BrainScope’s EEG-Based Biomarker Validated as Early Dementia Risk Predictor

A peer-reviewed study indicates that BrainScope’s EEG-based biomarker can identify cognitive decline risk within five to seven years before symptoms emerge, including progression to mild cognitive impairment (MCI)—a precursor to various forms of dementia—or advancement to Alzheimer’s-type dementia.

Using EEG data from an initial evaluation in older adults reporting only subjective memory concerns, this longitudinal study in Scientific Reports (Nature Portfolio) showed that BrainScope’s non-invasive, point-of-care EEG technology can detect functional changes in brain activity well before traditional diagnostic tools would identify disease-related pathology.

In the study, researchers collected baseline resting EEG recordings from 88 older adults with Subjective Cognitive Impairment (SCI) but no formal MCI or dementia diagnosis. Participants received annual clinical assessments and cognitive decline staging. During that period, some participants progressed to MCI or dementia, while others remained cognitively normal. Using BrainScope’s proprietary EEG-based biomarker platform, researchers identified distinct brain electrical activity patterns at the initial assessment that accurately predicted future cognitive decline.

“This publication in Nature Scientific Reports validates years of research using EEG to detect functional brain changes in normal elderly with subjective cognitive complaints,” BrainScope Chief Scientific Officer and first study author Leslie S. Prichep, Ph.D., said. “The importance of identifying risk of future cognitive decline, long before structural damage occurs, can have a significant impact on brain health in the elderly, early enough to meaningfully change outcomes.”

BrainScope’s EEG biomarker achieved an area under the curve (AUC) of 0.90, and its performance was validated across independent international cohorts. These findings demonstrate that—with BrainScope’s proprietary signal processing, deep domain expertise, and AI-enabled analytics—EEG can be transformed into a rapid, affordable, and non-invasive assessment capable of identifying Alzheimer’s-related brain dysfunction, thus enabling proactive monitoring and intervention years before meaningful memory loss occurs.

Early identification is critical, as by the time traditional diagnostics such as brain imaging detect Alzheimer’s pathology, significant and irreversible neurological damage has often already occurred. Identifying risk earlier aligns with a rapidly evolving therapeutic landscape in which many disease-modifying therapies and prevention-focused clinical trials require patients to be identified years before conventional diagnosis. Earlier awareness also enables individuals and families to pursue evidence-based lifestyle modifications, proactive care planning, and participation in research studies—shifting care from reactive management to proactive intervention.

Key funding for the biomarker’s development was provided by the Alzheimer’s Drug Discovery Foundation (ADDF), whose early support BrainScope credits as instrumental in achieving this milestone. The ADDF has helped advance Alzheimer’s diagnostics, including early support for technologies such as the first amyloid PET scan and the first blood-based biomarker test for the disease.

“The rapid evolution of Alzheimer’s therapeutics demands equally innovative biomarkers,” said Howard Fillit, M.D., co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation. “As the field moves toward more complex, combination therapy strategies and precision prevention, tools like BrainScope’s will play a critical role in early risk identification and enabling a tailored approach to treatment.”

This latest breakthrough coincides with BrainScope’s continued expansion of its artificial intelligence (AI)-enabled EEG platform into new clinical indications, including neurodegenerative diseases and stroke. BrainScope’s first commercial device, cleared by the U.S. Food and Drug Administration (FDA) for evaluating brain injury, demonstrated the ways in which advanced EEG analysis can yield rapid, objective insights at the point of care. The successful Alzheimer’s risk prediction study further reinforces the company’s strategic focus on early detection and prevention, with ongoing efforts to validate and integrate this biomarker into routine clinical practice.

“At BrainScope, our mission has always been to translate the brain’s electrical signals into clinically meaningful insights and build the platform that becomes the brain’s vital sign,” BrainScope CEO Matt Adams concluded.

BrainScope is a commercial-stage medical neurotechnology company applying AI and computational neuroscience to brain electrical activity (EEG) to develop noninvasive, objective diagnostic tools for brain health. With an FDA-cleared product in commercial use for head injury, a robust machine and deep learning platform, and a growing portfolio of digital biomarkers, BrainScope is advancing the methods for detecting, monitoring, and managing brain injuries and neurological diseases.