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Completed

NCT Number: NCT03447613

Retinal Nerve Fiber Layer Thickness and Cerebrospinal Fluid Aβ/Tau

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery

Procedure

All participants were scheduled to have elective total hip or knee replacement surgery, ureteroscopic lithotripsy and transurethral resection of the prostate under spinal anesthesia at the Shanghai 10th People's Hospital. After 5 years, the investigaors will follow up the participants including cognitive functions, PET-CT, thickness of Retinal Nerve Fiber Layer.

Primary outcomes

  1. 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

  1. retinal nerve fiber layer (RNFL) thickness

    Time frame: Within one week before surgery

    Optical coherence tomography (Carl Zeiss Meditec, Inc., Dublin, CA, USA) to measure RNFL thickness

  2. Cerebrospinal fluid (CSF) Aβ concentration

    Time frame: During the spinal anesthesia before the administration of the local anesthetic.

    ELISA kits (Aβ40: Cat. # 292-62301; Aβ42: Cat. # 296-64401, Wako, Richmond, VA) to measure Aβ concentration

  3. Cerebrospinal fluid (CSF) Tau concentration

    Time frame: During the spinal anesthesia before the administration of the local anesthetic.

    ELISA kits (Tau: Cat. # KHB0041, Invitrogen, San Francisco, CA) to measure Aβ concentration

  4. Global cognitive state

    Time frame: Within one week before surgery

    Mini-Mental State Examination (MMSE) to assess global cognitive function

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2018
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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