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Alzheimers DiseasePhase 3TRONTIER 1NCT07169578

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

A Phase 3 study testing Trontinemab in people with Alzheimers Disease, run by Hoffmann-La Roche at 142 sites in 13 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 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). Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimers Disease
What is being tested?
Trontinemab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,101 participants
Where
142 sitesin 13 countries
Study dates
17 Sep 2025to 16 Feb 2028
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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

142 sites in 13 countries.

142 sites in 13 countries

United States35 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • RE:Cognition (Chicago)

    Chicago, Illinois, 60611

  • Alzheimer's Research and Treatment Center - Columbus

    Columbus, Georgia, 31904

  • Ohio State University

    Columbus, Ohio, 43221

  • Kerwin Research Center, LLC

    Dallas, Texas, 75231

  • Accel Research Sites-NeuroStudies

    Decatur, Georgia, 30030

  • South Texas Research Institute - Edinburg

    Edinburg, Texas, 78539

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • Re:Cognition Health - Houston

    Houston, Texas, 77030

  • Irvine Center for Clinical Research

    Irvine, California, 92614

  • Genesis Neuroscience Clinic

    Knoxville, Tennessee, 37909

  • K2 Medical Research - The Villages

    Lady Lake, Florida, 32159

  • Basil Clinical

    Laurelton, New York, 11413-2016

  • Inglewood Clinicals

    Los Angeles, California, 90056

  • K2 Medical Research, LLC

    Maitland, Florida, 32751

  • Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072

  • K2 Medical Research - Nashville

    Nashville, Tennessee, 37204

  • Weill Cornell Medical College

    New York, New York, 10021

  • Adams Clinical Harlem

    New York, New York, 10029

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Butler Hospital

    Providence, Rhode Island, 02906

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia, 23294

  • The Cognitive and Research Center of New Jersey

    Ridgewood, New Jersey, 07450

  • UCSF - Memory and Aging Center

    San Francisco, California, 94158

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Axiom Brain Health LLC

    Tampa, Florida, 33609

  • Adams Clinical Bronx

    The Bronx, New York, 10461

  • Charter Research - Lady Lake/The Villages

    The Villages, Florida, 32162

  • Alzheimer?s Research and Treatment Center

    Wellington, Florida, 33414

  • Conquest Research, LLC

    Winter Park, Florida, 32789

Other trials in United States

China25 sites

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing, 100050

  • Peking University Sixth Hospital

    Beijing, 100083

  • The First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital - Sichuan University

    Chengdu, 610047

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Guangdong General Hospital

    Guangzhou, 510030

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260

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

    Hangzhou, 310016

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Anhui Provincial Hospital

    Hefei, 230088

  • Zhongda Hospital Affiliated to Southeast University

    Nanjing, 210009

  • Nanjing Brain Hospital

    Nanjing, 210029

  • Nanjing First Hospital

    Nanjing, 210029

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • Shanghai First People's Hospital

    Shanghai, 200080

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

    Shanghai, 200233

  • Shanghai Pudong Hospital

    Shanghai, 201399

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

Other trials in China

Germany13 sites

  • Uniklinik RWTH Aachen

    Aachen, 52074

  • Zentrum für klinische Forschung Dr. med. Irma Schöll

    Bad Homburg, 61348

  • Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie

    Bayreuth, 95445

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791

  • Gesundheit Nord, Klinikum Bremen-Ost

    Bremen, 28325

  • NeuroCentrum Odenwald

    Erbach/Odenwald, 64711

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106

  • MVZ Rheumatologie und Autoimummedizin Hamburg GmbH

    Hamburg, 20095

  • Neurology UKSH Campus Kiel

    Kiel, 24105

  • Klinikum rechts der Isar der TU München

    München, 81675

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

    Steglitz, 12163

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Japan11 sites

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization Utano National Hospital

    Kyoto, 616-8255

  • Mishuku Hospital

    Meguro-Ku, 153-0051

  • Mie University Hospital

    Mie, 514-8507

  • Memory Clinic Ochanomizu

    Tokyo, 113-0034

  • Keio University Hospital

    Tokyo, 160-8582

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    Tokyo, 173-0015

  • National Center of Neurology and Psychiatry

    Tokyo, 187-8551

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

    Tokyo, 190-8531

  • P-One Clinic

    Tokyo, 192-0071

  • Yamagata Tokusyukai Hospital

    Yamagata, 990-0834

Other trials in Japan

France9 sites

  • Hôpital Broca

    Le Kremlin Bicétre Cedex, 94275

  • Hopital B Roger Salengro

    Lille, 59037

  • Hôpital de la Timone

    Marseille, 13385

  • Hopital Lariboisiere

    Paris, 75475

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Gerontopole

    Toulouse, 31059

  • CHRU - Hôpital Bretonneau

    Tours, 37000

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54500

  • Hopital des Charpennes

    Villeurbanne, 69100

Other trials in France

Poland9 sites

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

    Bydgoszcz, 85-163

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

    Katowice, 40-749

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

    Krakow, 31-505

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

    Lublin, 20-410

  • Nmedis sp. z o.o.

    Rzeszów, 35-323

  • ETG Neuroscience Sp. z o.o.

