A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)

Purpose

The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo. Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.

Condition

  • Alzheimer's Disease

Eligibility

Eligible Ages
Between 55 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology. - Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. - Have adequate literacy, vision, and hearing for neuropsychological testing at screening. - Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment. - Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment. - If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.

Exclusion Criteria

  • Have dementia or significant other neurological disease that can affect cognition. - Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study. - Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence. - Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions. - Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study. - Have any contraindications for magnetic resonance imaging (MRI). - Have a centrally read MRI that does not meets study entry criteria. Prior or Current Therapies - Have ever had prior treatment with a passive anti-amyloid immunotherapy. - Have received active immunization against Aβ in any other study.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Remternetug 		Remternetug administered subcutaneously (SC).
  • Drug: Remternetug
    Administered SC
    Other names:
    • LY3372993
Placebo Comparator
Placebo 		Placebo administered SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

Parkway Medical Center
Birmingham, Alabama 35215
Contact:
205-876-2601

MD First Research - Chandler
Chandler, Arizona 85286
Contact:
480-508-1038

Care Access - 801 South Power Road, Mesa
Mesa, Arizona 85206
Contact:
480-801-9260

Banner Alzheimer's Institute
Phoenix, Arizona 85006
Contact:
602-839-6900

Banner Alzheimer's Institute Tucson
Tucson, Arizona 85718
Contact:
520-694-7021

Neuro-Pain Medical Center
Fresno, California 93710
Contact:
559-437-9700

Care Access - Huntington Beach
Huntington Beach, California 92648
Contact:
714-378-2440

Inglewood Clinical
Inglewood, California 90301
Contact:
949-753-1663

Irvine Clinical Research
Irvine, California 92614
Contact:
949-753-1663

Healthy Brain Clinic
Long Beach, California 90804
Contact:
562-606-5999

Riverside Clinical
Riverside, California 92506
Contact:
951-374-8000

Clinical Trials Research
Sacramento, California 95821
Contact:
916-434-8230

Artemis Institute for Clinical Research
San Diego, California 92103
Contact:
619-915-0496

Sharp Neurocognitive Research Center
San Diego, California 92123
Contact:
858-836-8350

Ray Dolby Brain Health Center
San Francisco, California 94114

The Neuron Clinic - San Marcos
San Marcos, California 92069

Syrentis Clinical Research
Santa Ana, California 92705
Contact:
714-542-3008

Providence Medical Foundation
Santa Rosa, California 95403
Contact:
707-290-1848

California Neuroscience Research, LLC
Sherman Oaks, California 91403
Contact:
818-990-2671

Care Access - Aurora
Aurora, Colorado 80012
Contact:
303-337-5707

Mountain Neurological Research Center
Basalt, Colorado 81621
Contact:
970-927-1141

Alpine Clinical Research Center
Boulder, Colorado 80301
Contact:
303-443-7229

CenExel Rocky Mountain Clinical Research
Englewood, Colorado 80113

Invicro
New Haven, Connecticut 06510
Contact:
203-401-4300

Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut 06905
Contact:
203-914-1903

JEM Research Institute
Atlantis, Florida 33462

VIN-Julie Schwartzbard
Aventura, Florida 33180
Contact:
305-933-5993

Bradenton Research Center, Inc.
Bradenton, Florida 34205
Contact:
941-708-0005

K2 Medical Research WINTER GARDEN
Clermont, Florida 34711
Contact:
321-234-0199

TecTum Research
Davie, Florida 33024
Contact:
954-865-6144

Brain Matters Research
Delray Beach, Florida 33445
Contact:
561-374-8461

Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida 33912
Contact:
239-939-7777

Indago Research & Health Center, Inc
Hialeah, Florida 33012
Contact:
305-825-6588

K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida 32159
Contact:
352-500-5252

