O1‐10‐02: How does differential effect of treatment in ApoE‐ɛ4+ carriers change clinical trial design in Alzheimer's disease?

plan and perform statistical analyses to understand the complexity of impact of APOE gene on multiple key parameters in a hypothesized clinical trial, such as determining trial duration, identifying target population, comparing potential clinical outcomes and testing the statistical interaction between APOE and multiple types of imaging biomarkers. Results:The observed ApoE gene effect on AD clinical progression appears to be modest during the first 2w3 years after enrollment in theMCI population. Over six years, cognitive decline rates are significantly different by ApoE status (Figure 1), and are influenced by brain Ab deposition status (Figure 2). In designing a clinical trial, this genetic by imaging interactionmay be translated to 30% reduction in sample size for certain clinical endpoints. Conclusions:A more effecient clinical trial may be designed by considering APOE, as well as other biomarkers, in population stratification. Moreover, public data, such as ADNI, is very helpful to design clinical trials.