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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Remternetug

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Birtinya, Australia, 4575
    • USC Clinical Trials Sunshine Coast
  • Botany, Australia, 2019
    • Emeritus Research
  • Box Hill, Australia, 3128
    • Box Hill Hospital
  • Camberwell, Australia, 3124
    • Emeritus Research
  • East Maitland, Australia, 2323
    • GenesisCare - Maitland
  • Herston, Australia, 4029
    • The University of Queensland
  • Ipswich, Australia, 4305
    • Ipswich Hospital
  • Ivanhoe, Australia, 3079
    • Austin Health
  • Kogarah, Australia, 2217
    • Southern Neurology
  • Macquarie Park, Australia, 2113
    • KARA Institute for Neurological Diseases
  • Malvern, Australia, 3144
    • HammondCare
  • Norwood, Australia, 5067
    • Fusion Clinical Research
  • Parkville, Australia, 3050
    • The Royal Melbourne Hospital
  • South Brisbane, Australia, 4101
    • USC Clinical Trials Brisbane (South Bank)
  • Sydney, Australia, 2010
    • St Vincent's Hospital
  • Woodville, Australia, 5011
    • The Queen Elizabeth Hospital
• Canada
  • Chicoutimi, Canada, G7H 0S7
    • Ecogene-21 - Cmas
  • Greenfield Park, Canada, J4V 2J2
    • MoCA Research and Innovation Inc.
  • Kelowna, Canada, V1Y 1Z9
    • OCT Research ULC
  • Lévis, Canada, G6V 0C9
    • Alpha Recherche Clinique - Lévis
  • Montreal, Canada, H3G 1H9
    • Clinique Memoire de Montreal
  • Montreal, Canada, H4A 3T2
    • Genge Partners
  • Ottawa, Canada, K1Z 1G3
    • Ottawa Memory Clinic
  • Peterborough, Canada, K9H 2P4
    • Kawartha Centre - Redefining Healthy Aging
  • Québec, Canada, G3K 2P8
    • ALPHA Recherche Clinique
  • Québec, Canada, G2J 0C4
    • ALPHA Recherche Clinique
  • Sarnia, Canada, N7T 4X3
    • Bluewater Clinical Research Group Inc.
  • Sherbrooke, Canada, J1J 2G2
    • Q&T Research Sherbrooke Inc.
  • Toronto, Canada, M3B 2S7
    • Toronto Memory Program
  • Toronto, Canada, M4N 3M5
    • Sunnybrook Research Institute
  • Toronto, Canada, M6A 2E1
    • Baycrest Health Sciences
  • Victoriaville, Canada, G6P 3Z8
    • Diex Recherche Inc. Division Victoriaville
  • West Vancouver, Canada, V7T 1C5
    • The Medical Arts Health Research Group - West Vancouver
• China
  • Beijing, China, 100071
    • Beijing Tiantan Hospital Affiliated to Capital Medical University
  • Beijing, China, 100088
    • Beijing Anding Hospital - Affiliated Capital University of Medical Science
  • Changchun, China, 100012
    • The First Hospital of Jilin University
  • Changsha, China, 410008
    • Xiangya Hospital Central South University
  • Chengdu, China, 610072
    • Sichuan Provincial People's Hospital
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510180
    • Guangzhou First People's Hospital
  • Guangzhou, China, 510280
    • Zhujiang Hospital
  • Guangzhou, China, 510260
    • Guangzhou Medical University 2nd Hospital
  • Hefei, China, 230036
    • Anhui Provincial Hospital
  • Jinan, China, 250013
    • Jinan Central Hospital
  • Luoyang, China, 471003
    • The First Affiliated Hospital of Henan University of Science &Technology
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Nanchang, China, 330000
    • The Second Affiliated Hospital of Nanchang University
  • Nanjing, China, 210029
    • Nanjing Brain Hospital
  • Nanjing, China, 211166
    • Sir Run Run Hospital of Nanjing Medical University
  • Shanghai, China, 200040
    • Huashan Hospital, Fudan University
  • Shanghai, China, 201200
    • Pudong New Area People's Hospital Shanghai
  • Shanghai, China, 200030
    • Shanghai Sixth People's Hospital
  • Shanghai, China, 200135
    • Renji Hospital Shanghai Jiao Tong University School of Medicine
  • Shijiazhuang, China, 050031
    • The First Hospital of Hebei Medical University
  • Suzhou, China, 215004
    • The Second Affiliated Hospital of Soochow University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Xi'an, China, 710077
