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

NCT07284264 | Recruiting

• 1 other identifier: KS2025225-002
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the AD-related cognitive impairment screening and diagnosis program.

  Baseline

Secondary Outcomes (4)

• Community feasibility and compliance

  Baseline

• Program completion rate

  Baseline

• Time to completion

  Baseline

• health-economic evaluatio for screening and diagnosis

  Baseline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community residents aged 50 and above who have resided in the community for over one-year, self-report no cognitive impairment disorder or use of anti-dementia medications, and are capable of communicating in Chinese. Participants with a self-reported or clinically confirmed diagnosis of severe psychiatric disorders, such as bipolar disorder or schizophrenia, as well as those with medical conditions that impair their ability to complete cognitive assessments, were excluded.

You may qualify if:

• 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.）

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (6)

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

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yi Tang, M.D., Ph.D

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Tang, M.D., Ph.D

CONTACT

00861083199456; tangyixw@vip.163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 16, 2025
• Study Start: August 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2025.8.01-2026.01.01

Locations

CN (6)