Table 2a:
Stage 1 | Stage 2 | Stage 3 | Stage 4 | |
---|---|---|---|---|
Preclinical | Prodromal (MCI) | Early AD | Mild-moderate AD | |
Definition |
|
|
|
|
Possible endpoints |
|
Cognitive scale(s) only (biomarker supported dx) | Clinical scale(s) to assess both daily function and cognitive effects | Clinical scale(s) to assess both daily function and cognitive effects |
Clinically meaningful effect for approval? | Not required | Clinically meaningful ideal; not required | Clinically meaningful effect required | Clinically meaningful effect required |
Approval type | Conditional approval | Conditional approval | Regular approval | Regular approval |