Alzheimer’s disease biomarker roadmap 2020: [18F]flortaucipir

Background In the last decade, the research community focused on defining reliable biomarkers for the early detection of the pathological hallmarks of Alzheimer’s Disease (AD). In 2017, the Geneva AD Biomarker Roadmap Initiative adapted the framework for the systematic validation of oncological diagnostic biomarkers to AD, with the aim to accelerate their development and implementation in clinical practice. With this work we assess the maturity of [18F]flortaucipir and we define the research priorities. Method In a two‐day workshop (Geneva, November 2019), we convened a panel of experts in AD biomarkers. The level of maturity of [18F]flortaucipir has been assessed based on the Biomarker Roadmap (Frisoni et al., 2017). Biomarker maturity and research priorities were processed by thematic subgroups before the meeting, and presented and discussed during the workshop Result [18F]flortaucipir binds with high affinity to paired helical filaments of tau and has favorable kinetic properties. It accurately discriminates between AD and patients with non‐AD neurodegenerative disorders as well as healthy controls. Initial studies showed high correlations between ante mortem and post‐mortem tau pathology. Further research is needed to investigate the effects of covariates on tracer binding and its ability to detect tau pathology in the early phase of AD. Conclusion [18F]flortaucipir provide partial evidence for clinical utility. In vivo [18F]flortaucipir PET shows excellent discrimination for AD from controls and non‐AD neurodegenerative disorders and promising results for the validation with autopsy. However, completion of studies on analytical validity is a requirement to investigate clinical utility properly.