Participant Prescreening and Screening
An optional ICF1a/ICFA prescreening program was created to aid sites that did not have access to a local or national registry with APOE genotyped individuals. Additionally, this program was beneficial for sites that preferred to handle the prescreening process themselves as it provided them more direct control compared to the multi-step course of referring interested individuals to outside local or national registries for genetic testing and, if genetically eligible, wait to receive an invitation to the Generation Program. This prescreening program provided sites with the flexibility to create their own local registries from which they could invite individuals for further screening into the Generation Program or other trials at their site. The prescreening process was described in brief informed consents (ICF1a for Generation Study 1, ICFA for Generation Study 2) (Sites stored the demographic information from participants who consented to ICF1a/ICFA and did not share the information with the sponsor. APOE genotype results obtained from the ICF1a/ICFA process were returned directly to the study site. Sites used the APOE results to determine which participants to invite for further screening (ICF1b or ICFB shown in 