Translation of imaging biomarkers from clinical research to healthcare

The use of biomarkers for diagnostics of Alzheimer’s disease (AD) has increased over the last years in specialized care and experimental settings. With the possibly upcoming availability of disease-modifying therapeutic agents, the diagnostics and treatment of patients with cognitive impairment will change. Biomarkers will be used as theranostic markers for case finding. The development and evaluation of biomarkers can be framed in a phase model from preclinical studies through trials in expert center settings to the evaluation of biomarkers in primary care, up to testing the efficacy and the impact of biomarkers on the healthcare system. Hippocampal volumetry is the most accepted and in-depth tested biomarker for AD diagnostics and prediction of the course. Therefore, hippocampus volumetry is used to illustrate the phase model of biomarker development and present the milestones already achieved and questions still to be resolved.