COMMETS- Combination MCI Metabolic Syndrome
Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study
Rutgers, The State University of New Jersey
80 participants
Jan 30, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria6
- 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.
Interventions
The medication is available in 3, 7, and 14-mg tablets for oral use. Participants will be instructed to start with an initiating dose of 3 mg once daily. If they do not experience adverse events (nausea, vomiting, and abdominal pain) then the dose will be titrated to 7 mg once daily after 30 days. Again, if the participant does not experience adverse events, the dose will be further titrated after 30 days to 14 mg once daily. This does will continue until the end of the study, at 12 months.
The study will use the ViaNase; Kurve Technology intranasal device to administer insulin intra-nasally. This device has been used in other studies of persons with AD and has shown insulin penetration into the brain via CSF studies. Through sniffing, the medication crosses the blood-brain barrier (BBB) at the top of the nasal cavity. Participants will be instructed to press a switch that will turn on the device, engaging a pump that releases a nebulized stream of insulin through a nose piece into a nostril for 20 seconds (the device includes an electronic timer), after which the device switches off. The process is then repeated in the other nostril. The investigators decided on administration of 20IU of INI twice per day as the literature suggests this as the optimal dosage.
Rybelsus semaglutide - this medicine will simulate taking the pill Rybelsus /semaglutide once a day. A pill identical to the medicine pill will be given.
The placebo used in this study is saline. The investigators will administer saline, with exactly the same methods as the INI insulin (twice per day, 20 seconds each sniff, in each nostril.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06072963