NCT07128186 The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
| NCT ID | NCT07128186 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Cognitive Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2025-04-22 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07128186 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07128186 currently recruiting?
Yes, NCT07128186 is actively recruiting participants. Contact the research team at yangyantj@qq.com for enrollment information.
Where is the NCT07128186 trial being conducted?
This trial is being conducted at Enshi, China, Huanggang, China, Huangshi, China, Jingzhou, China and 11 additional locations.
Who is sponsoring the NCT07128186 clinical trial?
NCT07128186 is sponsored by Tongji Hospital. The trial plans to enroll 5,000 participants.