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Hope for early Alzheimer's: large trial of trontinemab begins

NCT ID NCT07170150

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 4 times

Summary

This Phase 3 trial tests whether trontinemab can slow down Alzheimer's in people with early symptoms like mild memory problems. About 800 volunteers will receive either the drug or a placebo by IV for 72 weeks. The study measures changes in thinking, daily function, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trontinemab
What this could lead to
If it works, this could slow memory loss and daily function decline in early Alzheimer's, offering a new treatment option.
What could go wrong
This is still experimental. Even in Phase 3, the drug may fail to show benefit or cause side effects. Results are years away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimers disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    110 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A. O. U. Federico II

    RECRUITING

    Naples, Campania, 80131, Italy

  • AD-CARE, University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14620, United States

  • AO di Perugia - Ospedale S. Maria della Misericordia

    ACTIVE_NOT_RECRUITING

    Perugia, Umbria, 06156, Italy

  • Aalborg Universitetshospital

    RECRUITING

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital Skejby

    RECRUITING

    Aarhus N, 8200, Denmark

  • Adams Clinical Boston

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Adams Clinical Watertown

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Ajou University Medical Center

    ACTIVE_NOT_RECRUITING

    Gyeonggi-do, 16499, South Korea

  • Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Alzheimer's Research and Treatment Center

    RECRUITING

    Stuart, Florida, 34996, United States

  • Alzheimer?s Research Australia

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Ambulates Gesundheitszentrum der Charité GmbH

    RECRUITING

    Berlin, 12200, Germany

  • Asan Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 05505, South Korea

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Banner Alzheimer?s Institute

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Brain Attack Center Ota Memorial Hospital

    RECRUITING

    Hiroshima, 720-0825, Japan

  • Brain Research Center B.V

    ACTIVE_NOT_RECRUITING

    Amsterdam, 1081 GN, Netherlands

  • Brain Research Center Den Bosch

    ACTIVE_NOT_RECRUITING

    's-Hertogenbosch, 5223 LA, Netherlands

  • Brain Research Center Zwolle

    ACTIVE_NOT_RECRUITING

    Zwolle, 8025AZ, Netherlands

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    RECRUITING

    São Bernardo do Campo, São Paulo, 09715-090, Brazil

  • CHU Amiens Hopital Sud

    ACTIVE_NOT_RECRUITING

    Amiens Cedex1, 80054, France

  • CHU Dupruytren - Limoges

    ACTIVE_NOT_RECRUITING

    Limoges, 87042, France

  • CHU de Rouen Hopital

    WITHDRAWN

    Rouen, 76031, France

  • CHUV Lausanne Méd.Neurologie

    ACTIVE_NOT_RECRUITING

    Lausanne, 1011, Switzerland

  • CIER

    RECRUITING

    C. A. B. A., C1055AAF, Argentina

  • CenExel iResearch, LLC

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Cenexel California Neuroscience Research, LLC

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Center for Advanced Research & Education

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

    ACTIVE_NOT_RECRUITING

    Bordeaux, 33076, France

  • Centricity Research

    RECRUITING

    Halifax, Nova Scotia, B3S 1N2, Canada

  • Centrum Medyczne "MEDYK"

    ACTIVE_NOT_RECRUITING

    Rzeszów, 35-326, Poland

  • Ch Pitie Salpetriere

    ACTIVE_NOT_RECRUITING

    Paris, 75651, France

  • Charter Research - Winter Park/Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Chonnam National University Hospital

    ACTIVE_NOT_RECRUITING

    Gwangju, 61469, South Korea

  • Clinica Clinilive ltda

    RECRUITING

    Maringá, Paraná, 87013-250, Brazil

  • Clinica Neurologica

    RECRUITING

    Joinville, Santa Catarina, 89202-190, Brazil

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

    ACTIVE_NOT_RECRUITING

    Późna, 61-731, Poland

  • Conquest Research - Lake Nona

    RECRUITING

    Orlando, Florida, 32832, United States

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

    RECRUITING

    Berlin, 13125, Germany

  • El Faro Health and Therapeutics

    RECRUITING

    Rio Grande City, Texas, 78582, United States

  • Ewha Womans University Hospital (Seoul)

    ACTIVE_NOT_RECRUITING

    Seoul, 07804, South Korea

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Flourish Research ? Philadelphia

    RECRUITING

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Fundacion Scherbovsky

    RECRUITING

    Mendoza, 5500, Argentina

  • Fundación ACE

    RECRUITING

    Barcelona, 08028, Spain

  • Gachon University Gil Medical Center

    ACTIVE_NOT_RECRUITING

    Incheon, 21565, South Korea

  • Gadolin Research, LLC

    RECRUITING

    Beaumont, Texas, 77702, United States

  • Genge Partners Inc.

