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A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
NCT07169578 · Hoffmann-La Roche
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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 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
Study design
Enrollment target: 800 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-09-17
Estimated completion: 2028-06-07
Last updated: 2026-04-03
Interventions
Drug: TrontinemabOther: Placebo
Primary outcomes
- • Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) (Baseline - Week 72)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WN45443 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (134)
Banner Sun Health Research InstituteRecruiting
Sun City, Arizona, United States
Inglewood ClinicalsRecruiting
Inglewood, California, United States
Irvine Center for Clinical ResearchRecruiting
Irvine, California, United States
UCSF - Memory and Aging CenterRecruiting
San Francisco, California, United States
Syrentis Clinical ResearchRecruiting
Santa Ana, California, United States
K2 Medical Research - The VillagesRecruiting
Lady Lake, Florida, United States
K2 Medical Research, LLCRecruiting
Maitland, Florida, United States
Renstar Medical ResearchRecruiting
Ocala, Florida, United States
Axiom Brain Health LLCRecruiting
Tampa, Florida, United States
Charter Research - Lady Lake/The VillagesRecruiting
The Villages, Florida, United States
Alzheimer?s Research and Treatment CenterRecruiting
Wellington, Florida, United States
Conquest Research, LLCRecruiting
Winter Park, Florida, United States
Alzheimer's Research and Treatment Center - ColumbusRecruiting
Columbus, Georgia, United States
Accel Research Sites-NeuroStudiesRecruiting
Decatur, Georgia, United States
Hawaii Pacific NeuroscienceRecruiting
Honolulu, Hawaii, United States
RE:Cognition (Chicago)Recruiting
Chicago, Illinois, United States
Boston Center for MemoryRecruiting
Newton, Massachusetts, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
The Cognitive and Research Center of New JerseyRecruiting
Ridgewood, New Jersey, United States
Basil ClinicalRecruiting
Laurelton, New York, United States
Weill Cornell Medical CollegeRecruiting
New York, New York, United States
Adams Clinical HarlemRecruiting
New York, New York, United States
Adams Clinical BronxRecruiting
The Bronx, New York, United States
Triad Clinical TrialsRecruiting
Greensboro, North Carolina, United States
Butler HospitalRecruiting
Providence, Rhode Island, United States
Genesis Neuroscience ClinicRecruiting
Knoxville, Tennessee, United States
K2 Medical Research - NashvilleRecruiting
Nashville, Tennessee, United States
Kerwin Research Center, LLCRecruiting
Dallas, Texas, United States
South Texas Research Institute - EdinburgRecruiting
Edinburg, Texas, United States
Re:Cognition Health - HoustonRecruiting
Houston, Texas, United States
National Clinical Research Inc.-RichmondRecruiting
Richmond, Virginia, United States
Centro de Pesquisas Clinicas - CPCLINRecruiting
São Paulo, São Paulo, Brazil
Richmond Clinical TrialsRecruiting
Richmond, British Columbia, Canada
Baycrest Academy for Research and EducationRecruiting
North YORK, Ontario, Canada
Toronto Memory ProgramRecruiting
Toronto, Ontario, Canada
Centricity East YorkRecruiting
Toronto, Ontario, Canada
Toronto Western HospitalRecruiting
Toronto, Ontario, Canada
Clinique Memoire de MontrealRecruiting
Montreal, Quebec, Canada
Alpha Recherche CliniqueRecruiting
Québec, Canada
The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Xuzhou, Jiangsu, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
Peking University First HospitalRecruiting
Beijing, China
Beijing Friendship Hospital Affiliated of Capital University of Medical ScienceRecruiting
Beijing, China
Beijing Tiantan Hospital,Capital Medical UniversityRecruiting
Beijing, China
Peking University Sixth HospitalRecruiting
Beijing, China
The First Hospital of Jilin UniversityRecruiting
Changchun, China
West China Hospital - Sichuan UniversityRecruiting
Chengdu, China
The First Affiliated Hospital, Chongqing Medical UniversityRecruiting
Chongqing, China
Fujian Medical University Union HospitalRecruiting
Fuzhou, China
Guangdong General HospitalRecruiting
Guangzhou, China
The second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang UniversityRecruiting
Hangzhou, China
The First Affiliated Hospital of Anhui Medical UniversityRecruiting
Hefei, China
Anhui Provincial HospitalRecruiting
Hefei, China
Zhongda Hospital Affiliated to Southeast UniversityRecruiting
Nanjing, China
Nanjing Brain HospitalRecruiting
Nanjing, China
Nanjing First HospitalRecruiting
Nanjing, China
