Health TrialsbyHealthPanel

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

ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-75
SponsorCapital Medical University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,200 Participants
are grouped into 4 trial groups
Group A: Alzheimer's disease
Group B: MCI group
Group C: Non-AD dementia
Group D: Cognitively normal controls

Trial outcomes

Primary outcomes

1

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 .

Time frame
1 year
2

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.

Time frame
1 year
3

Relationship between biomarker and clinical symptom

The relationship is specifically expressed by relevance

Time frame
1 year

Secondary outcomes

1

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).

Time frame
1 year
2

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).

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Shandong Provincial Hospital

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

Xiangya Hospital of Central South University

Collaborator

Huashan Hospital

Collaborator

The First Hospital of Jilin University

Collaborator

Source ClinicalTrials.gov
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