A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
TRONTIER 2
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
1,060
16 countries
147
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 Nov 2025
147 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
November 12, 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
2.3 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 (147)
Banner Alzheimer?s Institute
Phoenix, Arizona, 85006, United States
Sun Valley Research Center, Inc.
Imperial, California, 92251, United States
Healthy Brain Clinic
Long Beach, California, 90804, United States
Oakland Clinical
Oakland, California, 94609, United States
Riverside Clinical
Riverside, California, 92506, United States
Cenexel California Neuroscience Research, LLC
Sherman Oaks, California, 91403, United States
Yale University
New Haven, Connecticut, 06510, United States
JEM Research LLC
Atlantis, Florida, 33462, United States
K2 Medical Research-Winter Garden
Clermont, Florida, 34711, United States
Visionary Investigators Network- Neurology Aventura
Miami, Florida, 33133, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, 32803, United States
Conquest Research - Lake Nona
Orlando, Florida, 32832, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, 34996, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville
Chicago, Illinois, 60640, United States
Adams Clinical Boston
Boston, Massachusetts, 02116, United States
Adams Clinical Watertown
Watertown, Massachusetts, 02472, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-8440, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
IMA Clinical Research - Albuquerque
Albuquerque, New Mexico, 87109, United States
AD-CARE, University of Rochester Medical Center
Rochester, New York, 14620, United States
Summit Research Network Inc.
Portland, Oregon, 97210, United States
Flourish Research ? Philadelphia
Plymouth Meeting, Pennsylvania, 19462, United States
Palmetto Clinical Trials
Summerville, South Carolina, 29485, United States
Gadolin Research, LLC
Beaumont, Texas, 77702, United States
Kerwin Medical Center
Dallas, Texas, 75216, United States
Re:Cognition Health - Fort Worth
Fort Worth, Texas, 76104, United States
Mt.Olympus Medical Research
Katy, Texas, 77450, United States
El Faro Health and Therapeutics
Rio Grande City, Texas, 78582, United States
Sana Research, LLC
Arlington, Virginia, 22205, United States
Re:Cognition Health
Fairfax, Virginia, 22031, United States
INECO Neurociencias Orono
Rosario, Santa Fe Province, S2000DTC, Argentina
CIER
C. A. B. A., C1055AAF, Argentina
Fundacion Scherbovsky
Mendoza, 5500, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Southern Neurology
Kogarah, New South Wales, 2217, Australia
KaRa Institute of Neurological Diseases
Macquarie Park, New South Wales, 2113, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Alzheimer?s Research Australia
Nedlands, Western Australia, 6009, Australia
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
Brasília, Federal District, 70200-730, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310, Brazil
Clinica Clinilive ltda
Maringá, Paraná, 87013-250, Brazil
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Clinica Neurologica
Joinville, Santa Catarina, 89202-190, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
Centricity Research
Halifax, Nova Scotia, B3S 1N2, Canada
Parkwood Institute Main Building
London, Ontario, N6C0A7, Canada
The Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H 2P4, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Genge Partners Inc.
