A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Last updated: July 1, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Dementia

Memory Problems

Memory Loss

Treatment

Trontinemab

Placebo

Clinical Study ID

NCT07169578
WN45443
2024-518006-40-00
  • Ages 50-90
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment [MCI] to mild dementia due to AD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willingness and ability to complete all aspects of the study (including MRI,clinical genotyping, and PET imaging or CSF as applicable) for the duration of thestudy. The participant should be capable of completing assessments either alone orwith the help of the study partner

  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient toperform the neuropsychological testing (eyewear and hearing aids are permitted)

  • Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSFtau181/Aβ42 ratio may be used as an alternative option if amyloid PET is notavailable

  • Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinicalsyndrome clinical Stage 3 or Stage 4

  • Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0

  • Participant- and/or Informant-reported history of cognitive decline with gradualonset and progression over the last 1 year before screening

  • A Repeatable Battery for the Assessment of Neuropsychological Status Delayed MemoryIndex (RBANS DMI) score of 85 or order

  • Availability of a "study partner" as defined by the protocol

Exclusion

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition

  • History or presence of clinically significant cerebrovascular disease

  • History of severe, clinically significant (persistent neurologic deficit orstructural brain damage) central nervous system (CNS) trauma

  • History or presence of clinically significant intracranial mass

  • MRI evidence of significant cerebral abnormalities or inability to tolerate MRIprocedures or contraindication to MRI

  • Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) whichare not stable and adequately controlled or which in the opinion of the investigatorcould affect the participant's safety in the study or interfere with the studyassessments

  • History of malignancy with the following exceptions: if considered to be cured;malignancies with a negligible risk of metastasis or death

Study Design

Total Participants: 800
Treatment Group(s): 2
Primary Treatment: Trontinemab
Phase: 3
Study Start date:
September 17, 2025
Estimated Completion Date:
June 07, 2028

Connect with a study center

  • Hospital Italiano

    CABA, C1199ABA
    Argentina

    Active - Recruiting

  • Sanatorio del Sur S.A.

    San Miguel de Tucumán, T4000IDK
    Argentina

    Active - Recruiting

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais 31270-901
    Brazil

    Active - Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul 90035-001
    Brazil

    Active - Recruiting

  • Centro de Pesquisas Clinicas - CPCLIN

    São Paulo, São Paulo 01228-200
    Brazil

    Active - Recruiting

  • Richmond Clinical Trials

    Richmond, British Columbia V6V 2L1
    Canada

    Active - Recruiting

  • Baycrest Academy for Research and Education

    North YORK, Ontario M6A 2E1
    Canada

    Active - Recruiting

  • Centricity East York

    Toronto, Ontario M4G 3E8
    Canada

    Active - Recruiting

  • Toronto Memory Program

    Toronto, Ontario M3B 2S7
    Canada

    Active - Recruiting

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Active - Recruiting

  • Clinique Memoire de Montreal

    Montreal, Quebec H2X 3B9
    Canada

    Active - Recruiting

  • Alpha Recherche Clinique

    Québec, G3K 2P8
    Canada

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221002
    China

    Active - Recruiting

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality 200127
    China

    Active - Recruiting

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050
    China

    Active - Recruiting

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, 100050
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, 100034
    China

    Active - Recruiting

  • Peking University Sixth Hospital

    Beijing, 100083
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing 1816670, 100034
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • West China Hospital - Sichuan University

    Chengdu, 610047
    China

    Active - Recruiting

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Active - Recruiting

  • Guangdong General Hospital

    Guangzhou, 510030
    China

    Active - Recruiting

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260
    China

    Active - Recruiting

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou 1809858, 510260
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310016
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei, 230088
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei 1808722, 230022
    China

    Active - Recruiting

  • Nanjing Brain Hospital

    Nanjing, 210029
    China

    Active - Recruiting

  • Nanjing First Hospital

    Nanjing, 210029
    China

    Active - Recruiting

  • Zhongda Hospital Affiliated to Southeast University

    Nanjing, 210009
    China

    Active - Recruiting

  • Nanjing First Hospital

    Nanjing 1799962, 210029
    China

    Active - Recruiting

  • Zhongda Hospital Affiliated to Southeast University

    Nanjing 1799962, 210009
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, 200040
    China

