NCT07128186 · RECRUITING
The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
This observational study is testing whether an AI-powered screening tool can detect early memory and thinking problems in people who have type 2 diabetes. Researchers will follow participants for 3 to 5 years, tracking blood sugar control alongside cognitive changes. There is no drug or treatment involved — just monitoring and testing. The phase is unspecified, meaning this is likely a feasibility or validation study, not a clinical treatment trial.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-08-17