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Clinical Trials in China / NCT05020106
Recruiting Observational

The Diagnostic Cut-off Value of Core Biomarkers of Alzheimer's Disease

NCT05020106 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Observational
Started
2018-09-01
Last updated
2026-03-23

Condition(s) studied

Alzheimer's Disease

Study summary

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).

Eligibility

Sex
ALL
Min age
55 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • The cut-off value in diagnosing AD — 1 year
    The best cut-off value of Aβ42, Aβ40, t-tau, p-tau, inflammatory factors, etc. in CSF and blood .
  • The receiver operating characteristic curve — 1 year
    The receiver operating characteristic curve is used to show the relationship between sensitivity and specificity of core CSF and blood biomarkers in diagnosing AD.
  • Relationship between biomarker and clinical symptom — 1 year
    The relationship is specifically expressed by relevance

Trial sites (1)

FacilityCityRegionStatus
Xuanwu Hospital of Capital Medical University Beijing Beijing Municipality Recruiting

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Other trials for the same condition

A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease Active, not recruiting
Greater-Bay-Area Healthy Aging Brain Study (GHABS) Recruiting
Deep Cervical Lymphovenous Anastomosis for Moderate Alzheimer's Disease Starting soon
Evaluate the Concordance Between PET Imaging of [18F]-APN-1607 Injection and Postmortem Brain Tissue Tau Pathology in Individuals With HV and MCI or AD. Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05020106 on ClinicalTrials.gov ↗ ← All trials in China