    RECRUITING

    Montreal, Quebec, H4A 3T2, Canada

  • German Center for Neurodegenerative Diseases (DZNE)

    RECRUITING

    Bonn, 53127, Germany

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

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Groupement Hospitalier Est - Hôpital Neurologique

    ACTIVE_NOT_RECRUITING

    Bron, 69677, France

  • Hanyang University Seoul Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, 04763, South Korea

  • Healthy Brain Clinic

    RECRUITING

    Long Beach, California, 90804, United States

  • Higashi-Shinjuku Clinic

    RECRUITING

    Tokyo, 169-0072, Japan

  • Hop Guillaume Et Rene Laennec

    ACTIVE_NOT_RECRUITING

    Saint-Herblain, 44800, France

  • Hopital Gui de Chauliac

    ACTIVE_NOT_RECRUITING

    Montpellier, 34295, France

  • Hospital Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Marques de Valdecilla

    RECRUITING

    Santander, Cantabria, 39011, Spain

  • Hospital Universitario la Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Victoria Eugenia

    RECRUITING

    Seville, 41009, Spain

  • Hospital Virgen del Rocío

    RECRUITING

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Hôpital Robertsau

    ACTIVE_NOT_RECRUITING

    Strasbourg, 67000, France

  • Hôpitaux universitaires de Genève

    ACTIVE_NOT_RECRUITING

    Geneva, 1211, Switzerland

  • IMA Clinical Research - Albuquerque

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • INECO Neurociencias Orono

    RECRUITING

    Rosario, Santa Fe Province, S2000DTC, Argentina

  • Inha University Hospital

    ACTIVE_NOT_RECRUITING

    Incheon, 22332, South Korea

  • Inselspital Bern Medizin Neurologie

    ACTIVE_NOT_RECRUITING

    Bern, 3010, Switzerland

  • Instituto de Neurologia de Curitiba

    RECRUITING

    Curitiba, Paraná, 81210-310, Brazil

  • Instituto do Cerebro do Rio Grande do Sul

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • JEM Research LLC

    RECRUITING

    Atlantis, Florida, 33462, United States

  • K2 Medical Research-Winter Garden

    RECRUITING

    Clermont, Florida, 34711, United States

  • KaRa Institute of Neurological Diseases

    RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • Kagawa University Hospital

    RECRUITING

    Kagawa, 761-0793, Japan

  • Kawartha Centre - Redefining Healthy Aging

    RECRUITING

    Peterborough, Ontario, K9H 2P4, Canada

  • Kerwin Medical Center

    RECRUITING

    Dallas, Texas, 75216, United States

  • Kobe University Hospital

    RECRUITING

    Hyōgo, 650-0017, Japan

  • Kochi Medical School Hospital

    RECRUITING

    Kochi, 783-8505, Japan

  • Korea University Guro Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, 08308, South Korea

  • Kotobuki Social Medical Corporation Tominaga Clinic

    RECRUITING

    Osaka, 556-0015, Japan

  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME

    RECRUITING

    Brasília, Federal District, 70200-730, Brazil

  • LMU Klinikum, Neurologische Klinik und Poliklinik

    RECRUITING

    München, 81377, Germany

  • Lancashire and South Cumbria NHS Foundation Trust

    RECRUITING

    Preston, PR2 8DW, United Kingdom

  • Ludwig-Maximilians-Univ.

    WITHDRAWN

    München, 81377, Germany

  • Manchester Mental Health and Social Care Trust

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Medizinische Fakultät Carl Gustav Carus

