{
  "abstract": "Aims 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.Methods 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 <6.Results 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 (>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.Conclusions 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@lilly.com",
  "authors": [
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Biglan Kevin"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Rizvi Erum"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Wang Tongrong"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Hufford Matthew"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Lidogoster Mausumi"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Dickson Christina"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Warner Susan"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Gueorguieva Ivelina"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Vandenburg Yvonne"
    },
    {
      "affiliations": [
        "Eli Lilly"
      ],
      "name": "Dabora Matan"
    }
  ],
  "title": "162 TRAILRUNNER-ALZ3: a phase-3 study of subcutaneous remternetug in preclinical and MCI Alzheimer’s disease population",
  "uid": "073b8923-d0f2-5748-a27d-c79f516a9c2d"
}