    • The First Affiliated Hospital of Xi'an Medical University
  • Xi'an, China, 710068
    • Shaanxi Provincial People's Hospital
  • Xianyang, China, 712000
    • Xianyang Hospital of Yan'an University
  • Xuzhou, China, 221006
    • The Affiliated Hospital of Xuzhou Medical College
  • Xuzhou, China, 221018
    • Xuzhou Central Hospital
  • Zigong, China, 643000
    • Zigong First People's Hospital
• Japan
  • Bunkyō City, Japan, 113-8655
    • The University of Tokyo Hospital
  • Chūōku, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic
  • Chūōku, Japan, 103-0027
    • Medical Corporation Chiseikai Tokyo Center Clinic
  • Chūōku, Japan, 104-0031
    • Fukuwa Clinic
  • Chūōku, Japan, 104-0031
    • Tokyo Asbo Clinic
  • Fujisawa, Japan, 251-0038
    • Kawashima Neurology Clinic
  • Fukuoka, Japan, 812-0025
    • Boocs Clinic Fukuoka
  • Fukuoka, Japan, 812-0018
    • UNB Sumiyoshi Jinjamae Clinic
  • Hachiōji, Japan, 192-0071
    • P-One Clinic
  • Himeji, Japan, 670-8560
    • Hyogo Prefectural Harima-Himeji General Medical Center
  • Imabari, Japan, 799-1592
    • Saiseikai Imabari Hospital
  • Kobe, Japan, 650-0017
    • Kobe University Hospital
  • Kodaira, Japan, 187-8510
    • Showa General Hospital
  • Kyoto, Japan, 600-8811
    • Tatsuoka Neurology Clinic
  • Minatoku, Japan, 106-0032
    • Sakurazaka Clinic SophyAnce
  • Osaka, Japan, 536-0007
    • Iwata Neurosurgery Clinic
  • Setagaya-ku, Japan, 158-8531
    • Kanto Central Hospital
  • Shinjuku, Japan, 160-0017
    • Samoncho Clinic
  • Shinjuku-ku, Japan, 160-0004
    • Clinical Research Hospital Tokyo
  • Shinjuku-ku, Japan, 160-0008
    • Heishinkai Medical Group ToCROM Clinic
  • Shinjuku-ku, Japan, 169-0072
    • Higashi Shinjuku Clinic
  • Suita-shi, Japan, 565-0853
    • Medical Corporation Heishinkai OCROM Clinic
  • Tachikawa, Japan, 190-8531
    • Tachikawa Hospital
  • Takatsuki-shi, Japan, 569-1192
    • Takatsuki Hospital
  • Wako, Japan, 351-0111
    • Wako Hospital
  • tabashi City, Japan, 173-0015
    • Tokyo Metropolitan Geriatric Hospital
  • Ōbu, Japan, 474-8511
    • National Center for Geriatrics and Gerontology
• Puerto Rico
  • Bayamón, Puerto Rico, 00961
    • SCB Research Center
  • San Juan, Puerto Rico, 00918
    • Instituto De Neurologia Dra. Ivonne Fraga
  • San Juan, Puerto Rico, 00918
    • INSPIRA Clinical Research
  • San Juan, Puerto Rico, 00918
    • Caribbean Medical Research Center
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Cheongju-si, South Korea, 28644
    • Chungbuk National University Hospital
  • Gangnam-gu, South Korea, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Gangseo-gu, South Korea, 07804
    • Ewha Womans University Seoul Hospital
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Incheon, South Korea, 22332
    • Inha University Hospital
  • Jeju City, South Korea, 63241
    • Jeju National University Hospital
  • Namdong-gu, South Korea, 21565
    • Gachon University Gil Medical Center
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center
  • Seoul, South Korea, 04763
    • Hanyang University Seoul Hospital
  • Suwon, South Korea, 16499
    • Ajou University Hospital
  • Wŏnju, South Korea, 26426
    • Wonju Severance Christian Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08005
    • Barcelonabeta Brain Research Center
  • Barcelona, Spain, 08028
    • Fundació ACE
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Universitario Quironsalud Madrid
  • San Sebastián, Spain, 20014
    • Policlinica Gipuzkoa
  • Seville, Spain, 41009
    • Hospital Victoria Eugenia
• Taiwan
  • Changhua County, Taiwan, 50006
    • Changhua Christian Hospital
  • Douliu, Taiwan, 640
    • National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
  • Kaohsiung Niao Sung Dist, Taiwan, 83301
    • Chang Gung Memorial Hospital at Kaohsiung
  • New Taipei City, Taiwan, 235
    • Taipei Medical University Shuang Ho Hospital
