PROJECT SUMMARY Alzheimer’s disease (AD) is a progressive, neurodegenerative condition that impacts 44 million people globally. It is the most common cause of dementia—accounting for 80% of all dementia diagnoses—and predominantly affects older people. To date, AD has no cure. Thus, it is imperative to diagnose patients as early as possible to maximize the efficacy of symptom management strategies. However, existing AD diagnostic and monitoring options remain subpar, leaving urgent need for sensitive, reliable, and convenient methods to measure AD. New research suggests that electroencephalography (EEG) -based biomarkers can assess neural degeneration caused by AD long before tissue loss or behavioral symptoms appear. SPARK Neuro aims to unlock the full potential of EEG through a novel software platform: SPARK Scan. Combining EEG with the capabilities of machine learning, SPARK Scan better assesses cognitive health and neurodegeneration, aiding the diagnosis of AD. In the proposed Direct-to-Phase II SBIR project, the company will enhance the existing SPARK platform by developing a novel Alzheimer’s Disease Pathology Index that tracks patient amyloid and tau burden. Developed with CSF data collected from Johns Hopkins University, the Pathology Index will be a continuous score that corresponds to a patient’s pathological disease burden. After updating the software, the SPARK team will employ Human Factors testing to enhance the usability and utility of the updated platform and clinical report before submitting findings for FDA De Novo approval. This work will progress the SPARK platform by providing a granular measure of AD-related pathology, extending beyond current capabilities.

PROJECT NARRATIVE Research spanning recent decades has established that electroencephalography (EEG) can be an effective tool for identifying Alzheimer’s disease (AD) at an early stage. Using machine learning, SPARK Neuro is unlocking the full potential of EEG to better assess cognitive health and neurodegeneration. This neuroanalytic platform— called SPARK Scan—will be a standardized, objective, non-invasive, cost-effective diagnostic tool capable of highly sensitive and specific detection of cognitive impairment across the entire disease continuum, vastly expanding AD screening initiatives and providing neurological insights to aid in the diagnosis and tracking of disease progression.