NCT07570719|Recruiting
Community-based Screening for Alzheimer's Disease
CSAD
Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
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CSAD
Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
Sponsor study identifier
observational
3,000
1 country
4
Study Start
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2026
Actual (reported)May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 6, 2026
Actual (reported)March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Blood biomarkers （pTau217、Aβ42、GFAP）
Baseline (at enrollment)
This is a purely observational cohort study with no intervention assigned to participants.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Fengcheng Community Health Service Center
Shanghai, Shanghai Municipality, China
Fengpu Community Health Service Center
Shanghai, Shanghai Municipality, China
Qingcun Community Health Service Center
First Submitted
April 29, 2026
First Posted
May 6, 2026
Study Start
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 31, 2027
Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease
Contact the study team to confirm eligibility.
Shanghai, Shanghai Municipality, China
Xidu Community Health Service Center
Shanghai, Shanghai Municipality, China
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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