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BrainScope Completes Proof-of-Concept for Groundbreaking Early Alzheimer’s Prediction Biomarker

Development funded by the Alzheimer’s Drug Discovery Foundation

ROCKVILLE, Md.–(BUSINESS WIRE)–#ADDF–BrainScope, a leader in brain diagnostics, today announced the successful completion of the proof-of-concept phase for a novel brain activity-based biomarker for the prediction of onset of Alzheimer’s disease at its earliest stage in normal elderly individuals with memory complaints. This breakthrough was supported by an investment from the Alzheimer’s Drug Discovery Foundation (ADDF).

The study utilized EEG data from a multi-year longitudinal investigation involving elderly individuals who initially presented with only subjective memory complaints but had not yet been diagnosed with mild cognitive impairment (MCI) or dementia. Following the initial EEG assessment, participants were followed clinically for 5 to 7 years for the evolution of cognitive decline. Using its proprietary EEG-based machine learning platform, BrainScope identified distinctive EEG profiles that differentiated those who showed no change, declined to MCI or converted to dementia, using only information gathered at their initial assessment. These findings have culminated in the development of an innovative biomarker with the potential to predict cognitive decline from the earliest signs of memory loss. The next phase will focus on validating this biomarker.

A recent World Alzheimer Report 2024 by Alzheimer’s Disease International found that over 90% of the 40,000 people surveyed across 166 countries said they would pursue a diagnosis if effective treatments were available. “One of the most significant challenges in treating Alzheimer’s patients is that by the time traditional diagnostic methods detect the disease, irreversible brain damage may have already occurred,” said Leslie S. Prichep, Ph.D., Chief Scientific Officer at BrainScope. “Our EEG-based biomarkers show great potential for detecting neurodegenerative disease at the first signs of functional changes to the brain, long before such structural damage takes place. Early identification of those at risk for future decline opens up new possibilities for therapies that could slow or stop the progression of this devastating disease.”

“BrainScope’s biomarker has the potential to serve as one of the frontline Alzheimer’s risk screening tools, helping predict patients at a higher risk most likely to later develop the disease,” says Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. “This research underscores the importance of monitoring for the disease before major symptom onset and diagnosis. In the near future, we will have a screening tool like this that can measure early-stage changes before significant neurodegeneration occurs—bringing us one step closer to preventing Alzheimer’s.”

Laurie Silver, CEO of BrainScope, added, “We are incredibly excited about the potential of this biomarker to transform how Alzheimer’s is diagnosed and treated. Our goal is to make early diagnosis and monitoring a routine part of care, improving outcomes and offering hope to millions of families affected by this disease.”

BrainScope’s approach to Alzheimer’s diagnostics marks a substantial improvement over current tools. Its machine and deep learning-driven EEG biomarkers are non-invasive, radiation-free, fast, affordable, and accessible, while being capable of detecting abnormalities even before symptoms emerge or brain damage becomes apparent. The potential applications of BrainScope’s technology extend far beyond early diagnosis — they could revolutionize the drug development process by improving clinical trial patient selection, reducing trial costs, and monitoring brain function during trials and post-market.

About BrainScope

BrainScope is a pioneering medical neurotechnology company dedicated to improving brain health through objective, diagnostic insights that enhance patient care. BrainScope applies state-of-the-art machine learning and deep learning to brain electrical activity (EEG) to create radiation-free, rapid, inexpensive and more accessible new biomarkers that greatly expands the utility of traditional EEG data. Known for its advancements in the assessment of mild traumatic brain injury, BrainScope’s commercial point of care device is the only FDA-cleared technology to objectively assess head-injured patients for both brain bleeds and concussions. BrainScope helps clinicians quickly rule out the need for head CT scans, while offering a rapid, objective assessment of concussion in about 10-15 minutes. The company is currently exploring new biomarkers including for Alzheimer’s, stroke assessment, concussion subtyping, military blast exposure and Covid brain fog. BrainScope is committed to revolutionizing brain health management across acute care, drug development, and consumer health. For more information, visit www.brainscope.com.

About The Alzheimer’s Drug Discovery Foundation (ADDF)

Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer’s Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer’s disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer’s, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF’s leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer’s PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer’s drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: http://www.alzdiscovery.org/.

Contacts

Media contact:

Laurie Silver, CEO

[email protected]

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