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Active, Not Recruiting

NCT Number: NCT06754254

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Correlation with CSF biomarkers

    Time frame: 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.).

  2. Correlation with brain Aβ burden

    Time frame: 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.

  3. Correlation with brain Tau burden

    Time frame: 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.

  4. Effects of comorbidities on blood biomarkers and diagnostic performance

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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