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RecruitingNCT06636201Updated Oct 10, 2024

Large-scale Multi-omics Analysis of Cerebrospinal Fluid

An observational study in Aging, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 0 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
0 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Aging

Keywords

  • biomarker
  • aging
  • neurodegenerative disease
03

In context

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: December 2024

07

Study locations

1 of 1 sites recruiting
  • The Second Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310058, China
    Recruiting
08

References and documents

Study documents

  • Study protocol · Jun 27, 2024
  • Informed consent form · Jun 27, 2024

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06636201
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Oct 10, 2024
Start date
Mar 1, 2024
Primary completion
Mar 1, 2025 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Oct 10, 2024

Study contacts

Junming Zhu, MD. phD
Contact
dr.zhujunming@zju.edu.cn
057187784815
Wei Gao
Contact
neurospine@zju.edu.cn
057187784815

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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