So we did a study that we combined a digital computerized marker, the Cognivue Clarity, with blood-based biomarkers done by Lucent diagnostics. So this was the Lucent AD Complete biomarker. So let me just go to the setting. So there was a study called the BioHermes study. And so this was a multi-site study involving clinical trial centers that do lots of Alzheimer clinical trials. And the idea was to try to understand how fluid and digital biomarkers perform in clinical trial samples...
So we did a study that we combined a digital computerized marker, the Cognivue Clarity, with blood-based biomarkers done by Lucent diagnostics. So this was the Lucent AD Complete biomarker. So let me just go to the setting. So there was a study called the BioHermes study. And so this was a multi-site study involving clinical trial centers that do lots of Alzheimer clinical trials. And the idea was to try to understand how fluid and digital biomarkers perform in clinical trial samples. So over a thousand people were recruited. They were healthy controls or people thought to have MCI due to Alzheimer’s or Alzheimer’s disease. And it was a cross-sectional study. So they had a screening visit and then they had a complete biomarker panel. And nearly everybody had amyloid PET scans so that we sort of have the gold standard question of whether they have amyloid in their brain or not. And so this has been a very interesting study in looking at individual biomarkers, and that’s been informative. But I think what’s really interesting is thinking about the power of potentially combining tools to improve our ability to screen, detect, recruit, and enroll people in clinical studies and potentially to get them into treatment protocols. So what the study was, there was 983 people who had an amyloid PET scan, the Cognivue Clarity, which is a digital computerized test, and the Lucent AD Complete blood-based biomarker panel. And we wanted to see is could we develop sort of an implementation screen to sort of have a quick two-stage screening to get people into protocols. So what we found was of the 983 people, Cognivue Clarity was able to sort of separate out people who were impaired versus not impaired and give you some sense of what their likely diagnosis was. From there, about 40% of the sample was unimpaired and about 60% of the sample was impaired. Of the people who were impaired, the Lucent AD Complete, which is a biomarker panel that looks at pTau217, the A beta 42/40 ratio, NFL, and GFAP, and an algorithm, and it generates a score. From there, you can get people who have a low risk, a high risk, or the middle group, which is sort of an intermediate or indeterminate risk. So we looked at people who were impaired and had the different biomarker panels. And most of the people fell into the low risk or the high risk. And because they all had PET scans, we knew what they ultimately had. And the people who Cognivue screened as impaired and Lucent screened as low risk had amyloid centiloid levels that were less than 10. So they had negative amyloid scans. Of the people who Cognivue picked out to be impaired and Lucent AD Complete picked out at high risk, those people had PET amyloid centiloid levels in the 70s. So very positive centiloid. And then it was a smaller group that sort of had an indeterminate group. And their centiloids were on the order about 21, which means that some people had amyloid and some people didn’t. For the people who were not impaired, the same thing with those three levels, we were able to identify people who were true controls and their PET scans were negative. We were able to identify a group of people who were preclinical AD, that is, they were cognitively unimpaired, but they had amyloid in their brain. And then a small group that had an indeterminate blood-based biomarker level. And again, their centiloid levels were 17. So again, there were some people who were positive and negative. So the upshot was by doing this two-stage thing, 85% of the people we screened with just two things, the Cognivue Clarity and the Lucent AD Complete were able to correctly classify and really didn’t need any other workup. Only 15% really needed to go on to have a confirmation biomarker like a PET scan. Now, if you think about this of a thousand people, 150 needed a PET scan. This would allow us to develop very high-throughput screening paradigms to enroll people in clinical trials or to identify people for treatment protocols and really limit the amount of people who would need a confirmation biomarker like a PET scan or a spinal tap. And I think that that has tremendous advantage, one, for enhancing and enriching clinical trial recruitment, and two, to get people into treatment protocols, particularly in areas where PET scans may not be readily available or in underserved populations that don’t have the resources, you know, to pay for some of these more expensive biomarkers. So very excited about that.
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