Performance of Blood Biomarkers in Different Circulation Sites on Detecting Alzheimer's Pathologies - the Delta Study

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 site in 1 country300 target enrollmentMarch 21, 2019

ConditionsAlzheimer Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alzheimer Disease
Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Enrollment: 300
Locations: 1
Primary Endpoint: Diagnostic performance
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this observational study is to explore the diagnostic performance of blood biomarkers from the internal jugular vein for the diagnosis of Alzheimer's disease (AD) in patients with cognitive symptoms or concerns. The main question it aims to answer is:

Whether blood biomarkers from the internal jugular vein outperform those from the median cubital vein which is the routine site for venous blood collection?

Registry

clinicaltrials.gov

Start Date

March 21, 2019

End Date

December 30, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Responsible Party

Principal Investigator

Yan-Jiang Wang

Prof.

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Eligibility Criteria

Inclusion Criteria

•age: 40-90 years old (including 40 and 90 years);
•patients with cognitive complaints or concerns;
•Willing and able to comply with all aspect of the protocol and provide written informed consent. If a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, if required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations).

Exclusion Criteria

•Severe medical conditions which are not stably and could affect the subject's safety;
•Presence of contraindications for PET examination, cerebrospinal fluid or blood collection;
•Unwilling and refuse to participate in this study.

Outcomes

Primary Outcomes

Diagnostic performance

Time Frame: 5 years from the enrollment of the first participant

area under the ROC curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value

Secondary Outcomes

Correlation with CSF biomarkers(5 years from the enrollment of the first participant)
Correlation with brain Aβ burden(5 years from the enrollment of the first participant)
Correlation with brain Tau burden(5 years from the enrollment of the first participant)
Effects of comorbidities on blood biomarkers and diagnostic performance(5 years from the enrollment of the first participant)