An observational study in Alzheimer Disease, sponsored by Shanghai 10th People's Hospital. Completed at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-11-30.
Sponsored by Shanghai 10th People's Hospital · Observational
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.
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.
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.
Exclusion Criteria:
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
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.
Specific cognitive function
Neuropsychological test battery to assess specific cognitive function, including immediate memory, visuospatial memory and executive function.
Time frame: Within one week before surgery
retinal nerve fiber layer (RNFL) thickness
Optical coherence tomography (Carl Zeiss Meditec, Inc., Dublin, CA, USA) to measure RNFL thickness
Time frame: Within one week before surgery
Cerebrospinal fluid (CSF) Aβ concentration
ELISA kits (Aβ40: Cat. # 292-62301; Aβ42: Cat. # 296-64401, Wako, Richmond, VA) to measure Aβ concentration
Time frame: During the spinal anesthesia before the administration of the local anesthetic.
Cerebrospinal fluid (CSF) Tau concentration
ELISA kits (Tau: Cat. # KHB0041, Invitrogen, San Francisco, CA) to measure Aβ concentration
Time frame: During the spinal anesthesia before the administration of the local anesthetic.
Global cognitive state
Mini-Mental State Examination (MMSE) to assess global cognitive function
Time frame: Within one week before surgery
Plan to share: Undecided
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Shanghai 10th People's Hospital