AZD-103 Now Recruiting for Phasell QOL & COG
Phasell for AZD-103 Now Recruiting. 340 Patients. AD MRI Scan Required
https://clinicaltrials.gov/ct2/show/NCT00568776?term=azd-103&rank=1
The FDA is clear as to Endpoint requirements for a Disease Modifying Drug for AD....Hit one COG and one QOL....log the biomarkers.
....Elans Lars Ekman..."the FDA is very clear of what they are asking for. They are asking for one cognitive endpoint, and that can be either a (?) or NTB, the Neuropsychiatric Test and that has to be combined with a quality of life endpoint, which could either be DAD or the physicians assessment, which is called CDR. So you have to hit one quality of life and one cognitive. The FDA also requires indirect measure of disease modification. That can be, for example, a change in beta amyloid revealed on head scan or change in CSF (?) which is a marker of disease activity. The Europeans do not ask for biological marker, however, they ask for slope divergence. So on the endpoints we’ve just discussed, they want to see that the slopes continue to diverge over 12 to 18 months."
......Note that a 3 month 'Peek' would not be acceptable due to "The Placebo Effect" which usually peaks at 3 months and then starts to decline in these studys.