RecruitingRecruiting
COMMETS- Combination MCI Metabolic Syndrome
NCT06072963 · Rutgers, The State University of New Jersey
In plain English
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Official title
Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-01-30
Estimated completion: 2028-12-01
Last updated: 2026-07-27
Interventions
Drug: SemaglutideDrug: Intranasal insulinOther: Semaglutide placeboOther: Intranasal insulin placebo
Primary outcomes
- • 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)
Sponsor
Rutgers, The State University of New Jersey · other
With: Alzheimer's Association
Contacts & investigators
ContactIscka Yore · contact · Iscka.Yore@sheba.health.gov.il · +972-35307262
ContactTal Niv · contact · Tal.Niv@sheba.health.gov.il · +972-35305406
InvestigatorTal Davidy · study_director, Sheba Medical Center
InvestigatorMichal Schnaider beeri · principal_investigator, Rutgers, The State University of New Jersey
All locations (1)
Joseph Sagol Neuroscience center, Sheba Medical CenterRecruiting
Ramat Gan, Israel