ClinCloud
Maitland, Florida 32751

K2 Medical Research ORLANDO
Maitland, Florida 32751
Contact:
407-500-5252

ClinCloud
Melbourne, Florida 32940
Contact:
407-680-0534

Merritt Island Medical Research, LLC
Merritt Island, Florida 32952

VIN-Andrew Lerman
Miami, Florida 33133
Contact:
786-655-8010

New Age Medical Research Corporation
Miami, Florida 33186
Contact:
305-596-9901

Adult Medicine of Lake County, Inc.
Mount Dora, Florida 32757
Contact:
352-383-8222

Aqualane Clinical Research
Naples, Florida 34105
Contact:
239-529-6780

Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652
Contact:
727-849-4131

Renstar Medical Research
Ocala, Florida 34470
Contact:
352-629-5800

Charter Research - Winter Park
Orlando, Florida 32803
Contact:
407-337-1000

AdventHealth Orlando
Orlando, Florida 32804
Contact:
407-303-6729

Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida 32504
Contact:
850-438-1136

Progressive Medical Research
Port Orange, Florida 32127
Contact:
386-304-7070

Alzheimer's Research and Treatment Center
Stuart, Florida 34997
Contact:
561-209-2400

Axiom Brain Health LLC
Tampa, Florida 33609
Contact:
813-353-9613

Stedman Clinical Trials
Tampa, Florida 33613
Contact:
813-971-8311

Care Access - Tampa
Tampa, Florida 33625
Contact:
855-339-1116

Charter Research - Lady Lake
The Villages, Florida 32162

Alzheimer's Research and Treatment Center
Wellington, Florida 33414
Contact:
561-209-2400

Palm Beach Neurology
West Palm Beach, Florida 33407
Contact:
561-845-0500

Conquest Research
Winter Park, Florida 32789
Contact:
407-916-0060

Columbus Memory Center, LLC
Columbus, Georgia 31909
Contact:
706-653-8455

Care Access - Decatur
Decatur, Georgia 30030
Contact:
351-222-5383

Center for Advanced Research & Education
Gainesville, Georgia 30501
Contact:
770-534-5154

North Georgia Clinical Research
Woodstock, Georgia 30189
Contact:
678-494-5735

Northwest Clinical Trials
Boise, Idaho 83704
Contact:
208-685-0600

Re:Cognition Health - Chicago
Chicago, Illinois 60611

Great Lakes Clinical Trials - Andersonville
Chicago, Illinois 60640
Contact:
773-275-3500

Care Access - Chicago
Chicago, Illinois 60649
Contact:
351-222-4915

Alexian Brothers Medical Center
Elk Grove Village, Illinois 60007
Contact:
847-593-8553

Care Access - South Indianapolis
Indianapolis, Indiana 46227
Contact:
351-222-6663

Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana 46256
Contact:
317-537-6099

Cedar Valley Medical Specialists
Waterloo, Iowa 50701
Contact:
319-888-8270

Cotton O'Neil Clinical Research Center
Topeka, Kansas 66606
Contact:
785-354-9591

Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana 70601
Contact:
337-602-6642

Tandem Clinical Research
Marrero, Louisiana 70072

Acadia Hospital
Bangor, Maine 04401
Contact:
207-973-6179

Care Access - Baltimore
Baltimore, Maryland 21213
Contact:
351-222-4915

Copley Clinical
Boston, Massachusetts 02116
Contact:
617-934-5743

Boston Clinical Trials
Boston, Massachusetts 02131
Contact:
617-477-4868

Boston Center for Memory
Newton, Massachusetts 02459
Contact:
617-699-6927

Care Access - Quincy
Quincy, Massachusetts 02169
Contact:
650-796-1586

MedVadis Research Corporation
Waltham, Massachusetts 02451
Contact:
617-744-1310

Adams Clinical
Watertown, Massachusetts 02472
Contact:
617-744-8542

Revival Research Institute, LLC
Dearborn, Michigan 48126
Contact:
586-276-7453

QUEST Research Institute
Farmington Hills, Michigan 48334
Contact:
248-957-8940

HealthPartners Neuroscience Center
Saint Paul, Minnesota 55130

Private Practice - Dr. Ronald Louis Schwartz
Hattiesburg, Mississippi 39401
Contact:
601-579-5016

