Digital screening plus blood biomarkers to detect early Alzheimer's changes

Biomarker-Integrated Digital Guidance for Early Alzheimer's Detection (BRIDGE-AD): A Nationwide Multicenter Study

This project will test whether a two-step approach—quick digital cognitive screening followed by blood-based biomarker tests—can find early Alzheimer's pathology in community-dwelling adults aged 50 and older who do not have diagnosed cognitive disorders.

Quick facts

• Study type: Observational
• Enrollment: 6000 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 6 sites (Beijing and 5 other locations)
• Trial ID: NCT07284264 on ClinicalTrials.gov

What this trial studies

This multicenter observational study uses a stepwise screening strategy beginning with rapid digital pre-screening that combines the SCD-9 questionnaire, a brief digital cognitive assessment, and a predictive risk model to identify people at higher dementia risk. Individuals flagged by the digital screen proceed to blood-based biomarker testing to confirm Alzheimer’s pathology, with multiple novel blood markers compared head-to-head for diagnostic utility. The study recruits community-dwelling adults aged 50 and older without prior diagnoses of mild cognitive impairment or dementia across several medical centers in China. Results aim to identify which combinations of digital measures and blood biomarkers work best for early, scalable detection in real-world community settings.

Who should consider this trial

Good fit: Ideal candidates are community-dwelling adults aged 50 or older in the study regions who have no prior diagnosis of cognitive impairment, can communicate in Chinese, and are willing to complete digital tests and blood sampling.

Not a fit: People with an established diagnosis of dementia or severe mental illness, those who cannot complete digital cognitive assessments, non-Chinese speakers, or long-term institutionalized patients are unlikely to benefit from this screening approach.

Why it matters

Potential benefit: If successful, this approach could enable earlier, simpler, and more scalable detection of Alzheimer's pathology using routine digital screening combined with blood tests, allowing earlier support or preventive strategies.

How similar studies have performed: Previous research has shown promising results for plasma Alzheimer's biomarkers and digital cognitive tests, but direct head-to-head comparisons of multiple novel blood markers in large community screening programs remain relatively novel.

Eligibility criteria

Inclusion Criteria:

1. adults aged 50 and above;
2. living in community for at least one year and having established medical records;
3. denying a history of cognitive disorders (mild cognitive impairment, dementia, Alzheimer's disease, etc.) and the use of anti-dementia drugs (cholinesterase inhibitors or memantine, etc.);
4. agreeing to participate in the study;
5. individual or their relatives can communicate normally in Chinese.
6. high-risk groups for dementia（including:1. Complaints of cognitive decline and/or statements by the informant;2. History of AD in first-degree relatives;3. Known ApoE e4 carrier.）

Exclusion Criteria:

1. Self-reporting or confirmation through inquiry indicates the presence of severe mental disorders, such as bipolar disorder or schizophrenia, etc.
2. Having a disease that makes it impossible to complete the cognitive assessment.

Where this trial is running

Beijing and 5 other locations

• Xuanwu Hospital, Capital Medical University — Beijing, China (RECRUITING)
• Hainan Medical University — Hainan, China (RECRUITING)
• General Hospital of Ningxia Medical University — Ningxiang, China (RECRUITING)
• The First Hospital of China Medical Unversity — Shenyang, China (RECRUITING)
• Shenzhen Center For Chronic Disease Control — Shenzhen, China (RECRUITING)
• Yichun People'S Hospital — Yichun, China (RECRUITING)

Study contacts

• Principal investigator: Yi Tang, M.D., Ph.D — Xuanwu Hospital, Beijing
• Study coordinator: Yi Tang, M.D., Ph.D

Conditions: Dementia