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

Last updated: November 5, 2024
Sponsor: Capital Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Dementia

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT05020106
Biomarker cut-off value
  • Ages 55-75
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • Aged 55-75. Written informed consent obtained from participant or legal guardianprior to any study-related procedures. The diagnosis of AD is made using theNational Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. Thediagnosis of aMCI is assigned according to 2004 Petersen criteria. As for non-ADdementia, the McKeith criteria are used for DLB, the revised diagnostic criteriaproposed by the International bvFTD Criteria Consortium for behavioral variant FTD,the Gorno-Tempini criteria for the semantic variant FTD or non-fluent aphasia, theMovement Disorder Society Task Force criteria for PDD, the vascular behavioral andcognitive disorders (Vas-Cog) criteria for VaD, the Armstrong's criteria for CBD,the CDC's diagnostic criteria for CJD, etc. In addition, normal cognition issupported by MMSE, CDR and other cognitive function scales.

Exclusion

Exclusion Criteria:

  • Other medical or psychiatric illness. No one can serve as an informant. Refused tocomplete a cognitive test and provide biospecimen.

Study Design

Total Participants: 3200
Study Start date:
September 01, 2018
Estimated Completion Date:
September 01, 2025

Study Description

  1. Incorporating patients who meet the criteria from Capital Medical University Xuanwu Hospital including AD, aMCI, non-AD dementia and cognitively normal control.

  2. 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.

  3. To quantify levels of Aβ42, Aβ40, t-tau, p-tau, inflammatory factors, etc. in CSF and blood.

  4. Detect all participants ApoE genotype.

  5. Independently establish the best cut-off value of Chinese people in our laboratory.

  6. Analysis the relationships between core biomarkers in CSF/blood and ApoE genotype and neuroimaging data.

  7. Establish combined diagnostic model.

Connect with a study center

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing 100053
    China

    Active - Recruiting

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