AzTrials
AzTrials

Alzheimer's DiseasePhase 3NCT06653153

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

A Phase 3 study testing Remternetug in people with Alzheimer's Disease, run by Eli Lilly and Company at 262 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 55 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Remternetug
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,400 participants
Where
262 sitesin 10 countries
Study dates
24 Oct 2024to Oct 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 10Show fewer
  • 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.

Trial locations and contacts

262 sites in 10 countries.

262 sites in 10 countries

United States123 sites

  • IMA Clinical Research

    Albuquerque, New Mexico, 87109

  • Care Access - Arlington 2

    Arlington, Virginia, 22206

  • Care Access - Arlington Heights

    Arlington Heights, Illinois, 60005

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Care Access - Aurora

    Aurora, Colorado, 80012

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • VIN - Aventura

    Aventura, Florida, 33180

  • Care Access - Baltimore

    Baltimore, Maryland, 21213

  • Acadia Hospital

    Bangor, Maine, 04401

  • Mountain Neurological Research Center

    Basalt, Colorado, 81621

  • Gadolin Research

    Beaumont, Texas, 77702

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Citizens Memorial Hospital District

    Bolivar, Missouri, 65613

  • Adams Clinical Boston

    Boston, Massachusetts, 02116

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

  • MD First Research - Chandler

    Chandler, Arizona, 85286

  • Care Access - Charlotte

    Charlotte, North Carolina, 28210

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Re:Cognition Health - Chicago

    Chicago, Illinois, 60611

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois, 60640

  • K2 Medical Research WINTER GARDEN

    Clermont, Florida, 34711

  • Columbus Memory Center, LLC

    Columbus, Georgia, 31909

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • Kerwin Medical Center - Oak Cliff

    Dallas, Texas, 75216

  • Kerwin Medical Center

    Dallas, Texas, 75231

  • TecTum Research

    Davie, Florida, 33024

  • Revival Research Institute, LLC

    Dearborn, Michigan, 48126

  • Care Access - Decatur

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado, 80113

  • Re:Cognition Health

    Fairfax, Virginia, 22031

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501

  • Care Access - Georgetown

    Georgetown, Texas, 78633

  • Medication Management

    Greensboro, North Carolina, 27405

  • Tribe Clinical Research, LLC- Greenville

    Greenville, South Carolina, 29607

  • Private Practice - Dr. Ronald Louis Schwartz

    Hattiesburg, Mississippi, 39401

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • Care Access - Hoboken

    Hoboken, New Jersey, 07030

  • Care Access - Houston

    Houston, Texas, 77054

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77054

  • Next Level Urgent Care

    Houston, Texas, 77057

  • Care Access - Huntington Beach

    Huntington Beach, California, 92648

  • Care Access - South Indianapolis

    Indianapolis, Indiana, 46227

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, Indiana, 46256

  • Inglewood Clinical

    Inglewood, California, 90301

  • Irvine Clinical Research

    Irvine, California, 92614

  • Genesis Neuroscience Clinic

    Knoxville, Tennessee, 37909

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, Florida, 32159

  • Care Access - Lake Charles (Bayou Pines)

    Lake Charles, Louisiana, 70601

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

  • Care Access - Lima

    Lima, Ohio, 45805

  • Healthy Brain Clinic

    Long Beach, California, 90804

  • ClinCloud

    Maitland, Florida, 32751

  • K2 Medical Research ORLANDO

    Maitland, Florida, 32751

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • ClinCloud

    Melbourne, Florida, 32940

  • Merritt Island Medical Research, LLC

    Merritt Island, Florida, 32952

  • Care Access - 801 South Power Road, Mesa

    Mesa, Arizona, 85206

  • VIN-Andrew Lerman

    Miami, Florida, 33133

  • New Age Medical Research Corporation

    Miami, Florida, 33186

  • North Star Medical Research

    Middleburg Heights, Ohio, 44130

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Adult Medicine of Lake County, Inc.

