A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
TRONTIER 1
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)
2 other identifiers
interventional
1,101
13 countries
142
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2025
CompletedFirst Posted
Study publicly available on registry
September 12, 2025
CompletedStudy Start
First participant enrolled
September 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 16, 2028
September 25, 2026
September 1, 2026
2.4 years
September 10, 2025
September 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Baseline - Week 72
Secondary Outcomes (15)
Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
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
Baseline - Week 72
Change From Baseline Through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)
Baseline - Week 72
Change From Baseline Through Week 72 in Mini-Mental State Examination (MMSE)
Baseline - Week 72
Change From Baseline in CDR-SB
Baseline up to but excluding Week 72
- +10 more secondary outcomes
Study Arms (2)
Trontinemab
EXPERIMENTALParticipants will receive intravenous (IV) trontinemab.
Placebo
PLACEBO COMPARATORParticipants will receive IV placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (142)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Irvine Center for Clinical Research
Irvine, California, 92614, United States
Inglewood Clinicals
Los Angeles, California, 90056, United States
UCSF - Memory and Aging Center
San Francisco, California, 94158, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
K2 Medical Research - The Villages
Lady Lake, Florida, 32159, United States
K2 Medical Research, LLC
Maitland, Florida, 32751, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Axiom Brain Health LLC
Tampa, Florida, 33609, United States
Charter Research - Lady Lake/The Villages
The Villages, Florida, 32162, United States
Alzheimer?s Research and Treatment Center
Wellington, Florida, 33414, United States
Conquest Research, LLC
Winter Park, Florida, 32789, United States
Alzheimer's Research and Treatment Center - Columbus
Columbus, Georgia, 31904, United States
Accel Research Sites-NeuroStudies
Decatur, Georgia, 30030, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
RE:Cognition (Chicago)
Chicago, Illinois, 60611, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The Cognitive and Research Center of New Jersey
Ridgewood, New Jersey, 07450, United States
Basil Clinical
Laurelton, New York, 11413-2016, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Adams Clinical Harlem
New York, New York, 10029, United States
Adams Clinical Bronx
The Bronx, New York, 10461, United States
Triad Clinical Trials
Greensboro, North Carolina, 27410, United States
Ohio State University
Columbus, Ohio, 43221, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Genesis Neuroscience Clinic
Knoxville, Tennessee, 37909, United States
K2 Medical Research - Nashville
Nashville, Tennessee, 37204, United States
Kerwin Research Center, LLC
Dallas, Texas, 75231, United States
South Texas Research Institute - Edinburg
Edinburg, Texas, 78539, United States
Re:Cognition Health - Houston
Houston, Texas, 77030, United States
National Clinical Research Inc.-Richmond
Richmond, Virginia, 23294, United States
Hospital Italiano
CABA, C1199ABA, Argentina
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, 31270-901, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, 01228-200, Brazil
Richmond Clinical Trials
Richmond, British Columbia, V6V 2L1, Canada
Baycrest Academy for Research and Education
North YORK, Ontario, M6A 2E1, Canada
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
Centricity East York
Toronto, Ontario, M4G 3E8, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Clinique Memoire de Montreal
Montreal, Quebec, H2X 3B9, Canada
Alpha Recherche Clinique
Québec, G3K 2P8, Canada
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Peking University First Hospital
Beijing, 100034, China
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing, 100050, China
Beijing Tiantan Hospital,Capital Medical University
Beijing, 100050, China
Peking University Sixth Hospital
Beijing, 100083, China
The First Hospital of Jilin University
Changchun, 130021, China
West China Hospital - Sichuan University
Chengdu, 610047, China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Guangdong General Hospital
Guangzhou, 510030, China
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510260, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Anhui Provincial Hospital
