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AAN 2023 | Use of AD blood-based biomarkers for trial enrolment

Philip Tipton, MD, Mayo Clinic, Jacksonville, FL, highlights some recent studies on blood-based biomarkers for prognosis in patients with early symptomatic Alzheimer’s disease (AD). Results from two trials over 5 and 6 years each, involving patients with mild cognitive impairment, seem to show that p-tau in the blood is the best predictor of cognitive prognosis and even at predicting the conversion of MMSE score to dementia threshold. One of these studies involved comparison of plasma p-tau 181 with other biomarkers, with plasma p-tau 181 found the most superior in identifying amyloid positivity. However, the C index of this biomarker was less than that of the clinical reference model; at a 0.73 score, this raises questions about its superiority. The other study in this area found p-tau 217 to be the most effective biomarker and even superior to the co-variants model. Further use of p-tau 181 and 217 in clinical trials are ongoing, with their use as pre-screening measures for trials in donanemab research. TRAILBLAZER-ALZ 2 had a subpopulation of the cohort undergo pre-screening with p-tau 181 and the rest of the patients with a usual PET scan. The patients who had p-tau 181 screening yielded enrollment of 2 out of 3 patients, whereas PET scan screened patients had a yield of 1 out of 3. This could benefit future clinical trials’ budgets as PET scanning is a great expense. Additionally, TRAILBLAZER-ALZ 3 used p-tau 217 as its pre-screening method. This interview took place at the American Academy of Neurology Annual Meeting 2023 in Boston, MA.

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