Detecting Alzheimer's Disease Biomarkers in Plasma
Detection of Alzheimer's Disease (AD)-Related Seeds as Biomarkers for Accurate Diagnosis of AD（AD-seeds-detector）
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 |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04850053 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.