AgingNCT06636201
Large-scale Multi-omics Analysis of Cerebrospinal Fluid
An observational study of Aging, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The aim of this study is to explore the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases. Read more about this study
- Who is it for?
- Ages 0 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Apr 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 0 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients admitted for spinal anesthesia surgery due to non-neurological conditions and pediatric patients undergoing surgery for tethered spinal cord syndrome.
- Inclusion Criteria:
- Patients aged 0 to 90 years will be selected for the study.
- Patients admitted for surgery under spinal anesthesia due to non-neurological conditions, such as lower limb fractures or hemorrhoids.
- Pediatric patients undergoing surgical treatment for tethered spinal cord syndrome.
- Exclusion Criteria:
- Patients with neurological conditions, including encephalitis, Parkinson's disease, Alzheimer's disease, hydrocephalus, brain tumors, and psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310058
Junming Zhu, MD. phD, 057187784815, dr.zhujunming@zju.edu.cn
About this study
Official title: Deputy Director of Department of Neurosurgery, the Second Affiliated Hospital of Zhejiang University School of Medicine；Professor；
The aim of this study is to explore the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases.
Read the detailed description
This study aims to investigate the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases, with a focus on the following objectives:
Analysis of Age-Related Changes in CSF Biomarkers: The study will analyze CSF samples from different age groups to identify biomarkers that undergo significant changes during the aging process. This includes the investigation of amyloid-beta (Aβ42), Tau proteins (including the phosphorylated form p-tau181), and other proteins related to neuroinflammation and blood-brain barrier function.
Development of a Predictive Model for Early Diagnosis: By categorizing and quantifying CSF proteins across various age groups, the study aims to establish a predictive model for the early diagnosis of neurodegenerative diseases, such as Alzheimer's disease. The ability to detect these diseases before clinical symptoms emerge could enable early intervention and treatment, offering a crucial window for therapeutic strategies.
Investigation of Dynamic Changes in CSF Biomarkers Across Disease Stages: The study will examine the dynamic changes in CSF biomarkers at different stages of neurodegenerative diseases, including early, middle, and late stages. Understanding the role of these biomarkers in disease progression will provide insights into the pathological processes and potential therapeutic windows.
Creation of a Comprehensive CSF Biomarker Database: A database will be established, encompassing CSF biomarkers from various age groups, disease states, and treatment responses. This resource will be invaluable for future research, facilitating the scientific community's understanding of neurodegenerative diseases and the development of new therapeutic approaches.
Through the achievement of these objectives, this study aims to advance the application of CSF biomarkers in neuroscience research and clinical practice, ultimately improving the diagnosis, management, and treatment of aging-related and neurodegenerative conditions.
- Conditions
- Aging
- Keywords
- biomarker, aging, neurodegenerative disease
- Medical subject headings
- Neurodegenerative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid (CSF) biomarkers
CSF samples from different ages were analyzed to identify biomarkers that change significantly during aging, such as amyloid beta (Aβ42), Tau protein (including the phosphorylated form p-tau181), and other proteins associated with neuroinflammation and blood-brain barrier function
Measured: December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636201
- Sponsor's protocol ID
- 2024-0969
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deputy Director of Department of Neurosurgery, the Second Affiliated Hospital of Zhejiang University School of Medicine；Professor；
- ClinicalTrials.gov ID
- NCT06636201
- Acronym / sponsor ID
- 2024-0969
- Conditions
- Aging
- Keywords
- biomarker, aging, neurodegenerative disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 10 Oct 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 aim of this study is to explore the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases.
Detailed description
This study aims to investigate the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases, with a focus on the following objectives:
Analysis of Age-Related Changes in CSF Biomarkers: The study will analyze CSF samples from different age groups to identify biomarkers that undergo significant changes during the aging process. This includes the investigation of amyloid-beta (Aβ42), Tau proteins (including the phosphorylated form p-tau181), and other proteins related to neuroinflammation and blood-brain barrier function.
Development of a Predictive Model for Early Diagnosis: By categorizing and quantifying CSF proteins across various age groups, the study aims to establish a predictive model for the early diagnosis of neurodegenerative diseases, such as Alzheimer's disease. The ability to detect these diseases before clinical symptoms emerge could enable early intervention and treatment, offering a crucial window for therapeutic strategies.
Investigation of Dynamic Changes in CSF Biomarkers Across Disease Stages: The study will examine the dynamic changes in CSF biomarkers at different stages of neurodegenerative diseases, including early, middle, and late stages. Understanding the role of these biomarkers in disease progression will provide insights into the pathological processes and potential therapeutic windows.
Creation of a Comprehensive CSF Biomarker Database: A database will be established, encompassing CSF biomarkers from various age groups, disease states, and treatment responses. This resource will be invaluable for future research, facilitating the scientific community's understanding of neurodegenerative diseases and the development of new therapeutic approaches.
Through the achievement of these objectives, this study aims to advance the application of CSF biomarkers in neuroscience research and clinical practice, ultimately improving the diagnosis, management, and treatment of aging-related and neurodegenerative conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted for spinal anesthesia surgery due to non-neurological conditions and pediatric patients undergoing surgery for tethered spinal cord syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cerebrospinal fluid (CSF) biomarkers
Time frame: December 2024
CSF samples from different ages were analyzed to identify biomarkers that change significantly during aging, such as amyloid beta (Aβ42), Tau protein (including the phosphorylated form p-tau181), and other proteins associated with neuroinflammation and blood-brain barrier function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
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.
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 Aging, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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?
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 10 Oct 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?
Contact Junming Zhu, MD. phD (057187784815, dr.zhujunming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrospinal fluid (CSF) biomarkers (time frame: December 2024). 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 10 Oct 2024.