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

NCT05020106 | Recruiting

• 1 other identifier: Biomarker cut-off value
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease

Outcome Measures

Primary Outcomes (3)

• The cut-off value in diagnosing AD

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

  1 year

• 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

• Relationship between biomarker and clinical symptom

  The relationship is specifically expressed by relevance

  1 year

Secondary Outcomes (2)

• The sensitivity

  1 year

• The specificity

  1 year

Study Arms (4)

Alzheimer's disease

Criteria for AD according to the 2011 NIA-AA

MCI group

aMCI diagnosed according to the criteria of 2004 Peterson.

Non-AD dementia

Frontotemporal dementia (FTD); or Parkinson's disease dementia (PDD); or dementia with Lewy bodies (DLB); or vascular dementia (VaD); or corticobasal degeneration (CBD); or dementia not otherwise specified.

Cognitively normal controls

Individuals with normal cognitive function

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

AD patients (n=800); aMCI patients (n=800);non-AD dementia patients (n=800). cognitively normal controls (n=800);

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Shandong Provincial Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Huashan Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related 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.

  PMID: 31422798 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

cerebrospinal fluid,blood

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jianping Jia, Doctor

CONTACT

8610-83199449; jiajp@vip.126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Director

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 25, 2021
• Study Start: September 1, 2018
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (1)