    RECRUITING

    Dresden, 01307, Germany

  • Mt.Olympus Medical Research

    RECRUITING

    Katy, Texas, 77450, United States

  • National Hospital Organization Hiroshima-Nishi Medical Center

    RECRUITING

    Hiroshima, 739-0696, Japan

  • NeuroProtect

    ACTIVE_NOT_RECRUITING

    Warsaw, 01-684, Poland

  • Neuropraxis München Süd

    RECRUITING

    Unterhaching, 82008, Germany

  • Nuovo Ospedale Civile S. Agostino-Estense

    RECRUITING

    Modena, Emilia-Romagna, 41126, Italy

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

    ACTIVE_NOT_RECRUITING

    ?cinawa, 59-330, Poland

  • Oakland Clinical

    RECRUITING

    Oakland, California, 94609, United States

  • Okanagan Clinical Trials

    RECRUITING

    Kelowna, British Columbia, V1Y 1Z9, Canada

  • Okayama City Hospital

    RECRUITING

    Okayama, 700-8557, Japan

  • Ospedale Isola Tiberina - Gemelli Isola

    RECRUITING

    Rome, Lazio, 00186, Italy

  • Ospedale Regionale di Lugano - Civico

    ACTIVE_NOT_RECRUITING

    Lugano, 6903, Switzerland

  • Otto-von-Guericke-Universität Magdeburg

    RECRUITING

    Magdeburg, 39120, Germany

  • Palmetto Clinical Trials

    RECRUITING

    Summerville, South Carolina, 29485, United States

  • Parkwood Institute Main Building

    RECRUITING

    London, Ontario, N6C0A7, Canada

  • Podlaskie Centrum Psychogeriatrii

    ACTIVE_NOT_RECRUITING

    Bia?ystok, 15-756, Poland

  • Policlinico Universitario Agostino Gemelli

    RECRUITING

    Rome, Lazio, 00168, Italy

  • ProNeuro Centrum Medyczne

    ACTIVE_NOT_RECRUITING

    ?ory, 44-240, Poland

  • Pusan National University Hospital

    ACTIVE_NOT_RECRUITING

    Busan, 602-739, South Korea

  • Queen Elizabeth Hospital

    RECRUITING

    Woodville, South Australia, 5011, Australia

  • Queen Elizabeth University Hospital Glasgow

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Quest Research Institute

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • RE:Cognition Health

    RECRUITING

    London, W1G 8TA, United Kingdom

  • Re:Cognition Health

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Re:Cognition Health - Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Re:Cognition Health Birmingham

    RECRUITING

    Birmingham, B16 8QQ, United Kingdom

  • ReMind UK

    RECRUITING

    Bath, BA1 3NG, United Kingdom

  • Rigshospitalet, Hukommelsesklinikken

    RECRUITING

    København Ø, 2100, Denmark

  • Rijikai Medical Corporation Katayama Medical Clinic

    RECRUITING

    Okayama, 710-0813, Japan

  • Riverside Clinical

    RECRUITING

    Riverside, California, 92506, United States

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 06351, South Korea

  • Sana Research, LLC

    RECRUITING

    Arlington, Virginia, 22205, United States

  • Scottish Brain Sciences

    RECRUITING

    Edinburgh, EH12 9DQ, United Kingdom

  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna

    ACTIVE_NOT_RECRUITING

    Sopot, 81-855, Poland

  • Seoul National University Bundang Hospital

    ACTIVE_NOT_RECRUITING

    Seongnam-si, 463-707, South Korea

  • Southampton University Hospitals NHS Trust

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • Southern Neurology

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • St George?s Hospital

    RECRUITING

    London, SW17 ORE, United Kingdom

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • St. Vincent's Hospital

    ACTIVE_NOT_RECRUITING

    Gyeonggi-do, 442-723, South Korea

  • Summit Research Network Inc.

    RECRUITING

    Portland, Oregon, 97210, United States

  • Sun Valley Research Center, Inc.

    RECRUITING

    Imperial, California, 92251, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Syberka-ClinHouse Sp. z o.o.

    RECRUITING

    B?dzin, 42-500, Poland

  • Szpital Uniwersytecki w Krakowie

    ACTIVE_NOT_RECRUITING

    Krakow, 30-688, Poland

  • The Cognitive and Research Center of New Jersey

    RECRUITING

    Springfield, New Jersey, 07081, United States

  • The Ottawa Memory Clinic

    RECRUITING

    Ottawa, Ontario, K1Z 1G3, Canada

  • The University of Tokyo Hospital

    RECRUITING

    Tokyo, 113-8655, Japan

  • UCL Institute of Neurology

    RECRUITING

    London, WC1N 3BG, United Kingdom

  • Universitaetsklinikum Erlangen

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198-8440, United States

  • Universität Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Jena, Klinik für Neurologie

    RECRUITING

    Jena, 07747, Germany

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, 50937, Germany

  • Universitätsklinikum Münster

    RECRUITING

    Münster, 48149, Germany

  • Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

    RECRUITING

    Homburg/Saar, 66421, Germany

  • Uniwersyteckie Centrum Kliniczne

    ACTIVE_NOT_RECRUITING

    Gdansk, 80-214, Poland

  • Uniwersytet Medyczny w Lodzi

    ACTIVE_NOT_RECRUITING

    ?ód?, 92-216, Poland

  • Visionary Investigators Network- Neurology Aventura

    RECRUITING

    Miami, Florida, 33133, United States

  • Warneford Hospital

    RECRUITING

    Oxford, OX3 7JX, United Kingdom

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie

    RECRUITING

    Mannheim, 68159, Germany

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