COMMETS- Combination MCI Metabolic Syndrome
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Alzheimer Disease, Mild Cognitive Impairment, Metabolic Syndrome
In brief
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.
Key facts
- Study ID
- NCT06072963
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 80
- Starts
- 2024-01-30
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Joseph Sagol Neuroscience center, Sheba Medical Center — Ramat Gan, Israel (enrolling)
Full record on ClinicalTrials.gov
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