Determining key biomarkers for diagnosing Alzheimer's disease
Official title: Study on the Diagnostic Cut-off Value of Core Biomarkers in Cerebrospinal Fluid and Blood of Alzheimer's Disease
Run by Capital Medical University · NCT05020106 · Data updated 2026-11-12
This study is trying to find the best blood and spinal fluid markers to help diagnose Alzheimer's disease and similar conditions in people, including those with mild memory issues and healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 55 Years to 75 Years |
| Sex | All |
| Enrollment | 3200 (estimated) |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 1, 2018 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT05020106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 55-75 with a diagnosis of Alzheimer's disease, amnestic mild cognitive impairment, non-Alzheimer's dementia, or those who are cognitively normal.
✕Probably not a fit
Patients with other medical or psychiatric illnesses or those who cannot provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to establish the optimal cut-off values for cerebrospinal fluid and blood biomarkers, including β-amyloid and tau proteins, in diagnosing Alzheimer's disease and related conditions. Participants will include individuals diagnosed with Alzheimer's disease, amnestic mild cognitive impairment, non-Alzheimer's dementia, and cognitively normal controls. The study will collect clinical assessments, neuroimaging data, and biological samples to analyze the relationships between these biomarkers and neuroimaging findings. The goal is to create a combined diagnostic model tailored for the Chinese population.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of Alzheimer's disease diagnosis, leading to earlier and more effective interventions.
How similar studies have gone: Other studies have shown promise in using biomarkers for Alzheimer's diagnosis, but this approach is tailored specifically for the Chinese population, making it a novel contribution.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 55-75. Written informed consent obtained from participant or legal guardian prior to any study-related procedures. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. The diagnosis of aMCI is assigned according to 2004 Petersen criteria. As for non-AD dementia, the McKeith criteria are used for DLB, the revised diagnostic criteria proposed by the International bvFTD Criteria Consortium for behavioral variant FTD, the Gorno-Tempini criteria for the semantic variant FTD or non-fluent aphasia, the Movement Disorder Society Task Force criteria for PDD, the vascular behavioral and cognitive disorders (Vas-Cog) criteria for VaD, the Armstrong's criteria for CBD, the CDC's diagnostic criteria for CJD, etc. In addition, normal cognition is supported by MMSE, CDR and other cognitive function scales. Exclusion Criteria: * Other medical or psychiatric illness. No one can serve as an informant. Refused to complete a cognitive test and provide biospecimen.
Where it's running
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Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Jianping Jia, Doctor
- Email: jiajp@vip.126.com
- Phone: 8610-83199449
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.