This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. We propose to clinically evaluate a novel, non-invasive early diagnostic procedure for Alzheimer's disease (AD). The procedure is based on our recent discoveries demonstrating Alzheimer's disease b-amyloid (A ) deposits and associated lens opacification (cataract) within a particular lens subregion known as the supranucleus. Because of the physiology of the lens and its optical accessibility from the periphery, we expect that locally increased lens Ab deposition may be detectable in the lens supranuclear region early in the course of AD. We propose to conduct a clinical validation study to look at the degree of protein deposition in the supranuclear region of the lens in living subjects at different stages in the clinical progression of AD. Our goal is to systematically evaluate our hypothesis about the development of this uncommon cataract in AD. We also wish to test whether a new device known as the Optiscan QEL 2400, which quantifies protein deposition in specific regions of the lens by measuring light scattering, can be used for early diagnosis of AD by detection of protein aggregation in the supranucleus of the lens. We will conduct this trial in three rigorously characterized groups of patients: 1) those with clinically diagnosed AD ('probable AD'), 2) those with mild cognitive impairment (MCI, essentially preclinical or prodromal AD), and 3) control subjects. Based on our hypothesis, we expect that the probable AD subjects, and to a lesser extent the MCI subjects, will exhibit evidence of increased light scattering in the supranuclear region of the lens compared to control patients. We further hypothesize that the degree of scattering in the supranuclear region will correlate with the degree of cognitive decline. To our knowledge, this will be the first clinical study to assess the possible overlapping molecular pathology between AD and cataract formation.
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