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Trial · Interventional

CompletedNot applicableRegistry data

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

Short name LIGHT-MCI

NCTNCT05313529 (opens ClinicalTrials.gov in a new tab)Other id2022-LCYJ-ZD-03
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
396 participants (actual)
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
8 Oct 2022
Primary completion
31 Dec 2025
Completion
1 Jul 2026
First posted
6 Apr 2022
Last update posted
6 Aug 2026
Conditions
Type 2 Diabetes Mellitus · Mild Cognitive Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024202520262027
  1. N/A

    LIGHT-MCI

    NCT05313529

    8 Oct 2022 to 1 Jul 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • EmpagliflozinDrug
  • LinagliptinDrug

Arms3

  • Experimental

    Liraglutide

    Liraglutide will be titrated from 0.6mg/day to a final dose 1.8mg/day during the first 2 weeks, if well tolerated. Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study. Visits at 8-week intervals will be performed to evaluate the safety of drugs. Metformin dose can be reduced in response to hypoglycaemia, but liraglutide could not be adjusted. If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.

  • Experimental

    Empagliflozin

    Empagliflozin will be initiated and maintained at 10mg/ day every morning until the completion of the study. Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study. Visits at 8-week intervals will be performed to evaluate the safety of drugs. Metformin dose can be reduced in response to hypoglycaemia, but Empagliflozin could not be adjusted. If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.

  • Experimental

    linagliptin

    linagliptin will be initiated at 5mg/ day every morning. Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study. Visits at 8-week intervals will be performed to evaluate the safety of drugs. Metformin dose can be reduced in response to hypoglycaemia, but linagliptin could not be adjusted. If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mild cognitive impairment (MCI) remission rate

    Time frame · The core study spans from baseline to 48 weeks

    Registry description

    MCI mitigation is defined by three criteria: an education-adjusted score of the Montreal Cognitive Assessment (MoCA) ≥26, no cognitive deficits in any explored cognitive subdomain, including processing speed, executive function, immediate memory, visuospatial construction ability, language, attention and delayed memory, evaluated by Trail-Making Test, Stroop Color-Word Test and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), respectively, and preservation of ability to perform instrumental activity of daily living (IADL) with a Functional Activities Questionnaire (FAQ) score \<5.

Secondary outcomes(20)

  1. Change in score of Mini-Mental State Examination (MMSE)

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    The MMSE contains a total of 30 items that assess orientation, registration, attention and calculation, recall, and language, with a score range from 0 to 30. Generally, a higher MMSE score reflects a better cognitive function.

  2. Changes in score of MoCA

    Time frame · from baseline to weeks 24, 48, and 76 of treatment (the core study spans from baseline to 24, and 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    The MoCA (Chinese version) is a screening instrument for MCI comprised of 30 items to assess multiple cognitive domains (memory recall, visuospatial abilities, executive functions, attention, language, and orientation to time and place; scores range from 0 to 30, with higher scores indicating better cognitive function). Participants received one additional point if they had a MoCA score \< 30 and 12 years or less of formal school education.

  3. Changes in total score of RBANS

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    The RBANS (Chinese version) is a brief neuropsychological screening battery with established test-retest reliability and age-appropriate normative data, which consists of 12 task tests assessing 5 cognitive domains, namely immediate memory, visuospatial/ constructional, language, attention and delayed memory, with a score range from 40 to 160. A higher RBANS score reflects a better global cognitive function.

  4. Change in the RBANS index score of immediate memory

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    The RBANS (Chinese version) is a brief neuropsychological screening battery with established test-retest reliability and age-appropriate normative data. The RBANS includes 12 sub-tests that generate five age-adjusted index scores and a total score. The five indices include immediate memory (consisting of list learning and story memory tests), visuospatial/constructional domain (consisting of figure copying and line orientation tests), language (consisting of picture naming and semantic fluency tests), attention (consisting of digit span and coding tests) and delayed memory (consisting of list recall, story recall, figure recall and list recognition tests). Generally, a higher index score reflects a better cognitive subdomain function.

