Alzheimer's disease currently affects an estimated 5.4 million Americans, and this number is expected to grow significantly in the coming decade. A critical and ultimate goal of Alzheimer's disease research is to improve methods of early diagnosis, so that patients can be identified sooner and, therefore, obtain greater advantage from available therapies. A second critical and more immediate goal is to develop better ways to detect individuals who are at risk or who are already on the trajectory for Alzheimer's but have not yet developed clinical symptoms, so that pharmaceutical companies and researchers can populate their clinical trials with appropriate individuals. A lack of early markers or predictors f impending disease represents a significant roadblock in the ability to develop new drugs that might treat or even cure Alzheimer's disease. Neurotrack Technologies, Inc. is a Palo Alto CA-based startup formed around a suite of behavioral and software technologies designed to facilitate the detection and prediction of Alzheimer's both at home and in the clinical setting. Th centerpiece of Neurotrack is a behavioral assay that uses eye-tracking technology along with data analysis algorithms to assess recognition memory. It is based on decades of research in nonhuman primates and in human amnesic patients by scientists and physicians at Emory University, who have developed a behavioral task that is highly sensitive to memory impairment and which has shown promise both in the early diagnosis of Alzheimer's disease and in the ability to predict the onset of Alzheimer's disease several years before clinical symptoms occur. Our behavioral test assesses recognition memory, a form of memory that critically depends on the integrity of the hippocampal region of the brain, one of the first areas to undergo morphological change in the course of Alzheimer's. Published results from our 5-year NIH-funded longitudinal study revealed that performance on this test was highly accurate in predicting cognitive decline. Neurotrack's technology has the potential to give pharmaceutical companies and research organizations the tools they need to recruit truly appropriate candidates for clinical trials and more effectively measure drug efficacy, speeding up drug discovery and development. This proposal consists of three aims: 1) to develop and optimize a commercial prototype for administering our test, 2) to beta test and refine this prototype with a small group of patients, and 3) to conduct an initial feasibility study comparing our new commercial version of the test to the established predictive assays currently available to researchers and clinicians. These improvements will advance the technology into a viable first generation commercial prototype in preparation for a large, multi-site clinical trial.
We (Neurotrack Technologies, Inc.) have developed an innovative behavioral assay of memory ability, using infrared eye tracking and computerized software. Performance scores on this cognitive behavioral test predict, up to three years prior to a change in clinical diagnosis, individuals who will and those who will not progress to Mild Cognitive Impairment (MCI) or Alzheimer's disease (AD), regardless of diagnostic status at the time of testing. This is the first available test with such accurate and long-term predictability, nd in order to validate Neurotrack's product for deployment in a large-scale clinical trial, the preset proposal seeks to further the technology into a beta prototype and test for usability in an elderly population by developing a turn-key solution for administering the test, developing infrastructure modules for data management and analysis, and performing an initial usability study across two clinical sites.