NCT07570719Recruiting
Community-based Screening for Alzheimer's Disease
Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 29 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Kuang XiaoJun
- Diseases
- Alzheimer disease
- NCT number
- NCT07570719
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 1 May 2026 to the primary completion date, 31 Mar 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe mental disorders
- 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)
Other
- Severe visual, auditory, comprehension or mobility impairments
- Current participation in other health intervention clinical studies
- Unable to comply with study procedures with no legal guardian
Who the study is looking for
- Aged 60-80 years
- Capable of normal communication and able to complete the questionnaire
Age in the registry: 60 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fengpu Community Health Service Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Fengcheng Community Health Service Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Xidu Community Health Service Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Qingcun Community Health Service Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.