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NCT07395960RECRUITINGanonymous

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)

Sponsor

Source record

Fudan University

Phase

Source record

PHASE1

Modality

AI-normalized

small molecule

Target

AI-normalized

Metfomin

Indication / condition

AI-normalized

Mild Cognitive Impairment

Intervention

Source record

Metfomin

Source & freshness

Source record

NCT ID

NCT07395960

Original source

ClinicalTrials.gov

Source last updated

Feb 09, 2026

Ingested at

Jun 07, 2026

Internal sync

Jun 07, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT07395960

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)

Sponsor

Fudan University

Status

RECRUITING

Phase

PHASE1

Condition raw

Mild Cognitive Impairment, Overweight or Obesity, Elderly

Condition normalized

Mild Cognitive Impairment, Overweight or Obesity, Elderly

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Metfomin

Target normalized

Metfomin

Interventions

Metfomin

Public preview

Source record

The prevalence of cognitive impairment in elderly obese patients is high, and the burden on families and society is heavy. Early intervention for mild cognitive impairment (MCI) is of great value. Central nervous system insulin resistance plays a role in the pathogenesis of cognitive impairment, and functional magnetic resonance imaging(fMRI) can evaluate cognitive impairment by observing central insulin resistance. Some large database studies of Type 2 Diabetes show that metformin is related to reducing the risk of dementia, but some studies have different conclusions, and there is few related study in elderly obese patients. The investigators speculate that metformin may improve cognitive dysfunction by improving central insulin resistance in elderly obese patients.

A prospective, randomized controlled single center clinical cohort study will be conducted on 54 elderly obese patients with MCI. One group will receive metformin and lifestyle intervention, while the control group will receive simple lifestyle intervention. All subjects will be followed up for 26 weeks. Medical history collection, physical examination, and laboratory tests will be conducted before and after intervention, and the Montreal Cognitive Assessment Scale will be used for evaluation. Nasal insulin inhalation combined with fMRI will be used to evaluate central insulin resistance status as an objective basis for cognitive function evaluation. The main purpose of the study is to provide more accurate clinical research evidence for the prevention and treatment of MCI in elderly obese patients, in order to reduce the risk of developing dementia and alleviate the burden on families and society.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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