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. Author manuscript; available in PMC: 2017 Oct 23.
Published in final edited form as: J Prev Alzheimers Dis. 2017 Apr 25;4(2):109–115. doi: 10.14283/jpad.2017.12

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