Montreal, Quebec, H4A 3T2, Canada
Aalborg Universitetshospital
Aalborg, 9000, Denmark
Aarhus Universitetshospital Skejby
Aarhus N, 8200, Denmark
Rigshospitalet, Hukommelsesklinikken
København Ø, 2100, Denmark
CHU Amiens Hopital Sud
Amiens Cedex1, 80054, France
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
Bordeaux, 33076, France
Groupement Hospitalier Est - Hôpital Neurologique
Bron, 69677, France
CHU Dupruytren - Limoges
Limoges, 87042, France
Hopital Gui de Chauliac
Montpellier, 34295, France
Ch Pitie Salpetriere
Paris, 75651, France
Hop Guillaume Et Rene Laennec
Saint-Herblain, 44800, France
Hôpital Robertsau
Strasbourg, 67000, France
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Ambulates Gesundheitszentrum der Charité GmbH
Berlin, 12200, Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, 13125, Germany
German Center for Neurodegenerative Diseases (DZNE)
Bonn, 53127, Germany
Universitätsklinikum Köln
Cologne, 50937, Germany
Medizinische Fakultät Carl Gustav Carus
Dresden, 01307, Germany
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
Homburg/Saar, 66421, Germany
Universitätsklinikum Jena, Klinik für Neurologie
Jena, 07747, Germany
Universität Leipzig
Leipzig, 04103, Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120, Germany
Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie
Mannheim, 68159, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Neuropraxis München Süd
Unterhaching, 82008, Germany
A. O. U. Federico II
Naples, Campania, 80131, Italy
Nuovo Ospedale Civile S. Agostino-Estense
Modena, Emilia-Romagna, 41126, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
Ospedale Isola Tiberina - Gemelli Isola
Rome, Lazio, 00186, Italy
AO di Perugia - Ospedale S. Maria della Misericordia
Perugia, Umbria, 06156, Italy
Brain Attack Center Ota Memorial Hospital
Hiroshima, 720-0825, Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, 739-0696, Japan
Kobe University Hospital
Hyōgo, 650-0017, Japan
Kagawa University Hospital
Kagawa, 761-0793, Japan
Kochi Medical School Hospital
Kochi, 783-8505, Japan
Okayama City Hospital
Okayama, 700-8557, Japan
Rijikai Medical Corporation Katayama Medical Clinic
Okayama, 710-0813, Japan
Kotobuki Social Medical Corporation Tominaga Clinic
Osaka, 556-0015, Japan
The University of Tokyo Hospital
Tokyo, 113-8655, Japan
Higashi-Shinjuku Clinic
Tokyo, 169-0072, Japan
Brain Research Center Den Bosch
's-Hertogenbosch, 5223 LA, Netherlands
Brain Research Center B.V
Amsterdam, 1081 GN, Netherlands
Brain Research Center Zwolle
Zwolle, 8025AZ, Netherlands
O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
?cinawa, 59-330, Poland
ProNeuro Centrum Medyczne
?ory, 44-240, Poland
Uniwersytet Medyczny w Lodzi
?ód?, 92-216, Poland
Syberka-ClinHouse Sp. z o.o.
B?dzin, 42-500, Poland
Podlaskie Centrum Psychogeriatrii
Bia?ystok, 15-756, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 30-688, Poland
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Późna, 61-731, Poland
Centrum Medyczne "MEDYK"
Rzeszów, 35-326, Poland
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
Sopot, 81-855, Poland
NeuroProtect
Warsaw, 01-684, Poland
Pusan National University Hospital
Busan, 602-739, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Ajou University Medical Center
Gyeonggi-do, 16499, South Korea
St. Vincent's Hospital
Gyeonggi-do, 442-723, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ewha Womans University Hospital (Seoul)
Seoul, 07804, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39011, Spain
Fundación ACE
Barcelona, 08028, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Victoria Eugenia
Seville, 41009, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Universitario la Fe
Valencia, 46026, Spain
Inselspital Bern Medizin Neurologie
Bern, 3010, Switzerland
Hôpitaux universitaires de Genève
Geneva, 1211, Switzerland
CHUV Lausanne Méd.Neurologie
Lausanne, 1011, Switzerland
Ospedale Regionale di Lugano - Civico
Lugano, 6903, Switzerland
ReMind UK
Bath, BA1 3NG, United Kingdom
Re:Cognition Health Birmingham
Birmingham, B16 8QQ, United Kingdom
Scottish Brain Sciences
Edinburgh, EH12 9DQ, United Kingdom
Queen Elizabeth University Hospital Glasgow
Glasgow, G51 4TF, United Kingdom
St George?s Hospital
London, SW17 ORE, United Kingdom
RE:Cognition Health
London, W1G 8TA, United Kingdom
UCL Institute of Neurology
London, WC1N 3BG, United Kingdom
Manchester Mental Health and Social Care Trust
Manchester, M13 9WL, United Kingdom
Warneford Hospital
Oxford, OX3 7JX, United Kingdom
Lancashire and South Cumbria NHS Foundation Trust
Preston, PR2 8DW, United Kingdom
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD, 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
November 12, 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