NCT06072963 COMMETS- Combination MCI Metabolic Syndrome
| NCT ID | NCT06072963 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2024-01-30 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Tal Davidy
STUDY DIRECTOR
Sheba Medical Center
Frequently Asked Questions
Who can join the NCT06072963 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 90 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06072963 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06072963 currently recruiting?
Yes, NCT06072963 is actively recruiting participants. Contact the research team at Iscka.Yore@sheba.health.gov.il for enrollment information.
Where is the NCT06072963 trial being conducted?
This trial is being conducted at Ramat Gan, Israel.
Who is sponsoring the NCT06072963 clinical trial?
NCT06072963 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Tal Davidy at Sheba Medical Center. The trial plans to enroll 80 participants.
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