Table 2.
Approach to levels of clinical and biomarker evidence in support of disease modification
Population | Level of Evidence | Clinical Design | Clinical Outcome | Biomarker Data |
---|---|---|---|---|
Mild-Moderate AD | A1 | Delayed start or delayed withdrawal | Significant effect on cognitive and functional or global measures | Significant effects on several independent biomarkers |
A2 | Parallel group | Significant effect on cognitive and functional or global measures | Significant effects on several related biomarkers | |
B1 | Delayed start or delayed withdrawal | Significant effect on cognitive and functional measures | Significant effects on one biomarker or biomarkers limited to one aspect of AD | |
B2 | Parallel group | Significant effect on cognitive and functional measures | Significant effects on one biomarker or biomarkers limited to one aspect of AD | |
C1 | Parallel group | Trend on cognitive and functional measures | Significant effects on several independent biomarkers | |
C2 | Parallel group | Trend on cognitive and functional measures | Significant effects on one biomarker or biomarkers limited to one aspect of AD |