There are now tests being developed and validated that can predict AD many years in advance, using bio makers. If the bio markers can be changed then the FDA would be inclined to do an approval with a P4.
I put some thought into this a while back… I’d also like to draw attention to the PR, it seems to indicate the preventative trial includes Alzheimer’s risk patients. I’m wondering if they will capture other CNS prevention in this trial as well.
The trial would need to be exceptionally lengthy. I’d guess ~3-5 years. I suppose guidance from regulators could have it shorter but it’s hard to imagine that. They could enroll patients with MCI and see if dosing prevents degradation into full blown AD. Additionally, they could do genomic analysis for APOE4 patients (most likely to get AD) and see if there is any positive correlation there. There are statistics on the number of certain aged peoples (65 year olds) have AD. We could see if our patient cohort has dramatically decreased AD vs. U.S. population or placebo (or both).
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