A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

Last updated: October 17, 2023
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Alzheimer's Disease

Dementia

Treatment

Remternetug (SC)

Placebo

Remternetug (IV)

Clinical Study ID

NCT05463731
J1G-MC-LAKC
  • Ages 60-85
  • All Genders

Study Summary

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early Alzheimer's disease (AD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gradual and progressive change in cognitive function ≥6 months prior to screening.
  • A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening.
  • Has a P-tau result consistent with the presence of amyloid pathology.
  • Has an amyloid PET scan result consistent with the presence of brain amyloid pathology.
  • Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.
  • Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
  • Males and females will be eligible for this study.
  • Women not of childbearing potential (WNOCBP) may participate in this trial.

Exclusion

Exclusion Criteria:

  • Significant neurological disease affecting the central nervous system (CNS) other than AD, that may affect cognition or ability to complete the study.
  • Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.
  • History of cancer with high risk of recurrence and preventing completion of the trial.
  • Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study.
  • History of of clinically significant multiple or severe drug allergies.
  • Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia.
  • Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.
  • Have any contraindications for MRI or positron emission tomography (PET).
  • Have had prior treatment with a passive anti-amyloid immunotherapy that is <5 half-lives prior to randomization.
  • Have received active immunization against Aβ in any other study.
  • Have known allergies to remternetug related compounds, or any components of the formulation.

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Remternetug (SC)
Phase: 3
Study Start date:
August 01, 2022
Estimated Completion Date:
October 22, 2026

Study Description

TRAILRUNNER-ALZ 1 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of remternetug in participants with early symptomatic AD. Initially, 600 participants will enrollin the double- blind treatment period. Participants in the double-blind treatment period will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion.

Following the 52-week main study period, participants will continue participation for up to an additional 52 weeks in an extension period. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Thus, all participants will receive remternetug if they complete the study.

An additional 640 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via subcutaneous injection or intravenous infusion. Participants enrolled into the addendum safety cohort are not eligible for the extension period.

Connect with a study center

  • North County Neurology Associates

    Carlsbad, California 92011
    United States

    Active - Recruiting

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Active - Recruiting

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Active - Recruiting

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Active - Recruiting

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Alzheimer's Research and Treatment Center

    Stuart, Florida 34997
    United States

    Active - Recruiting

  • Brain Matters Research

    Stuart, Florida 34997
    United States

    Active - Recruiting

  • Alzheimer's Research and Treatment Center

    Wellington, Florida 33414
    United States

    Active - Recruiting

  • Charter Research - Winter Park

    Winter Park, Florida 32792
    United States

    Active - Recruiting

  • Conquest Research

    Winter pARK, Florida 32789
    United States

    Active - Recruiting

  • Cotton O’Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • Las Vegas Medical Research

    Las Vegas, Nevada 89113
    United States

    Active - Recruiting

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey 07081
    United States

    Active - Recruiting

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey 08755
    United States

    Active - Recruiting

  • AMC Research, LLC

    Matthews, North Carolina 28105
    United States

    Active - Recruiting

  • NeuroScience Research Center

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Neurology Diagnostics, Inc.

    Dayton, Ohio 45459
    United States

    Active - Recruiting

  • Center for Cognitive Health

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island 02914
    United States

    Active - Recruiting

  • Neurology Clinic, P.C.

    Cordova, Tennessee 38018
    United States

    Active - Recruiting

  • Neurology Consultants of Dallas, PA

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • Central Texas Neurology Consultants

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • The Memory Clinic

    Bennington, Vermont 05201
    United States

    Active - Recruiting

  • Re:Cognition Health

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

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