Intranasal Insulin for Improving Cognitive Function in Multiple Sclero
Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Insulin human
Insulin receptor agonist
Placebo
- Placebo (Sterile diluent)
Results by group
Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT)
Up to week 24 visit
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Intranasal Insulin 20 International Units | 0.145 score on a scale | 0–0.29 | 32 |
| Intranasal Insulin 10 International Units | 0.207 score on a scale | 0.033–0.381 | 30 |
| Placebo | 0.163 score on a scale | 0.029–0.297 | 32 |
Intranasal Insulin 20 International Units
Intranasal Insulin 10 International Units
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Intranasal Insulin 20 International Units | 37 | 5 (13.5%) | 0 |
| Intranasal Insulin 10 International Units | 33 | 3 (9.1%) | 0 |
| Placebo | 35 | 5 (14.3%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT)
Up to week 24 visit
Thinking and memory
Other measures (8)
Number of Participants With Adverse Events Leading to Study Discontinuation
Up to week 24 visit
SafetyFingerstick Blood Glucose (Subset)
At the baseline visit, monitored twice within the 90 minutes following the first dose administration of study drug
Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT)
Up to week 24 visit
Thinking and memoryChange From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II)
Up to week 24 visit
Thinking and memoryChange From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall
Up to week 24 visit
Thinking and memoryChange in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT)
Up to week 24 visit
Thinking and memoryChange From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO)
Up to week 24 visit
Thinking and memoryChange From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test
Up to week 24 visit
Thinking and memory
Who could take part
Relapsing and progressive · 18 to 70
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Intranasal insulin for improving cognitive function in multiple sclerosis.Neurotherapeutics · 2025
Background
Benedict RH, Cookfair D, Gavett R, Gunther M, Munschauer F, Garg N, Weinstock-Guttman B. Validity of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). J Int Neuropsychol Soc. 2006 Jul;12(4):549-58. doi: 10.1017/s1355617706060723.Background
Ruet A, Deloire M, Hamel D, Ouallet JC, Petry K, Brochet B. Cognitive impairment, health-related quality of life and vocational status at early stages of multiple sclerosis: a 7-year longitudinal study. J Neurol. 2013 Mar;260(3):776-84. doi: 10.1007/s00415-012-6705-1. Epub 2012 Oct 19.Background
Strober LB, Christodoulou C, Benedict RH, Westervelt HJ, Melville P, Scherl WF, Weinstock-Guttman B, Rizvi S, Goodman AD, Krupp LB. Unemployment in multiple sclerosis: the contribution of personality and disease. Mult Scler. 2012 May;18(5):647-53. doi: 10.1177/1352458511426735. Epub 2011 Dec 19.Background
Morrow SA, Drake A, Zivadinov R, Munschauer F, Weinstock-Guttman B, Benedict RH. Predicting loss of employment over three years in multiple sclerosis: clinically meaningful cognitive decline. Clin Neuropsychol. 2010 Oct;24(7):1131-45. doi: 10.1080/13854046.2010.511272. Epub 2010 Sep 8.Background
Schultheis MT, Weisser V, Ang J, Elovic E, Nead R, Sestito N, Fleksher C, Millis SR. Examining the relationship between cognition and driving performance in multiple sclerosis. Arch Phys Med Rehabil. 2010 Mar;91(3):465-73. doi: 10.1016/j.apmr.2009.09.026.Background
Patti F. Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence. Patient Prefer Adherence. 2010 Feb 4;4:1-9. doi: 10.2147/ppa.s8230.Background
Rao SM, Leo GJ, Ellington L, Nauertz T, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. II. Impact on employment and social functioning. Neurology. 1991 May;41(5):692-6. doi: 10.1212/wnl.41.5.692.Background
Amato MP, Razzolini L, Goretti B, Stromillo ML, Rossi F, Giorgio A, Hakiki B, Giannini M, Pasto L, Portaccio E, De Stefano N. Cognitive reserve and cortical atrophy in multiple sclerosis: a longitudinal study. Neurology. 2013 May 7;80(19):1728-33. doi: 10.1212/WNL.0b013e3182918c6f. Epub 2013 Apr 10.Background
Amato MP, Ponziani G, Siracusa G, Sorbi S. Cognitive dysfunction in early-onset multiple sclerosis: a reappraisal after 10 years. Arch Neurol. 2001 Oct;58(10):1602-6. doi: 10.1001/archneur.58.10.1602.
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History
Started
Dec 2017
Main results due
Dec 2021
Finished
Dec 2021
Results posted
Mar 2023