Alzheimer DiseaseNCT07286812
Digital Technology Combined With Blood Marker Screening and Diagnosis for Community Populations Based on Classification Theory: an Integrated Study
An observational study of Alzheimer Disease, run by First Hospital of China Medical University at 1 site in China.
Trial summary
Our research hypothesis is as follows: A step - by - step screening strategy based on screening technologies can resolve the issue of insufficient efficiency in the traditional scale - based screening model. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 31 Jul 2026
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents aged 50 and above who were included in the communities from December 2025 to April 2026
Who may be able to join
- Adults aged 50 and above;
- Residents of this community for at least one year, with established medical records;
- Deny a history of cognitive impairment diseases (mild cognitive impairment, dementia, Alzheimer's, etc.) and the use of anti-dementia drugs (cholinesterase inhibitors or memantine, etc.);
- Agree to participate in the study;
- The individual and their relatives can communicate normally in Chinese.
Who cannot join
- Self-reported or confirmed through inquiry that there is a severe mental disorder, such as bipolar disorder or schizophrenia, etc.
- Suffering from a disease that makes it impossible to complete the cognitive assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Huayan Liu, PhD., +86 13609831417, liuhy@cmu1h.com
About this study
Our research hypothesis is as follows: A step - by - step screening strategy based on screening technologies can resolve the issue of insufficient efficiency in the traditional scale - based screening model. Meanwhile, performing pathological diagnoses on patients with suspected cognitive impairment identified through screening is conducive to the further implementation of etiology - based treatment and intervention, thus bringing benefits to patients at the earliest possible stage.
By exploring the characteristic changes in gait, facial expressions, and language of patients with suspected cognitive impairment and analyzing their diagnostic efficiency for cognitive impairment patients, new ideas can be provided for the early diagnosis of the disease.
Through longitudinal observation of the changes in disease - related information during the progression and transformation of the disease, a predictive model for the early diagnosis of cognitive impairment and the prediction of disease progression can be constructed.
Read the detailed description
Cognitive impairment refers to the impairment of cognitive functions caused by various factors, involving multiple cognitive domains such as orientation, memory, calculation ability, attention, language function, executive function, reasoning ability, and visuospatial function, and affecting patients' social functions and quality of life to varying degrees. Cognitive impairment is classified into mild cognitive impairment and dementia based on its severity. Alzheimer's disease is the most common type of dementia causing cognitive impairment, accounting for 60% to 80% of all dementia cases. The prevalence of cognitive impairment is increasing rapidly and showing a trend of younger onset, becoming a pressing public health issue in the process of global aging.
Dementia in the elderly, especially Alzheimer's disease, generally undergoes a 15 to 20-year latent development process. Studies have shown that through early screening to identify high-risk individuals and implement precise intervention, the rate of cognitive decline can be effectively reduced, and the disease progression can be delayed. Communities, as the main place for the elderly's daily life, are important platforms for implementing dementia screening and health intervention. Conducting early screening in the community population and adopting a forward-looking prevention strategy can effectively identify patients at the stage of mild cognitive impairment. Through comprehensive intervention measures such as improving lifestyle, controlling chronic diseases, and strengthening cognitive training, the occurrence and development of cognitive impairment can be effectively prevented or delayed. For identified dementia patients, establishing an effective multi-level cognitive impairment prevention and intervention system "hospital - community - family - patient" will help improve the quality of life of patients. Early screening and diagnosis of cognitive impairment is extremely important, and researching the early screening and diagnosis system of cognitive impairment is of great significance.
