US boost for early dementia detection system

German medtech firm AIRAmed has received FDA clearance for AI software which targets the early detection of dementias.

The medical image management and processing system provides relevant brain volumetry data to assist physicians in early detection of Alzheimer’s and other dementias.

AIRAscore uses deep learning and artificial intelligence (AI) technology to provide quantitative assessment of brain volume with objectively verifiable data using standard MRI brain scans in as little as five minutes.

According to the US CDC, an estimated 5.8 million people in the US have Alzheimer’s disease and related dementias, including 5.6 million aged 65 and older and about 200,000 under age 65 with younger-onset Alzheimer’s.

Moreover, lifetime risk for Alzheimer’s at age 45 for women is one in five, and for men one in 10. Dementia has historically been diagnosed in more advanced stages, when potentially irreversible damage may have already occurred. Early and accurate detection is a key factor in positively influencing the course of the disease.

Dr. Tobias Lindig, founder and MD of AIRAmed, says: “For so long, we’ve been limited to reading a patient’s MRI to detect Alzheimer’s and other dementias.

“However, we know from several studies that patients with these brain diseases suffer from subtle brain volume loss early in their disease course that cannot be observed with the human eye.

“With AIRAscore, we are now offering physicians a highly precise, quantitative tool for the rapid detection of areas with a brain volume below the normal range.

“We believe our technology has the potential to be a game changer in the patient care journey, as brain volumes are of interest to physicians in the early disease course and also during the course of a disease to monitor the brain volume over time during therapy.”

AIRAscore provides physicians with a clear narrative and pictogram showing absolute values with accurate volumes of tissues and brain areas, standardised to each individual’s anatomy.

It compares volumes of individual brain areas to a large reference population, corrected for head size, age, and sex, and presents the information in an easily understandable manner similar to a blood laboratory report.

Detailed information on the different lobes and limbic structures allows the identification of brain volumes that are not age appropriate, with different distribution patterns depending on the type of neurodegenerative disease.

The technology therefore provides valuable information that supports physicians in the differentiated clarification of dementia forms, including Alzheimer’s Disease, frontotemporal dementia (FTD) as well as other dementias, movement disorders like atypical Parkinson syndromes and more diseases with known patterns of volume loss.

Prof. Dr. Ahmed Othman, neuroradiologist, University Hospital Mainz, Germany, said: “The innovative brain volumetry system AIRAscore offers new possibilities in diagnosis and treatment of neurodegenerative diseases with an easily accessible surrogate parameter of disease activity.

“This is a big milestone for early detection, differential diagnostics and disease monitoring in dementias.”

AIRAscore has been used commercially in Europe for 4 years and will be available for purchase in the US in the first quarter of 2024.