Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate if giving insulin that is administered in the nostrils (intranasal) is safe and tolerable for people with multiple sclerosis (MS). It is also being done to evaluate if intranasal insulin improves cognitive function in people with MS and to evaluate how it might be working.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: United States Department of Defense
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Meets 2010 criteria for MS

• No relapse in past 3 months

• At least mild cognitive impairment (based off of SDMT/PST score)

• Capacity to learn and self-administer intranasal insulin/placebo, or presence of a caregiver with such capacity who is willing to do it for the duration of the trial

• Untreated/on the same MS therapy for at least 6 months, with no anticipated change in the next year

• Willing to prevent pregnancy during study if female of childbearing potential

Exclusion Criteria:

• Current, active major depression

• No tricyclic antidepressant or anticonvulsant (except carbamazepine, pregabalin or gabapentin) use within 6 weeks of screening; if on oxybutynin or tolterodine, on stable dose for > 6 months without plans for changing dose in next year

• If taking selective serotonin (± norepinephrine) reuptake inhibitors, pregabalin, gabapentin, sympathomimetic, monoamine oxidase inhibitor, antipsychotic, amantadine, cholinesterase inhibitor, memantine, modafanil, armodafinil, or evening short-acting benzodiazepines, on stable dose for 6 weeks or greater

• Pregnant or nursing

• THC; illicit drug or alcohol abuse in past 3 months

• History of diabetes mellitus or insulin resistance

• Active liver disease, stage IV/V kidney disease or severe metabolic derangements

• CNS disorder other than MS or headache