  5. Change in the RBANS index score of visuospatial/constructional

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as the RBANS index score of immediate memory.

  6. Change in the RBANS index score of language

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as the RBANS index score of immediate memory.

  7. Change in the RBANS index score of attention

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as the RBANS index score of immediate memory.

  8. Change in the RBANS index score of delayed memory

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as the RBANS index score of immediate memory.

  9. Change in aggregate time to test completion for Trail Making Test (TMT)

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    The TMT is a validated timed measure of processing speed, which consists of part A and part B (TMT-A and TMT-B). The time limits for performing the TMT-A and TMT-B are 180 and 300 seconds, respectively. Processing speed is estimated by the aggregate time in seconds to complete TMT-A and TMT-B such that less time indicate faster processing speed.

  10. Change in aggregate time to test completion for Victoria Stroop Color-Word Test

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    The Victoria Stroop Color-Word Test is a well-known measure of executive function. There are three indices including Stroop-dot, Stroop-word and Stroop-color word in the test. The color task consists of colored dots; the word task comprises ordinary words that are unrelated to the meaning of color; the color-word task consists of words written in color that indicate the meaning of the color, but the color of these words differs from the meaning of the word itself. The participants were asked to quickly read the color of the dots or Chinese words on the cards. The sum of consuming time taken to read the three cards is used as an index of executive function performance. Less time indicates better executive function.

  11. Changes in MRI-derived total brain volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Philips TX 3.0T superconducting clinical MRI will be used for magnetic resonance scanning (Philips Achieva 3T TX Medical Systems, Eindhoven, the Netherlands). T1 images were processed using Freesurfer software (version 8.1.0, https://surfer.nmr.mgh.harvard.edu) to calculate intracranial volume, total gray matter volume, total white matter volume, cerebrospinal fluid volume and volumes of 68 cortical and 14 subcortical regions based on the Desikan-Killiany atlas23. The total brain volume was calculated as the sum of the gray matter and white matter volumes.

  12. Changes in MRI-derived total gray matter volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as total brain volume.

  13. Changes in MRI-derived total white matter volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as total brain volume.

  14. Changes in MRI-derived cerebrospinal fluid volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as total brain volume.

  15. Changes in MRI-derived white matter hyperintensity volume (WMH)

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Total white matter hyperintensity volume was measured from FLAIR images using the Lesion Segmentation Tool for Statistical Parametric Mapping (SPM) 12.0.

  16. Changes in MRI-derived frontal gray matter volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as total brain volume. Frontal gray matter volume was calculated as the sum of all frontal lobe regions parcellated by FreeSurfer (Desikan-Killiany atlas).

  17. Changes in MRI-derived parietal gray matter volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as total brain volume. Parietal gray matter volume was calculated as the sum of all parietal lobe regions parcellated by FreeSurfer (Desikan-Killiany atlas).

  18. Changes in MRI-derived temporal gray matter volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as total brain volume. Temporal gray matter volume was calculated as the sum of all temporal lobe regions parcellated by FreeSurfer (Desikan-Killiany atlas).

  19. Changes in MRI-derived occipital gray matter volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as total brain volume. Occipital gray matter volume was calculated as the sum of all occipital lobe regions parcellated by FreeSurfer (Desikan-Killiany atlas).

  20. Changes in MRI-derived insula gray matter volume

    Time frame · from baseline to week 48, and 76 of treatment (the core study spans from baseline to 48 weeks, and the week 76 assessment will be analyzed and reported after the extension phase).

    Registry description

    Measurements and instruments are the same as total brain volume.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Clinical trial · 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.

