FDA Approves BrainSee, First-in-Class Test to Predict Progression of Alzheimer Disease


BrainSee creates a new standard for progression prediction in Alzheimer disease, marking a step forward in brain health management with non-invasive screening.

The FDA has approved a first-in-class clinical test, BrainSee, which uses imaging processing and medical artificial intelligence to predict the progression from amnestic mild cognitive impairment (aMCI) to Alzheimer dementia. According to a press release, BrainSee creates a new standard for progression prediction in Alzheimer disease (AD), marking a step forward in brain health management with a non-invasive screening process.1

Elderly woman holding brain symbol of missing jigsaw puzzle, Alzheimer disease concept | Image Credit: ipopba - stock.adobe.com

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According to the Alzheimer’s Association, aMCI primarily affects an individual’s memory, causing them to start forgeting important information that they used to easily recall, such as appointments, conversations, or recent events in their lives. The organization added that approximately 12% to 18% of individuals aged 60 or older have some form of MCI, with about one-third developing AD within 5 years. Additionally, they added that more than 80% of Americans know little or are not familiar with MCI, which can be a sign of early-stage AD.2

"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 is the first product of this vision, backed by our solid technological infrastructure that is capable of driving further transformations and scalable innovations in the brain health landscape," Padideh Kamali-Zare, PhD, founder and CEO of Darmiyan, said in the press release.1

The clinical test is a fully automated software platform, combining standard magnetic resonance imaging (MRI) and cognitive assessments.1 Using MRI data, BrainSee can pull information related to brain tissue degeneration, according to the company website.3 The platform can generate scores that predict the likelihood of progression from aMCI to AD within 5 years, according to the press release.1 The score can be between 0 to 100, with a lower score being positive, and physicians can use this information to determine the likelihood of progression.3 The platform was designed based on approximately 40 years of neuroscience and thousands of real-world patient data, according to the product website.3

With early screening and risk stratification, the program helps to get individuals at risk of progression to AD timely and personalized treatments, which could help delay dementia onset and lower risk of progression. According to the press release, this would also reduce costly and invasive tests as well as the financial and emotional burdens for patients. BrainSee also provides accurate same-day results, with integration into clinical workflow. Further, the platform shifts the paradigm in aMCI workup from biomarker-based methods with invasiveness and inaccessibility to a non-invasive method to determine progression.1

According to the company website, reassurance can be provided to patients who are at low risk for progression and also offer early interventions to delay the onset of dementia for those at high risk. BrainSee can also be repeated annually to further provide reassurance and monitoring of progression. The program also includes a printable reported with prognostic scores and provides instructions on how to interpret the scores.3

The FDA previously granted BrainSee breakthrough designation in 2021. The approval coincided with the JP Morgan HealthCare conference, according to the press release.1


  1. Darmiyan receives FDA approval for BrainSee, the first prognostic test for predicting likelihood of progression to Alzheimer's dementia. News release. PR Newswire. January 12, 2024. Accessed January 12, 2024. https://www.prnewswire.com/news-releases/darmiyan-receives-fda-approval-for-brainsee-the-first-prognostic-test-for-predicting-likelihood-of-progression-to-alzheimers-dementia-302033616.html
  2. Alzheimer’s Association. Mild Cognitive Impairment (MCI). Accessed January 12, 2024. https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment
  3. BrainSee. Updated January 2024. Accessed January 12, 2024. https://brainsee.ai/
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