Hefei, 230088, China
Zhongda Hospital Affiliated to Southeast University
Nanjing, 210009, China
Nanjing Brain Hospital
Nanjing, 210029, China
Nanjing First Hospital
Nanjing, 210029, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
Shanghai First People's Hospital
Shanghai, 200080, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200233, China
Shanghai Pudong Hospital
Shanghai, 201399, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Hôpital Broca
Le Kremlin Bicétre Cedex, 94275, France
Hopital B Roger Salengro
Lille, 59037, France
Hôpital de la Timone
Marseille, 13385, France
Hopital Lariboisiere
Paris, 75475, France
CHU Rennes - Hopital Pontchaillou
Rennes, 35033, France
Gerontopole
Toulouse, 31059, France
CHRU - Hôpital Bretonneau
Tours, 37000, France
Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500, France
Hopital des Charpennes
Villeurbanne, 69100, France
Uniklinik RWTH Aachen
Aachen, 52074, Germany
Zentrum für klinische Forschung Dr. med. Irma Schöll
Bad Homburg, 61348, Germany
Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie
Bayreuth, 95445, Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum, 44791, Germany
Gesundheit Nord, Klinikum Bremen-Ost
Bremen, 28325, Germany
NeuroCentrum Odenwald
Erbach/Odenwald, 64711, Germany
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Freiburg im Breisgau, 79106, Germany
MVZ Rheumatologie und Autoimummedizin Hamburg GmbH
Hamburg, 20095, Germany
Neurology UKSH Campus Kiel
Kiel, 24105, Germany
Klinikum rechts der Isar der TU München
München, 81675, Germany
Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
Steglitz, 12163, Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, 54292, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Fondazione Santa Lucia IRCCS
Rome, Lazio, 00179, Italy
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, 00185, Italy
Azienda Ospedaliero Universitaria San Martino
Genoa, Liguria, 16132, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25123, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Kyoto University Hospital
Kyoto, 606-8507, Japan
National Hospital Organization Utano National Hospital
Kyoto, 616-8255, Japan
Mishuku Hospital
Meguro-Ku, 153-0051, Japan
Mie University Hospital
Mie, 514-8507, Japan
Memory Clinic Ochanomizu
Tokyo, 113-0034, Japan
Keio University Hospital
Tokyo, 160-8582, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Tokyo, 173-0015, Japan
National Center of Neurology and Psychiatry
Tokyo, 187-8551, Japan
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tokyo, 190-8531, Japan
P-One Clinic
Tokyo, 192-0071, Japan
Yamagata Tokusyukai Hospital
Yamagata, 990-0834, Japan
Centrum Medyczne Neuromed Sp. z.o.o.
Bydgoszcz, 85-163, Poland
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Katowice, 40-749, Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow, 31-505, Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, 20-410, Poland
Nmedis sp. z o.o.
Rzeszów, 35-323, Poland
ETG Neuroscience Sp. z o.o.
Warsaw, 02-677, Poland
Centrum Leczenia Zaburzen Pamieci
Warsaw, 03-839, Poland
NZOZ WCA
Wroc?aw, 53-659, Poland
SPSK nr 1
Zabrze, 41-800, Poland
Hospital General De Catalunya
Sant Cugat del Vallès, Barcelona, 8195, Spain
Hospital Mutua De Terrasa
Terrassa, Barcelona, 08222, Spain
Policlínica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Hospital Universitario de Santa Maria
Lleida, Lerida, 25198, Spain
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Taipei Medical University ?Shuang Ho Hospital
New Taipei City, 23561, Taiwan
China Medical University Hospital
North Dist., 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan City, 333, Taiwan
Lynfield Mount hospital
Bradford, BD9 6DP, United Kingdom
Recognition Health Bristol
Bristol, BS32 4SY, United Kingdom
Surrey and Borders NHS Foundation Trust
Chertsey, KT16 9AU, United Kingdom
Department of Old Age Psychiatry Kings College
London, SE5 8AF, United Kingdom
RE:Cognition Health
London, W1G 8TA, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Campus for Ageing & Vitality
Newcastle, NE4 5PL, United Kingdom
Tees,Esk and Wear Valleys NHS Foundation Trust
York, YO31 8TA, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2025
First Posted
September 12, 2025
Study Start
September 17, 2025
Primary Completion (Estimated)
February 16, 2028
Study Completion (Estimated)
February 16, 2028
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
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