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Evaluating the effects of liraglutide, empagliflozin and linagliptin on mild cognitive impairment remission in patients with type 2 diabetes (LIGHT-MCI): study protocol for a multicentre, randomised controlled trial with an extension phase
Congcong Yu, Huijie Yang, Bing Zhang, Shihua Chen, Sijue Yang, Fangyi Li, Wenhui Zhu, Beibei Zhai et al.. BMJ Open, 2025-08-01
Topic: Brain proteins, microglia and lab models
INTRODUCTION: Diabetes is a significant modifiable risk factor for cognitive dysfunction. There are currently no effective treatments that delay or reverse the progression of cognitive dysfunction. Accumulating evidence demonstrates that specific antidiabetes medications hold promise in improving cognitive function. However, the comparative effects of various antidiabetic drug classes on cognitive protection remain to be fully elucidated. This study aims to investigate and compare the cognitive benefits of liraglutide, empagliflozin and linagliptin on achieving mild cognitive impairment (MCI) remission in individuals with type 2 diabetes (T2D). METHODS AND ANALYSIS: The LIGHT-MCI trial is an investigator-initiated, multicentre, open-label, parallel-group, randomised, superiority trial involving T2D patients with MCI, consisting of a 48-week core study followed by an extension phase through to 76 weeks. A total of 396 participants will be randomly allocated 1:1:1 to receive liraglutide, empagliflozin or linagliptin treatment. The primary outcome measure is the efficacy difference of liraglutide, empagliflozin and linagliptin in achieving MCI remission in individuals with T2D. The key secondary outcome measures include changes in scores of general cognition and various cognitive subdomains (including processing speed, executive function, immediate memory, visuospatial construction ability, language, attention and delayed memory), basic and instrumental daily living ability, MRI-derived normalised measures of total brain volume, cerebral microstructures, cortical and nuclear volume, white matter hyperintensity, volume, white matter microstructural integrity, odour-induced brain activation and resting-state functional connectivity, olfactory function and metabolic parameters. ETHICS AND DISSEMINATION: The LIGHT-MCI trial has received approval from the Ethics Committees of the Drum Tower Hospital Affiliated to Nanjing University Medical School (2022-092-02) and other participating centres in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation for Good Clinical Practice (ICH GCP E6). Informed consent is required for participation. Findings from this trial are disseminated through peer-reviewed publications, conference presentations, newsletters and social media. TRIAL REGISTRATION NUMBER: NCT05313529.
Key findings
- INTRODUCTION: Diabetes is a significant modifiable risk factor for cognitive dysfunction.
Why it matters
This is a protocol for a randomized trial comparing liraglutide, empagliflozin, and linagliptin for achieving mild cognitive impairment remission in people with type 2 diabetes. It has not yet produced results, so it cannot yet say whether any of these drugs treat, cure, or prevent Alzheimer's disease.
Study details
- Study designopen-label trial
- Participants396
- Evidence strengthHigh
How this study scored 46/100
Published in a peer-reviewed journal. Scored zero for study design and effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (BMJ Open) |
| Journal's citation record | 2 / 4 | BMJ Open: journal h-index 240 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | Design recorded as “open-label trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 2 / 4 | 396 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 1 / 7 | Cited 2 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.7 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 2 / 6 | Cited 1.2× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 2 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Yan Bi: h-index 33 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Nanjing University: institution h-index 850 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 8 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40840993) |
| Free to read | 2 / 2 | Free to read |
| Total | 46 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Yu, C., Yang, H., Zhang, B., Chen, S., Yang, S., Li, F., et al. (2025). Evaluating the effects of liraglutide, empagliflozin and linagliptin on mild cognitive impairment remission in patients with type 2 diabetes (LIGHT-MCI): study protocol for a multicentre, randomised controlled trial with an extension phase. BMJ Open. https://doi.org/10.1136/bmjopen-2024-095382
Vancouver
Yu C, Yang H, Zhang B, Chen S, Yang S, Li F, et al. Evaluating the effects of liraglutide, empagliflozin and linagliptin on mild cognitive impairment remission in patients with type 2 diabetes (LIGHT-MCI): study protocol for a multicentre, randomised controlled trial with an extension phase. BMJ Open. 2025. doi:10.1136/bmjopen-2024-095382. PMID: 40840993.
BibTeX
@article{yu2025-40840993,
author = {Yu, Congcong and Yang, Huijie and Zhang, Bing and Chen, Shihua and Yang, Sijue and Li, Fangyi and Zhu, Wenhui and Zhai, Beibei and others},
title = {{Evaluating the effects of liraglutide, empagliflozin and linagliptin on mild cognitive impairment remission in patients with type 2 diabetes (LIGHT-MCI): study protocol for a multicentre, randomised controlled trial with an extension phase}},
journal = {BMJ Open},
year = {2025},
doi = {10.1136/bmjopen-2024-095382},
pmid = {40840993},
url = {https://doi.org/10.1136/bmjopen-2024-095382}
}
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