  • New Taipei City, Taiwan, 236
    • New Taipei Municipal TuCheng Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 404332
    • China Medical University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • ReMind UK
  • Birmingham, United Kingdom, B16 8LT
    • Re:Cognition Health - Birmingham
  • Blackpool, United Kingdom, FY3 7EN
    • Layton Medical Centre
  • Edinburgh, United Kingdom, EH12 5PJ
    • Scottish Brain Sciences
  • London, United Kingdom, EC2Y 8EA
    • St Pancras Clinical Research
  • Manchester, United Kingdom, M13 9WL
    • NIHR Manchester Clinical Research Facility
  • Motherwell, United Kingdom, ML1 4UF
    • NeuroClin
  • Plymouth, United Kingdom, PL6 6PH
    • Roborough Surgery
  • Redruth, United Kingdom, TR16 4ET
    • Homecroft Surgery
  • Romsey, United Kingdom, SO51 7QN
    • Abbeywell Surgery
  • Southampton, United Kingdom, SO30 3JB
    • Moorgreen Hospital
  • West Kirby, United Kingdom, CH48 5AA
    • Marine Lake Medical Practice
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • Parkway Medical Center
  • Arizona
    • Chandler, Arizona, United States, 85286
      • MD First Research - Chandler
    • Mesa, Arizona, United States, 85206
      • Care Access - 801 South Power Road, Mesa
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Tucson, Arizona, United States, 85718
      • Banner Alzheimer's Institute Tucson
  • California
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center
    • Huntington Beach, California, United States, 92648
      • Care Access - Huntington Beach
    • Inglewood, California, United States, 90301
      • Inglewood Clinical
    • Irvine, California, United States, 92614
      • Irvine Clinical Research
    • Long Beach, California, United States, 90804
      • Healthy Brain Clinic
    • Riverside, California, United States, 92506
      • Riverside Clinical
    • Sacramento, California, United States, 95821
      • Clinical Trials Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92123
      • Sharp Neurocognitive Research Center
    • San Francisco, California, United States, 94114
      • Ray Dolby Brain Health Center
    • San Marcos, California, United States, 92069
      • The Neuron Clinic - San Marcos
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
    • Santa Rosa, California, United States, 95403
      • Providence Medical Foundation
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research, LLC
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Care Access - Aurora
    • Basalt, Colorado, United States, 81621
      • Mountain Neurological Research Center
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
    • Englewood, Colorado, United States, 80113
      • CenExel Rocky Mountain Clinical Research
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Invicro
    • Stamford, Connecticut, United States, 06905
      • Ki Health Partners, LLc, dba New England Institute for Clinical Research
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Aventura, Florida, United States, 33180
      • VIN - Aventura
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center, Inc.
    • Clermont, Florida, United States, 34711
      • K2 Medical Research WINTER GARDEN
    • Davie, Florida, United States, 33024
      • TecTum Research
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc
    • Lady Lake, Florida, United States, 32159
      • K2 MEDICAL Research THE VILLAGES
    • Maitland, Florida, United States, 32751
      • ClinCloud
    • Maitland, Florida, United States, 32751
      • K2 Medical Research ORLANDO
    • Melbourne, Florida, United States, 32940
      • ClinCloud
    • Merritt Island, Florida, United States, 32952
      • Merritt Island Medical Research, LLC
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corporation
    • Miami, Florida, United States, 33133
      • VIN-Andrew Lerman
    • Mt. Dora, Florida, United States, 32757
      • Adult Medicine of Lake County, Inc.
