Actively Recruiting

Phase 2
Age: 60Years - 90Years
All Genders
NCT06072963

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

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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

Age: 60Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Joseph Sagol Neuroscience center, Sheba Medical Center

Ramat Gan, Israel, 5265601

Actively Recruiting

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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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