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Alzheimers DiseasePhase 3TRONTIER 2NCT07170150

A Clinical Trial 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 147 sites in 16 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
1,060 participants
Where
147 sitesin 16 countries
Study dates
12 Nov 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

147 sites in 16 countries.

147 sites in 16 countries

United States33 sites

  • IMA Clinical Research - Albuquerque

    Albuquerque, New Mexico, 87109

  • Sana Research, LLC

    Arlington, Virginia, 22205

  • JEM Research LLC

    Atlantis, Florida, 33462

  • Gadolin Research, LLC

    Beaumont, Texas, 77702

  • Adams Clinical Boston

    Boston, Massachusetts, 02116

  • Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville

    Chicago, Illinois, 60640

  • K2 Medical Research-Winter Garden

    Clermont, Florida, 34711

  • Kerwin Medical Center

    Dallas, Texas, 75216

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030

  • Re:Cognition Health

    Fairfax, Virginia, 22031

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Re:Cognition Health - Fort Worth

    Fort Worth, Texas, 76104

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501

  • Sun Valley Research Center, Inc.

    Imperial, California, 92251

  • Mt.Olympus Medical Research

    Katy, Texas, 77450

  • Healthy Brain Clinic

    Long Beach, California, 90804

  • Visionary Investigators Network- Neurology Aventura

    Miami, Florida, 33133

  • Yale University

    New Haven, Connecticut, 06510

  • Oakland Clinical

    Oakland, California, 94609

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-8440

  • Charter Research - Winter Park/Orlando

    Orlando, Florida, 32803

  • Conquest Research - Lake Nona

    Orlando, Florida, 32832

  • Banner Alzheimer?s Institute

    Phoenix, Arizona, 85006

  • Flourish Research ? Philadelphia

    Plymouth Meeting, Pennsylvania, 19462

  • Summit Research Network Inc.

    Portland, Oregon, 97210

  • El Faro Health and Therapeutics

    Rio Grande City, Texas, 78582

  • Riverside Clinical

    Riverside, California, 92506

  • AD-CARE, University of Rochester Medical Center

    Rochester, New York, 14620

  • Cenexel California Neuroscience Research, LLC

    Sherman Oaks, California, 91403

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Alzheimer's Research and Treatment Center

    Stuart, Florida, 34996

  • Palmetto Clinical Trials

    Summerville, South Carolina, 29485

  • Adams Clinical Watertown

    Watertown, Massachusetts, 02472

Other trials in United States

Germany13 sites

  • Ambulates Gesundheitszentrum der Charité GmbH

    Berlin, 12200

  • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

    Berlin, 13125

  • German Center for Neurodegenerative Diseases (DZNE)

    Bonn, 53127

  • Universitätsklinikum Köln

    Cologne, 50937

  • Medizinische Fakultät Carl Gustav Carus

    Dresden, 01307

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

    Homburg/Saar, 66421

  • Universitätsklinikum Jena, Klinik für Neurologie

    Jena, 07747

  • Universität Leipzig

    Leipzig, 04103

  • Otto-von-Guericke-Universität Magdeburg

    Magdeburg, 39120

  • Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie

    Mannheim, 68159

  • Universitätsklinikum Münster

    Münster, 48149

  • Neuropraxis München Süd

    Unterhaching, 82008

Other trials in Germany

South Korea12 sites

  • Pusan National University Hospital

    Busan, 602-739

  • Chonnam National University Hospital

    Gwangju, 61469

  • Ajou University Medical Center

    Gyeonggi-do, 16499

  • St. Vincent's Hospital

    Gyeonggi-do, 442-723

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Ewha Womans University Hospital (Seoul)

    Seoul, 07804

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Poland11 sites

  • O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie

    ?cinawa, 59-330

  • Uniwersytet Medyczny w Lodzi

    ?ód?, 92-216

  • ProNeuro Centrum Medyczne

    ?ory, 44-240

  • Syberka-ClinHouse Sp. z o.o.