    Mt. Dora, Florida, 32757

  • Aqualane Clinical Research

    Naples, Florida, 34105

  • Invicro

    New Haven, Connecticut, 06510

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Eastern Virginia Medical School (EVMS) Medical Group

    Norfolk, Virginia, 23510

  • Renstar Medical Research

    Ocala, Florida, 34470

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Charter Research - Winter Park

    Orlando, Florida, 32803

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Emerald Coast Neurology - Airport Boulevard

    Pensacola, Florida, 32504

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Keystone Clinical Studies

    Plymouth Meeting, Pennsylvania, 19462

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Summit Headlands

    Portland, Oregon, 97210

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Care Access - Quincy

    Quincy, Massachusetts, 02169

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • The Cognitive and Research Center of New Jersey - Ridgewood

    Ridgewood, New Jersey, 07450

  • El Faro Health and Therapeutics

    Rio Grande City, Texas, 78582

  • Riverside Clinical

    Riverside, California, 92506

  • Central Texas Neurology Consultants, PA

    Round Rock, Texas, 78681

  • Clinical Trials Research

    Sacramento, California, 95821

  • HealthPartners Neuroscience Center

    Saint Paul, Minnesota, 55130

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Sharp Neurocognitive Research Center

    San Diego, California, 92123

  • 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

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • California Neuroscience Research, LLC

    Sherman Oaks, California, 91403

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

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

    Stamford, Connecticut, 06905

  • Alzheimer's Research and Treatment Center

    Stuart, Florida, 34997

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Axiom Brain Health LLC

    Tampa, Florida, 33609

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Care Access - Tampa

    Tampa, Florida, 33625

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Banner Alzheimer's Institute Tucson

    Tucson, Arizona, 85718

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Cedar Valley Medical Specialists

    Waterloo, Iowa, 50701

  • Adams Clinical Watertown

    Watertown, Massachusetts, 02472

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33414

  • Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Conquest Research

    Winter Park, Florida, 32789

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

China29 sites

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

    Beijing, 100071

  • Beijing Anding Hospital - Affiliated Capital University of Medical Science

    Beijing, 100088

  • The First Hospital of Jilin University

    Changchun, 100012

  • Xiangya Hospital Central South University

    Changsha, 410008

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • Guangzhou First People's Hospital

    Guangzhou, 510180

  • Guangzhou Medical University 2nd Hospital

    Guangzhou, 510260

  • Zhujiang Hospital

    Guangzhou, 510280

  • Anhui Provincial Hospital

    Hefei, 230036

  • Jinan Central Hospital

    Jinan, 250013

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, 471003

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Nanjing Brain Hospital

    Nanjing, 210029

  • Sir Run Run Hospital of Nanjing Medical University

    Nanjing, 211166

  • Shanghai Sixth People's Hospital

    Shanghai, 200030

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, 200135

  • Pudong New Area People's Hospital Shanghai

    Shanghai, 201200

  • The First Hospital of Hebei Medical University

    Shijiazhuang, 050031

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Shaanxi provincial people's hospital

