A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (TRONTIER 1)

June 1, 2026 updated by: Hoffmann-La Roche

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Argentina
      • CABA, Argentina, C1199ABA
        • Recruiting
        • Hospital Italiano
      • San Miguel de Tucumán, Argentina, T4000IDK
        • Recruiting
        • Sanatorio del Sur S.A.
  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 31270-901
        • Recruiting
        • Hospital das Clinicas - UFMG
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Recruiting
        • Hospital Moinhos de Vento
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01228-200
        • Recruiting
        • Centro de Pesquisas Clinicas - CPCLIN
  • Canada
      • Québec, Canada, G3K 2P8
        • Recruiting
        • Alpha Recherche Clinique
    • British Columbia
      • Richmond, British Columbia, Canada, V6V 2L1
        • Recruiting
        • Richmond Clinical Trials
    • Ontario
      • North YORK, Ontario, Canada, M6A 2E1
        • Recruiting
        • Baycrest Academy for Research and Education
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M3B 2S7
        • Recruiting
        • Toronto Memory Program
      • Toronto, Ontario, Canada, M4G 3E8
        • Recruiting
        • Centricity East York
    • Quebec
      • Montreal, Quebec, Canada, H2X 3B9
        • Recruiting
        • Clinique Memoire de Montreal
  • China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
      • Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital,Capital Medical University
      • Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital Affiliated of Capital University of Medical Science
      • Beijing, China, 100083
        • Recruiting
        • Peking University Sixth Hospital
      • Changchun, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
      • Chengdu, China, 610047
        • Recruiting
        • West China Hospital - Sichuan University
      • Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital, Chongqing Medical University
      • Fuzhou, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
      • Guangzhou, China, 510260
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, China, 510030
        • Recruiting
        • Guangdong General Hospital
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Hefei, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, China, 230088
        • Recruiting
        • Anhui Provincial Hospital
      • Nanjing, China, 210009
        • Recruiting
        • Zhongda Hospital Affiliated to Southeast University
      • Nanjing, China, 210029
        • Recruiting
        • Nanjing Brain Hospital
      • Nanjing, China, 210029
        • Recruiting
        • Nanjing First Hospital
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai First People's Hospital
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
      • Shanghai, China, 201399
        • Recruiting
        • Shanghai Pudong Hospital
      • Shanghai, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
      • Suzhou, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221002
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • France
      • Le Kremlin Bicétre Cedex, France, 94275
        • Recruiting
        • Hopital BROCA
      • Lille, France, 59037
        • Recruiting
        • Hopital B Roger Salengro
      • Marseille, France, 13385
        • Recruiting
        • Hopital De La Timone
      • Paris, France, 75475
        • Recruiting
        • Hôpital Lariboisière
      • Rennes, France, 35033
        • Recruiting
        • CHU Rennes - Hopital Pontchaillou
      • Toulouse, France, 31059
        • Recruiting
        • Gerontopole
      • Tours, France, 37000
        • Recruiting
        • CHRU - Hôpital Bretonneau
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • Hôpital de Brabois
      • Villeurbanne, France, 69100
        • Recruiting
        • Hopital des Charpennes
  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • Uniklinik RWTH Aachen
      • Bad Homburg, Germany, 61348
        • Recruiting
        • Zentrum für klinische Forschung Dr. med. Irma Schöll
      • Bayreuth, Germany, 95445
        • Recruiting
        • Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie
      • Bochum, Germany, 44791
        • Recruiting
        • St. Josef-Hospital, Klinik für Neurologie
      • Bremen, Germany, 28325
        • Recruiting
        • Gesundheit Nord, Klinikum Bremen-Ost
      • Erbach/Odenwald, Germany, 64711
        • Recruiting
        • NeuroCentrum Odenwald
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
      • Hamburg, Germany, 20095
        • Recruiting
        • MVZ Rheumatologie und Autoimummedizin Hamburg GmbH
      • Kiel, Germany, 24105
        • Recruiting
        • Neurology UKSH Campus Kiel
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar der TU München
      • Steglitz, Germany, 12163
        • Recruiting
        • Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
      • Trier, Germany, 54292
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
      • Ulm, Germany, 89081
        • Recruiting
        • Universitätsklinikum Ulm
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00179
        • Recruiting
        • Fondazione Santa Lucia IRCCS
      • Rome, Lazio, Italy, 00185
        • Recruiting
        • Umberto I Policlinico di Roma-Università di Roma La Sapienza
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Recruiting
        • Azienda Ospedaliero Universitaria San Martino
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Recruiting
        • ASST degli Spedali Civili di Brescia
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Irccs Ospedale San Raffaele
  • Japan
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
      • Kyoto, Japan, 616-8255
        • Recruiting
        • National Hospital Organization Utano National Hospital
      • Meguro-Ku, Japan, 153-0051
        • Recruiting
        • Mishuku Hospital
      • Mie, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
      • Tokyo, Japan, 113-0034
        • Recruiting
        • Memory Clinic Ochanomizu
      • Tokyo, Japan, 187-8551
