Alzheimer's Disease(AD)CSADNCT07570719
Community-based Screening for Alzheimer's Disease
An observational study of Alzheimer's Disease(AD) and Mild Cognitive Impairment (MCI), run by Kuang XiaoJun at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI), Cognitive Impairment
- What is being tested?
- No study-specific intervention
- How many people
- 3,000 participants
- Where
- 4 sitesChina
- Study dates
- 1 May 2026to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Aged 60-80 years
- Capable of normal communication and able to complete the questionnaire
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Fengcheng Community Health Service Center
Shanghai, Shanghai Municipality
Zhongming Sheng, 021-57131233
- Recruiting
Fengpu Community Health Service Center
Shanghai, Shanghai Municipality
Zhiping Jin, 021-37136190
- Recruiting
Qingcun Community Health Service Center
Shanghai, Shanghai Municipality
Jingxin Zhu, 021-57561250
- Recruiting
Xidu Community Health Service Center
Shanghai, Shanghai Municipality
Xiaoqing Gu, 021-37130155
About this study
Official title: Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
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.
- Being tested
- No study-specific intervention
- Keywords
- Alzheimer's disease, Cognitive Impairment, Screening, Blood biomarker
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study-specific interventionOther
This is a purely observational cohort study with no intervention assigned to participants.
| Study group | Role | What they receive |
|---|---|---|
| Screening group | Not described Receives: Other: No study-specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood biomarkers （pTau217、Aβ42、GFAP）
Measured: Baseline (at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease(AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuang XiaoJun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kuang XiaoJun, Shanghai Fengxian District Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570719
- Sponsor's protocol ID
- IRB2026KY01802
- Acronym
- CSAD
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
- ClinicalTrials.gov ID
- NCT07570719
- Acronym / sponsor ID
- CSAD / IRB2026KY01802
- Keywords
- Alzheimer's disease, Cognitive Impairment, Screening, Blood biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kuang XiaoJunUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening group | – | Other: No study-specific intervention |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Aged 60-80 years
- Capable of normal communication and able to complete the questionnaire
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No study-specific interventionThis is a purely observational cohort study with no intervention assigned to participants. | Other | Screening group |
Primary outcome
Blood biomarkers （pTau217、Aβ42、GFAP）
Time frame: Baseline (at enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease(AD) and Mild Cognitive Impairment (MCI), run by Kuang XiaoJun at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Kuang, PhD (021-57426172, xj_kuang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood biomarkers （pTau217、Aβ42、GFAP） (time frame: Baseline (at enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.