NCT06072963RecruitingPhase 2
COMMETS- Combination MCI Metabolic Syndrome
Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
The investigators propose a proof of concept RCT (randomized clinical trial), testing the efficacy of intranasal insulin (INI) with semaglutide, a combination therapy with strong biological plausibility to benefit impaired cognition through vascular mechanisms, in older adults with MetS (metabolic syndrome) and MCI (Mild Cognitive Impairment), who are enriched for cerebrovascular disease and at high dementia risk. The study will focus on cognitive and biological outcomes, allowing identification of relevant mechanisms.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 3 Nov 2022
- Start date
- 30 Jan 2024
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Rutgers, The State University of New Jersey
- Diseases
- Alzheimer disease
- NCT number
- NCT06072963
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 30 Jan 2024 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes (of any type)
- 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,
Lab values
- Taking medications that may affect glucose metabolism (including a GLP-1RA).
- Medications that may affect glucose metabolism such as corticosteroids.
Other
- contraindications to either insulin or Semaglutide.
Who the study is looking for
- 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
Age in the registry: 60 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joseph Sagol Neuroscience center, Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.