Could common diabetes drugs reverse early memory loss?
NCT ID NCT05313529
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 4 times
Summary
This study tests whether three diabetes medications—liraglutide, empagliflozin, and linagliptin—can help reverse mild cognitive impairment (early memory and thinking problems) in people with type 2 diabetes. About 396 participants will take one of the drugs for 48 weeks, with an additional 28-week follow-up. The goal is to see if these drugs can improve memory and daily function enough to no longer meet the criteria for mild cognitive impairment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- liraglutide, empagliflozin, and linagliptin (diabetes medications)
- What this could lead to
- If successful, this could point toward a way to treat mild cognitive impairment in people with type 2 diabetes using existing diabetes drugs.
- What could go wrong
- This is an early-stage, open-label trial with no placebo group, so results may be less reliable. The cognitive benefits may be small or not last long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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396 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \<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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Endocrinology, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University
Changzhou, Jiangsu, 213000, China
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Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000, China
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Department of Endocrinology, The Affiliated Wuxi People's Hospital of Nanjing Medical University
Wuxi, Jiangsu, 214000, China
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Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
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Department of Endocrinology, the Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, Jiangsu, 211100, China
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