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

Last updated: February 13, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Dementia

Mental Disability

Mild Cognitive Impairment

Treatment

Placebo

Trontinemab

Clinical Study ID

NCT07170150
WN45447
  • 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: Placebo
Phase: 3
Study Start date:
November 12, 2025
Estimated Completion Date:
June 07, 2028

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Active - Recruiting

  • Southern Neurology

    Kogarah 2161185, New South Wales 2155400 2217
    Australia

    Active - Recruiting

  • KaRa Institute of Neurological Diseases

    Macquarie Park 8347858, New South Wales 2155400 2113
    Australia

    Active - Recruiting

  • Box Hill Hospital

    Box Hill 2174360, Victoria 2145234 3128
    Australia

    Active - Recruiting

  • Austin Health

    Heidelberg 2163654, Victoria 2145234 3084
    Australia

    Active - Recruiting

  • Alfred Hospital

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Active - Recruiting

  • L2 Ip Instituto de Pesquisas Clinicas Ltda ME

    Brasília 3469058, Federal District 3463504 70200-730
    Brazil

    Active - Recruiting

  • Instituto de Neurologia de Curitiba

    Curitiba 3464975, Paraná 3455077 81210-310
    Brazil

    Active - Recruiting

  • Clinica Clinilive ltda

    Maringá 3457671, Paraná 3455077 87013-250
    Brazil

    Active - Recruiting

  • Instituto do Cerebro do Rio Grande do Sul

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90610-000
    Brazil

    Active - Recruiting

  • Okanagan Clinical Trials

    Kelowna 5990579, British Columbia 5909050 V1Y 1Z9
    Canada

    Active - Recruiting

  • Parkwood Institute Main Building

    London 6058560, Ontario 6093943 N6C0A7
    Canada

    Active - Recruiting

  • The Ottawa Memory Clinic

    Ottawa 6094817, Ontario 6093943 K1Z 1G3
    Canada

    Active - Recruiting

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough 6101645, Ontario 6093943 K9H 2P4
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto 6167865, Ontario 6093943 M4N 3M5
    Canada

    Active - Recruiting

  • Genge Partners Inc.

    Montreal 6077243, Quebec 6115047 H4A 3T2
    Canada

    Active - Recruiting

  • Aalborg Universitetshospital

    Aalborg 2624886, 9000
    Denmark

    Active - Recruiting

  • Aarhus Universitetshospital Skejby

    Aarhus N 11746890, 8200
    Denmark

    Active - Recruiting

  • Rigshospitalet, Hukommelsesklinikken

    København Ø 11746747, 2100
    Denmark

    Active - Recruiting

  • CHU Amiens Hopital Sud

    Amiens Cedex1, 80054
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

    Bordeaux 3031582, 33076
    France

    Active - Recruiting

  • Groupement Hospitalier Est - Hôpital Neurologique

    Bron 3029931, 69677
    France

    Active - Recruiting

  • CHU Dupruytren - Limoges

    Limoges 2998286, 87042
    France

    Active - Recruiting

  • Hopital Gui de Chauliac

    Montpellier 2992166, 34295
    France

    Active - Recruiting

  • Ch Pitie Salpetriere

    Paris 2988507, 75651
    France

    Active - Recruiting

  • CHU de Rouen Hopital

    Rouen 2982652, 76031
    France

    Active - Recruiting

  • Hop Guillaume Et Rene Laennec

    Saint-Herblain 2979590, 44800
    France

    Active - Recruiting

  • Hôpital Robertsau

    Strasbourg 2973783, 67000
    France

    Active - Recruiting

  • Universitaetsklinikum Erlangen

    Erlangen 2929567, Bavaria 2951839 91054
    Germany

    Active - Recruiting

  • Ambulates Gesundheitszentrum der Charité GmbH

    Berlin 2950159, 12200
    Germany

    Active - Recruiting

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

    Berlin 2950159, 13125
    Germany

    Active - Recruiting

  • German Center for Neurodegenerative Diseases (DZNE)

    Bonn 2946447, 53127
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln

    Cologne 2886242, 50937
    Germany

    Active - Recruiting

  • Medizinische Fakultät Carl Gustav Carus

    Dresden 2935022, 01307
    Germany

    Active - Recruiting

  • Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

    Homburg/Saar, 66421
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena, Klinik für Neurologie

