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

Last updated: April 23, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Memory Loss

Dementia

Alzheimer's Disease

Treatment

Remternetug (SC)

Remternetug (IV)

Placebo

Clinical Study ID

NCT05463731
18467
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 symptomatic 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 30 (inclusive) at screening.

  • Has an amyloid PET scan result consistent with the eligibility criteria.

  • Have a reliable study partner who will provide written informed consent toparticipate and is in frequent contact with the participant.

  • Have adequate literacy, vision, and hearing for the neuropsychological testing inthe opinion of the investigator at the time of screening.

  • Are reliable and willing to make themselves available for the duration of the studyand 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:

  • Current serious or unstable illnesses that, in the investigator's opinion, couldinterfere 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 thetrial.

  • Participants with any current primary psychiatric diagnosis other than AD that inthe investigator's opinion, is likely to confound interpretation of the drug effect,affect cognitive assessment, or affect the participant's ability to complete thestudy.

  • History of clinically significant multiple or severe drug allergies.

  • Have any clinically important abnormality at screening, as determined byinvestigator that could be detrimental to the participant, could compromise thestudy, or show evidence of other etiologies for dementia.

  • Screening magnetic resonance imaging (MRI) which shows evidence of significantabnormality that would suggest another potential etiology for progressive dementiaor a clinically significant finding that may impact the participant's ability tosafely participate in the study.

  • Have any contraindications for MRI or positron emission tomography (PET).

  • Have had prior treatment with a passive anti-amyloid immunotherapy.

  • Have received active immunization against Aβ in any other study.

  • Have known allergies to remternetug related compounds, or any components of theformulation.

Study Design

Total Participants: 1667
Treatment Group(s): 3
Primary Treatment: Remternetug (SC)
Phase: 3
Study Start date:
August 01, 2022
Estimated Completion Date:
March 31, 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 enroll in 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 76 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 974 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

  • Memory Clinic Toride

    Toride, Ibaraki 302-0004
    Japan

    Site Not Available

  • Katayama Medical Clinic

    Kurashiki, Okayama 710-0813
    Japan

    Site Not Available

  • Memory Clinic Ochanomizu

    Bunkyo-ku, Tokyo 113-0034
    Japan

    Site Not Available

  • Memory Clinic Ochanomizu

    Bunkyō-Ku, Tokyo 113-0034
    Japan

    Site Not Available

  • Memory Clinic Ochanomizu

    Tokyo, 113-0034
    Japan

    Site Not Available

  • MD First Research - Chandler

    Chandler, Arizona 85286
    United States

    Site Not Available

  • Hope Clinical Research, Inc.

    Canoga Park, California 91303
    United States

    Site Not Available

  • North County Neurology Associates

    Carlsbad, California 92011
    United States

    Site Not Available

  • Wr- Pri, Llc

    Encino, California 91316
    United States

    Site Not Available

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Site Not Available

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Kaizen Brain Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Anderson Clinical Research

    Redlands, California 92374
    United States

    Site Not Available

  • Mountain Neurological Research Center

    Basalt, Colorado 81621
    United States

    Site Not Available

  • Alpine Clinical Research Center

    Boulder, Colorado 80301
    United States

    Site Not Available

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Ki Health Partners, LLc, dba New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Site Not Available

  • VIN-Julie Schwartzbard

    Aventura, Florida 33180
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Finlay Medical Research

    Greenacres City, Florida 33467
    United States

    Site Not Available

  • Encore Research Group- Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Charter Research - Lady Lake

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • ClinCloud - Maitland

    Maitland, Florida 32751
    United States

    Site Not Available

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • ClinCloud - Viera

    Melbourne, Florida 32940
    United States

    Site Not Available

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida 32952
    United States

    Site Not Available

  • Optimus U Corporation

    Miami, Florida 33135
    United States

    Site Not Available

  • VIN-Andrew Lerman

    Miami, Florida 33133
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • Charter Research - Winter Park

    Orlando, Florida 32803
    United States

    Site Not Available

  • Emerald Coast Neurology - Airport Boulevard

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Alzheimer's Research and Treatment Center

    Stuart, Florida 34997
    United States

    Site Not Available

  • Brain Matters Research

    Stuart, Florida 34997
    United States

    Site Not Available

  • Tallahassee Neurological Clinic

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Charter Research - Lady Lake

    The Villages, Florida 32162
    United States

    Site Not Available

  • Alzheimer's Research and Treatment Center

    Wellington, Florida 33414
    United States

    Site Not Available

  • Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Charter Research - Winter Park

    Winter Park, Florida 32792
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Columbus Memory Center, LLC

    Columbus, Georgia 31909
    United States

    Site Not Available

  • Columbus Memory Center, PC

    Columbus, Georgia 31909
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois 60640
    United States

    Site Not Available

  • AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research

    Elk Grove Village, Illinois 60007
    United States

    Site Not Available

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois 60007
    United States

    Active - Recruiting

  • Covenant Medical Center

    Waterloo, Iowa 50702
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center - Central Office

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Care Access - Lake Charles

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Covenant Medical Center

    Saginaw, Michigan 48602
    United States

    Site Not Available

  • Citizens Memorial Hospital District

    Bolivar, Missouri 65613
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Las Vegas Medical Research

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey 07081
    United States

    Site Not Available

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Neurological Associates Albany

    Albany, New York 12208
    United States

    Site Not Available

  • AMC Research

    Matthews, North Carolina 28105
    United States

    Site Not Available

  • AMC Research, LLC

    Matthews, North Carolina 28105
    United States

    Active - Recruiting

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • NeuroScience Research Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • Valley Medical Research

    Centerville, Ohio 45459
    United States

    Site Not Available

  • Neurology Diagnostics, Inc.

    Dayton, Ohio 45459
    United States

    Site Not Available

  • Center for Cognitive Health

    Portland, Oregon 97225
    United States

    Site Not Available

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Keystone Clinical Studies

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Neurology Clinic, P.C.

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas 78749
    United States

    Site Not Available

  • Gadolin Research

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Kerwin Medical Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Neurology Consultants of Dallas, PA

    Dallas, Texas 75243
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77054
    United States

    Site Not Available

  • Central Texas Neurology Consultants

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Sugar Land, Texas 77054
    United States

    Site Not Available

  • The Memory Clinic

    Bennington, Vermont 05201-9810
    United States

    Site Not Available

  • Re:Cognition Health

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • National Clinical Research, Inc

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Universal Research Group

    Tacoma, Washington 98405
    United States

    Site Not Available

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