        • Recruiting
        • National Center of Neurology and Psychiatry
      • Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University Hospital
      • Tokyo, Japan, 190-8531
        • Recruiting
        • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
      • Tokyo, Japan, 192-0071
        • Recruiting
        • P-One Clinic
      • Tokyo, Japan, 173-0015
        • Recruiting
        • Tokyo Metropolitan Institute for Geriatrics and Gerontology
      • Yamagata, Japan, 990-0834
        • Recruiting
        • Yamagata Tokusyukai Hospital
  • Poland
      • Bydgoszcz, Poland, 85-163
        • Recruiting
        • Centrum Medyczne Neuromed Sp. z.o.o.
      • Katowice, Poland, 40-749
        • Recruiting
        • Neuro-Care sp. z o.o. sp. Komandytowa
      • Krakow, Poland, 31-505
        • Recruiting
        • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
      • Lublin, Poland, 20-410
        • Recruiting
        • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
      • Rzeszów, Poland, 35-323
        • Recruiting
        • Nmedis sp. z o.o.
      • Warsaw, Poland, 02-677
        • Recruiting
        • ETG Neuroscience Sp. z o.o.
      • Warsaw, Poland, 03-839
        • Recruiting
        • Centrum Leczenia Zaburzen Pamieci
      • Wroc?aw, Poland, 53-659
        • Recruiting
        • NZOZ WCA
      • Zabrze, Poland, 41-800
        • Recruiting
        • SPSK nr 1
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Vall d'Hebron
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Dr. Peset
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 8195
        • Recruiting
        • Hospital General de Catalunya
      • Terrassa, Barcelona, Spain, 08222
        • Recruiting
        • Hospital Mutua De Terrasa
    • Guipuzcoa
      • Donostia / San Sebastian, Guipuzcoa, Spain, 20014
        • Recruiting
        • Policlinica Guipuzcoa
    • Lerida
      • Lleida, Lerida, Spain, 25198
        • Recruiting
        • Hospital Universitario de Santa Maria
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • Hospital Quiron de Madrid
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Hospital
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University ?Shuang Ho Hospital
      • North Dist., Taiwan, 40447
        • Recruiting
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation Linkou Branch
  • United Kingdom
      • Bradford, United Kingdom, BD9 6DP
        • Recruiting
        • Lynfield Mount hospital
      • Bristol, United Kingdom, BS32 4SY
        • Recruiting
        • Recognition Health Bristol
      • Chertsey, United Kingdom, KT16 9AU
        • Recruiting
        • Surrey and Borders NHS Foundation Trust
      • London, United Kingdom, W6 8RF
        • Recruiting
        • Charing Cross Hospital
      • London, United Kingdom, W1G 8TA
        • Recruiting
        • Re:Cognition Health
      • London, United Kingdom, SE5 8AF
        • Recruiting
        • Department of Old Age Psychiatry Kings College
      • Newcastle, United Kingdom, NE4 5PL
        • Recruiting
        • Campus for Ageing & Vitality
      • York, United Kingdom, YO31 8TA
        • Recruiting
        • Tees,Esk and Wear Valleys NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Banner Sun Health Research Institute
    • California
      • Irvine, California, United States, 92614
        • Recruiting
        • Irvine Center for Clinical Research
      • Los Angeles, California, United States, 90056
        • Recruiting
        • Inglewood Clinicals
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF - Memory and Aging Center
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Syrentis Clinical Research
    • Florida
      • Lady Lake, Florida, United States, 32159
        • Recruiting
        • K2 Medical Research - The Villages
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research, LLC
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Renstar Medical Research
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Axiom Brain Health LLC
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - Lady Lake/The Villages
      • Wellington, Florida, United States, 33414
        • Recruiting
        • Alzheimer?s Research and Treatment Center
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research, LLC
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • Alzheimer's Research and Treatment Center - Columbus
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Accel Research Sites-NeuroStudies
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Pacific Neuroscience
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • RE:Cognition (Chicago)
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Tandem Clinical Research, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Womens Hospital
      • Newton, Massachusetts, United States, 02459
        • Recruiting
        • Boston Center for Memory
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • The Cognitive and Research Center of New Jersey
    • New York
      • Laurelton, New York, United States, 11413-2016
        • Recruiting
        • Basil Clinical
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medical College
      • New York, New York, United States, 10029
        • Recruiting
        • Adams Clinical Harlem
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Adams Clinical Bronx
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Recruiting
        • Triad Clinical Trials
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Ohio State University
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Butler Hospital
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Genesis Neuroscience Clinic
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • K2 Medical Research - Nashville
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Kerwin Research Center, LLC
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • South Texas Research Institute - Edinburg
      • Houston, Texas, United States, 77030
        • Recruiting
        • Re:Cognition Health - Houston
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Recruiting
        • National Clinical Research Inc.-Richmond

