COMMETS- Combination MCI Metabolic Syndrome
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cognition, alzheimers
- Who it enrolls
- age 60 Years to 90 Years; excludes diabetes; no BMI minimum stated; conditions: Alzheimer Disease; Mild Cognitive Impairment; Metabolic Syndrome
- Interventions
- Semaglutide; Intranasal insulin; Semaglutide placebo; Intranasal insulin placebo
- Conditions
- Alzheimer Disease; Mild Cognitive Impairment; Metabolic Syndrome
- Phase and size
- Phase 2 · 80 participants
- Dates
- Start 2024-01-30
Primary completion 2027-12-01 - Sponsor
- Rutgers, The State University of New Jersey (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Cognitive change - The effect of the combination of Semaglutide and intranasal insulin on cognitive functioning.12 months
- Neuroimaging outcome -- The effect of the combination of Semaglutide and intranasal insulin on cerebral blood flow (CBF).6 months
- Neuroimaging outcome -- The effect of the combination of Semaglutide and intranasal insulin on brain glucose intake.6 months
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.