Retinal Nerve Fiber Layer Thickness and Cerebrospinal Fluid Aβ/Tau

Completed

• Conditions: Alzheimer Disease
• Interventions: Procedure: surgery

• Registration Number: NCT03447613
• Lead Sponsor: Shanghai 10th People's Hospital

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 Timeline

• Study Start: 2013-08-01
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Study First Submitted: 2018-02-17
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. 50 years old or older;
2. five years or more of education and scores of MMSE ≥ 24 points;
3. Chinese as their first language;
4. Having spinal anesthesia.

Exclusion Criteria

1. prior diagnoses of neurologic diseases, e.g., dementia, Parkinson's diseases, multiple sclerosis or stroke according to DSM-IV;
2. history of mental disorders (e.g., major depressive disorder and schizophrenia) diagnosed according to DSM-IV;
3. 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;
4. unwillingness to comply with the cognitive assessments;
5. ungradable images of OCT.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
elderly participants with surgery	surgery	The studied cohort were participants 50 years old or older, without a diagnosis of dementia, and scheduled to have orthopedic or urological surgery under spinal anesthesia at Shanghai 10th People's Hospital.

Primary Outcome Measures

Name	Time	Method
Specific cognitive function	Within one week before surgery	Neuropsychological test battery to assess specific cognitive function, including immediate memory, visuospatial memory and executive function.

Secondary Outcome Measures

Name	Time	Method
retinal nerve fiber layer (RNFL) thickness	Within one week before surgery	Optical coherence tomography (Carl Zeiss Meditec, Inc., Dublin, CA, USA) to measure RNFL thickness
Cerebrospinal fluid (CSF) Aβ concentration	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
Cerebrospinal fluid (CSF) Tau concentration	During the spinal anesthesia before the administration of the local anesthetic.	ELISA kits (Tau: Cat. # KHB0041, Invitrogen, San Francisco, CA) to measure Aβ concentration
Global cognitive state	Within one week before surgery	Mini-Mental State Examination (MMSE) to assess global cognitive function

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China