasal insulin, in one of two dosing regimens, compared to intranasal saline (placebo) in 105 people with MS who have some evidence of impaired cognition. Participants will complete a set of standardized cognitive tests at the beginning of the trial and throughout a 24-week treatment period. After this treatment, the same cognitive tests will be completed periodically for another 24 weeks to evaluate how long the impact of insulin on cognitive performance lasts. We will evaluate the safety of intranasal insulin and will also evaluate its impact on blood measures indicating damage to the nervous system associated with MS. While insulin therapy is typically given to people with diabetes, administering insulin through nasal inhalation, which directly delivers insulin to the CNS, has been studied in other neurological disorders. In people with early memory problems or who already had established Alzheimer s disease, intranasal insulin was safe and improved many aspects of cognition. Cognitive impairment is devastating for people with MS and their loved ones, and it is important that more research is done to evaluate medications to combat this problem. The proposed study will be the first to evaluate if intranasal insulin improves aspects of cognition and memory in people with MS. We will evaluate the safety of this therapy in people with MS and will also evaluate whether intranasal insulin improves markers of nervous system damage and related processes. 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. Further, the blood studies may help us understand how intranasal insulin works, which may provide exciting clues to suggest that this medication could reduce overall damage to the nervous system and decrease long-term disability for people with MS. 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.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 31, 2017
- Source ID
- W81XWH1610693
Entities
People
- Ellen M Mowry
Organizations
- Johns Hopkins University
- United States Army