Status:
RECRUITING
COMMETS- Combination MCI Metabolic Syndrome
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Alzheimer's Association
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
60-90 years
Phase:
PHASE2
Brief 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 plausibili...
Detailed 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 trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06072963
Start Date
January 30 2024
End Date
December 1 2028
Last Update
March 22 2024
Active Locations (1)
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1
Joseph Sagol Neuroscience center, Sheba Medical Center
Ramat Gan, Israel, 5265601