    Jena 2895044, 07747
    Germany

    Active - Recruiting

  • Universität Leipzig

    Leipzig 2879139, 04103
    Germany

    Active - Recruiting

  • Otto-von-Guericke-Universität Magdeburg

    Magdeburg 2874545, 39120
    Germany

    Active - Recruiting

  • Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie

    Mannheim 2873891, 68159
    Germany

    Active - Recruiting

  • LMU Klinikum, Neurologische Klinik und Poliklinik

    München 2867711, 81377
    Germany

    Active - Recruiting

  • Ludwig-Maximilians-Univ.

    München 2867711, 81377
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster 2867543, 48149
    Germany

    Active - Recruiting

  • Ospedale Isola Tiberina - Gemelli Isola

    Rome 3169070, Lazio 3174976 00186
    Italy

    Active - Recruiting

  • AO di Perugia - Ospedale S. Maria della Misericordia

    Perugia 3171180, Umbria 3165048 06156
    Italy

    Active - Recruiting

  • Brain Attack Center Ota Memorial Hospital

    Hiroshima 1862415, 720-0825
    Japan

    Active - Recruiting

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Hiroshima 1862415, 739-0696
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Hyōgo 2129969, 650-0017
    Japan

    Active - Recruiting

  • Kagawa University Hospital

    Kagawa 1860837, 761-0793
    Japan

    Active - Recruiting

  • Kochi Medical School Hospital

    Kochi 1859146, 783-8505
    Japan

    Active - Recruiting

  • Okayama City Hospital

    Okayama 1854383, 700-8557
    Japan

    Active - Recruiting

  • Rijikai Medical Corporation Katayama Medical Clinic

    Okayama 1854383, 710-0813
    Japan

    Active - Recruiting

  • Kotobuki Social Medical Corporation Tominaga Clinic

    Osaka 1853909, 556-0015
    Japan

    Active - Recruiting

  • Higashi-Shinjuku Clinic

    Tokyo 1850147, 169-0072
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital

    Tokyo 1850147, 113-8655
    Japan

    Active - Recruiting

  • Brain Research Center Den Bosch

    's-Hertogenbosch 2747351, 5223 LA
    Netherlands

    Active - Recruiting

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

    ?cinawa, 59-330
    Poland

    Active - Recruiting

  • Uniwersytet Medyczny w Lodzi

    ?ód?, 92-216
    Poland

    Active - Recruiting

  • Syberka-ClinHouse Sp. z o.o.

    B?dzin, 42-500
    Poland

    Active - Recruiting

  • Podlaskie Centrum Psychogeriatrii

    Bia?ystok, 15-756
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk 3099434, 80-214
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki w Krakowie

    Krakow 3094802, 30-688
    Poland

    Active - Recruiting

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

    Późna 7534652, 61-731
    Poland

    Active - Recruiting

  • Centrum Medyczne "MEDYK"

    Rzeszów 759734, 35-326
    Poland

    Active - Recruiting

  • Senior Sp. Z O.O. Poradnia Psychogeriatryczna

    Sopot 3085151, 81-855
    Poland

    Active - Recruiting

  • NeuroProtect

    Warsaw 756135, 01-684
    Poland

    Active - Recruiting

  • Pusan National University Hospital

    Busan 1838524, 602-739
    South Korea

    Active - Recruiting

  • Chonnam National University Hospital

    Gwangju 1841811, 61469
    South Korea

    Active - Recruiting

  • Ajou University Medical Center

    Gyeonggi-do 6363696, 16499
    South Korea

    Active - Recruiting

  • St. Vincent's Hospital

    Gyeonggi-do 6363696, 442-723
    South Korea

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon 1843564, 21565
    South Korea

    Active - Recruiting

  • Inha University Hospital

    Incheon 1843564, 22332
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si 1897000, 463-707
    South Korea

    Active - Recruiting

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Ewha Womans University Hospital (Seoul)

