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NCT Number: NCT05020106

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

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).

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Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Jianping Jia, Doctor

CONTACT

[email protected]

8610-83199449

About this study

  • Incorporating patients who meet the criteria from Capital Medical University Xuanwu Hospital including AD, aMCI, non-AD dementia and cognitively normal control.
  • Collect the information of clinical and neuropsychological assessment (mini-mental state examination, MMSE, Montreal cognitive assessment, MoCA, and clinical dementia rating scale, CDR), neuroimaging data including medial temporal atrophy (MTA) score, Fazekas score, MRI, and PET(optional), as well as the biological sample, such as CSF and peripheral blood.
  • To quantify levels of Aβ42, Aβ40, t-tau, p-tau, inflammatory factors, etc. in CSF and blood.
  • Detect all participants ApoE genotype.
  • Independently establish the best cut-off value of Chinese people in our laboratory.
  • Analysis the relationships between core biomarkers in CSF/blood and ApoE genotype and neuroimaging data.
  • Establish combined diagnostic model.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The cut-off value in diagnosing AD

    Time frame: 1 year

    The best cut-off value of Aβ42, Aβ40, t-tau, p-tau, inflammatory factors, etc. in CSF and blood .

  2. The receiver operating characteristic curve

    Time frame: 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.

  3. Relationship between biomarker and clinical symptom

    Time frame: 1 year

    The relationship is specifically expressed by relevance

Secondary outcomes

  1. The sensitivity

    Time frame: 1 year

    The sensitivity is used to show the ability of core CSF and blood biomarkers to diagnose AD patients and is represented by true positive/ (true positive +false negative).

  2. The specificity

    Time frame: 1 year

    The specificity is used to show the ability of core CSF and blood biomarkers to avoid false AD patients and rule out AD patients and is represented by true negative/ (false positive + true negative).

Study contacts

Contact information is provided by the study sponsor or research team.

Jianping Jia, Doctor

CONTACT

[email protected]

8610-83199449

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Huashan Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Shandong Provincial Hospital
  • The First Hospital of Jilin University
  • Xiangya Hospital of Central South University

Registry information

Official study title

Study on the Diagnostic Cut-off Value of Core Biomarkers in Cerebrospinal Fluid and Blood of Alzheimer's Disease

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2021
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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