Clinical Trial: Measurement of Retinal Nerve Fiber Layer Thickness - a Biomarker for the Early Detection of Alzheimer's Disease?
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Pilot Study That Investigates the Potential of Using OCT (Optical Coherence Tomography) Measurements of the Thickness of the Retinal Nerve Fiber Layer as a Biomarker for the Early Detection of Alzheim
Brief Summary: The purpose of this study is to determine whether by measuring changes in the thickness of the retinal nerve fibre layer (the photosensitive layer at the back of the eye) you could predict if someone would develop Alzheimer's disease in the future. The measurement is made by OCT (ocular coherence tomography), a noninvasive and relatively inexpensive test that uses light waves to scan the back of the eye.
Detailed Summary:
Alzheimer's Disease (AD) is a degenerative neurological disorder characterized by the insidious onset of a progressive decline in cognitive function. It is the most common form of dementia affecting an estimated 26 million people worldwide in 2006, a number that is expected to quadruple by 2050 due to the anticipated increase in life expectancy. Difficulty remembering names and recent events is often an early clinical symptom as is apathy and depression. Later symptoms include impaired judgment, disorientation, confusion, behavior changes and difficulty in swallowing and walking.
New criteria and guidelines for diagnosing Alzheimer's published in 2011 recommend that it be considered a disease that begins well before the development of symptoms. Brain changes in individuals with Alzheimer's are thought to begin 10 years or more before symptoms such as memory loss occur - the asymptomatic preclinical phase of AD. Researchers believe that treatment to slow down or stop progression of Alzheimer's and preserve brain function will be most effective when administered early in the course of the disease. The pursuit of biomarkers to detect asymptomatic preclinical AD is a current issue and potential biomarkers such as: brain volume, level of glucose metabolism in the brain, levels of beta-amyloid and tau in the CSF, detection of apoptosing retinal cells (DARC), are being investigated. In this study we would like to propose the measurement of retinal nerve fiber layer thickness as a potential key biomarker for the detection of asymptomatic preclinical Alzheimer's and Mild Cognitive Impairment (MCI).
The eye can be considered a window to the brain and the retina exists as an extension of the CNS. Changes that occur in the retina can be visualized non-invasively and directly with increasingly sophisticated imaging techniques. It is no
Sponsor: Carmel Medical Center
Current Primary Outcome: Measurement of retinal nerve fiber layer thickness [ Time Frame: a once off measurement which will be performed within a year of recruitment to the study ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Cognitive function [ Time Frame: a once off assessment that will be performed within a month of the opthalmic examination and OCT test. This will be completed within a year of recruitment to the study ]
Original Secondary Outcome: Same as current
Information By: Carmel Medical Center
Dates:
Date Received: January 26, 2014
Date Started: February 2014
Date Completion: February 2015
Last Updated: January 30, 2014
Last Verified: January 2014