    Xi'an, 710068

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077

  • Xianyang Hospital of Yan'an University

    Xianyang, 712000

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, 221006

  • Xuzhou Central Hospital

    Xuzhou, 221018

  • Zigong First People's Hospital

    Zigong, 643000

Other trials in China

Japan27 sites

  • The University of Tokyo Hospital

    Bunkyō City, 113-8655

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Chūōku, 103-0027

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027

  • Fukuwa Clinic

    Chūōku, 104-0031

  • Tokyo Asbo Clinic

    Chūōku, 104-0031

  • Kawashima Neurology Clinic

    Fujisawa, 251-0038

  • UNB Sumiyoshi Jinjamae Clinic

    Fukuoka, 812-0018

  • Boocs Clinic Fukuoka

    Fukuoka, 812-0025

  • P-One Clinic

    Hachiōji, 192-0071

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, 670-8560

  • Saiseikai Imabari Hospital

    Imabari, 799-1592

  • Kobe University Hospital

    Kobe, 650-0017

  • Showa General Hospital

    Kodaira, 187-8510

  • Tatsuoka Neurology Clinic

    Kyoto, 600-8811

  • Sakurazaka Clinic SophyAnce

    Minatoku, 106-0032

  • National Center for Geriatrics and Gerontology

    Ōbu, 474-8511

  • Iwata Neurosurgery Clinic

    Osaka, 536-0007

  • Kanto Central Hospital

    Setagaya-ku, 158-8531

  • Samoncho Clinic

    Shinjuku, 160-0017

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, 160-0004

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, 160-0008

  • Higashi Shinjuku Clinic

    Shinjuku-ku, 169-0072

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, 565-0853

  • Tokyo Metropolitan Geriatric Hospital

    tabashi City, 173-0015

  • Tachikawa Hospital

    Tachikawa, 190-8531

  • Takatsuki Hospital

    Takatsuki-shi, 569-1192

  • Wako Hospital

    Wako, 351-0111

Other trials in Japan

Canada17 sites

  • Ecogene-21 - Cmas

    Chicoutimi, G7H 0S7

  • MoCA Research and Innovation Inc.

    Greenfield Park, J4V 2J2

  • OCT Research ULC

    Kelowna, V1Y 1Z9

  • Alpha Recherche Clinique - Lévis

    Lévis, G6V 0C9

  • Clinique Mémoire de Montréal

    Montreal, H3G 1H9

  • Genge Partners

    Montreal, H4A 3T2

  • Ottawa Memory Clinic

    Ottawa, K1Z 1G3

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, K9H 2P4

  • Alpha Recherche Clinique

    Québec, G2J 0C4

  • ALPHA Recherche Clinique

    Québec, G3K 2P8

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3

  • Q&T Research Sherbrooke Inc.

    Sherbrooke, J1J 2G2

  • Toronto Memory Program

    Toronto, M3B 2S7

  • Sunnybrook Research Institute

    Toronto, M4N 3M5

  • Baycrest Health Sciences

    Toronto, M6A 2E1

  • Diex Recherche Inc. Division Victoriaville

    Victoriaville, G6P 3Z8

  • The Medical Arts Health Research Group - West Vancouver

    West Vancouver, V7T 1C5

Other trials in Canada

South Korea17 sites

  • Pusan National University Hospital

    Busan, 49241

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Gangnam Severance Hospital, Yonsei University Health System

    Gangnam-gu, 06273

  • Ewha Womans University Seoul Hospital

    Gangseo-gu, 07804

  • Chonnam National University Hospital

    Gwangju, 61469

  • Inha University Hospital

    Incheon, 22332

  • Jeju National University Hospital

    Jeju City, 63241

  • Gachon University Gil Medical Center

    Namdong-gu, 21565

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, 06591

  • Ajou University Hospital

    Suwon, 16499

  • Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Australia16 sites

  • USC Clinical Trials Sunshine Coast

    Birtinya, 4575

  • Emeritus Research

    Botany, 2019

  • Box Hill Hospital

    Box Hill, 3128

  • Emeritus Research

    Camberwell, 3124

  • GenesisCare - Maitland

    East Maitland, 2323

  • The University of Queensland

    Herston, 4029

  • Ipswich Hospital

    Ipswich, 4305

  • Austin Health

    Ivanhoe, 3079

  • Southern Neurology

    Kogarah, 2217

  • KARA Institute for Neurological Diseases

    Macquarie Park, 2113

  • HammondCare

    Malvern, 3144

  • Fusion Clinical Research

    Norwood, 5067

  • The Royal Melbourne Hospital

    Parkville, 3050

  • USC Clinical Trials Brisbane (South Bank)

