Cognitive DysfunctionNCT07128186
The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
An observational study of Cognitive Dysfunction, run by Tongji Hospital at 21 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- follow-up observation
- How many people
- 5,000 participants
- Where
- 21 sitesChina
- Study dates
- 22 Apr 2025to 30 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll 5,000 eligible participants from 20 participating centers across Hubei Province for a 3- to 5-year longitudinal follow-up, with strict adherence to the predefined inclusion/exclusion criteria.
Who may be able to join
- 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).
Who cannot join
- 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:
Show all 13Show fewer
- 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
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
Minda Hospital Affiliated to Hubei Minzu University
Enshi, Hubei
Maorong Wang, +8613986865499, snowwhite734@163.com
- Recruiting
Huanggang Central Hospital
Huanggang, Hubei
Ting Ding, +8615377133959, 54431050@qq.com
- Recruiting
Huangshi Central Hospital
Huangshi, Hubei
Yong Chen, +8613807237201, chenyong2055@163.com
- Recruiting
Jingzhou Central Hospital
Jingzhou, Hubei
Junli Xue, +8618972160273, L10045@yangtzeu.edu.cn
- Not yet recruiting
Sinopharm Dongfeng General Hospital
Shiyan, Hubei
Kun Yang, +8613797816312, 1732310370@qq.com
- Not yet recruiting
Suizhou Central Hospital
Suizhou, Hubei
Mingjin Sun, +8615172768081, sunmingjin108@163.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Yan Prof. Yang, Doctor, +8618827397697, yangyantj@qq.com
Yan Prof. Yang, Doctor
- Recruiting
China Resources & WISCO General Hospital
Wuhan, Hubei
Ying Fang, +8613554511717, 3328262378@qq.com
- Recruiting
Hubei Provincial Hospital of Integrated Chinese & Western Medicine
Wuhan, Hubei
Jing Zhang, Doctor, +8613317168907, btxd0707@163.com
- Not yet recruiting
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
Wuhan, Hubei
Yang Yang, +8613554623321, 13554623321@126.com
- Recruiting
Wuhan Central Hospital
Wuhan, Hubei
Zhongjing Wang, Doctor, +8613007111056, doctorwangzj@163.com
- Recruiting
Wuhan Fifth Hospital
Wuhan, Hubei
Ying Xu, +8618507199149, 1069236217@qq.com
- Recruiting
Wuhan Fourth Hospital
Wuhan, Hubei
Mei Lin, +8613618623607, lmei2007@163.com
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei
Shaoyong Xu, +8618629680357, yoji_xu@hotmail.com
- Recruiting
Xiangyang First People's Hospital
Xiangyang, Hubei
Xingjian Zhou, +8615971100271, xin.xin1018@163.com
- Recruiting
Xianning Central Hospital
Xianning, Hubei
Fengping Lin, +8613986610602, 907816476@qq.com
- Not yet recruiting
Xiantao First People's Hospital
Xiantao, Hubei
Wenzao Sun, +8618071979609, sunwenzao@sina.cn
- Recruiting
Xiaogan Central Hospital
Xiaogan, Hubei
Min Wu, +8613972658585, minwuy@126.com
- Recruiting
Renhe Hospital Affiliated to China Three Gorges University
Yichang, Hubei
Linchi Guo, +8613895076066, guolinchi@163.com
- Not yet recruiting
Sinopharm Gezhouba Central Hospital
Yichang, Hubei
Jieqiang Chen, +8613872563782, 447169331@qq.com
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei
Zhaoyang Zeng, +8615871555358, zengzhaoyang68@163.com
About this study
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.
