Alzheimer Disease
Conditions
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?
Interventions
DIAGNOSTIC_TESTblood biomarkers from the internal jugular vein
blood biomarkers (Aβ42/40, p-tau217, p-tau181, NFL, GFAP, etc.) from the internal jugular vein
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Outcome results
None listed