Alzheimer DiseaseNCT06754254
Blood Biomarkers from Internal Jugular Vein for the Diagnosis of Alzheimer's Disease
An observational study of Alzheimer Disease, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- blood biomarkers from the internal jugular vein
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2019to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with cognitive symptoms or concerns were consectively recruited from memory clinics.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Conditions
- Alzheimer Disease
- Being tested
- blood biomarkers from the internal jugular vein
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood biomarkers from the internal jugular veinDiagnostic test
blood biomarkers (Aβ42/40, p-tau217, p-tau181, NFL, GFAP, etc.) from the internal jugular vein
| Study group | Role | What they receive |
|---|---|---|
| Aβ PET (+) | Not described Receives: Diagnostic Test: blood biomarkers from the internal jugular vein | |
| Aβ PET (-) | Not described Receives: Diagnostic Test: blood biomarkers from the internal jugular vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance
area under the ROC curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value
Measured: 5 years from the enrollment of the first participant
Secondary outcomes (4)
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.).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 5 years from the enrollment of the first participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start21 Mar 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan-Jiang Wang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754254
- Sponsor's protocol ID
- IJV-AD-24
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Blood Biomarkers in Different Circulation Sites on Detecting Alzheimer's Pathologies - the Delta Study
- ClinicalTrials.gov ID
- NCT06754254
- Acronym / sponsor ID
- IJV-AD-24
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aβ PET (+) | – | Diagnostic Test: blood biomarkers from the internal jugular vein |
| Aβ PET (-) | – | Diagnostic Test: blood biomarkers from the internal jugular vein |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cognitive symptoms or concerns were consectively recruited from memory clinics.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood biomarkers from the internal jugular veinblood biomarkers (Aβ42/40, p-tau217, p-tau181, NFL, GFAP, etc.) from the internal jugular vein | Diagnostic test | Aβ PET (+), Aβ PET (-) |
Primary outcome
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
4 secondary outcomes
Correlation with CSF biomarkers
Time frame: 5 years from the enrollment of the first participant
Correlation with brain Aβ burden
Time frame: 5 years from the enrollment of the first participant
Correlation with brain Tau burden
Time frame: 5 years from the enrollment of the first participant
Effects of comorbidities on blood biomarkers and diagnostic performance
Time frame: 5 years from the enrollment of the first participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: 5 years from the enrollment of the first participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.