ACTIVE_NOT_RECRUITING

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

Talk to us

Conditions

Alzheimer's Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline

Quick Facts

Study Start:2024-10-24
Study Completion:2030-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06653153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
  2. * Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
  3. * Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
  4. * Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
  5. * Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
  6. * If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.
  1. * Have dementia or significant other neurological disease that can affect cognition.
  2. * Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.
  3. * Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.
  4. * Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
  5. * 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.
  6. * Have any contraindications for magnetic resonance imaging (MRI).
  7. * Have a centrally read MRI that does not meets study entry criteria.
  8. * Have ever had prior treatment with a passive anti-amyloid immunotherapy.
  9. * Have received active immunization against Aβ in any other study.

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Parkway Medical Center
Birmingham, Alabama, 35215
United States
MD First Research - Chandler
Chandler, Arizona, 85286
United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206
United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
United States
Banner Alzheimer's Institute Tucson
Tucson, Arizona, 85718
United States
Neuro-Pain Medical Center
Fresno, California, 93710
United States
Care Access - Huntington Beach
Huntington Beach, California, 92648
United States
Inglewood Clinical
Inglewood, California, 90301
United States
Irvine Clinical Research
Irvine, California, 92614
United States
Healthy Brain Clinic
Long Beach, California, 90804
United States
Riverside Clinical
Riverside, California, 92506
United States
Clinical Trials Research
Sacramento, California, 95821
United States
Artemis Institute for Clinical Research
San Diego, California, 92103
United States
Sharp Neurocognitive Research Center
San Diego, California, 92123
United States
Ray Dolby Brain Health Center
San Francisco, California, 94114
United States
The Neuron Clinic - San Marcos
San Marcos, California, 92069
United States
Syrentis Clinical Research
Santa Ana, California, 92705
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
California Neuroscience Research, LLC
Sherman Oaks, California, 91403
United States
Care Access - Aurora
Aurora, Colorado, 80012
United States
Mountain Neurological Research Center
Basalt, Colorado, 81621
United States
Alpine Clinical Research Center
Boulder, Colorado, 80301
United States
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, 80113
United States
Invicro
New Haven, Connecticut, 06510
United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905
United States
JEM Research Institute
Atlantis, Florida, 33462
United States
VIN - Aventura
Aventura, Florida, 33180
United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
United States
K2 Medical Research WINTER GARDEN
Clermont, Florida, 34711
United States
TecTum Research
Davie, Florida, 33024
United States
Brain Matters Research
Delray Beach, Florida, 33445
United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
United States
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, 32159
United States
ClinCloud
Maitland, Florida, 32751
United States
K2 Medical Research ORLANDO
Maitland, Florida, 32751
United States
ClinCloud
Melbourne, Florida, 32940
United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952
United States
VIN-Andrew Lerman
Miami, Florida, 33133
United States
New Age Medical Research Corporation
Miami, Florida, 33186
United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, 32757
United States
Aqualane Clinical Research
Naples, Florida, 34105
United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Charter Research - Winter Park
Orlando, Florida, 32803
United States
AdventHealth Orlando
Orlando, Florida, 32804
United States
Emerald Coast Neurology - Airport Boulevard
Pensacola, Florida, 32504
United States
Progressive Medical Research
Port Orange, Florida, 32127
United States
Alzheimer's Research and Treatment Center
Stuart, Florida, 34997
United States
Axiom Brain Health LLC
Tampa, Florida, 33609
United States
Stedman Clinical Trials
Tampa, Florida, 33613
United States
Care Access - Tampa
Tampa, Florida, 33625
United States
Charter Research - Lady Lake
The Villages, Florida, 32162
United States
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414
United States
Palm Beach Neurology
West Palm Beach, Florida, 33407
United States
Conquest Research
Winter Park, Florida, 32789
United States
Columbus Memory Center, LLC
Columbus, Georgia, 31909
United States
Care Access - Decatur
Decatur, Georgia, 30030
United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
Northwest Clinical Trials
Boise, Idaho, 83704
United States
Care Access - Arlington Heights
Arlington Heights, Illinois, 60005
United States
Re:Cognition Health - Chicago
Chicago, Illinois, 60611
United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640
United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
United States
Care Access - South Indianapolis
Indianapolis, Indiana, 46227
United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
United States
Cedar Valley Medical Specialists
Waterloo, Iowa, 50701
United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601
United States
Tandem Clinical Research
Marrero, Louisiana, 70072
United States
Acadia Hospital
Bangor, Maine, 04401
United States
Care Access - Baltimore
Baltimore, Maryland, 21213
United States
Adams Clinical Boston
Boston, Massachusetts, 02116
United States
Boston Clinical Trials
Boston, Massachusetts, 02131
United States
Boston Center for Memory
Newton, Massachusetts, 02459
United States
Care Access - Quincy
Quincy, Massachusetts, 02169
United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451
United States
Adams Clinical Watertown
Watertown, Massachusetts, 02472
United States
Revival Research Institute, LLC
Dearborn, Michigan, 48126
United States
QUEST Research Institute
Farmington Hills, Michigan, 48334
United States
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
United States
Private Practice - Dr. Ronald Louis Schwartz
Hattiesburg, Mississippi, 39401
United States
Citizens Memorial Hospital District
Bolivar, Missouri, 65613
United States
Clinical Research Professionals
Chesterfield, Missouri, 63005
United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Vector Clinical Trials
Las Vegas, Nevada, 89128
United States
Care Access - Hoboken
Hoboken, New Jersey, 07030
United States
The Cognitive and Research Center of New Jersey - Ridgewood
Ridgewood, New Jersey, 07450
United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081
United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755
United States
IMA Clinical Research
Albuquerque, New Mexico, 87109
United States
Care Access - Charlotte
Charlotte, North Carolina, 28210
United States
Medication Management
Greensboro, North Carolina, 27405
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Care Access - Lima
Lima, Ohio, 45805
United States
North Star Medical Research
Middleburg Heights, Ohio, 44130
United States
Summit Headlands
Portland, Oregon, 97210
United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462
United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914
United States
Butler Hospital
Providence, Rhode Island, 02906
United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
United States
Palmetto Clinical Research
Summerville, South Carolina, 29485
United States
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
United States
Genesis Neuroscience Clinic
Knoxville, Tennessee, 37909
United States
Senior Adults Specialty Research
Austin, Texas, 78757
United States
Gadolin Research
Beaumont, Texas, 77702
United States
Kerwin Medical Center - Oak Cliff
Dallas, Texas, 75216
United States
Kerwin Medical Center
Dallas, Texas, 75231
United States
Care Access - Georgetown
Georgetown, Texas, 78633
United States
Care Access - Houston
Houston, Texas, 77054
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
United States
Next Level Urgent Care
Houston, Texas, 77057
United States
El Faro Health and Therapeutics
Rio Grande City, Texas, 78582
United States
Central Texas Neurology Consultants, PA
Round Rock, Texas, 78681
United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
United States
Care Access - Arlington 2
Arlington, Virginia, 22206
United States
Re:Cognition Health
Fairfax, Virginia, 22031
United States
Eastern Virginia Medical School (EVMS) Medical Group
Norfolk, Virginia, 23510
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Rainier Clinical Research Center
Renton, Washington, 98057
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-24
Study Completion Date2030-10

Study Record Updates

Study Start Date2024-10-24
Study Completion Date2030-10

Terms related to this study

Additional Relevant MeSH Terms

  • Alzheimer's Disease