How to improve the ability of cognitive impairment screening tools, optimize the diagnostic process, has always been a key scientific issue in establishing a cognitive impairment early screening and diagnosis system. Studies have found that through a two-stage stratified screening scheme combining rapid pre-screening with AMT/PFQ and precise diagnosis with MMSE/MOCA, the screening time can be shortened by more than 50%, and the negative predictive value remains above 99%. This optimized path reduces the cost consumption in the resource-intensive stage by shrinking the scale of individuals requiring advanced cognitive assessment. Moreover, the latest research shows that many clinical symptoms of AD occur in the early stage of the disease, which can not only help indicate the occurrence of the disease but also help predict the progression of the disease. However, these symptoms are often complex and difficult to be comprehensively and accurately evaluated through clinical observation by doctors, such as gait abnormalities, facial expressions, and language disorders. Gait is a very complex task that requires coordinated interaction of a wide range of brain regions to complete, and mild cognitive impairment will lead to abnormal gait. Therefore, gait abnormalities not only reflect the severity of dementia but also can help indicate early mild cognitive impairment and predict the occurrence of cognitive impairment. Existing research on the assessment of gait abnormalities still relies on quantitative indicators such as walking speed, stride length, and stride width, but gait is a dynamic process, and these indicators cannot comprehensively and precisely reflect the overall situation of gait abnormalities of patients. The olfactory cortex is most easily damaged in the early stage of AD, and the damage of the amygdala will specifically lead to the disorder of emotion processing in patients, especially the disorder of facial expression recognition and expression. More research indicates that the disorder of emotion recognition and expression will seriously affect the quality of life of patients and is the main reason for conflicts and burdens between caregivers and patients. However, there is still less research on facial expression disorders, and there is no effective method for identifying and evaluating the abnormality of patients' facial microexpressions and their emotional perception disorders. Language disorder is the core feature of cognitive impairment, which not only can predict the occurrence of cognitive impairment but also can reflect the severity of cognitive damage. However, there is still no universal system in clinical practice for comprehensive detection of language disorders. Currently, it mainly relies on specialist doctors using various complex scales to assess patients' language disorders. This often leads to significant differences in symptom assessment and interpretation. In summary, gait, facial expressions, and language disorders can all play important roles in the early diagnosis and disease course assessment of AD and MCI.
Our research hypothesis is: The stepwise screening strategy based on screening techniques can solve the problem of insufficient efficiency in the traditional scale screening model. At the same time, conducting pathological diagnosis for suspected cognitive impairment patients can help further implement etiological-based treatment and intervention, bringing benefits to patients as early as possible; by exploring the change characteristics of gait, facial expressions, and language in suspected cognitive impairment patients, analyzing their diagnostic efficacy for cognitive impairment patients, providing new ideas for early diagnosis of the disease; through longitudinal observation of the changes in disease-related information as the disease progresses and transforms, constructing a prediction model for early diagnosis and disease progression of cognitive impairment.
- Conditions
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive impairment group | The subjects diagnosed with AD-related cognitive impairment through early screening of cognitive disorders and examination of AD blood markers | |
| Healthy population group | The subjects who were diagnosed as negative through early screening for cognitive impairment and examination of AD blood markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic efficiency of the cognitive impairment screening and diagnosis protocol
The diagnostic efficiency will be measured by the area under curve(AUC)of receiver operating characteristic(ROC)curve.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start25 Dec 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Huayan, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286812
- Sponsor's protocol ID
- 2025733
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Technology Combined With Blood Marker Screening and Diagnosis for Community Populations Based on Classification Theory: an Integrated Study
- ClinicalTrials.gov ID
- NCT07286812
- Acronym / sponsor ID
- 2025733
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 16 Dec 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.
Our research hypothesis is as follows: A step - by - step screening strategy based on screening technologies can resolve the issue of insufficient efficiency in the traditional scale - based screening model. Meanwhile, performing pathological diagnoses on patients with suspected cognitive impairment identified through screening is conducive to the further implementation of etiology - based treatment and intervention, thus bringing benefits to patients at the earliest possible stage.
By exploring the characteristic changes in gait, facial expressions, and language of patients with suspected cognitive impairment and analyzing their diagnostic efficiency for cognitive impairment patients, new ideas can be provided for the early diagnosis of the disease.
Through longitudinal observation of the changes in disease - related information during the progression and transformation of the disease, a predictive model for the early diagnosis of cognitive impairment and the prediction of disease progression can be constructed.
Detailed description
Cognitive impairment refers to the impairment of cognitive functions caused by various factors, involving multiple cognitive domains such as orientation, memory, calculation ability, attention, language function, executive function, reasoning ability, and visuospatial function, and affecting patients' social functions and quality of life to varying degrees. Cognitive impairment is classified into mild cognitive impairment and dementia based on its severity. Alzheimer's disease is the most common type of dementia causing cognitive impairment, accounting for 60% to 80% of all dementia cases. The prevalence of cognitive impairment is increasing rapidly and showing a trend of younger onset, becoming a pressing public health issue in the process of global aging.
Dementia in the elderly, especially Alzheimer's disease, generally undergoes a 15 to 20-year latent development process. Studies have shown that through early screening to identify high-risk individuals and implement precise intervention, the rate of cognitive decline can be effectively reduced, and the disease progression can be delayed. Communities, as the main place for the elderly's daily life, are important platforms for implementing dementia screening and health intervention. Conducting early screening in the community population and adopting a forward-looking prevention strategy can effectively identify patients at the stage of mild cognitive impairment. Through comprehensive intervention measures such as improving lifestyle, controlling chronic diseases, and strengthening cognitive training, the occurrence and development of cognitive impairment can be effectively prevented or delayed. For identified dementia patients, establishing an effective multi-level cognitive impairment prevention and intervention system "hospital - community - family - patient" will help improve the quality of life of patients. Early screening and diagnosis of cognitive impairment is extremely important, and researching the early screening and diagnosis system of cognitive impairment is of great significance.
