Another development in Alzheimer’s diagnosis and treatment has earned the FDA’s “breakthrough” designation — but this one is not a drug. It’s a virtual microscope designed to detect Alzheimer’s called BrainSee.
Following a diagnosis of mild cognitive impairment, patients can find themselves in a state of limbo, caught between being cognitively normal and living with dementia. In this situation, says Dr. Kaveh Vejdani of biotech startup Darmiyan, the future can be uncertain, and often, it isn’t clear whether they will progress to dementia.
“Once mild cognitive impairment is established, it’s a big question mark in terms of a prognosis and diagnosis of etiology,” Vejdani, Darmiyan’s co-founder, and chief medical and technology officer, told Being Patient. “So, is it due to Alzheimer’s disease? Am I going to progress to dementia? And what do I need to do?”
Through objective and non-invasive measures, the company’s artificial intelligence diagnostic tool, BrainSee, aims to help provide answers. Recently, the FDA issued its breakthrough designation to Darmiyan’s technology as a way to work with the company to advance pre-market development and to prioritize the review of its regulatory submissions.
There are diagnostic tools to measure Alzheimer’s biomarkers like amyloid, but they are costly, inaccessible and invasive. Vejdani adds that another pitfall to measuring amyloid in patients’ brains is that results still remain inconclusive. Because BrainSee integrates standard MRI technology, it can help address these drawbacks and detect early-stage Alzheimer’s.
BrainSee extracts information from MRI imaging, quantifying details of brain tissue such as the size, shape and distribution of cells, akin to studying tissue structure under the microscope. Through machine learning, BrainSee then identifies patterns of Alzheimer’s across different brain regions.
The software combines these findings with patients’ clinical information including age, gender and cognitive test results, generating a composite score that reflects their chances of developing dementia of the Alzheimer’s type in the next five years.
“The intention is for BrainSee to be useful and interpretable by as many [physicians in] different specialties as possible,” Vejdani said. He continued, “The output is designed to be simple enough for any physician to be able to interpret it correctly and make [an] appropriate decision based on that.”
For patients at heightened risk of progressing to dementia of the Alzheimer’s type, Vejdani explained that they could then take steps to potentially slow the onset of dementia, like managing their comorbidities and implementing lifestyle changes. A greater certainty about the future also means that patients and families could develop care plans and better manage aspects of daily life, including their finances and relationships.
In Alzheimer’s research, Vejdani noted that BrainSee could help researchers identify patients with early-stage Alzheimer’s for clinical trials. The lack of a reliable diagnosis of early-stage Alzheimer’s has hampered research efforts, he explained, and BrainSee could aid in the search for effective therapies.
