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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020106
• Other study ID #: Biomarker cut-off value
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: Capital Medical University
• Contact: Jianping Jia, Doctor
• Phone: 8610-83199449
• Email: jiajp[@]vip.126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
China	Xuanwu Hospital of Capital Medical University	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Capital Medical University	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

Country where clinical trial is conducted

China, 

References & Publications (1)

Jia L, Qiu Q, Zhang H, Chu L, Du Y, Zhang J, Zhou C, Liang F, Shi S, Wang S, Qin W, Wang Q, Li F, Wang Q, Li Y, Shen L, Wei Y, Jia J. Concordance between the assessment of Abeta42, T-tau, and P-T181-tau in peripheral blood neuronal-derived exosomes and cerebrospinal fluid. Alzheimers Dement. 2019 Aug;15(8):1071-1080. doi: 10.1016/j.jalz.2019.05.002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cut-off value in diagnosing AD	The best cut-off value of Aß42, Aß40, t-tau, p-tau, inflammatory factors, etc. in CSF and blood .	1 year
Primary	The receiver operating characteristic curve	The receiver operating characteristic curve is used to show the relationship between sensitivity and specificity of core CSF and blood biomarkers in diagnosing AD.	1 year
Primary	Relationship between biomarker and clinical symptom	The relationship is specifically expressed by relevance	1 year
Secondary	The sensitivity	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).	1 year
Secondary	The specificity	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).	1 year