    Active - Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025
    China

    Active - Recruiting

  • Shanghai First People's Hospital

    Shanghai, 200080
    China

    Active - Recruiting

  • Shanghai Pudong Hospital

    Shanghai, 201399
    China

    Active - Recruiting

  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200233
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai 1796236, 200040
    China

    Active - Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai 1796236, 200025
    China

    Active - Recruiting

  • Shanghai First People's Hospital

    Shanghai 1796236, 200080
    China

    Active - Recruiting

  • Shanghai Pudong Hospital

    Shanghai 1796236, 201399
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Active - Recruiting

  • Hôpital Broca

    Le Kremlin Bicétre Cedex, 94275
    France

    Site Not Available

  • Hopital B Roger Salengro

    Lille, 59037
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille, 13385
    France

    Site Not Available

  • Hopital Lariboisiere

    Paris, 75475
    France

    Site Not Available

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Gerontopole

    Toulouse, 31059
    France

    Site Not Available

  • CHRU - Hôpital Bretonneau

    Tours, 37000
    France

    Site Not Available

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

  • Hopital des Charpennes

    Villeurbanne, 69100
    France

    Site Not Available

  • Uniklinik RWTH Aachen

    Aachen, 52074
    Germany

    Active - Recruiting

  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg, 61348
    Germany

    Active - Recruiting

  • Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie

    Bayreuth, 95445
    Germany

    Active - Recruiting

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791
    Germany

    Active - Recruiting

  • Gesundheit Nord, Klinikum Bremen-Ost

    Bremen, 28325
    Germany

    Active - Recruiting

  • NeuroCentrum Odenwald

    Erbach/Odenwald, 64711
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106
    Germany

    Active - Recruiting

  • MVZ Rheumatologie und Autoimummedizin Hamburg GmbH

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Neurology UKSH Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU München

    München, 81675
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann

    Steglitz, 12163
    Germany

    Active - Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Fondazione Santa Lucia IRCCS

    Rome, Lazio 00179
    Italy

    Active - Recruiting

  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio 00185
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria San Martino

    Genoa, Liguria 16132
    Italy

    Active - Recruiting

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy 25123
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy 20132
    Italy

    Active - Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507
    Japan

    Active - Recruiting

  • National Hospital Organization Utano National Hospital

    Kyoto, 616-8255
    Japan

    Active - Recruiting

  • Mishuku Hospital

    Meguro-Ku, 153-0051
    Japan

    Active - Recruiting

  • Mie University Hospital

    Mie, 514-8507
    Japan

    Active - Recruiting

  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

    Tokyo, 190-8531
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo, 160-8582
    Japan

    Active - Recruiting

  • Memory Clinic Ochanomizu

    Tokyo, 113-0034
    Japan

    Active - Recruiting

  • National Center of Neurology and Psychiatry

    Tokyo, 187-8551
    Japan

    Active - Recruiting

  • P-One Clinic

    Tokyo, 192-0071
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Geriatric Hospital

    Tokyo, 173-0015
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    Tokyo, 173-0015
    Japan

    Active - Recruiting

  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

    Tokyo 1850147, 190-8531
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo 1850147, 160-8582
    Japan

    Active - Recruiting

  • Memory Clinic Ochanomizu

    Tokyo 1850147, 113-0034
    Japan

    Active - Recruiting

  • National Center of Neurology and Psychiatry

    Tokyo 1850147, 187-8551
    Japan

    Active - Recruiting

  • P-One Clinic

    Tokyo 1850147, 192-0071
    Japan

    Active - Recruiting

  • Yamagata Tokusyukai Hospital

    Yamagata, 990-0834
    Japan

    Active - Recruiting

  • Centrum Medyczne Neuromed Sp. z.o.o.

    Bydgoszcz, 85-163
    Poland

    Active - Recruiting

  • NEURO-CARE Sp. z o.o. Sp. Komandytowa

    Katowice, 40-749
    Poland

    Active - Recruiting

  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

    Krakow, 31-505
    Poland

    Active - Recruiting

  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

    Lublin, 20-410
    Poland

    Active - Recruiting

  • Nmedis sp. z o.o.

