Community-based Screening for Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-80
SponsorKuang XiaoJun
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 60-80 years
Capable of normal communication and able to complete the questionnaire
Disqualifiers
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
Trial population
Community-dwelling Chinese older adults recruited from community physical examination and outpatient settings across 4 multicenter sites, who voluntarily participate in Alzheimer's disease screening and meet the study's eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No study-specific intervention
Other interventionThis is a purely observational cohort study with no intervention assigned to participants.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Screening group1 intervention
Trial outcomes
Primary outcomes
1
Blood biomarkers （pTau217、Aβ42、GFAP）
Time frame
Baseline (at enrollment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kuang XiaoJun
Lead sponsor
Shanghai Fengxian District Central Hospital
Sponsor institution
Source ClinicalTrials.gov