Phase 2
Completed N=105
Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting · Multiple Sclerosis, Secondary Progressive · Multiple Sclerosis, Primary Progressive
Source: ClinicalTrials.gov NCT02988401 ↗
Enrolled (actual)
105
Serious AEs
12.4%
Results posted
Mar 2023
Primary outcomePrimary: Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) — 0.145; 0.207; 0.163 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT) |
0.145; 0.207; 0.163 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Study Discontinuation |
3; 2; 1 | — |
| SECONDARY Fingerstick Blood Glucose (Subset) |
97.8; 95.8; 90.0; 88.4; 92.2; 87.8 | — |
| SECONDARY Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT) |
0.090; 0.070; 0.021 | — |
| SECONDARY Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II) |
0.082; 0.021; 0.020 | — |
| SECONDARY Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall |
0.027; 0.059; 0.030 | — |
| SECONDARY Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT) |
0.372; 0.363; 0.212 | — |
| SECONDARY Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO) |
-0.031; 0.047; -0.005 | — |
| SECONDARY Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test |
-0.001; 0.027; 0.002 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02988401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.