Yu et al. 2025BMJ open

PMID 40840993PMC12374654DOI 10.1136/bmjopen-2024-095382PUB-40840993

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2022

9 results

Enhancement of Impaired Olfactory Neural Activation and Cognitive Capacity by Liraglutide, but Not Dapagliflozin or Acarbose, in Patients With Type 2 Diabetes: A 16-Week Randomized Parallel Comparative Study.

Cheng et al. 2022Diabetes carecited by 57

PMID 35263425DOI 10.2337/dc21-2064PUB-35263425

Full text at the publisher9 results
Publisher pageSee results (9)

Indexing hint: Randomized controlled trial · 2019

3 results

Olfactory Dysfunction Mediates Adiposity in Cognitive Impairment of Type 2 Diabetes: Insights From Clinical and Functional Neuroimaging Studies.

Zhang et al. 2019Diabetes carecited by 96

PMID 31221697DOI 10.2337/dc18-2584PUB-31221697

Full text at the publisher3 results
Publisher pageSee results (3)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultZhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Lu J, Bi Y, Zhu D. Altered Odor-Induced Brain Activity as an Early Manifestation of Cognitive Decline in Patients With Type 2 Diabetes. Diabetes. 2018 May;67(5):994-1006. doi: 10.2337/db17-1274. Epub 2018 Mar 2. PMID 29500313

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria 1. Participants aged ≥40 and ≤75 years, of any gender. 2. Type 2 diabetes diagnosed according to the American Diabetes Association criteria 3. Mild cognitive impairment diagnosed according to the established criteria 1. Cognitive concern from the patient, or an informant or skilled clinicians 2. 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 3. Preservation of independence in daily living abilities: Barthel Index score ≥ 60 4. Absence of dementia 4. Treatment with a stable glucose lowering regimen of metformin monotherapy (≥ 1,000 mg daily) or combination with sulfonylurea/glibenclamide/glycosidase inhibitor/basal insulin over the previous 3 months 5. Glycosylated hemoglobin (HbA1c) during screening between ≥7.0% and ≤10.0% 6. BMI of ≥ 19 kg/m2 7. Education duration of ≥6 years 8. Right-handed participants 9. Understanding of the research procedures and methods, potential benefits and risks of the trial, and sign written informed consent Exclusion criteria 1. History of other dementia-related neurological diseases, depression within the past 2 years, developmental disorders, mania, depression, schizophrenia, etc. 2. Significant nasal sinusitis, nasal cavity and sinus polyps, cranial or nasopharyngeal tumors and other space-occupying lesions, congenital diseases and trauma of the nose, maxillofacial area, and skull base that affect olfaction. Symptoms of upper respiratory tract infection on the day of MRI examination, including nasal congestion, rhinorrhea, fever, etc. 3. Acute metabolic complications such as diabetic ketoacidosis, hyperglycemic hyperosmolar state and hypoglycemic coma within the previous 6 months 4. Severe organ dysfunction of heart, liver, kidneys, and thyroid, including unstable angina, myocardial infarction, or grade II and above cardiac insufficiency within 3 months before screening; estimated glomerular filtration rate (eGFR) by CKD-EPI formula \&lt;45 mL/min/1.73 m², alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater exceeding twice the upper limit of normal, hyperthyroidism or uncontrolled hypothyroidism 5. History of medullary thyroid carcinoma, pancreatitis, multiple endocrine neoplasia syndrome type 2, recurrent urinary tract infections, severe gastrointestinal diseases or history of gastrointestinal surgery, history of malignant tumors 6. With MRI contraindications, such as implanted metal prosthesis, claustrophobia, etc. 7. Females who are pregnant, lactating, breast feeding or of child bearing age without effective contraception 8. Participated in other clinical trials within the previous 6 months 9. Known or suspected allergy to the study drugs 10. Received treatment with GLP-1RAs, dual GLP-1R/GCGR agonist, SGLT-2 inhibitors or DPP4 inhibitors in the past 3 months 11. Known history of drug or alcohol abuse within the past 6 months

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