Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No study-specific intervention | Other | This is a purely observational cohort study with no intervention assigned to participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood biomarkers (pTau217、Aβ42、GFAP) | Baseline (at enrollment) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojun Kuang, PhD | Contact | 021-57426172 | xj_kuang@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fengcheng Community Health Service Center | Recruiting | Shanghai | Shanghai Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Fengpu Community Health Service Center | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Qingcun Community Health Service Center | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Xidu Community Health Service Center | Recruiting | Shanghai | Shanghai Municipality | China |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |