Attributions

Silk ABeta Spot Test

Philip Verghese, PhD C2N Diagnostics

Co-Principal Investigators

Joel Braunstein, MD, MBA C2N Diagnostics

Summary

Alzheimer disease (AD) is the most common cause of dementia and currently affects more than 5 million people in the USA alone, with millions more at high risk. Alzheimer’s deprives people of their memories, independence, and functional capacity. The quality of rational drug development in AD has suffered from the absence of relevant and simple dynamic biomarkers. Dynamic biomarkers can be essential for selecting patients in studies who are most likely to benefit from therapy. Such biomarkers can help validate drug action, eliminate undeserving drug candidates early, and optimize dosing and scheduling to maximize future chances of clinical drug development success. A dynamic marker also can assist in monitoring drug activity in pre-symptomatic patients. It can track the therapeutic responsiveness of individual patients, predict clinical benefit, and follow disease progression. As of today, no simple dynamic biomarker for AD exists. C2N Diagnostics has unique and novel platforms, termed stable isotope labeling kinetics (SILK™) and Stable Isotope Spike Absolute Quantification (SISAQTM), that measure the metabolism and abundance of brain-derived biomolecules implicated in AD and other forms of neurodegeneration. The primary objective of C2N’s BrightFocus award is to develop novel and simple blood tests using the SILK™ and SISAQ platforms that can be used for 1) aiding in selection of patients for inclusion in AD trials, 2) demonstrating drug target engagement, and 3) tracking disease progression.