Detecting Alzheimer's Disease Biomarkers in Plasma
Official title: Detection of Alzheimer's Disease (AD)-Related Seeds as Biomarkers for Accurate Diagnosis of AD（AD-seeds-detector）
Run by Capital Medical University · NCT04850053 · Data updated 2026-11-12
This study is testing a new device to see if it can find specific markers in blood that help diagnose Alzheimer's disease more accurately compared to healthy people and those with other types of dementia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 55 Years to 75 Years |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 26, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT04850053 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 55-75 who have been diagnosed with Alzheimer's Disease or other types of dementia, as well as cognitively normal individuals.
✕Probably not a fit
Patients with other medical or psychiatric illnesses or those who refuse to complete cognitive tests and provide biospecimens may 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 investigate the presence of Aβ and Tau seeds in plasma as potential biomarkers for Alzheimer's Disease (AD) using a novel device called the AD-seeds-detector. The study will compare the sensitivity and specificity of these biomarkers in diagnosing AD against age-matched cognitively normal controls and patients with other types of dementia. It will involve two cohorts: a single-center group of 150 AD patients and a multi-center group of 400 AD patients, alongside appropriate control groups. The goal is to enhance the accuracy of AD diagnosis through high throughput analysis of these biomarkers.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and early diagnosis of Alzheimer's Disease, improving patient management and treatment outcomes.
How similar studies have gone: While the approach of using Aβ and Tau seeds as biomarkers is being explored, this specific method and device for detection is novel and has not been widely tested in previous studies.
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. As for non-AD dementia, the McKeith criteria are used for DLB,the revised diagnostic criteria proposed by the International behavioral variant (bvFTD) Criteria Consortium for bvFTD,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.