Recruiting PHASE2 Alzheimer Disease

New treatment option for Alzheimer Disease

Official title COMMETS- Combination MCI Metabolic Syndrome

ClinicalTrials.gov ID: NCT06072963

What this study is testing

What is Semaglutide?

Semaglutide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alzheimer disease.

Also referred to as Rybelsus.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 60 to 90

You may be able to join if

  • 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...
  • Fluent in Hebrew
  • The study requires an active study partner

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Ramat Gan, Israel

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 60 years to 90 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Ramat Gan, Israel. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.