Actively Recruiting
COMMETS- Combination MCI Metabolic Syndrome
Led by Rutgers, The State University of New Jersey · Updated on 2024-03-22
80
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
A
Alzheimer's Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COMMETS- Combination MCI Metabolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of mild cognitive impairment (MOCA <27 and CDR score of 0.5)
- Diagnosis of metabolic syndrome with abdominal obesity and glucose intolerance plus dyslipidemia or high blood pressure
- Fluent in Hebrew
- Must have an active study partner to support participation
You will not qualify if you...
- Diagnosis of any type of diabetes
- Use of medications affecting glucose metabolism, including GLP-1 receptor agonists or corticosteroids
- Diagnosis of dementia or conditions directly affecting cognition
- Short life expectancy or medical conditions preventing consistent study participation
- Contraindications to insulin or semaglutide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Joseph Sagol Neuroscience center, Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
Research Team
I
Iscka Yore
CONTACT
T
Tal Niv
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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