Community-based Screening for Alzheimer's Disease

Sponsor
Kuang XiaoJun
Study ID
NCT07570719
Status
Recruiting
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Conditions

  • Alzheimer's Disease(AD)
  • Cognitive Impairment
  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • No study-specific intervention — OTHER
    This is a purely observational cohort study with no intervention assigned to participants.

Study Details

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.

Key Dates

First listed
May 6, 2026
Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Screening group

Primary Outcome Measure

Blood biomarkers （pTau217、Aβ42、GFAP） [ Time Frame: Baseline (at enrollment) ]

Central Contacts

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