F4-01-01: plasma test for amyloid risk screening: the c2n sponsored paris add-on study to ideas.

A critical unmet need exists for a commercially available blood-based biomarker test that predicts brain amyloidosis in people at risk for Alzheimer's disease. In IDEAS, qualitative brain amyloid imaging status was determined in a large cohort of ≥65-year-old adults with progressive, unexplained MCI, or dementia of uncertain etiology. However, no biofluids were collected and archived from IDEAS participants. C2N Diagnostics is conducting an add-on study to IDEAS known as the Plasma test for Amyloidosis RIsk Screening (PARIS study); a blinded cross-sectional two-phase study that collects blood samples from eligible IDEAS participants. C2N Diagnostics will quantify plasma Aβ42 and Aβ40 peptides and their ratio using C2N's proprietary stable isotope spike absolute quantitation (pSISAQTM) liquid chromatography-tandem mass spectrometry assay. Pending study completion. After unblinding, C2N will evaluate concordance between their pSISAQTM test and the amyloid PET imaging results obtained from IDEAS participants.