Retinal Nerve Fiber Layer Thickness and Cerebrospinal Fluid Aβ/Tau

NCT03447613 | Completed DMC

• 1 other identifier: dsyy001
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

retinal nerve fiber layer; cerebrospinal fluid Aβ and Tau

Outcome Measures

Primary Outcomes (1)

• Specific cognitive function

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

  Within one week before surgery

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Procedure: surgery

Interventions

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.

elderly participants with surgery

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 300 old adults who were scheduled to have elective total hip or knee replacement surgery, ureteroscopic lithotripsy and transurethral resection of the prostate at the Shanghai 10th People's Hospital were asked to participate in this study. A total of 104 participants were enrolled from August 2013 to December 2014, and the data from 86 participants were finally included in the study.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (3)

• 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.

  PMID: 23165340 RESULT

• 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.

  PMID: 24011928 RESULT

• 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.

  PMID: 3736630 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 ml of CSF was collected from a spinal needle by anesthesiologists during the spinal anesthesia before the administration of the local anesthetic. The CSF was collected in an Eppendorf tube and was immediately stored in a -80 °C degree freezer until the time of measurement.

MeSH Terms

Conditions

Alzheimer Disease; Pick Disease of the Brain

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Study Officials

• Yuan Shen, MD, PhD

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychiatry Department

Study Record Dates

• First Submitted: February 17, 2018
• First Posted: February 27, 2018
• Study Start: August 1, 2013
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

CN (1)