    South Brisbane, 4101

  • St Vincent's Hospital

    Sydney, 2010

  • The Queen Elizabeth Hospital

    Woodville, 5011

Other trials in Australia

United Kingdom12 sites

  • ReMind UK

    Bath, BA1 3NG

  • Re:Cognition Health - Birmingham

    Birmingham, B16 8LT

  • Layton Medical Centre

    Blackpool, FY3 7EN

  • Scottish Brain Sciences

    Edinburgh, EH12 5PJ

  • St Pancras Clinical Research

    London, EC2Y 8EA

  • NIHR Manchester Clinical Research Facility

    Manchester, M13 9WL

  • NeuroClin

    Motherwell, ML1 4UF

  • Roborough Surgery

    Plymouth, PL6 6PH

  • Homecroft Surgery

    Redruth, TR16 4ET

  • Abbeywell Surgery

    Romsey, SO51 7QN

  • Moorgreen Hospital

    Southampton, SO30 3JB

  • Marine Lake Medical Practice

    West Kirby, CH48 5AA

Other trials in United Kingdom

Taiwan10 sites

  • Changhua Christian Hospital

    Changhua County, 50006

  • National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region

    Douliu, 640

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, 83301

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 235

  • New Taipei Municipal TuCheng Hospital

    New Taipei City, 236

  • China Medical University Hospital

    Taichung, 404332

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Spain7 sites

  • Barcelonabeta Brain Research Center

    Barcelona, 08005

  • Fundació ACE

    Barcelona, 08028

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

  • Policlinica Gipuzkoa

    San Sebastián, 20014

  • Hospital Victoria Eugenia

    Seville, 41009

Other trials in Spain

Puerto Rico4 sites

  • SCB Research Center

    Bayamón, 00961

  • Caribbean Medical Research Center

    San Juan, 00918

  • INSPIRA Clinical Research

    San Juan, 00918

  • Instituto De Neurologia Dra. Ivonne Fraga

    San Juan, 00918

Other trials in Puerto Rico

About this study

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

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.

Being tested
Remternetug, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemternetugDrug

    Also called LY3372993

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06653153
Study groupRoleWhat they receive
RemternetugExperimentalRemternetug administered subcutaneously (SC).
Receives: Drug: Remternetug
PlaceboPlacebo comparatorPlacebo administered SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR)

    Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).

    Measured: Baseline to Time to Event up to Week 255

Secondary outcomes (11)

  1. Change from Baseline in Clinical Dementia Rate Box Score (SB)

    Change from baseline in Clinical Dementia Rate Box Score (SB) scores range from 0 to 18, with higher scores indicative of more impairment.

    Measured: Baseline, Week 255

  2. Change from Baseline in Montreal Cognitive Assessment (MoCA)

    Change from baseline in Montreal Cognitive Assessment (MoCA). Total MoCA score is 0 to 30, with lower scores indicating greater level of impairment.

    Measured: Baseline, Week 255

  3. Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory

    Change from baseline in the Category Fluency - Language, Executive Function, Semantic Memory. The total score reflects the sum of correct responses generated across all categories presented, with higher values indicating better performance.

    Measured: Baseline, Week 255

  4. Change from Baseline in the Continuous Paired Associate Learning (CPAL)

    Change from baseline in Continuous Paired Associate Learning (CPAL) - Visual episodic memory.

    Measured: Baseline, Week 255

  5. Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem

    Change from baseline in the International Shopping List Test (ISLT) - verbal episodic memory.

    Measured: Baseline, Week 255

  6. Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory

    Change from baseline in the International Daily Symbol Substitution Test-Medicines (iDSSTm) - complex attention memory.

    Measured: Baseline, Week 255

  7. Change from Baseline in Cognitive Function Index (CFI)

    Change from baseline in the Cognitive Function Index (CFI).

    Measured: Baseline, Week 255

  8. Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C)

    Change from baseline in the Mild Behavioral Impairment Checklist (MBI-C) The MBI-C total score range is 0 to 102, with higher scores indicating greater impairment.

    Measured: Baseline, Week 255

  9. Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI)

    Change from baseline in the Activities of Daily Living - Prevention Instrument total scores range from 0 to 54, with higher scores indicating better performance.

    Measured: Baseline, Week 255

  10. Pharmacokinetics: Serum Concentrations of Remternetug

    PK: serum concentration of remternetug.

    Measured: Baseline through Week 255

  11. Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)

    Number of participants with treatment emergent anti-drug antibodies (TE-ADAs).

    Measured: Baseline through Week 255

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2024
  2. Study start24 Oct 2024
  3. Primary completionApr 2029 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06653153
Sponsor's protocol ID
27183
Other IDs
J1G-MC-LAKI, 2024-515656-20-00
Status last verified
Oct 2026
First submitted
21 Oct 2024
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remternetug in people with Alzheimer's Disease, run by Eli Lilly and Company at 262 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 262 sites in United States, China, Japan, Canada, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR) (time frame: Baseline to Time to Event up to Week 255). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06653153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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Clinical Trial NCT06653153 | AzTrials