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Clinical Trials/NCT03447613
NCT03447613CompletedNot Applicable

Association of Retinal Nerve Fiber Layer (RNFL) Thickness With Cerebrospinal Fluid Aβ and Tau Concentration

Shanghai 10th People's Hospital1 site in 1 country86 target enrollmentStarted: August 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
86
Locations
1
Primary Endpoint
Specific cognitive function

Study Overview

Brief Summary

To test the hypothesis that retinal nerve fiber layer (RNFL) thickness is correlated with Aβ and Tau concentration of cerebrospinal fluid (CSF) in an older population.

Detailed Description

retinal nerve fiber layer (RNFL) thickness changing has been reported in Alzheimer's Disease (AD) patients at an early stage, and has been demonstrated as a potential biomarker able to predict cognitive deterioration (Hinton DR et al., N Engl J Med 1986; London A et al. Nat Rev Neurol 2013; Chang LY et al., Alzheimers Dement 2014). However, whether RNFL thickness is correlated with cerebrospinal fluid (CSF) features of AD pathogenesis (e.g., Aβ and Tau) remains unclear. The investigators thus conducted this observational cohort study to test the correlation between RNFL thickness changing and CSF, to further validate RNFL as a potential AD biomarker.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 50 years old or older;
  • five years or more of education and scores of MMSE ≥ 24 points;
  • Chinese as their first language;
  • Having spinal anesthesia.

Exclusion Criteria

  • prior diagnoses of neurologic diseases, e.g., dementia, Parkinson's diseases, multiple sclerosis or stroke according to DSM-IV;
  • history of mental disorders (e.g., major depressive disorder and schizophrenia) diagnosed according to DSM-IV;
  • known diseases contributing to the retina pathologies, e.g., diabetes, glaucoma or increased intraocular pressure (more than 22 mmHg), cataract, and macular degeneration and hypermyopia;
  • unwillingness to comply with the cognitive assessments;
  • ungradable images of OCT.

Outcomes

Primary Outcomes

Specific cognitive function

Time Frame: Within one week before surgery

Neuropsychological test battery to assess specific cognitive function, including immediate memory, visuospatial memory and executive function.

Secondary Outcomes

  • retinal nerve fiber layer (RNFL) thickness(Within one week before surgery)
  • Cerebrospinal fluid (CSF) Aβ concentration(During the spinal anesthesia before the administration of the local anesthetic.)
  • Cerebrospinal fluid (CSF) Tau concentration(During the spinal anesthesia before the administration of the local anesthetic.)
  • Global cognitive state(Within one week before surgery)

Investigators

Sponsor
Shanghai 10th People's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yuan Shen, MD, PhD

Chief of Psychiatry Department

Shanghai 10th People's Hospital

Study Sites (1)

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