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 the study. The participant should be capable of completing assessments either alone or with the help of the study partner
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
  • Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available
  • Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome 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 gradual onset and progression over the last 1 year before screening
  • A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order
  • Availability of a "study partner" as defined by the protocol

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 or structural 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 MRI procedures or contraindication to MRI
  • Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
  • History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trontinemab
Participants will receive intravenous (IV) trontinemab.
Drug: Trontinemab
Participants will receive IV trontinemab.
Other Names:
  • RO7126209
Placebo Comparator: Placebo
Participants will receive IV placebo.
Other: Placebo
Participants will receive IV placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Time Frame: Baseline - Week 72
Baseline - Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
Time Frame: Baseline - Week 72
Baseline - Week 72
Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score
Time Frame: Baseline - Week 72
Baseline - Week 72
Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)
Time Frame: Baseline - Week 72
Baseline - Week 72
Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)
Time Frame: Baseline - Week 72
Baseline - Week 72
Change from baseline in CDR-SB
Time Frame: Baseline up to but excluding Week 72
Baseline up to but excluding Week 72
Time to increase in Clinical Dementia Rating, Global Score (CDR-GS)
Time Frame: Baseline - Week 72
Baseline - Week 72
Percentage of participants with adverse events (AEs)
Time Frame: Baseline - Week 72
Baseline - Week 72
Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings
Time Frame: Baseline - Week 72
Baseline - Week 72
Percentage of participants with infusion-related reactions (IRR)
Time Frame: Baseline - Week 72
Baseline - Week 72
Percentage of participants with anti-drug antibodies (ADAs) to trontinemab
Time Frame: Baseline - Week 72
Baseline - Week 72
Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan
Time Frame: Baseline - Week 72
Baseline - Week 72
Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants
Time Frame: Baseline - Week 72
Baseline - Week 72
Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants
Time Frame: Baseline - Week 72
Baseline - Week 72
Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)
Time Frame: Baseline - Week 72
Baseline - Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 17, 2025

Primary Completion (Estimated)

June 7, 2028

Study Completion (Estimated)

June 7, 2028

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Actual)

September 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WN45443
  • 2024-518006-40-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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