Seems the various cognitive and functional tests in the early stages of AD are very imprecise.
Anavex have gone for the ‘traditional’ measures in their P2/3 trial in AD as primary endpoints. With the genetic biomarkers as secondary.
Hope A2-73 sticks with powerful enough effect in mild AD to be stat sig.
What the discussion really shows, I think is that finding dependable biological markers of developing AD is critical to both early diagnosis and to determining the effect of a treatment in trials.
I suggest RWE-RWD will be a significant value added data set until a better complimentary metric is developed, particularly at stage 2 levels. "Where the money is".
(in other words , if it cannot be measured it cannot be managed.)
FDA continues to hold onto the Amyloid Thesis, b/c it can be measured by PET, etc...cause vs correlation? HUH??
Well, IMO the most reliable measure for AD must be how the patient feels, sleeps, acts and functions. IMO, caregivers and the patients observed QOL will have to remain the standard. When science eventually is able to correlate before-after (some test) results, then they will be able to define the proper metric. Until then they are in the dark, obviously.