Determining key biomarkers for diagnosing Alzheimer's disease
Study on the Diagnostic Cut-off Value of Core Biomarkers in Cerebrospinal Fluid and Blood of Alzheimer's Disease
Capital Medical University · NCT05020106
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 |
|---|---|
| Enrollment | 3200 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | Capital Medical University (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05020106 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other medical or psychiatric illnesses or those who cannot provide informed consent will not benefit from this study.
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 performed: 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.
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. 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 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.
Conditions: Alzheimer's Disease, Alzheimer's disease