Citizens Memorial Hospital District
Bolivar, Missouri 65613
Contact:
417-328-7781

Clinical Research Professionals
Chesterfield, Missouri 63005
Contact:
636-220-1200

University Of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
402-559-9953

Vector Clinical Trials
Las Vegas, Nevada 89128
Contact:
702-750-000

Care Access - Hoboken
Hoboken, New Jersey 07030
Contact:
650-796-1586

The Cognitive and Research Center of New Jersey - Ridgewood
Ridgewood, New Jersey 07450
Contact:
973-850-4622

The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081

Advanced Memory Research Institute of New Jersey
Toms River, New Jersey 08755
Contact:
732-341-9500

IMA Clinical Research
Albuquerque, New Mexico 87109
Contact:
505-848-3773

Care Access - Charlotte
Charlotte, North Carolina 28210
Contact:
351-222-5383

Medication Management
Greensboro, North Carolina 27405
Contact:
336-763-6968

Monroe Biomedical Research
Monroe, North Carolina 28112
Contact:
704-283-7359

Care Access - Lima
Lima, Ohio 45805
Contact:
351-222-6663

North Star Medical Research
Middleburg Heights, Ohio 44130

Summit Headlands
Portland, Oregon 97210
Contact:
503-279-8252

Clinical Research of Philadelphia
Philadelphia, Pennsylvania 19114
Contact:
215-676-6696

Keystone Clinical Studies
Plymouth Meeting, Pennsylvania 19462

Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island 02914
Contact:
401-435-8950

Butler Hospital
Providence, Rhode Island 02906
Contact:
401-655-6403

Tribe Clinical Research, LLC
Greenville, South Carolina 29607

Palmetto Clinical Research
Summerville, South Carolina 29485
Contact:
843-569-1856

Neurology Clinic, P.C.
Cordova, Tennessee 38018
Contact:
901-866-9252

Genesis Neuroscience Clinic
Knoxville, Tennessee 37909

Senior Adults Specialty Research
Austin, Texas 78757
Contact:
512-407-8628

Gadolin Research
Beaumont, Texas 77702
Contact:
409-331-6040

Kerwin Medical Center - Oak Cliff
Dallas, Texas 75216
Contact:
972-433-9100

Kerwin Medical Center
Dallas, Texas 75231
Contact:
972-433-9100

Care Access - Georgetown
Georgetown, Texas 78633
Contact:
737-279-4880

Care Access - Houston
Houston, Texas 77054
Contact:
351-222-6663

The University of Texas Health Science Center at Houston
Houston, Texas 77054
Contact:
713-486-0536

Next Level Urgent Care
Houston, Texas 77057
Contact:
832-460-3311

El Faro Health and Therapeutics
Rio Grande City, Texas 78582

Central Texas Neurology Consultants, PA
Round Rock, Texas 78681
Contact:
512-218-1222

IMA Clinical Research San Antonio
San Antonio, Texas 78229
Contact:
210-692-7157

Consano Clinical Research, LLC
Shavano Park, Texas 78231
Contact:
210-545-4900

Care Access - Arlington
Arlington, Virginia 22206
Contact:
650-796-1586

Re:Cognition Health
Fairfax, Virginia 22031
Contact:
703-520-9703

Eastern Virginia Medical School (EVMS) Medical Group
Norfolk, Virginia 23510
Contact:
757-446-5675

Northwest Clinical Research Center
Bellevue, Washington 98007
Contact:
425-453-0404

Rainier Clinical Research Center
Renton, Washington 98057
Contact:
425-251-1722

SCB Research Center
Bayamon, Puerto Rico 00961
Contact:
(787) 798-4592

Caribbean Medical Research Center
San Juan, Puerto Rico 00918

INSPIRA Clinical Research
San Juan, Puerto Rico 00918
Contact:
7877539515 ext 296

Instituto De Neurologia Dra. Ivonne Fraga
San Juan, Puerto Rico 00918
Contact:
17874035534

More Details

NCT ID
NCT06653153
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
3176154559
clinical_inquiry_hub@lilly.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center