- Conditions
- Cognitive Dysfunction
- Being tested
- follow-up observation
- Keywords
- mild cognitive impairment, type 2 diabetes mellitus, artificial intelligence-based multimodal cognitive screening system
- Medical subject headings
- Cognitive Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up observationOther
In this study, no additional interventions were administered to any enrolled participants; only 3-5 years of follow-up observation were conducted, with cognitive status data collected at both baseline and endpoint.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Normal Group | Healthy control group without significant cognitive impairment in the study Receives: Other: follow-up observation | |
| Mild Cognitive Impairment Group | An intermediate state with subjective or objective cognitive decline (e.g., memory, executive function) that does not meet the diagnostic criteria for dementia Receives: Other: follow-up observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Identification Accuracy of the AI System
Sensitivity, specificity, and area under the ROC curve (AUC) of the AI system in detecting Mild Cognitive Impairment (MCI), compared with traditional scales (MMSE/MoCA).
Measured: From enrollment to the end of follow-up for 3-5 years
Cognitive Deterioration Rate
Conversion rates from:Cognitively Normal (CN) → MCI; MCI → Alzheimer's Disease (AD)
Measured: From enrollment to the end of follow-up for 3-5 years
Secondary outcomes (2)
Association Between Diabetic Metabolic Indicators and Cognitive Decline
Correlation of glucose variability (e.g., MAGE) and glycated hemoglobin (HbA1c) with changes in cognitive scores.
Measured: From enrollment to the end of follow-up for 3-5 years
Predictive Value of Multimodal Data
Predictive efficacy of voice features, facial expressions, drawing trajectories, and other biomarkers in forecasting cognitive deterioration
Measured: From enrollment to the end of follow-up for 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start22 Apr 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yangyan, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128186
- Sponsor's protocol ID
- TJ-IRB202503076
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of an AI-driven Multimodal Predictive Model for Cognitive Impairment in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07128186
- Acronym / sponsor ID
- TJ-IRB202503076
- Conditions
- Cognitive Dysfunction
- Keywords
- mild cognitive impairment, type 2 diabetes mellitus, artificial intelligence-based multimodal cognitive screening system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Normal Group | – | Other: follow-up observationHealthy control group without significant cognitive impairment in the study |
| Mild Cognitive Impairment Group | – | Other: follow-up observationAn intermediate state with subjective or objective cognitive decline (e.g., memory, executive function) that does not meet the diagnostic criteria for dementia |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll 5,000 eligible participants from 20 participating centers across Hubei Province for a 3- to 5-year longitudinal follow-up, with strict adherence to the predefined inclusion/exclusion criteria.
Key inclusion criteria (7 listed)
- 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:
- 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).
Key exclusion criteria (13 listed)
- Other types of diabetes (e.g., type 1 diabetes, gestational diabetes).
- Education level <6 years.
- Metabolic disorders that may affect cognition, including:
- Neurological/psychiatric conditions that may impair cognition:
- Substance abuse (past 2 years), including nicotine/alcohol dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow-up observationIn this study, no additional interventions were administered to any enrolled participants; only 3-5 years of follow-up observation were conducted, with cognitive status data collected at both baseline and endpoint. | Other | Cognitive Normal Group, Mild Cognitive Impairment Group |
Primary outcome
Early Identification Accuracy of the AI System
Time frame: From enrollment to the end of follow-up for 3-5 years
Sensitivity, specificity, and area under the ROC curve (AUC) of the AI system in detecting Mild Cognitive Impairment (MCI), compared with traditional scales (MMSE/MoCA).
Cognitive Deterioration Rate
Time frame: From enrollment to the end of follow-up for 3-5 years
Conversion rates from:Cognitively Normal (CN) → MCI; MCI → Alzheimer's Disease (AD)
2 secondary outcomes
Association Between Diabetic Metabolic Indicators and Cognitive Decline
Time frame: From enrollment to the end of follow-up for 3-5 years
Predictive Value of Multimodal Data
Time frame: From enrollment to the end of follow-up for 3-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by Tongji Hospital at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Yang, Doctor (86-18827397697, yangyantj@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Identification Accuracy of the AI System (time frame: From enrollment to the end of follow-up for 3-5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.