How about a cell phone app that will reliably tell you if you are developing Alzheimer's dementia -- even before the disease becomes evident? Well, earlier this month, the FDA granted Altoida, Inc. "breakthrough device status" to a cell phone app that uses AI to diagnose Alzheimer's disease. This will allow an acceleration of the development, testing, and approval process for the device.
What does the app do? According to a press release, it measures 800 "digital biomarkers" (whatever those are) in eleven cognitive domains. It "collects personalized brain data by asking users to complete a 10 minute set of augmented reality and motor activities on their smartphone or tablet. With this data, the device will use artificial intelligence to predict if an individual aged 55+ with Mild Cognitive Impairment (MCI) will or will not convert to Alzheimer’s disease within 12 months."
Now, we can see right away that whomever wrote the release could use a lesson in how Alzheimer's disease progresses. As we wrote in Beating the Dementia Monster, Alzheimer's disease is one of many possible causes of MCI, and Alzheimer's disease begins well before the first symptoms of MCI appear. So there are two possible things the app may be predicting. One is if and when a case of MCI due to Alzheimer's disease might progress to dementia. The other is to discern whether the cause of the MCI is Alzheimer's disease or one of the 30-odd other conditions known to cause MCI. Both are possible, but it's not clear to me.
Altoida has partnered with Esai, Inc. in this and other research. You will recall that Esai partnered with Biogen in development of Aduhelm and they continue to investigate lecanemab together.
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