162 TRAILRUNNER-ALZ3: a phase-3 study of subcutaneous remternetug in preclinical and MCI Alzheimer’s disease population

a:2:{s:4:"lang";s:2:"en";s:7:"content";s:1552:"<h3>Aims</h3> TRAILRUNNER-ALZ3 (TR3; NCT06653153) tests the hypothesis that remternetug treatment will delay clinical progression of Alzheimer’s disease (AD) versus placebo in individuals with preclinical AD and AD with MCI, the earliest stages of the pathological cascade, which precede dementia. <h3>Methods</h3> TR3 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, event-driven trial evaluating efficacy and safety of subcutaneous remternetug versus placebo in participants with preclinical AD and AD with MCI. The primary endpoint is time to clinical progression, defined as an increase in Clinical Dementia Rating (CDR) score. Participants will have evidence of amyloid pathology by plasma P-tau, Mini-Mental State Examination (MMSE) score ≥27, and Functional Activities Questionnaire (FAQ) score &lt;6. <h3>Results</h3> Applying TR3 criteria to publicly available data suggests TR3 will enroll a population consistent with preclinical AD and AD with MCI. Internal trial cohort analyses suggest the study population will have low tau burden (&gt;50% very low/no tau assessed by tau PET). TR3, sponsored by Eli Lilly and Company, is being conducted at multiple sites globally. Enrollment opened in Q4, 2024. <h3>Conclusions</h3> The TR3 study entry criteria are anticipated to facilitate enrollment of the appropriate population to demonstrate that remternetug meaningfully slows clinical progression in individuals with preclinical AD and AD with MCI. gueorguieva_ivelina{at}lilly.com ";}