Validation of a novel EEG-based neurodiagnostic platform for assessing cognitive impairment and Alzheimer's Disease

PROJECT ABSTRACT Alzheimer’s Disease (AD) is the most common cause of dementia, accounting for 80% of all dementia diagnoses. In July 2023, the Alzheimer’s Association (AA) posted an update to their joint NIA-AA position on diagnosing AD. It now requires biomarker evidence of AD-type pathology for diagnosis while also determining that biomarker tests should not be ordered or interpreted in the absence of clinical context. This new path for diagnosing and treating AD intensifies the need to ease the early, accurate, and accessible identification of the patients who should undergo AD biomarker testing. Unfortunately, today’s techniques for evaluating cognitive status and indicating the appropriateness of AD biomarker testing do not meet the clinical need. These weaknesses hinder proper diagnosis of cognitive impairment, thereby limiting identification of candidates for AD biomarker testing and treatment of AD. To address these problems, SPARK Neuro is developing SPARK Scan, a standardized, objective, non-invasive, and cost-effective diagnostic tool capable of identifying and staging cognitive impairment that is highly sensitive to the presence of AD. In the proposed Phase II SBIR project, SPARK Neuro will build upon findings from a successful Phase I in preparation for an FDA De Novo Submission and eventual commercialization. This effort will include a pivotal clinical study (N=200) that will validate algorithm performance (Aim 1). Following this validation, SPARK Neuro will finalize product software and cloud-based infrastructure, completing Verification and Validation (“V&V) (Aim 2).