OBSERVATIONALRECRUITINGNCT05020106
Study on the Diagnostic Cut-off Value of Core Biomarkers in Cerebrospinal Fluid and Blood 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).
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-03-23
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- Not reported
- Enrollment
- 3,200 (ESTIMATED)
- Start date
- 2018-09-01
- Sponsor
- Capital Medical University
- Design
- Not reported
- Locations
- 1
- Results record
- Not present in registry snapshot
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.
Alzheimer's DiseaseAlzheimer's disease
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Cannabinoids and active compounds
No governed compound link was found.
Medicines
No exact medicine-name link was found.
Interventions
What was registered
No structured intervention was reported.
Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 55 Years
- Maximum age
- 75 Years
- Healthy volunteers
- Accepted
Study population
AD patients (n=800); aMCI patients (n=800);non-AD dementia patients (n=800). cognitively normal controls (n=800);
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 outcomes
primary measures
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 .
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.
Relationship between biomarker and clinical symptom
Time frame: 1 year
The relationship is specifically expressed by relevance
secondary outcomes
secondary measures
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).
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).
Publications
Locally readable linked articles
No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- 21197c51-4dc9-4e80-a17d-3cae52b91c5f
- Retrieved
- 11/09/2026, 14:55:02
- SHA-256
- 7164663cbc5ece77bd19f030112996a5d6cd8e35076c565faaca5e29c4d0e944