Blood Biomarkers from Internal Jugular Vein for the Diagnosis of Alzheimer's Disease

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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Diagnostic test: blood biomarkers from the internal jugular vein

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Daping Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with cognitive symptoms or concerns were consectively recruited from memory clinics.

Description

Inclusion Criteria:

1. age: 40-90 years old (including 40 and 90 years);
2. patients with cognitive complaints or concerns;
3. 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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aβ PET (+)	Diagnostic test: blood biomarkers from the internal jugular vein; blood biomarkers (Aβ42/40, p-tau217, p-tau181, NFL, GFAP, etc.) from the internal jugular vein
Aβ PET (-)	Diagnostic test: blood biomarkers from the internal jugular vein; blood biomarkers (Aβ42/40, p-tau217, p-tau181, NFL, GFAP, etc.) from the internal jugular vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance	area under the ROC curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value	5 years from the enrollment of the first participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with CSF biomarkers	Correlations of blood biomarkers (Aβ42, Aβ40, Aβ42/40 ratio, p-tau217, p-tau181, p-tau217/Aβ42 ratio, p-tau181/Aβ42 ratio, NFL, GFAP, etc.) with CSF biomarkers (Aβ42，Aβ40， Aβ42/40 ratio, p-tau181，p-tau181/Aβ42 ratio, GFAP，NFL, etc.).	5 years from the enrollment of the first participant
Correlation with brain Aβ burden	Correlations of blood biomarkers (Aβ42, Aβ40, Aβ42/40 ratio, p-tau217, p-tau181, p-tau217/Aβ42 ratio, p-tau181/Aβ42 ratio, NFL, GFAP, etc.) with brain Aβ burden measured by Aβ PET.	5 years from the enrollment of the first participant
Correlation with brain Tau burden	Correlations of blood biomarkers (Aβ42, Aβ40, Aβ42/40 ratio, p-tau217, p-tau181, p-tau217/Aβ42 ratio, p-tau181/Aβ42 ratio, NFL, GFAP, etc.) with brain tau burden measured by Tau PET.	5 years from the enrollment of the first participant
Effects of comorbidities on blood biomarkers and diagnostic performance	Associations (beta value) of comorbidites (hypertension, diabetes, history of stroke or myocardial infarction, hepatic or renal insufficiency, etc.) with the levels of blood biomarkers (Aβ42, Aβ40, Aβ42/40 ratio, p-tau217, p-tau181, p-tau217/Aβ42 ratio, p-tau181/Aβ42 ratio, NFL, GFAP, etc.) and their diagnostic performance (area under the curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value).	5 years from the enrollment of the first participant

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: IJV-AD-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No