We present a novel study design for J4Y-MC-S003, TEACH-AD (NCT07140744), which will evaluate impact of plasma P-tau217 testing on early management of patients presenting with subjective cognitive impairment complaints (SCIC). TEACH-AD will use a unique clinical practice database for participant identification and data collection.

Blood-based biomarker tests including P-tau217 support timely and practical evaluation for amyloid pathology in patients with cognitive decline; however evidence for test integration into clinical care for SCIC is limited. Evaluating primary care pathways is especially challenging. TEACH-AD will utilize an innovative, real-world healthcare provider (HCP) practice database to identify HCPs/patients and compare pre-defined management actions between patients receiving study-sponsored commercial plasma P-tau217 testing versus standard of care.

TEACH-AD is a prospective, diagnostic, interventional clinical utility study assessing the impact of P-tau217 testing on evaluation of patients ≥50 years with ≥1 SCIC, presenting to primary or secondary/tertiary care providers (PCPs, S/TCPs, respectively). HCPs/patients will be identified and endpoints assessed using a unique electronic health record (EHR) database, enabling agile, real-world practice participation not typical in clinical trials. Approximately 585 HCPs will be randomized in a 2:1 ratio at practice level to interventional or control arms. Interventional HCPs will incorporate study-sponsored P-tau217 testing into clinical workup. Control HCPs will remain uncontacted, without mandatory P-tau217 testing, and followed through EHR interrogation. The primary outcome is the difference between groups in proportion of patients receiving ≥1 pre-specified management action in primary care, at 6-months. Secondary outcomes include the same analysis with S/TCPs, differences in time to management action, and differences in International Classification of Diseases (ICD-10) coding.

This abstract will present design/rationale of TEACH-AD.

The TEACH-AD clinical utility study design will demonstrate the feasibility of measuring impact of plasma P-tau217 testing implementation within PCP and S/TCP practices, using a unique EHR database to identify/collect data from enrolled HCPs/patients.