Clinical trial Recruiting at 4 sites Observational Ages 60 to 80

Community screening with blood biomarkers for Alzheimer's in older adults

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

Run by Shanghai Fengxian District Central Hospital · NCT07570719 · Data updated 2026-11-12

This project will test whether two blood biomarkers (pTau217/Aβ42 ratio and GFAP) can detect Alzheimer's disease or mild cognitive impairment in community-dwelling older adults.

More Cognitive Impairment trials

Quick facts

Study typeObservational
Ages60 Years to 80 Years
SexAll
Enrollment3000 (estimated)
SponsorShanghai Fengxian District Central Hospital
Academic / other
Locations4 sites (Shanghai, Shanghai Municipality and 3 other locations)
StatusRecruiting
StartedMay 27, 2026
Main results expectedMarch 31, 2027
Study endsMarch 31, 2028
Registry record updatedNovember 6, 2026
Trial IDNCT07570719 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are community-dwelling adults aged 60–80 who can communicate normally and complete questionnaires and who do not meet the listed exclusion criteria.

Probably not a fit

People with severe mental disorders, major sensory or mobility impairments, severe organ failure or specific MRI abnormalities, current anticoagulant use, or those already enrolled in other interventional studies are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational cohort will enroll adults aged 60–80 from three Shanghai community health centers during routine physical examinations and outpatient visits. All participants will undergo blood testing for pTau217/Aβ42 ratio and GFAP, and those with abnormal results will complete a full cognitive test battery. The study will establish baseline population levels and reference intervals for these biomarkers in Chinese older adults and measure their screening performance in a real-world community setting. No study-specific interventions are administered; the protocol observes participants and records clinical and biomarker data.

Why it matters

Potential benefit: If successful, this work could enable earlier, less invasive identification of people at risk for Alzheimer's and provide normative biomarker ranges for Chinese older adults to guide referral and follow-up.

How similar studies have gone: Prior research shows plasma pTau217 and GFAP correlate with Alzheimer's pathology and are promising biomarkers, but their performance for community-based screening and in Chinese population cohorts remains under validation.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Fengcheng Community Health Service Center
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Fengpu Community Health Service Center
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Qingcun Community Health Service Center
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Xidu Community Health Service Center
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.