The intent of the FY20 PRARP ADTBI is to support high-impact, human-based development of robust diagnostic and/or prognostic biomarkers for chronic TBI as they pertain to AD/ADRD. It is anticipated that the proposed work will qualify clinically useful biomarkers for rapid transfer to clinical practice. The FY20 PRARP ADTBI mechanism defines biomarker qualification as the evidentiary process of linking a biomarker with biological processes and clinical end points. Applications may consider elements of biomarker validation as part of the application.

Biomarker validation is defined as assessing the biomarker’s measurement performance characteristics in terms of reproducibility, accuracy, precision, and limits of sensitivity. Applications that detail biomarker validation work should demonstrate how this research is relevant to overall biomarker qualification. As part of the application, the proposed biomarkers should demonstrate their potential for improved specificity and sensitivity with respect to diagnosis and/or prognosis of chronic TBI as it pertains to AD/ADRD as the study endpoint. The FY20 PRARP ADTBI does not support basic discovery of biomarkers. As such, animal research is prohibited. The proposed biomarker for investigation must correlate with clinical endpoints to include cognition and/or behavior relevant to both TBI and AD/ADRD research. As part of the application, the PI should demonstrate that the study team has experience in both TBI and AD/ADRD research.

The FY20 PRARP ADTBI encourages applications to consider fluid-based, imaging-based, retinal or wearable devices as potential diagnostics. Demonstration of access to an already existing cohort or provision of a plan that demonstrates expedited participant accrual is required. In addition, suitability of the existing cohort or participant population must be detailed. Applications must therefore describe how the anticipated outcome(s) can be attributable to the results of the proposed research (short-term gains), as well as consider the long-term scientific gains from the proposed research project. FY20 PRARP ADTBI applications must be Impact-based.