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

Recruiting now

Conditions studied: Cognitive Dysfunction

In brief

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.

Key facts

Study ID

NCT07128186

Run by

Tongji Hospital

People needed

5000

Starts

2025-04-22

Expected to finish

2028-12-30

Last updated by the study team

2025-08-17

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion Criteria
• 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).

You may not qualify if…

• Other types of diabetes (e.g., type 1 diabetes, gestational diabetes).
• Education level <6 years.
• 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.
• Substance abuse (past 2 years), including nicotine/alcohol dependence.
• Recent medication use (within 1 month):
• Anti-Parkinsonian drugs, antiepileptics, sedatives/hypnotics.
• Cognitive-enhancing drugs (e.g., donepezil, memantine).
• Inability to complete AI screening or follow-up due to:
• Speech/hearing/visual impairments or other disabilities

Where it is running

• Yichang Central People's Hospital — Yichang, Hubei, China (enrolling)
• Huanggang Central Hospital — Huanggang, Hubei, China (enrolling)
• Huangshi Central Hospital — Huangshi, Hubei, China (enrolling)
• Jingzhou Central Hospital — Jingzhou, Hubei, China (enrolling)
• Wuhan Fourth Hospital — Wuhan, Hubei, China (enrolling)
• Xiangyang First People's Hospital — Xiangyang, Hubei, China (enrolling)
• Xianning Central Hospital — Xianning, Hubei, China (enrolling)
• Xiaogan Central Hospital — Xiaogan, Hubei, China (enrolling)
• Renhe Hospital Affiliated to China Three Gorges University — Yichang, Hubei, China (enrolling)
• Minda Hospital Affiliated to Hubei Minzu University — Enshi, Hubei, China (enrolling)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• China Resources & WISCO General Hospital — Wuhan, Hubei, China (enrolling)
• Hubei Provincial Hospital of Integrated Chinese & Western Medicine — Wuhan, Hubei, China (enrolling)
• Wuhan Central Hospital — Wuhan, Hubei, China (enrolling)
• Wuhan Fifth Hospital — Wuhan, Hubei, China (enrolling)
• Sinopharm Dongfeng General Hospital — Shiyan, Hubei, China
• Suizhou Central Hospital — Suizhou, Hubei, China
• Xiangyang Central Hospital — Xiangyang, Hubei, China
• Xiantao First People's Hospital — Xiantao, Hubei, China
• Sinopharm Gezhouba Central Hospital — Yichang, Hubei, China
• Tianyou Hospital Affiliated to Wuhan University of Science and Technology — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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