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Retinal Nerve Fiber Layer Thickness and Cerebrospinal Fluid Aβ/Tau

NCT ID: NCT03447613

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-01

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease

Keywords

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retinal nerve fiber layer cerebrospinal fluid Aβ and Tau

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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elderly participants with 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.

surgery

Intervention Type 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.

Interventions

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surgery

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuan Shen, MD, PhD

Chief of Psychiatry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuan Shen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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London A, Benhar I, Schwartz M. The retina as a window to the brain-from eye research to CNS disorders. Nat Rev Neurol. 2013 Jan;9(1):44-53. doi: 10.1038/nrneurol.2012.227. Epub 2012 Nov 20.

Reference Type RESULT
PMID: 23165340 (View on PubMed)

Chang LY, Lowe J, Ardiles A, Lim J, Grey AC, Robertson K, Danesh-Meyer H, Palacios AG, Acosta ML. Alzheimer's disease in the human eye. Clinical tests that identify ocular and visual information processing deficit as biomarkers. Alzheimers Dement. 2014 Mar;10(2):251-61. doi: 10.1016/j.jalz.2013.06.004. Epub 2013 Sep 5.

Reference Type RESULT
PMID: 24011928 (View on PubMed)

Hinton DR, Sadun AA, Blanks JC, Miller CA. Optic-nerve degeneration in Alzheimer's disease. N Engl J Med. 1986 Aug 21;315(8):485-7. doi: 10.1056/NEJM198608213150804.

Reference Type RESULT
PMID: 3736630 (View on PubMed)

Other Identifiers

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dsyy001

Identifier Type: -

Identifier Source: org_study_id