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

Tongji Hospital

Status: Enrolling

Conditions: Cognitive Dysfunction

Treatments: Other: follow-up observation

Study type: Observational

Funder types: Other

Identifiers

NCT07128186

TJ-IRB202503076

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria

1. Diagnosed with type 2 diabetes mellitus (T2DM).

2. Aged 40-75 years, with self-reported or informant-reported memory complaints.

3. Cognitive assessment scores consistent with either:

   • Cognitive Normal (CN) or
   • Mild Cognitive Impairment (MCI).

4. Preserved ability to perform basic activities of daily living (ADLs).

5. Memory-specific deficits only (e.g., partial forgetfulness), with intact other cognitive domains (e.g., reasoning, judgment, attention, and executive function).

Exclusion criteria

1. Other types of diabetes (e.g., type 1 diabetes, gestational diabetes).

2. Education level <6 years.

3. 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.

4. Neurological/psychiatric conditions that may impair cognition:

   • History of head trauma, depression, anxiety, delirium, severe pulmonary/renal disease, heart failure, or malignancy.

5. Substance abuse (past 2 years), including nicotine/alcohol dependence.

6. Recent medication use (within 1 month):

   • Anti-Parkinsonian drugs, antiepileptics, sedatives/hypnotics.

7. Cognitive-enhancing drugs (e.g., donepezil, memantine).

8. Inability to complete AI screening or follow-up due to:

   • Speech/hearing/visual impairments or other disabilities

Trial design

5,000 participants in 2 patient groups

Cognitive Normal Group

Description:

Healthy control group without significant cognitive impairment in the study

Treatment:

Other: follow-up observation

Mild Cognitive Impairment Group

Description:

An intermediate state with subjective or objective cognitive decline (e.g., memory, executive function) that does not meet the diagnostic criteria for dementia

Treatment:

Other: follow-up observation