TL31: Unique Statistical Considerations in Alzheimer's Disease Studies: Delayed Start, Biomarkers and More.
*Hong Liu-Seifert, Eli Lilly and Company 

Keywords: Alzheimer's Disease, statistical consideration, missing data, sensitivity analysis, biomarkers, delayed start, non-inferiority margin

There are unique methodological considerations in the design and analyses of clinical trials for Alzheimer's Disease (AD), a neurodegenerative disease. For example, novel clinical trial designs, such as Delayed Start, have been utilized in studies that investigate putative disease modifying drugs. This roundtable discussion is intended to bring together statisticians from FDA, academia and industry and discuss challenges and opportunities of some of the methodological considerations in AD.

1. How to conduct Delayed Start analysis and what would be a reasonable Non-Inferiority Margin for Delayed Start analysis?

2. How can we statistically model the disease progression in terms of clinical outcomes and biomarkers, and also importantly assess the relationship between clinical outcomes and biomarkers.

3. How to handle missing data and sensitivity analyses unique to Alzheimer's Disease?