COMMETS- Combination MCI Metabolic Syndrome

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06072963
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — 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 — 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.

Study Details

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.

Key Dates

Start date
Jan 30, 2024
Status verified
Mar 2024
Primary completion
Dec 1, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Will receive intranasal insulin therapy as well as Oral Semaglutide.
  • Sham Comparator: Group 2
    Will receive active intranasal insulin therapy and placebo Oral Semaglutide.
  • Sham Comparator: Group 3
    Will receive intranasal insulin placebo and active Oral Semaglutide .
  • Placebo Comparator: Group 4
    Will receive intranasal insulin placebo and Oral Semaglutide placebo.

Primary Outcome Measure

Cognitive change - The effect of the combination of Semaglutide and intranasal insulin on cognitive functioning. [ Time Frame: 12 months ]

Central Contacts

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