Community screening with blood biomarkers for Alzheimer's in older adults
Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Fengxian District Central Hospital Academic / other |
| Locations | 4 sites (Shanghai, Shanghai Municipality and 3 other locations) |
| Trial ID | NCT07570719 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality and 3 other locations
- 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
- Study coordinator: Xiaojun Kuang, PhD
- Email: xj_kuang@126.com
- Phone: 021-57426172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.