Evidence map›Paper›PMID 40253245›Full record

Trial reportNeurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics2025

Intranasal insulin for improving cognitive function in multiple sclerosis.

Scott D Newsome, Kathryn C Fitzgerald, Abbey Hughes, Meghan Beier, Jacqueline Koshorek, Yujie Wang, Daniela Pimentel Maldonado, Thomas Shoemaker, Taimur Malik, Tarik Bayu and 8 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Scott D NewsomeJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA. Electronic address: snewsom2@jhmi.edu.
Kathryn C FitzgeraldJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Abbey HughesJohns Hopkins University School of Medicine, Division of Rehabilitation Psychology and Neuropsychology, Baltimore, MD, USA.
Meghan BeierJohns Hopkins University School of Medicine, Division of Rehabilitation Psychology and Neuropsychology, Baltimore, MD, USA.
Jacqueline KoshorekJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Yujie WangJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Daniela Pimentel MaldonadoJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Thomas ShoemakerJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Taimur MalikJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Tarik BayuJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Pablo E RavennaJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Ama AvornuJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Elias S SotirchosJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Meghan RombaJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
John MuschelliJohns Hopkins Bloomberg School of Public Health, Department of Biostatistics, Baltimore, MD, USA.
Todd T BrownJohns Hopkins University School of Medicine, Division of Endocrinology, Baltimore, MD, USA.
Peter A CalabresiJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Ellen M MowryJohns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cognitive impairment is common in people with multiple sclerosis (PwMS). There is an urgent need to identify/develop novel therapies that can help cognitive function in MS. Insulin is critical for helping with regulation of multiple CNS functions, including learning and memory. Insulin administrated intranasally has shown to improve memory and learning in healthy people and in those with some neurodegenerative disorders. Hence, there was rationale for investigating intranasal insulin in PwMS who experience cognitive impairment. We completed a phase Ib/II, randomized, double-blind, placebo-controlled trial; participants were randomized in a 1:1:1 fashion, stratified by relapsing versus progressive MS, to intranasal insulin 10 ​international units (IU) twice a day, 20 IU twice a day, or placebo for 24 weeks. One-hundred and five PwMS were enrolled, 69 of whom had at least one follow up visit during the active treatment phase of the trial (baseline to week 24). The cohort's mean age was 52.4 ​± ​9.7years, 62 ​% were female, and ∼60 ​% had relapsing-remitting MS. The most common side effects amongst treatment groups included headache, rhinorrhea, and dizziness. There were 13 SAEs which were not deemed study drug related; there were no deaths. The main clinical outcome measure, SDMT, did not demonstrate any difference between intranasal insulin and placebo. Similar findings were noted for all secondary outcome measures. Intranasal insulin appeared safe and well-tolerated in PwMS. However, it was not superior to placebo in any of the clinical outcome measures assessed, which could have been impacted by the duration of the trial, small sample size for a three-arm trial design, data missingness (particularly during COVID-19), outcome measure insensitivity to change, baseline cognitive reserve, or other factors. Nonetheless, intranasally-administered therapeutics may be of interest to develop further as a way to get across the blood brain barrier.

Indexed as

CognitionCognitive DysfunctionHypoglycemic AgentsInsulinMultiple SclerosisAdministration, IntranasalAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedHypoglycemic AgentsInsulinClinical trialsCognitive dysfunctionInsulinIntranasal treatmentsMultiple sclerosis

Identifiers

PMID40253245
PMCPMC12418434

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.