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Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
Led by Kuang XiaoJun · Updated on 2026-05-06
3000
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter observational cohort study to evaluate blood-based biomarkers for Alzheimer's disease (AD) screening in a real-world community setting among Chinese older adults aged 60 to 80. The study aims to determine the clinical value of biomarkers like phosphorylated tau 217 to amyloid β 42 ratio (pTau217/Aβ42) and glial fibrillary acidic protein (GFAP) for identifying AD in community-dwelling older adults. It also seeks to establish baseline levels and reference intervals of these biomarkers for this population. Participants are randomly enrolled from community-dwelling older adults undergoing routine physical exams or outpatient visits. All participants will have blood drawn for biomarker testing. Those with positive biomarker results—defined by abnormal pTau217/Aβ42 ratio and/or GFAP levels—will complete a full set of cognitive tests 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). Additionally, 15% of participants with negative biomarker results will be randomly selected to complete the same cognitive assessments. Throughout the study, researchers will monitor blood biomarker levels at enrollment and follow cognitive function through standardized assessments. The study observes participants' health and cognitive status without any assigned treatments or interventions. This observational approach allows for understanding the screening performance of these blood markers and their relation to cognitive function in older adults. Participation involves routine blood tests and cognitive questionnaires, with no study-specific treatments administered.
CONDITIONS
Brief Title
Community-based Screening for Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 60-80 years
- Capable of normal communication and able to complete the questionnaire
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment
Participants undergo blood biomarker assessments to evaluate Alzheimer's disease indicators.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over time without receiving any study-specific intervention.
Visits as scheduled by the study team
Trial Site Locations
Total: 4 locations
1
Fengcheng Community Health Service Center
Shanghai, Shanghai Municipality, China
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2
Fengpu Community Health Service Center
Shanghai, Shanghai Municipality, China
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3
Qingcun Community Health Service Center
Shanghai, Shanghai Municipality, China
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4
Xidu Community Health Service Center
Shanghai, Shanghai Municipality, China
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Research Team
X
Xiaojun Kuang, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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