How to improve the ability of cognitive impairment screening tools, optimize the diagnostic process, has always been a key scientific issue in establishing a cognitive impairment early screening and diagnosis system. Studies have found that through a two-stage stratified screening scheme combining rapid pre-screening with AMT/PFQ and precise diagnosis with MMSE/MOCA, the screening time can be shortened by more than 50%, and the negative predictive value remains above 99%. This optimized path reduces the cost consumption in the resource-intensive stage by shrinking the scale of individuals requiring advanced cognitive assessment. Moreover, the latest research shows that many clinical symptoms of AD occur in the early stage of the disease, which can not only help indicate the occurrence of the disease but also help predict the progression of the disease. However, these symptoms are often complex and difficult to be comprehensively and accurately evaluated through clinical observation by doctors, such as gait abnormalities, facial expressions, and language disorders. Gait is a very complex task that requires coordinated interaction of a wide range of brain regions to complete, and mild cognitive impairment will lead to abnormal gait. Therefore, gait abnormalities not only reflect the severity of dementia but also can help indicate early mild cognitive impairment and predict the occurrence of cognitive impairment. Existing research on the assessment of gait abnormalities still relies on quantitative indicators such as walking speed, stride length, and stride width, but gait is a dynamic process, and these indicators cannot comprehensively and precisely reflect the overall situation of gait abnormalities of patients. The olfactory cortex is most easily damaged in the early stage of AD, and the damage of the amygdala will specifically lead to the disorder of emotion processing in patients, especially the disorder of facial expression recognition and expression. More research indicates that the disorder of emotion recognition and expression will seriously affect the quality of life of patients and is the main reason for conflicts and burdens between caregivers and patients. However, there is still less research on facial expression disorders, and there is no effective method for identifying and evaluating the abnormality of patients' facial microexpressions and their emotional perception disorders. Language disorder is the core feature of cognitive impairment, which not only can predict the occurrence of cognitive impairment but also can reflect the severity of cognitive damage. However, there is still no universal system in clinical practice for comprehensive detection of language disorders. Currently, it mainly relies on specialist doctors using various complex scales to assess patients' language disorders. This often leads to significant differences in symptom assessment and interpretation. In summary, gait, facial expressions, and language disorders can all play important roles in the early diagnosis and disease course assessment of AD and MCI.
Our research hypothesis is: The stepwise screening strategy based on screening techniques can solve the problem of insufficient efficiency in the traditional scale screening model. At the same time, conducting pathological diagnosis for suspected cognitive impairment patients can help further implement etiological-based treatment and intervention, bringing benefits to patients as early as possible; by exploring the change characteristics of gait, facial expressions, and language in suspected cognitive impairment patients, analyzing their diagnostic efficacy for cognitive impairment patients, providing new ideas for early diagnosis of the disease; through longitudinal observation of the changes in disease-related information as the disease progresses and transforms, constructing a prediction model for early diagnosis and disease progression of cognitive impairment.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive impairment group | – | –The subjects diagnosed with AD-related cognitive impairment through early screening of cognitive disorders and examination of AD blood markers |
| Healthy population group | – | –The subjects who were diagnosed as negative through early screening for cognitive impairment and examination of AD blood markers |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents aged 50 and above who were included in the communities from December 2025 to April 2026
Key inclusion criteria (5 listed)
- Adults aged 50 and above;
- Residents of this community for at least one year, with established medical records;
- Deny a history of cognitive impairment diseases (mild cognitive impairment, dementia, Alzheimer's, etc.) and the use of anti-dementia drugs (cholinesterase inhibitors or memantine, etc.);
- Agree to participate in the study;
- The individual and their relatives can communicate normally in Chinese.
Key exclusion criteria (2 listed)
- Self-reported or confirmed through inquiry that there is a severe mental disorder, such as bipolar disorder or schizophrenia, etc.
- Suffering from a disease that makes it impossible to complete the cognitive assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic efficiency of the cognitive impairment screening and diagnosis protocol
Time frame: 1 year
The diagnostic efficiency will be measured by the area under curve(AUC)of receiver operating characteristic(ROC)curve.
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by First Hospital of China Medical University at 1 site 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Huayan Liu, PhD. (+86 13609831417, liuhy@cmu1h.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic efficiency of the cognitive impairment screening and diagnosis protocol (time frame: 1 year). 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 16 Dec 2025.