Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 10 January 2022
• Main ID: NCT02988401
• Date of registration: 07/12/2016
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
• Scientific title: Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
• Date of first enrolment: December 1, 2017
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02988401
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Scott Newsome, DO
• Affiliation: Johns Hopkins University

• Name: Ellen Mowry, MD, MCR
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Secondary Progressive

Multiple Sclerosis, Relapsing-Remitting

Multiple Sclerosis, Primary Progressive

Intervention(s)

Drug: Insulin

Drug: Placebo (Sterile diluent)

Primary Outcome(s)

Change from baseline in cognitive function as assessed by the Symbol Digit Modalities Test (SDMT) [Time Frame: 1 year]

Secondary Outcome(s)

Determine safety by assessing the number of subjects with adverse events with placebo. [Time Frame: 1 year]

Change from baseline in cognitive function as assessed by the Delis-Kaplan Executive Function System sorting test. [Time Frame: 1 year]

Change from baseline in cognitive function as assessed by the Judgement of Line Orientation Test (JLO). [Time Frame: 1 year]

Change from baseline in cognitive function as assessed by the California Verbal Learning Test, Second Edition (CVLT-II). [Time Frame: 1 year]

Change from baseline in cognitive function as assessed by the Controlled Oral Word Association Test (COWAT). [Time Frame: 1 year]

Change from baseline in cognitive function as assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R). [Time Frame: 1 year]

Change from baseline in cognitive function as assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT). [Time Frame: 1 year]

Determine safety by assessing the number of subjects with adverse events with treatment as compared to placebo. [Time Frame: 1 year]

Secondary ID(s)

IRB00095554

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United States Department of Defense