The goal of this study is to determine how blood biomarker tests (ptau217 and ptau217/Aβ42) performed in primary care influence the patient trajectory in individuals with cognitive concerns.
Participants will provide a blood sample for biomarker testing and undergo clinical assessments as part of diagnostic evaluation.
Patients between 55 and 85 years old who consult their PCP due to concerns about their cognitive status.
Comorbidities that would interfere with study cooperation or interpretability of study results (for instance substance abuse or cardiac, renal or hepatic failure).
Concomitant medications that would interfere with cognitive assessments.
A prior diagnosis of AD and related disorders or other neurodegenerative disease.
Single group
ptau217
Diagnostic testQuantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma.
Change in referral decision and working diagnosis
Change in working diagnosis and referral decision (n = 240): The % of cases where a change occurs will be calculated from the contingency matrix.
Cognitive decline
Positive (PPV) and negative (NPV) predictive value, the positive (LR+) and negative (LR-) likelihood ratio for predicting cognitive decline in the subsequent four years.
Click on the lead sponsor to view all of their trials.