Ruijin Hospital Shanghai Jiaotong University School of MedicineRecruiting
Shanghai, China
Huashan Hospital, Fudan UniversityRecruiting
Shanghai, China
Shanghai First People's HospitalRecruiting
Shanghai, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, China
Shanghai Pudong HospitalRecruiting
Shanghai, China
The Second Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, China
Tianjin Medical University General HospitalRecruiting
Tianjin, China
Hôpital BrocaRecruiting
Le Kremlin Bicétre Cedex, France
Hopital B Roger SalengroRecruiting
Lille, France
Hôpital de la TimoneRecruiting
Marseille, France
Hopital LariboisiereRecruiting
Paris, France
CHU Rennes - Hopital PontchaillouRecruiting
Rennes, France
GerontopoleRecruiting
Toulouse, France
CHRU - Hôpital BretonneauRecruiting
Tours, France
Hôpital de BraboisRecruiting
Vandœuvre-lès-Nancy, France
Hopital des CharpennesRecruiting
Villeurbanne, France
Uniklinik RWTH AachenRecruiting
Aachen, Germany
Zentrum für klinische Forschung Dr. med. Irma SchöllRecruiting
Bad Homburg, Germany
Klinikum Bayreuth Standort Hohe Warte Klinik fur NeurologieRecruiting
Bayreuth, Germany
St. Josef-Hospital, Klinik für NeurologieRecruiting
Bochum, Germany
Gesundheit Nord, Klinikum Bremen-OstRecruiting
Bremen, Germany
NeuroCentrum OdenwaldRecruiting
Erbach/Odenwald, Germany
Universitätsklinikum Freiburg, Klinik für Neurologie und NeurophysiologieRecruiting
Freiburg im Breisgau, Germany
MVZ Rheumatologie und Autoimummedizin Hamburg GmbHRecruiting
Hamburg, Germany
Neurology UKSH Campus KielRecruiting
Kiel, Germany
Klinikum rechts der Isar der TU MünchenRecruiting
München, Germany
Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle BrinckmannRecruiting
Steglitz, Germany
Krankenhaus der Barmherzigen Brüder TrierRecruiting
Trier, Germany
Universitätsklinikum UlmRecruiting
Ulm, Germany
Fondazione Santa Lucia IRCCSRecruiting
Rome, Lazio, Italy
Umberto I Policlinico di Roma-Università di Roma La SapienzaRecruiting
Rome, Lazio, Italy
Azienda Ospedaliero Universitaria San MartinoRecruiting
Genoa, Liguria, Italy
Asst Degli Spedali Civili Di BresciaRecruiting
Brescia, Lombardy, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
Kyoto University HospitalRecruiting
Kyoto, Japan
National Hospital Organization Utano National HospitalRecruiting
Kyoto, Japan
Mishuku HospitalRecruiting
Meguro-Ku, Japan
Mie University HospitalRecruiting
Mie, Japan
Memory Clinic OchanomizuRecruiting
Tokyo, Japan
Keio University HospitalRecruiting
Tokyo, Japan
Tokyo Metropolitan Geriatric HospitalRecruiting
Tokyo, Japan
National Center of Neurology and PsychiatryRecruiting
Tokyo, Japan
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa HospitalRecruiting
Tokyo, Japan
P-One ClinicRecruiting
Tokyo, Japan
Yamagata Tokusyukai HospitalRecruiting
Yamagata, Japan
Centrum Medyczne Neuromed Sp. z.o.o.Recruiting
Bydgoszcz, Poland
NEURO-CARE Sp. z o.o. Sp. KomandytowaRecruiting
Katowice, Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii KRecruiting
Krakow, Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.Recruiting
Lublin, Poland
Nmedis sp. z o.o.Recruiting
Rzeszów, Poland
ETG Neuroscience Sp. z o.o.Recruiting
Warsaw, Poland
Centrum Leczenia Zaburzen PamieciRecruiting
Warsaw, Poland
NZOZ WCARecruiting
Wroc?aw, Poland
SPSK nr 1Recruiting
Zabrze, Poland
Hospital General De CatalunyaRecruiting
Sant Cugat del Vallès, Barcelona, Spain
Hospital Mutua De TerrasaRecruiting
Terrassa, Barcelona, Spain
Policlínica GuipuzcoaRecruiting
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital Universitario de Santa MariaRecruiting
Lleida, Lerida, Spain
Hospital Quiron de MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Reina SofiaRecruiting
Córdoba, Spain
Hospital Universitario de la PrincesaRecruiting
Madrid, Spain
Hospital Universitario Dr. PesetRecruiting
Valencia, Spain
Kaohsiung Medical University HospitalRecruiting
Kaohsiung City, Taiwan
Taipei Medical University ?Shuang Ho HospitalRecruiting
New Taipei City, Taiwan
China Medical University HospitalRecruiting
North Dist., Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Chang Gung Medical Foundation Linkou BranchRecruiting
Taoyuan, Taiwan
Lynfield Mount hospitalRecruiting
Bradford, United Kingdom
Recognition Health BristolRecruiting
Bristol, United Kingdom
Surrey and Borders NHS Foundation TrustRecruiting
Chertsey, United Kingdom
Department of Old Age Psychiatry Kings CollegeRecruiting
London, United Kingdom
RE:Cognition HealthRecruiting
London, United Kingdom
Charing Cross HospitalRecruiting
London, United Kingdom
Campus for Ageing & VitalityRecruiting
Newcastle, United Kingdom
Tees,Esk and Wear Valleys NHS Foundation TrustRecruiting
York, United Kingdom