Community-based Screening for Alzheimer's Disease

NCT07570719 | Recruiting

• 1 other identifier: IRB2026KY01802
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Alzheimer's Disease(AD); Mild Cognitive Impairment (MCI); Cognitive Impairment

Keywords

Alzheimer's disease; Cognitive Impairment; Screening; Blood biomarker

Outcome Measures

Primary Outcomes (1)

• Blood biomarkers （pTau217、Aβ42、GFAP）

  Baseline (at enrollment)

Study Arms (1)

Screening group

Other: No study-specific intervention

Interventions

No study-specific intervention OTHER

This is a purely observational cohort study with no intervention assigned to participants.

Screening group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Aged 60-80 years
• Capable of normal communication and able to complete the questionnaire

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuang XiaoJun: lead

Study Sites (4)

Fengcheng Community Health Service Center

Shanghai, Shanghai Municipality, China

RECRUITING

Fengpu Community Health Service Center

Shanghai, Shanghai Municipality, China

RECRUITING

Qingcun Community Health Service Center

Shanghai, Shanghai Municipality, China

RECRUITING

Xidu Community Health Service Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Xiaojun Kuang, PhD

CONTACT

021-57426172; xj_kuang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Researcher

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)