Retinal Nerve Fiber Layer Thickness and Cerebrospinal Fluid Aβ/Tau

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447613
• Other study ID #: dsyy001
• Status: Completed
• Start date: August 1, 2013
• Est. completion date: December 31, 2014

Study information

• Verified date: November 2018
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital	Massachusetts General Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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 Ma — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	retinal nerve fiber layer (RNFL) thickness	Optical coherence tomography (Carl Zeiss Meditec, Inc., Dublin, CA, USA) to measure RNFL thickness	Within one week before surgery
Secondary	Cerebrospinal fluid (CSF) Aß concentration	ELISA kits (Aß40: Cat. # 292-62301; Aß42: Cat. # 296-64401, Wako, Richmond, VA) to measure Aß concentration	During the spinal anesthesia before the administration of the local anesthetic.
Secondary	Cerebrospinal fluid (CSF) Tau concentration	ELISA kits (Tau: Cat. # KHB0041, Invitrogen, San Francisco, CA) to measure Aß concentration	During the spinal anesthesia before the administration of the local anesthetic.
Secondary	Global cognitive state	Mini-Mental State Examination (MMSE) to assess global cognitive function	Within one week before surgery