LIGHT-MCI Trial: GLP-1 Agonist, SGLT2 Inhibitor, and DPP-4 Inhibitor for MCI Remission in Type 2 Diabetes

What Was Tested

In this not phased trial, researchers set out to test Liraglutide.

This is an investigator-led prospective, randomized, open label, parallel study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linagliptin on the cognitive function in T2DM patients with mild cognitive impairment (MCI), consisting of a 48-week core study followed by a 28-week extension phase.

It had three arms (groups): Liraglutide (experimental), Empagliflozin (experimental) and linagliptin (experimental).

The registry classes the interventions as drug.

More on the Plan

The LIGHT-MCI trial is an investigator-led, prospective, randomized, open label, parallel, multi-center study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linagliptin on the MCI remission in T2DM patients with MCI inadequately controlled with metformin monotherapy.

The trial consists of a 48-week core study followed by an extension phase through to 76 weeks and the investigators will screen in the outpatient and inpatient departments to enroll 396 patients (132 for each arm) totally with the inclusion and exclusion criteria.

The patients will be randomized at a 1:1:1 ratio into Liraglutide, Empagliflozin and Linagliptin treatment group with a computer-generated random order.

Participants who complete the 48-week core study will have the option to receive an additional 28 weeks of intervention after signing an extension consent form.

Who Took Part

396 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants aged ≥40 and ≤75 years, of any gender. Type 2 diabetes diagnosed according to the American Diabetes Association criteria. Mild cognitive impairment diagnosed according to the established criteria. Cognitive concern from the patient, or an informant or skilled clinicians. Objective evidence of cognitive impairment: education-adjusted MoCA score ≤ 25 and ≥ 18; or ≥1.0 standard deviation below the mean of age- and education-specific groups on any cognitive subdomain.

The full record lists 13 inclusion and 11 exclusion criteria; among the exclusions: history of other dementia-related neurological diseases, depression within the past 2 years, developmental disorders, mania, depression, schizophrenia, etc; acute metabolic complications such as diabetic ketoacidosis, hyperglycemic hyperosmolar state and hypoglycemic coma within the previous 6 months; with mri contraindications, such as implanted metal prosthesis, claustrophobia, etc.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2022-10-08 with completion listed for 2025-12-31.

It ran at 5 sites in China (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mild cognitive impairment (MCI) remission rate (time frame: The core study spans from baseline to 48 weeks).

It also tracked 75 secondary outcomes, for example Change in score of Mini-Mental State Examination (MMSE), Changes in score of MoCA, Changes in total score of RBANS, Change in the RBANS index score of immediate memory, Change in the RBANS index score of visuospatial/constructional and Change in the RBANS index score of language.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 396 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.