BrainSee test is now FDA-approved to predict Alzheimer’s dementia

Technology may identify high-risk patients early to enable timely treatment

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

Share this article:

Share article via email
An illustration shows hands together in a circle giving the thumbs-up sign.

The U.S. Food and Drug Administration (FDA) has approved BrainSee, Darmiyan’s software for predicting the likelihood that a person with mild cognitive impairment (MCI) will progress to Alzheimer’s disease-associated dementia.

Darmiyan believes the technology will help to screen and identify high-risk patients early, enabling a prompt start to treatments that may delay dementia onset. The technology also helps to avoid costly and invasive testing for patients who are at lower risk.

The BrainSee platform is already available to physicians through a secure web portal. Patients can also request more information on the website.

“Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way,” Padideh Kamali-Zare, PhD, founder and CEO of Darmiyan, said in a company press release. “BrainSee is the first product of this vision.”

Recommended Reading
main graphic for column titled

What you need to know about wandering and dementia

Amnestic mild cognitive impairment affects more than 100 million worldwide

Amnestic MCI, or MCI characterized mainly by memory loss, affects more than 100 million people worldwide. It may involve the forgetting of things that had previously been easy to remember, such as appointments or recent events.

There are a number of possible causes of amnestic MCI and many people will remain stable or improve over time. However, it can also be an early sign of Alzheimer’s disease and progress to dementia, where cognitive impairments are substantial enough to interfere significantly with daily life.

As more Alzheimer’s treatments become available, there is a growing interest in developing accurate tests to help doctors predict which course the disease will take. That could allow high-risk patients to start treatment earlier, thus slowing Alzheimer’s progression.

Current methods involve screening for certain disease-associated biomarkers. This typically involves collecting a sample of spinal fluid or through brain imaging using a PET scan. However, these methods may be limited in their real-world utility due to their invasiveness, lack of specificity, cost, and access limitations, according to Darmiyan.

BrainSee is an artificial-intelligence-based medical software that analyzes brain MRI data in conjunction with cognitive test scores to generate an accurate and objective score predicting the likelihood that a person with amnestic MCI will progress to Alzheimer’s dementia in the next five years. Scores range from 0-100, with a higher score indicating a higher risk of Alzheimer’s dementia.

In a clinical study, doctors not affiliated with Darmiyan used the BrainSee software to predict the prognosis of 107 people with amnestic MCI, then compared the prediction to clinical outcomes five years later.

BrainSee was found to be 91% accurate in predicting Alzheimer’s dementia. Similar findings were obtained in a retrospective analysis involving 411 people.

Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way.

BrainSee touted as non-invasive, affordable, convenient

Compared with other prognostic tests, BrainSee is non-invasive, affordable, and convenient, with results returned on the same day that the doctor submits the clinical data, according to Darmiyan. Moreover, because MRI is widely available and routinely used to assess MCI patients in clinical practice, the technology can be easily adopted globally.

Output from the test is intended to help clinicians proactively choose the best course of action for a person experiencing MCI. More effective disease management may also help to lower the billions of dollars spent on Alzheimer’s disease care every year, according to the company.

BrainSee was previously granted FDA breakthrough designation in 2021, a status that seeks to facilitate the development of technologies which could contribute to better treatment or diagnosis of life-threatening conditions.