    Warsaw, 02-677

  • Centrum Leczenia Zaburzen Pamieci

    Warsaw, 03-839

  • NZOZ WCA

    Wroc?aw, 53-659

  • SPSK nr 1

    Zabrze, 41-800

Other trials in Poland

Spain9 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Policlínica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Universitario de Santa Maria

    Lleida, Lerida, 25198

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital General De Catalunya

    Sant Cugat del Vallès, Barcelona, 8195

  • Hospital Mutua De Terrasa

    Terrassa, Barcelona, 08222

  • Hospital Universitario Dr. Peset

    Valencia, 46017

Other trials in Spain

United Kingdom8 sites

  • Lynfield Mount hospital

    Bradford, BD9 6DP

  • Recognition Health Bristol

    Bristol, BS32 4SY

  • Surrey and Borders NHS Foundation Trust

    Chertsey, KT16 9AU

  • Department of Old Age Psychiatry Kings College

    London, SE5 8AF

  • RE:Cognition Health

    London, W1G 8TA

  • Charing Cross Hospital

    London, W6 8RF

  • Campus for Ageing & Vitality

    Newcastle, NE4 5PL

  • Tees,Esk and Wear Valleys NHS Foundation Trust

    York, YO31 8TA

Other trials in United Kingdom

Canada7 sites

  • Clinique Memoire de Montreal

    Montreal, Quebec, H2X 3B9

  • Baycrest Academy for Research and Education

    North YORK, Ontario, M6A 2E1

  • Alpha Recherche Clinique

    Québec, G3K 2P8

  • Richmond Clinical Trials

    Richmond, British Columbia, V6V 2L1

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • Centricity East York

    Toronto, Ontario, M4G 3E8

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Taiwan7 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Taipei Medical University ?Shuang Ho Hospital

    New Taipei City, 23561

  • China Medical University Hospital

    North Dist., 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

Italy5 sites

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25123

  • Azienda Ospedaliero Universitaria San Martino

    Genoa, Liguria, 16132

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Fondazione Santa Lucia IRCCS

    Rome, Lazio, 00179

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

    Rome, Lazio, 00185

Other trials in Italy

Brazil3 sites

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais, 31270-901

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Centro de Pesquisas Clinicas - CPCLIN

    São Paulo, São Paulo, 01228-200

Other trials in Brazil

Argentina1 site

  • Hospital Italiano

    CABA, C1199ABA

Other trials in Argentina

About this study

Official title: 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).

Being tested
Trontinemab, Placebo
Keywords
Early Alzheimers Disease, Mild Cognitive Impairment, Mild Dementia
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

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

  • TrontinemabDrug

    Also called RO7126209

    Participants will receive IV trontinemab.

  • PlaceboOther

    Participants will receive IV placebo.

Study groups in NCT07169578
Study groupRoleWhat they receive
TrontinemabExperimentalParticipants will receive intravenous (IV) trontinemab.
Receives: Drug: Trontinemab
PlaceboPlacebo comparatorParticipants will receive IV placebo.
Receives: Other: Placebo

What is being measured

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

  1. Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

    Measured: Baseline - Week 72

Secondary outcomes (15)

  1. Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)

    Measured: Baseline - Week 72

  2. Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score

    Measured: Baseline - Week 72

  3. Change From Baseline Through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)

    Measured: Baseline - Week 72

  4. Change From Baseline Through Week 72 in Mini-Mental State Examination (MMSE)

    Measured: Baseline - Week 72

  5. Change From Baseline in CDR-SB

    Measured: Baseline up to but excluding Week 72

  6. Time to Increase in Clinical Dementia Rating, Global Score (CDR-GS)

    Measured: Baseline - Week 72

  7. Percentage of Participants With Adverse Events (AEs)

    Measured: Baseline - Week 72

  8. Change from Baseline in C-SSRS (Columbia-Suicide Severity Rating Scale)

    Measured: Baseline - Week 72

  9. Percentage of Participants With Amyloid-related Imaging Abnormalities (ARIA) Magnetic Resonance Imaging (MRI) Findings

    Measured: Baseline - Week 72

  10. Percentage of Participants With Infusion-related Reactions (IRR)

    Measured: Baseline - Week 72

  11. Percentage of Participants With Anti-drug Antibodies (ADAs) to Trontinemab

    Measured: Baseline - Week 72

  12. Change From Baseline Through Week 72 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan

    Measured: Baseline - Week 72

  13. Change From Baseline to Week 72 in Brain tau Load as Measured by tau PET Scan in a Subset of Participants

    Measured: Baseline - Week 72

  14. Change From Baseline Through Week 72 in Cerebrospinal Fluid (CSF) Biomarkers of Disease p-tau181, Neurogranin, Amyloid Beta(Aβ)42, Aβ42/40 in a Subset of Participants

    Measured: Baseline - Week 72

  15. Change From Baseline Through Week 72 in Blood Biomarkers p-tau217, Glial Fibrillar Acidic Protein (GFAP), Aβ42, Aβ42/40

    Measured: Baseline - Week 72

Timeline

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

  1. First posted12 Sep 2025
  2. Study start17 Sep 2025
  3. Primary completion16 Feb 2028 (estimated)
  4. Study completion16 Feb 2028 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169578
Sponsor's protocol ID
WN45443
Other IDs
2024-518006-40-00
Acronym
TRONTIER 1
Status last verified
Sep 2026
First submitted
10 Sep 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trontinemab in people with Alzheimers Disease, run by Hoffmann-La Roche at 142 sites in 13 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 8 inclusion and 7 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, China, Germany, Japan, France and 8 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?

Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) (time frame: Baseline - Week 72). 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 NCT07169578.

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 25 Sep 2026.

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