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

NCT06754254 | Active Not Recruiting DMC

• 1 other identifier: IJV-AD-24
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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?

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Aβ PET (+)

Diagnostic Test: blood biomarkers from the internal jugular vein

Aβ PET (-)

Diagnostic Test: blood biomarkers from the internal jugular vein

Interventions

blood biomarkers from the internal jugular vein DIAGNOSTIC_TEST

blood biomarkers (Aβ42/40, p-tau217, p-tau181, NFL, GFAP, etc.) from the internal jugular vein

Aβ PET (+); Aβ PET (-)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and cerebrospinal fluid.

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: December 31, 2024
• Study Start: March 21, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)