    B?dzin, 42-500

  • Podlaskie Centrum Psychogeriatrii

    Bia?ystok, 15-756

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

    Późna, 61-731

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-326

  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna

    Sopot, 81-855

  • NeuroProtect

    Warsaw, 01-684

Other trials in Poland

United Kingdom11 sites

  • ReMind UK

    Bath, BA1 3NG

  • Re:Cognition Health Birmingham

    Birmingham, B16 8QQ

  • Scottish Brain Sciences

    Edinburgh, EH12 9DQ

  • Queen Elizabeth University Hospital Glasgow

    Glasgow, G51 4TF

  • St George?s Hospital

    London, SW17 ORE

  • RE:Cognition Health

    London, W1G 8TA

  • UCL Institute of Neurology

    London, WC1N 3BG

  • Manchester Mental Health and Social Care Trust

    Manchester, M13 9WL

  • Warneford Hospital

    Oxford, OX3 7JX

  • Lancashire and South Cumbria NHS Foundation Trust

    Preston, PR2 8DW

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

Other trials in United Kingdom

Japan10 sites

  • Brain Attack Center Ota Memorial Hospital

    Hiroshima, 720-0825

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Hiroshima, 739-0696

  • Kobe University Hospital

    Hyōgo, 650-0017

  • Kagawa University Hospital

    Kagawa, 761-0793

  • Kochi Medical School Hospital

    Kochi, 783-8505

  • Okayama City Hospital

    Okayama, 700-8557

  • Rijikai Medical Corporation Katayama Medical Clinic

    Okayama, 710-0813

  • Kotobuki Social Medical Corporation Tominaga Clinic

    Osaka, 556-0015

  • The University of Tokyo Hospital

    Tokyo, 113-8655

  • Higashi-Shinjuku Clinic

    Tokyo, 169-0072

Other trials in Japan

Australia9 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Austin Health

    Heidelberg, Victoria, 3084

  • Southern Neurology

    Kogarah, New South Wales, 2217

  • KaRa Institute of Neurological Diseases

    Macquarie Park, New South Wales, 2113

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Alzheimer?s Research Australia

    Nedlands, Western Australia, 6009

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Canada8 sites

  • Centricity Research

    Halifax, Nova Scotia, B3S 1N2

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • Parkwood Institute Main Building

    London, Ontario, N6C0A7

  • Genge Partners Inc.

    Montreal, Quebec, H4A 3T2

  • The Ottawa Memory Clinic

    Ottawa, Ontario, K1Z 1G3

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H 2P4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

France8 sites

  • CHU Amiens Hopital Sud

    Amiens Cedex1, 80054

  • Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

    Bordeaux, 33076

  • Groupement Hospitalier Est - Hôpital Neurologique

    Bron, 69677

  • CHU Dupruytren - Limoges

    Limoges, 87042

  • Hopital Gui de Chauliac

    Montpellier, 34295

  • Ch Pitie Salpetriere

    Paris, 75651

  • Hop Guillaume Et Rene Laennec

    Saint-Herblain, 44800

  • Hôpital Robertsau

    Strasbourg, 67000

Other trials in France

Spain8 sites

  • Fundación ACE

    Barcelona, 08028

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39011

  • Hospital Victoria Eugenia

    Seville, 41009

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Universitario la Fe

    Valencia, 46026

Other trials in Spain

Brazil6 sites

  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME

    Brasília, Federal District, 70200-730

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

  • Clinica Neurologica

    Joinville, Santa Catarina, 89202-190

  • Clinica Clinilive ltda

    Maringá, Paraná, 87013-250

  • Instituto do Cerebro do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-000

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, São Paulo, 09715-090

Other trials in Brazil

Italy5 sites

  • Nuovo Ospedale Civile S. Agostino-Estense

    Modena, Emilia-Romagna, 41126

  • A. O. U. Federico II

    Naples, Campania, 80131

  • AO di Perugia - Ospedale S. Maria della Misericordia

    Perugia, Umbria, 06156

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Ospedale Isola Tiberina - Gemelli Isola

    Rome, Lazio, 00186

Other trials in Italy

Switzerland4 sites

  • Inselspital Bern Medizin Neurologie

    Bern, 3010

  • Hôpitaux universitaires de Genève

    Geneva, 1211

  • CHUV Lausanne Méd.Neurologie

    Lausanne, 1011

  • Ospedale Regionale di Lugano - Civico

    Lugano, 6903

Other trials in Switzerland

Argentina3 sites

  • CIER

    C. A. B. A., C1055AAF

  • Fundacion Scherbovsky

    Mendoza, 5500

  • INECO Neurociencias Orono

    Rosario, Santa Fe Province, S2000DTC

Other trials in Argentina

Denmark3 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200

  • Rigshospitalet, Hukommelsesklinikken

    København Ø, 2100

Other trials in Denmark

Netherlands3 sites

  • Brain Research Center Den Bosch

    's-Hertogenbosch, 5223 LA

  • Brain Research Center B.V

    Amsterdam, 1081 GN

  • Brain Research Center Zwolle

    Zwolle, 8025AZ

Other trials in Netherlands

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 NCT07170150
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 start12 Nov 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
1,060 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07170150
Sponsor's protocol ID
WN45447
Other IDs
2024-518008-33-00
Acronym
TRONTIER 2
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 147 sites in 16 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 147 sites in United States, Germany, South Korea, Poland, United Kingdom and 11 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 NCT07170150.

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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