    • Naples, Florida, United States, 34105
      • Aqualane Clinical Research
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Orlando, Florida, United States, 32804
      • AdventHealth Orlando
    • Orlando, Florida, United States, 32803
      • Charter Research - Winter Park
    • Pensacola, Florida, United States, 32504
      • Emerald Coast Neurology - Airport Boulevard
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Stuart, Florida, United States, 34997
      • Alzheimer's Research and Treatment Center
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Tampa, Florida, United States, 33625
      • Care Access - Tampa
    • Tampa, Florida, United States, 33609
      • Axiom Brain Health LLC
    • The Villages, Florida, United States, 32162
      • Charter Research - Lady Lake
    • Wellington, Florida, United States, 33414
      • Alzheimer's Research and Treatment Center
    • West Palm Beach, Florida, United States, 33407
      • Palm Beach Neurology
    • Winter Park, Florida, United States, 32789
      • Conquest Research
  • Georgia
    • Columbus, Georgia, United States, 31909
      • Columbus Memory Center, LLC
    • Decatur, Georgia, United States, 30030
      • Care Access - Decatur
    • Gainesville, Georgia, United States, 30501
      • Center for Advanced Research & Education
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Care Access - Arlington Heights
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials - Andersonville
    • Chicago, Illinois, United States, 60611
      • Re:Cognition Health - Chicago
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Josephson Wallack Munshower Neurology, PC
    • Indianapolis, Indiana, United States, 46227
      • Care Access - South Indianapolis
  • Iowa
    • Waterloo, Iowa, United States, 50701
      • Cedar Valley Medical Specialists
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Care Access - Lake Charles (Bayou Pines)
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • Maine
    • Bangor, Maine, United States, 04401
      • Acadia Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21213
      • Care Access - Baltimore
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Boston, Massachusetts, United States, 02116
      • Adams Clinical Boston
    • Newton, Massachusetts, United States, 02459
      • Boston Center for Memory
    • Quincy, Massachusetts, United States, 02169
      • Care Access - Quincy
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical Watertown
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Revival Research Institute, LLC
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • HealthPartners Neuroscience Center
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Private Practice - Dr. Ronald Louis Schwartz
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Citizens Memorial Hospital District
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Vector Clinical Trials
  • New Jersey
    • Hoboken, New Jersey, United States, 07030
      • Care Access - Hoboken
    • Ridgewood, New Jersey, United States, 07450
      • The Cognitive and Research Center of New Jersey - Ridgewood
    • Springfield, New Jersey, United States, 07081
      • The Cognitive and Research Center of New Jersey
    • Toms River, New Jersey, United States, 08755
      • Advanced Memory Research Institute of New Jersey
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Ima Clinical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Care Access - Charlotte
    • Greensboro, North Carolina, United States, 27405
      • Medication Management
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
  • Ohio
    • Lima, Ohio, United States, 45805
      • Care Access - Lima
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Headlands
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Keystone Clinical Studies
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island Mood & Memory Research Institute
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research, LLC- Greenville
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic, P.C.
    • Knoxville, Tennessee, United States, 37909
      • Genesis Neuroscience Clinic
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research
    • Beaumont, Texas, United States, 77702
      • Gadolin Research
    • Dallas, Texas, United States, 75231
      • Kerwin Medical Center
    • Dallas, Texas, United States, 75216
      • Kerwin Medical Center - Oak Cliff
    • Georgetown, Texas, United States, 78633
      • Care Access - Georgetown
    • Houston, Texas, United States, 77054
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77057
      • Next Level Urgent Care
    • Houston, Texas, United States, 77054
      • Care Access - Houston
    • Rio Grande City, Texas, United States, 78582
      • El Faro Health and Therapeutics
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants, PA
    • San Antonio, Texas, United States, 78229
      • IMA Clinical Research San Antonio
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, LLC
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Care Access - Arlington 2
    • Fairfax, Virginia, United States, 22031
      • Re:Cognition Health
    • Norfolk, Virginia, United States, 23510
      • Eastern Virginia Medical School (EVMS) Medical Group
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered SC.	Drug: Placebo; Administered SC
Experimental: Remternetug; Remternetug administered subcutaneously (SC).	Drug: Remternetug; Administered SC; Other Names: LY3372993

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to Time to Event up to Week 255

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 255
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.	Baseline, Week 255
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.	Baseline, Week 255
Change from Baseline in the Continuous Paired Associate Learning (CPAL)	Change from baseline in Continuous Paired Associate Learning (CPAL) - Visual episodic memory.	Baseline, Week 255
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.	Baseline, Week 255
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.	Baseline, Week 255
Change from Baseline in Cognitive Function Index (CFI)	Change from baseline in the Cognitive Function Index (CFI).	Baseline, Week 255
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.	Baseline, Week 255
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.	Baseline, Week 255
Pharmacokinetics: Serum Concentrations of Remternetug	PK: serum concentration of remternetug.	Baseline through Week 255
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)	Number of participants with treatment emergent anti-drug antibodies (TE-ADAs).	Baseline through Week 255

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 27183; J1G-MC-LAKI (Other Identifier: Eli Lilly and Company); 2024-515656-20-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No