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NCT Number: NCT07570719

Community-based Screening for Alzheimer's Disease

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fengcheng Community Health Service Center, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 60-80 years
  • Capable of normal communication and able to complete the questionnaire

Exclusion criteria

  • Severe mental disorders
  • Severe visual, auditory, comprehension or mobility impairments
  • Current participation in other health intervention clinical studies
  • Severe renal insufficiency, heart failure, cerebrovascular disease, anemia, hyperthyroidism, hypothyroidism
  • Multiple cerebral infarctions, severe white matter hyperintensities, history of cerebral hemorrhage, current anticoagulant use, MRI abnormalities (cortical iron deposition, cerebral contusion)
  • Unable to comply with study procedures with no legal guardian

Treatment and study plan

No study-specific intervention

Other

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

Primary outcomes

  1. Blood biomarkers (pTau217、Aβ42、GFAP)

    Time frame: Baseline (at enrollment)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojun Kuang, PhD

CONTACT

[email protected]

021-57426172

Sponsors and collaborators

Lead sponsor

Kuang XiaoJun

Other

Registry information

Official study title

Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study

Acronym: CSAD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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