Hopefully soon, the donanemab Phase III data will be released and so that’s the next major clinical trial to read out. Donanemab had encouraging results in Phase II. That’s another amyloid lowering antibody and we’ll see what the results show and if they’re positive, I’m sure they will plan on seeking FDA approval. Probably the biggest thing that’s coming is there’s going to be a decision by FDA whether or not to grant full approval for lecanemab and CMS will then decide how to cover it and to what degree they’re going to cover it and what restrictions might be placed on that for either lecanemab or donanemab...
Hopefully soon, the donanemab Phase III data will be released and so that’s the next major clinical trial to read out. Donanemab had encouraging results in Phase II. That’s another amyloid lowering antibody and we’ll see what the results show and if they’re positive, I’m sure they will plan on seeking FDA approval. Probably the biggest thing that’s coming is there’s going to be a decision by FDA whether or not to grant full approval for lecanemab and CMS will then decide how to cover it and to what degree they’re going to cover it and what restrictions might be placed on that for either lecanemab or donanemab. So that’s really important.
And I want to make your viewers aware about ALZ-NET, which is a new network that the Alzheimer’s Association put in place with the American College of Radiology to help monitor safety and efficacy of patients who go on disease modifying treatments. And I would encourage all clinicians to enroll patients in ALZ-NET who go on these medicines or who are being considered for them so we can track it and make sure that it’s safe and make any modifications and help clinicians provide better care. So this this will help us really improve the standard of care for Alzheimer’s disease.
I guess the biggest thing that’s coming in addition to everything I’ve just said, which is a lot, are the new blood tests that are already here. I used to say they’re on the horizon, but they’re here now and there are different types. They they look at amyloid ratios in the blood. They look at different isomers of phospho-tau. They’re looking really good and there are different types. One uses a mass spec technique, another use immunoassays. And that’s really going to help with screening for these disease modifying treatments, screening for clinical trials and also to improve diagnosis and clinical practice, so clinicians should keep their eyes out.
