Abstract Body

A number of disease-modifying therapies (DMT) for Alzheimer’s disease (AD) are being tested in clinical trials, whereas those conducted in the dementia stages have largely failed, underscoring the necessity of early intervention. Notably, positive outcomes of recent anti-amyloid-β trials have been made possible by molecular imaging and fluid biomarkers, underscoring the needs of biomarkers that surrogate the clinical and pathophysiological progression of AD. Longitudinal observational studies as represented by AD Neuroimaging Initiative (ADNI) in the North America and the Japanese ADNI have contributed greatly towards the goal of very early treatment at the prodromal and preclinical AD stages by delineating the early natural course of AD and facilitating the development of biomarkers. Furthermore, secondary prevention trials on the preclinical, i.e., asymptomatic, stage of AD are highlighted as the future direction of development of AD DMTs. To overcome the difficulties in recruiting and correctly characterizing the preclinical AD candidates, establishing trial ready cohorts (TRC) of preclinical and prodromal AD is an effective approach. We have started J-TRC comprised of a webstudy for on-line registration and screening, followed by the on-site study to characterize the elderly volunteers by in-person visits conducting psychometry, amyloid PET and blood biomarkers. J-TRC webstudy so far recruited ~6900 web registrations, and the J-TRC onsite study screened ~250 volunteers and enrolled ~60 participants with intermediate to positive amyloid levels. These clinical activities, accelerated by the development and implementation of biomarkers, will pave the way toward the successful development of AD DMTs targeting its very early stages.