COMMETS- Combination MCI Metabolic Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-90
SponsorRutgers, The State University of New Jersey
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Semaglutide
- Intranasal insulin
- Semaglutide placebo
- Intranasal insulin placebo
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Rutgers, The State University of New Jersey
Lead sponsor
Alzheimer's Association
Collaborator
Source ClinicalTrials.gov