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Community-based Screening for Alzheimer's Disease

NCT07570719 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-05-06

No results posted yet for this study

Summary

The goal of this prospective, multicenter, observational cohort study is to evaluate the screening performance of blood-based biomarkers for Alzheimer's disease (AD) in a real-world community screening setting, and to establish the population baseline levels and reference intervals of these biomarkers in Chinese older adults.

The main questions it aims to answer is:

What is the clinical screening value of blood biomarkers (phosphorylated tau 217 to amyloid β 42 ratio \[pTau217/Aβ42\] and glial fibrillary acidic protein \[GFAP\]) for AD among community-dwelling older adults? Eligible study participants will be randomly enrolled from community-dwelling older adults undergoing routine physical examinations and outpatient clinic attendees. All enrolled participants will undergo AD screening via blood biomarker testing. Participants with positive blood biomarker results (defined as abnormal pTau217/Aβ42 ratio and/or GFAP levels) will further complete a full battery of cognitive scale assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Activities of Daily Living (ADL) scale, and 17-item Hamilton Depression Rating Scale (HAMD-17). In addition, 15% of participants with negative blood biomarker results, selected via random sampling, will also complete the same cognitive scale assessments.

Conditions

Interventions

OTHER

No study-specific intervention

This is a purely observational cohort study with no intervention assigned to participants.

Sponsors & Collaborators

  • Kuang XiaoJun

    lead OTHER

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570719 on ClinicalTrials.gov