COMMETS- Combination MCI Metabolic Syndrome

NCT06072963 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether a combination of two medications, semaglutide and intranasal insulin, can help improve thinking and memory in adults with mild cognitive impairment or early Alzheimer’s disease who also have metabolic syndrome.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 80 people Planned (estimated).

Who can join Ages 60–90 · all sexes

Timeline Started 2024-01 · est. completion 2028-12

Where 1 site · Israel

What this study is testing ClinicalTrials.gov NCT06072963 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide also known as Rybelsus Drug

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.
Intranasal insulin also known as Actrapid Drug

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.
Semaglutide placebo Other

Rybelsus semaglutide - this medicine will simulate taking the pill Rybelsus /semaglutide once a day. A pill identical to the medicine pill will be given.
Intranasal insulin placebo Other

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.

Main thing measured	Cognitive change - The effect of the combination of Semaglutide and intranasal insulin on cognitive functioning.
Sponsor	Rutgers, The State University of New Jersey
Conditions studied	Alzheimer Disease, Mild Cognitive Impairment, Metabolic Syndrome
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06072963 ↗