NCT05020106Recruiting
The Diagnostic Cut-off Value of Core Biomarkers of Alzheimer's Disease
Study on the Diagnostic Cut-off Value of Core Biomarkers in Cerebrospinal Fluid and Blood of Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
The participant in this study includes Alzheimer's disease (AD including familial AD and sporadic AD) patients, amnestic mild cognitive impairment (aMCI) patients, non-AD dementia patients and cognitively normal control. The purpose of this study is to establish the best cut-off value of cerebrospinal fluid (CSF) and blood β-amyloid (Aβ) 42/40, total tau (t-tau) , phosphorylated tau ,inflammatory factors, etc. in diagnosis of Alzheimer's disease (AD).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3200 (estimated)
- First submitted
- 23 Jul 2021
- Start date
- 1 Sept 2018
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Capital Medical University
- Diseases
- Alzheimer disease
- NCT number
- NCT05020106
What you commit to
- Study type: Observational
- Planned participants: 3200
- From 1 Sept 2018 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other medical or psychiatric illness. No one can serve as an informant. Refused to complete a cognitive test and provide biospecimen.
Who the study is looking for
- 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.
Age in the registry: 55 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital of Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.