Biomarker-Integrated Digital Guidance for Early Alzheimer's Detection (BRIDGE-AD): A Nationwide Multicenter Study
Recruiting · NCT07284264 · Observational (researchers observe without assigning treatment) · Lead sponsor: Xuanwu Hospital, Beijing
View the official record on ClinicalTrials.gov →What this trial is about
The investigators propose a stepwise screening approach. The first step involves rapid digital pre-screening of cognitive function through three components: the SCD-9 questionnaire to capture subjective cognitive complaints, a digital cognitive assessment to evaluate objective performance, and a predictive model to estimate future dementia risk in cognitively normal individuals. The second step confirms the presence of AD pathology using blood-based biomarkers, with a head-to-head comparison of multiple novel candidates to identify those with the greatest diagnostic utility.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- adults aged 50 and above;
- living in community for at least one year and having established medical records;
- 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.);
- agreeing to participate in the study;
- individual or their relatives can communicate normally in Chinese.
- 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
- Self-reporting or confirmation through inquiry indicates the presence of severe mental disorders, such as bipolar disorder or schizophrenia, etc.
- Having a disease that makes it impossible to complete the cognitive assessment.
Where it is running
6 locations listed.
- Xuanwu Hospital, Capital Medical University - Beijing, China
- Hainan Medical University - Hainan, China
- General Hospital of Ningxia Medical University - Ningxiang, China
- The First Hospital of China Medical Unversity - Shenyang, China
- Shenzhen Center For Chronic Disease Control - Shenzhen, China
- Yichun People'S Hospital - Yichun, China