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NCT07128186Recruiting

The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The objective of this observational study is to evaluate the accuracy and feasibility of an artificial intelligence-based multimodal cognitive screening system in early identification of diabetes-related mild cognitive impairment (MCI) among type 2 diabetes mellitus (T2DM) patients through a 3-5 year follow-up. It also aims to analyze the correlation between diabetic metabolic indicators (such as glycemic variability and HbA1c levels) and cognitive function changes, thereby determining the value of this intelligent screening system in early detection and intervention of cognitive impairment in T2DM patients, which constitutes the key focus of this research.

Status (registry)
Recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
11 Aug 2025
Start date
Apr 2025
Primary completion date
Dec 2028
Lead sponsor
Tongji Hospital
NCT number
NCT07128186

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From Apr 2025 to the primary completion date, Dec 2028
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent medication use (within 1 month):
    • Anti-Parkinsonian drugs, antiepileptics, sedatives/hypnotics.
  • Cognitive-enhancing drugs (e.g., donepezil, memantine).

Other illness

  • Other types of diabetes (e.g., type 1 diabetes, gestational diabetes).
  • Metabolic disorders that may affect cognition, including:
    • Acute carbohydrate metabolism events within 3 months (e.g., severe hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state).
    • Hypothyroidism or other endocrine disorders.
  • Neurological/psychiatric conditions that may impair cognition:
    • History of head trauma, depression, anxiety, delirium, severe pulmonary/renal disease, heart failure, or malignancy.

Age

  • Education level \<6 years.

Other

  • Substance abuse (past 2 years), including nicotine/alcohol dependence.
  • Inability to complete AI screening or follow-up due to:
    • Speech/hearing/visual impairments or other disabilities

Who the study is looking for

  • Diagnosed with type 2 diabetes mellitus (T2DM).
  • Aged 40-75 years, with self-reported or informant-reported memory complaints.
  • Cognitive assessment scores consistent with either:
    • Cognitive Normal (CN) or
    • Mild Cognitive Impairment (MCI).
  • Preserved ability to perform basic activities of daily living (ADLs).
  • Memory-specific deficits only (e.g., partial forgetfulness), with intact other cognitive domains (e.g., reasoning, judgment, attention, and executive function).

Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Minda Hospital Affiliated to Hubei Minzu University
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EnshiChinaRecruiting
Huanggang Central Hospital
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HuanggangChinaRecruiting
Huangshi Central Hospital
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HuangshiChinaRecruiting
Jingzhou Central Hospital
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JingzhouChinaRecruiting
Sinopharm Dongfeng General Hospital
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ShiyanChinaNot yet recruiting
Suizhou Central Hospital
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SuizhouChinaNot yet recruiting
Wuhan Fourth Hospital
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WuhanChinaRecruiting
Wuhan Central Hospital
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WuhanChinaRecruiting
Hubei Provincial Hospital of Integrated Chinese & Western Medicine
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WuhanChinaRecruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaRecruiting
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
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WuhanChinaNot yet recruiting
China Resources WISCO General Hospital
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WuhanChinaRecruiting
Wuhan Fifth Hospital
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WuhanChinaRecruiting
Xiangyang First People's Hospital
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XiangyangChinaRecruiting
Xiangyang Central Hospital
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XiangyangChinaNot yet recruiting
Xianning Central Hospital
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XianningChinaRecruiting
Xiantao First People's Hospital
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XiantaoChinaNot yet recruiting
Xiaogan Central Hospital
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XiaoganChinaRecruiting
Sinopharm Gezhouba Central Hospital
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YichangChinaNot yet recruiting
Renhe Hospital Affiliated to China Three Gorges University
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YichangChinaRecruiting
Yichang Central People's Hospital
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YichangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.