    Rzeszów, 35-323
    Poland

    Active - Recruiting

  • Centrum Leczenia Zaburzen Pamieci

    Warsaw, 03-839
    Poland

    Active - Recruiting

  • ETG Neuroscience Sp. z o.o.

    Warsaw, 02-677
    Poland

    Active - Recruiting

  • ETG Neuroscience Sp. z o.o.

    Warsaw 756135, 02-677
    Poland

    Active - Recruiting

  • NZOZ WCA

    Wroc?aw, 53-659
    Poland

    Active - Recruiting

  • SPSK nr 1

    Zabrze, 41-800
    Poland

    Active - Recruiting

  • Hospital General De Catalunya

    Sant Cugat del Vallès, Barcelona 8195
    Spain

    Active - Recruiting

  • Hospital Mutua De Terrasa

    Terrassa, Barcelona 08222
    Spain

    Active - Recruiting

  • Policlínica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa 20014
    Spain

    Active - Recruiting

  • Hospital Universitario de Santa Maria

    Lleida, Lerida 25198
    Spain

    Active - Recruiting

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid 28223
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital Universitario de la Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Dr. Peset

    Valencia, 46017
    Spain

    Active - Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807
    Taiwan

    Active - Recruiting

  • Taipei Medical University ?Shuang Ho Hospital

    New Taipei City, 23561
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    North Dist., 40447
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei 1668341, 100
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • Lynfield Mount hospital

    Bradford, BD9 6DP
    United Kingdom

    Active - Recruiting

  • Recognition Health Bristol

    Bristol, BS32 4SY
    United Kingdom

    Active - Recruiting

  • Surrey and Borders NHS Foundation Trust

    Chertsey, KT16 9AU
    United Kingdom

    Active - Recruiting

  • Charing Cross Hospital

    London, W6 8RF
    United Kingdom

    Active - Recruiting

  • Department of Old Age Psychiatry Kings College

    London, SE5 8AF
    United Kingdom

    Active - Recruiting

  • RE:Cognition Health

    London, W1G 8TA
    United Kingdom

    Active - Recruiting

  • Charing Cross Hospital

    London 2643743, W6 8RF
    United Kingdom

    Active - Recruiting

  • RE:Cognition Health

    London 2643743, W1G 8TA
    United Kingdom

    Active - Recruiting

  • Campus for Ageing & Vitality

    Newcastle, NE4 5PL
    United Kingdom

    Active - Recruiting

  • Tees,Esk and Wear Valleys NHS Foundation Trust

    York, YO31 8TA
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Irvine Center for Clinical Research

    Irvine, California 92614
    United States

    Active - Recruiting

  • Inglewood Clinicals

    Los Angeles, California 90056
    United States

    Active - Recruiting

  • UCSF - Memory and Aging Center

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • K2 Medical Research - The Villages

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

  • K2 Medical Research, LLC

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Axiom Brain Health LLC

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Charter Research - Lady Lake/The Villages

    The Villages, Florida 32162
    United States

    Active - Recruiting

  • Alzheimer?s Research and Treatment Center

    Wellington, Florida 33414
    United States

    Active - Recruiting

  • Conquest Research, LLC

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Alzheimer's Research and Treatment Center - Columbus

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Accel Research Sites-NeuroStudies

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • RE:Cognition (Chicago)

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Tandem Clinical Research, LLC

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Boston Center for Memory

    Newton, Massachusetts 02459
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • The Cognitive and Research Center of New Jersey

    Ridgewood, New Jersey 07450
    United States

    Active - Recruiting

  • Basil Clinical

    Laurelton, New York 11413-2016
    United States

    Active - Recruiting

  • Adams Clinical Harlem

    New York, New York 10029
    United States

    Active - Recruiting

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Active - Recruiting

  • Adams Clinical Bronx

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Triad Clinical Trials

    Greensboro, North Carolina 27410
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43221
    United States

    Active - Recruiting

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • Genesis Neuroscience Clinic

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • K2 Medical Research - Nashville

    Nashville, Tennessee 37204
    United States

    Active - Recruiting

  • Kerwin Research Center, LLC

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • South Texas Research Institute - Edinburg

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Re:Cognition Health - Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia 23294
    United States

    Active - Recruiting

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