    Seoul 1835848, 07804
    South Korea

    Active - Recruiting

  • Hanyang University Seoul Hospital

    Seoul 1835848, 04763
    South Korea

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul 1835848, 08308
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander 3109718, Cantabria 3336898 39011
    Spain

    Active - Recruiting

  • Fundación ACE

    Barcelona 3128760, 08028
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, 08041
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Hospital Victoria Eugenia

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocío

    Seville 2510911, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario la Fe

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • ReMind UK

    Bath 2656173, BA1 3NG
    United Kingdom

    Active - Recruiting

  • Re:Cognition Health Birmingham

    Birmingham 2655603, B16 8QQ
    United Kingdom

    Active - Recruiting

  • Scottish Brain Sciences

    Edinburgh 2650225, EH12 9DQ
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth University Hospital Glasgow

    Glasgow 2648579, G51 4TF
    United Kingdom

    Active - Recruiting

  • St George?s Hospital

    London 2643743, SW17 ORE
    United Kingdom

    Active - Recruiting

  • UCL Institute of Neurology

    London 2643743, WC1N 3BG
    United Kingdom

    Active - Recruiting

  • Manchester Mental Health and Social Care Trust

    Manchester 2643123, M13 9WL
    United Kingdom

    Active - Recruiting

  • Warneford Hospital

    Oxford 2640729, OX3 7JX
    United Kingdom

    Active - Recruiting

  • Lancashire and South Cumbria NHS Foundation Trust

    Preston 2639912, PR2 8DW
    United Kingdom

    Active - Recruiting

  • Southampton University Hospitals NHS Trust

    Southampton 2637487, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Banner Alzheimer?s Institute

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Active - Recruiting

  • Healthy Brain Clinic

    Long Beach 5367929, California 5332921 90804
    United States

    Active - Recruiting

  • Oakland Clinical

    Oakland 5378538, California 5332921 94609
    United States

    Active - Recruiting

  • Riverside Clinical

    Riverside 5387877, California 5332921 92506
    United States

    Active - Recruiting

  • Cenexel California Neuroscience Research, LLC

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Active - Recruiting

  • Yale University

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • JEM Research LLC

    Atlantis 4146372, Florida 4155751 33462
    United States

    Active - Recruiting

  • K2 Medical Research-Winter Garden

    Clermont 4151352, Florida 4155751 34711
    United States

    Active - Recruiting

  • Visionary Investigators Network- Neurology Aventura

    Miami 4164138, Florida 4155751 33133
    United States

    Active - Recruiting

  • Charter Research - Winter Park/Orlando

    Orlando 4167147, Florida 4155751 32803
    United States

    Active - Recruiting

  • Conquest Research - Lake Nona

    Orlando 4167147, Florida 4155751 32832
    United States

    Active - Recruiting

  • Alzheimer's Research and Treatment Center

    Stuart 4174201, Florida 4155751 34997
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Decatur 4191124, Georgia 4197000 30030
    United States

    Active - Recruiting

  • Center for Advanced Research & Education

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Active - Recruiting

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

    Chicago 4887398, Illinois 4896861 60640
    United States

    Active - Recruiting

  • Adams Clinical Watertown

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha 5074472, Nebraska 5073708 68198-8440
    United States

    Active - Recruiting

  • The Cognitive and Research Center of New Jersey

    Springfield 5104952, New Jersey 5101760 07081
    United States

    Active - Recruiting

  • AD-CARE, University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14620
    United States

    Active - Recruiting

  • Summit Research Network Inc.

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • Flourish Research ? Philadelphia

    Plymouth Meeting 5206666, Pennsylvania 6254927 19462
    United States

    Active - Recruiting

  • Gadolin Research, LLC

    Beaumont 4672989, Texas 4736286 77702
    United States

    Active - Recruiting

  • Kerwin Medical Center

    Dallas 4684888, Texas 4736286 75216
    United States

    Active - Recruiting

  • Re:Cognition Health - Fort Worth

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Active - Recruiting

  • Mt.Olympus Medical Research

    Katy 4702732, Texas 4736286 77450
    United States

    Active - Recruiting

  • Sana Research, LLC

    Arlington 4744709, Virginia 6254928 22205
    United States

    Active - Recruiting

  • Re:Cognition Health

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

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