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Diagnosis of Alzheimer's Disease through the Eye and its Correlation with Cognitive Tests and Brain Imaging

Despite decades of research, there is no definite pre-mortem diagnosis for Alzheimer’s disease (AD). Clinical diagnosis of the disease, even with newer biomarkers such as CSF and amyloid PET is not considered definite; it can only be confirmed postmortem through histopathological identification in the brain of its characteristic features including beta-amyloid (Aβ) plaques. There is a clear need for a technique capable of improving the in-vivo diagnosis of AD at early stages. We review here our previously published clinical studies using a Fluorescent Ligand Eye Scanning (FLES) System to differentiate between patients with probable AD and healthy volunteers (HV) as well as some new analyses. FLES is a combination of a fluorescent ligand and a laser eye scanning device. The fluorescent ligand was dosed topically to the inside of the lower eyelid of the study eyes the evening before the day of the measurement with the device. Our published phase 2 trial showed by clinical diagnosis, the AD and HV groups could be differentiated with sensitivity of 85% and specificity of 95%, (p<0.001). Further, all but five of the clinically diagnosed AD patients were amyloid PET positive and all but three of HV were amyloid negative supporting the validity of their diagnoses. In addition, the results in the eye showed significant correlation with the Standard Uptake Value ratios (SUVr) obtained by amyloid brain imaging Positron Emission Tomography (PET) using florbetapir. We also report here new analyses showing the correlations between FLES eye findings and cognitive tests, as well as the effect of apolipoprotein (APOE) gene.