COMMETS- Combination MCI Metabolic Syndrome

Last updated: March 21, 2024
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Prevention

Memory Loss

Dementia

Treatment

Semaglutide

Semaglutide placebo

Intranasal insulin

Clinical Study ID

NCT06072963
Pro2023001136
  • Ages 60-90
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Diagnosis of MCI (based on a MOCA <27 and a clinical dementia rating scale [CDR] scoreof 0.5 representing questionable dementia).
  • Diagnosis of MetS -requiring a) abdominal obesity (waist circumference >102cm for menand >88cm for women), and b) glucose intolerance (fasting glucose>110 mg/dL) and atleast one of the following-c) dyslipidemia (high triglycerides [>150 mg/dL] and lowHDL [<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

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 participationin the study,
  • contraindications to either insulin or Semaglutide.
  • Medications that may affect glucose metabolism such as corticosteroids.

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: Semaglutide
Phase: 2
Study Start date:
January 30, 2024
Estimated Completion Date:
December 01, 2028

Study Description

The Specific Aims of the study are:

Aim 1. To examine the ease and precision of use of the intranasal device and once daily semaglutide pill.

Aim 2. To examine the adherence to the two types of treatment.

Aim 3. To examine the safety profile of the combination of intranasal insulin with semaglutide. The safety profile of each has been published broadly, but the safety of their combination has not been examined.

Aim 4. Although the primary goal of the pilot study is proof of concept essential to design a large combination therapy RCT, The investigators will compare the combination of intranasal insulin and semaglutide with the other three groups on a) cognition, b) cerebral blood flow (via ASL MRI), c) glucose uptake (via FDG PET), ADRD(Alzheimer's disease and related disorders)-related blood biomarkers (Aβ42/Aβ40 ratio, pTau181 and 231, NfL and GFAP), and expression of insulin signaling genes from brain derived exosomes.

Connect with a study center

  • Joseph Sagol Neuroscience center, Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

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