Combination therapy for cognitive impairment and metabolic syndrome
Official title: Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study
Run by Rutgers, The State University of New Jersey · NCT06072963 · Data updated 2026-11-12
This study is testing a new treatment using a nasal insulin spray and a diabetes medication to see if it can help older adults with mild cognitive impairment and metabolic syndrome improve their thinking and overall health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Ramat Gan) |
| Status | Recruiting |
| Started | January 30, 2024 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2028 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT06072963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are older adults diagnosed with Mild Cognitive Impairment and Metabolic Syndrome who are fluent in Hebrew and have an active study partner.
✕Probably not a fit
Patients with diabetes, dementia, or those taking medications affecting glucose metabolism may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial tests the efficacy of a combination therapy using intranasal insulin and semaglutide in older adults with Mild Cognitive Impairment (MCI) and Metabolic Syndrome (MetS). The study aims to evaluate the ease of use, adherence, and safety of this treatment while comparing its effects on cognitive function, cerebral blood flow, glucose uptake, and relevant blood biomarkers. Participants will be monitored for various cognitive and biological outcomes to identify potential mechanisms of action. The findings will inform the design of larger trials in the future.
Why it matters
Potential benefit: If successful, this combination therapy could improve cognitive function and reduce the risk of dementia in patients with MCI and MetS.
How similar studies have gone: While the combination of intranasal insulin and semaglutide is a novel approach, previous studies have shown promise in using these treatments separately for cognitive impairment.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of MCI (based on a MOCA \<27 and a clinical dementia rating scale \[CDR\] score of 0.5 representing questionable dementia). * Diagnosis of MetS -requiring a) abdominal obesity (waist circumference \>102cm for men and \>88cm for women), and b) glucose intolerance (fasting glucose\>110 mg/dL) and at least one of the following-c) dyslipidemia (high triglycerides \[\>150 mg/dL\] and low HDL \[\<40mg/dL for men and \<50 mg/dL for women\]), or d) elevated blood pressure (\>130/\>85 mmHg). * Fluent in Hebrew * The study requires an active study partner Exclusion Criteria: * Diabetes (of any type) * Taking medications that may affect glucose metabolism (including a GLP-1RA). * Diagnosis of dementia and its subtypes, conditions that may directly affect cognition, * short life expectancy or a medical condition that precludes consistent participation in the study, * contraindications to either insulin or Semaglutide. * Medications that may affect glucose metabolism such as corticosteroids.
Where it's running
-
Joseph Sagol Neuroscience center, Sheba Medical Center
Ramat Gan, Israel Recruiting
Study contacts
- Principal investigator: Michal Schnaider beeri — Rutgers, The State University of New Jersey
- Study coordinator: Iscka Yore
- Email: Iscka.Yore@sheba.health.gov.il
- Phone: +972-35307262
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.