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

Active, not recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT06754254
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-21
• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-12-28
• Last Update Submitted: 2024-12-28
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance	5 years from the enrollment of the first participant	area under the ROC curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Daping Hospital; 🇨🇳 Chongqing, Chongqing, China