Metformin for older overweight adults with mild cognitive impairment
Official title: The Efficacy and Safety of Metformin Intervention in Elderly Overweight or Obesity With Mild Cognitive Impairment by a Single-center, Randomized, Placebo-controlled Interventional Study (Include Elderly Patients With Obesity or Overweight)
Run by Fudan University · NCT07395960 · Data updated 2026-11-12
This will test whether taking metformin alongside lifestyle changes can help thinking and memory in older overweight adults with mild cognitive impairment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years to 75 Years |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT07395960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 60–75 with BMI ≥24 kg/m2, MoCA scores in the MCI range, HbA1c under 8.5%, no recent use of hypoglycemic drugs, able to undergo MRI, and willing to sign informed consent.
✕Probably not a fit
Patients with type 1 diabetes, recent use of hypoglycemic drugs, advanced dementia, prior stroke/vascular dementia, significant liver or kidney dysfunction, severe comorbidities, or who cannot tolerate metformin or MRI are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, single-center phase 1/2 trial enrolling 54 elderly overweight or obese participants with mild cognitive impairment. Participants will be assigned to receive metformin plus lifestyle intervention or to a control arm, with cognitive performance and brain imaging followed over time. Functional MRI will be used to examine central insulin resistance while cognitive scales (such as MoCA), metabolic measures, and safety labs will be tracked. The goal is to see if metformin can improve brain insulin signaling and slow or improve cognitive decline in this population.
Why it matters
Potential benefit: If successful, metformin could improve or stabilize thinking and memory in older overweight people with MCI by improving brain insulin resistance.
How similar studies have gone: Large observational studies in people with type 2 diabetes have linked metformin to lower dementia risk but results are mixed and randomized interventional data in elderly obese patients with MCI are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 60 - 75 years old * Body Mass Index: ≥ 24 kg/m2 * Glycated Hemoglobin \< 8.5% * Moca Scale score: 20-26 points (education\> 10 years) or 20-25 points (education≤ 10 years) * Sign the informed consent form Exclusion Criteria: * Any hypoglycemic drugs have been used within 8 weeks prior to enrollment * Type 1 diabetes * Unable to undergo central nervous system magnetic resonance examination * History of alcohol or drug addiction * Severe gastrointestinal diseases, history of gastrointestinal surgery, severe cardiac or pulmonary dysfunction, malignant tumors and other diseases * Abnormal liver function (liver enzyme indicators more than 2.5 times the upper limit of the reference range) or abnormal kidney function (estimated glomerular filtration rate\< 45 ml/min) * There are diseases such as cerebral infarction and vascular dementia * There are conditions judged by the investigator as being unsuitable for enrollment
Where it's running
-
Huadong Hospital, Fudan University
Shanghai, China Recruiting
Study contacts
- Study coordinator: Xiaoming Tao
- Email: t983166@163.com
- Phone: +8613042190822
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.