Alzheimer's Predictive Tool: Altoida DNS Receives Breakthrough Device Designation

Last updated: January 2022

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Altoida Digital Neuro Signature (DNS), a noninvasive software device that measures and monitors neurocognitive function.1

Altoida DNS is designed to use artificial intelligence to detect mild cognitive impairment (MCI) that can lead to Alzheimer's later in life. Evaluating cognitive ability is important for diagnosing Alzheimer's disease. It is also key for monitoring its progression.1

The FDA's Breakthrough Device Program is a voluntary program for some medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. The program's Breakthrough Designation means devices, like Altoida DNS, can be made available sooner.2

Current methods of Alzheimer’s detection

Finding Alzheimer's early can help improve function throughout life; it can also slow decline. Doctors use several tools to detect Alzheimer's, including blood tests, brain imaging, and biomarkers. Efficient and precise detection is key for early intervention.1,3-4

Current methods to detect Alzheimer's are "cross-sectional." This means there is 1 long test conducted at 1 point in time. This test is then repeated at regular intervals. However, cross-sectional tests can be limited. They may not predict future cognitive decline. They also may not capture the whole picture.1

Cross-sectional tests can also be affected by other factors, such as:1

  • Motivation
  • Attention
  • Mood
  • Testing environment
  • Sleep quality before the test
  • Anxiety or nerves

These factors can make it harder to get an accurate diagnosis or assess if a treatment is working. These sorts of tests are better at finding moderate to severe cognitive impairment. MCI accuracy is varied. This makes it more difficult for these tests to detect Alzheimer's early.1

How does Altoida DNS diagnosis Alzheimer's?

Altoida DNS is not a cross-sectional test. Instead, it is a "longitudinal" test. These are more frequent observations in 1 person over time. These types of tests use 2 main measurements:1

  • How the processes in the brain work
  • How these processes relate to each other

These measurements can much more helpful in detecting early Alzheimer's.1

Altoida DNS checks many things, including reaction time. Reaction time is a good measure because it cannot be improved with practice in the way other tests can be.1

Altoida DNS also uses digital biomarkers to track disease progression. These are biological or behavioral markers collected from digital tools like a computer, smartphone, tablet, or digital watch. These can track active measurements like reaction time. But they can also track passive measurements. Passive measurements are things like tremor, hesitation, gait, and touch pressure.1

The Altoida DNS test takes 10 minutes and tracks multiple things, including cognitive and motor skills. It does this by looking at eye-tracking, motor tests, and others. It can predict the risk of MCI due to Alzheimer's with high accuracy.1

What does this mean for people with Alzheimer's?

Altoida DNS allows for faster and more accurate testing. It only takes 10 minutes as opposed to 45 to 120 minutes for a traditional test. It is also better at detecting specific changes and more precise than traditional tests.1

Importantly, Altoida DNS can spot the shift from MCI to Alzheimer's. This is key for early detection. More sensitive testing means you and your doctor can catch the shift earlier.2

There is no cure for Alzheimer's. However, beginning treatment earlier can improve disease outcomes. Some medicines for Alzheimer’s also work better in the early stages.2

Early detection also helps people with Alzheimer's and their families prepare for the future. Finances, living arrangements, and support networks can all be found earlier. And it gives people the chance to participate in clinical trials or studies for new treatments. Altoida DNS may be useful to look at cognitive training or drug effectiveness as well.1,3

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