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Clinical Trials/NCT04315038
NCT04315038
Completed
Not Applicable

Metabolomics Profiling and Biomarker Research of Human Cerebrospinal Fluid in Aging Process and Age-related Neurodegenerative Diseases

Chang Gung Memorial Hospital1 site in 1 country190 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Chang Gung Memorial Hospital
Enrollment
190
Locations
1
Primary Endpoint
Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Perform quantitative metabolomics on human cerebrospinal fluid (CSF) samples and establish the first human CSF Metabolome Database of aging process in Taiwan.

Detailed Description

Metabolomics is new science based on metabolite profiles in biofluids and tissues, which under bioinformatics approaches and analyses could help to characterize metabolomic status of CSF in aging process. In this prospective study, the investigators plan to enroll 200 health volunteers and 40 neurodegenerative diseases patients with received operation under spinal anesthesia. Blood and CSF samples will be analyzed using hydrogen-1 nuclear magnetic resonance (1H-NMR) and lipid chromatography-mass spectrometry (LC-MS).

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
July 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aging groups:
  • . Above 20 years.
  • . No history of central nerve system injury and neurologic illness
  • . Written informed consent from the patient
  • Aged-related neurodegenerative diseases group:
  • . Above 60 years of age
  • . Medical record proved the history of Parkinsonism or Alzheimer disease
  • . Written informed consent from the patient or guardian by statute.

Exclusion Criteria

  • patient refuses to sign informed consent
  • patients with coagulopathy, systemic infective disease and severe liver and renal function impairment
  • patients with spine or brain tumor and CNS disease
  • the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study (e.g. acute pancreatitis, stroke, liver cirrhosis, congestive heart failure, and systemic immune disorder etc
  • Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

Outcomes

Primary Outcomes

Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases

Time Frame: An average of 1 year

Metabolites analysis of CSF will be investigated by NMR, LC-MS. Peak lists of all NMR and LC/MS/MS spectra will be searched against the database through a web server for metabolomic data analysis and further establish the CSF Metabolome Database.

Study Sites (1)

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