TrialPath
← Back to searchRecruiting

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

NCT07170150 · 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: 2025-11-12
Estimated completion: 2028-06-07
Last updated: 2026-04-13
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: WN45447 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (146)
Banner Alzheimer?s InstituteRecruiting
Phoenix, Arizona, United States
Sun Valley Research Center, Inc.Recruiting
Imperial, California, United States
Healthy Brain ClinicRecruiting
Long Beach, California, United States
Oakland ClinicalRecruiting
Oakland, California, United States
Riverside ClinicalRecruiting
Riverside, California, United States
Cenexel California Neuroscience Research, LLCRecruiting
Sherman Oaks, California, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
JEM Research LLCRecruiting
Atlantis, Florida, United States
K2 Medical Research-Winter GardenRecruiting
Clermont, Florida, United States
Visionary Investigators Network- Neurology AventuraRecruiting
Miami, Florida, United States
Charter Research - Winter Park/OrlandoRecruiting
Orlando, Florida, United States
Conquest Research - Lake NonaRecruiting
Orlando, Florida, United States
Alzheimer's Research and Treatment CenterRecruiting
Stuart, Florida, United States
CenExel iResearch, LLCRecruiting
Decatur, Georgia, United States
Center for Advanced Research & EducationRecruiting
Gainesville, Georgia, United States
Great Lakes Clinical Trials Chicago d/b/a Flourish Research AndersonvilleRecruiting
Chicago, Illinois, United States
Adams Clinical BostonRecruiting
Boston, Massachusetts, United States
Adams Clinical WatertownRecruiting
Watertown, Massachusetts, United States
Quest Research InstituteRecruiting
Farmington Hills, Michigan, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
The Cognitive and Research Center of New JerseyRecruiting
Springfield, New Jersey, United States
AD-CARE, University of Rochester Medical CenterRecruiting
Rochester, New York, United States
Summit Research Network Inc.Recruiting
Portland, Oregon, United States
Flourish Research ? PhiladelphiaRecruiting
Plymouth Meeting, Pennsylvania, United States
Gadolin Research, LLCRecruiting
Beaumont, Texas, United States
Kerwin Medical CenterRecruiting
Dallas, Texas, United States
Re:Cognition Health - Fort WorthRecruiting
Fort Worth, Texas, United States
Mt.Olympus Medical ResearchRecruiting
Katy, Texas, United States
El Faro Health and TherapeuticsRecruiting
Rio Grande City, Texas, United States
Sana Research, LLCRecruiting
Arlington, Virginia, United States
Re:Cognition HealthRecruiting
Fairfax, Virginia, United States
Fundacion ScherbovskyRecruiting
Mendoza, Argentina
Royal Prince Alfred HospitalRecruiting
Camperdown, New South Wales, Australia
Southern NeurologyRecruiting
Kogarah, New South Wales, Australia
KaRa Institute of Neurological DiseasesRecruiting
Macquarie Park, New South Wales, Australia
Flinders Medical CentreRecruiting
Bedford Park, South Australia, Australia
Queen Elizabeth HospitalRecruiting
Woodville, South Australia, Australia
Box Hill HospitalRecruiting
Box Hill, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Alzheimer?s Research AustraliaRecruiting
Nedlands, Western Australia, Australia
L2 Ip Instituto de Pesquisas Clinicas Ltda MERecruiting
Brasília, Federal District, Brazil
Instituto de Neurologia de CuritibaRecruiting
Curitiba, Paraná, Brazil
Clinica Clinilive ltdaRecruiting
Maringá, Paraná, Brazil
Instituto do Cerebro do Rio Grande do SulRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Clinica NeurologicaRecruiting
Joinville, Santa Catarina, Brazil
CEMEC - Centro Multidisciplinar de Estudos ClínicosRecruiting
São Bernardo do Campo, São Paulo, Brazil
Okanagan Clinical TrialsRecruiting
Kelowna, British Columbia, Canada
Centricity ResearchRecruiting
Halifax, Nova Scotia, Canada
Parkwood Institute Main BuildingRecruiting
London, Ontario, Canada
The Ottawa Memory ClinicRecruiting
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy AgingRecruiting
Peterborough, Ontario, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
St. Michael's HospitalRecruiting
Toronto, Ontario, Canada
Genge Partners Inc.Recruiting
Montreal, Quebec, Canada
Aalborg UniversitetshospitalRecruiting
Aalborg, Denmark
Aarhus Universitetshospital SkejbyRecruiting
Aarhus N, Denmark
Rigshospitalet, HukommelsesklinikkenRecruiting
København Ø, Denmark
CHU Amiens Hopital SudRecruiting
Amiens Cedex1, France
Centre Hospitalier Universitaire de Bordeaux Hopital PellegrinRecruiting
Bordeaux, France
Groupement Hospitalier Est - Hôpital NeurologiqueRecruiting
Bron, France
CHU Dupruytren - LimogesRecruiting
Limoges, France
Hopital Gui de ChauliacRecruiting
Montpellier, France
Ch Pitie SalpetriereRecruiting
Paris, France
CHU de Rouen HopitalRecruiting
Rouen, France
Hop Guillaume Et Rene LaennecRecruiting
Saint-Herblain, France
Hôpital RobertsauRecruiting
Strasbourg, France
Universitaetsklinikum ErlangenRecruiting
Erlangen, Bavaria, Germany
Ambulates Gesundheitszentrum der Charité GmbHRecruiting
Berlin, Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory ClinicRecruiting
Berlin, Germany
German Center for Neurodegenerative Diseases (DZNE)Recruiting
Bonn, Germany
Universitätsklinikum KölnRecruiting
Cologne, Germany
Medizinische Fakultät Carl Gustav CarusRecruiting
Dresden, Germany
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und PsychotherapieRecruiting
Homburg/Saar, Germany
Universitätsklinikum Jena, Klinik für NeurologieRecruiting
Jena, Germany
Universität LeipzigRecruiting
Leipzig, Germany
Otto-von-Guericke-Universität MagdeburgRecruiting
Magdeburg, Germany
Zentralinstitut für Seelische Gesundheit Abt.GerontopsychiatrieRecruiting
Mannheim, Germany
LMU Klinikum, Neurologische Klinik und PoliklinikRecruiting
München, Germany
Ludwig-Maximilians-Univ.Recruiting
München, Germany
Universitätsklinikum MünsterRecruiting
Münster, Germany
Neuropraxis München SüdRecruiting
Unterhaching, Germany
A. O. U. Federico IIRecruiting
Naples, Campania, Italy
Nuovo Ospedale Civile S. Agostino-EstenseRecruiting
Modena, Emilia-Romagna, Italy
Policlinico Universitario Agostino GemelliRecruiting
Rome, Lazio, Italy
Ospedale Isola Tiberina - Gemelli IsolaRecruiting
Rome, Lazio, Italy
AO di Perugia - Ospedale S. Maria della MisericordiaRecruiting
Perugia, Umbria, Italy
Brain Attack Center Ota Memorial HospitalRecruiting
Hiroshima, Japan
National Hospital Organization Hiroshima-Nishi Medical CenterRecruiting
Hiroshima, Japan
Kobe University HospitalRecruiting
Hyōgo, Japan
Kagawa University HospitalRecruiting
Kagawa, Japan
Kochi Medical School HospitalRecruiting
Kochi, Japan
Okayama City HospitalRecruiting
Okayama, Japan
Rijikai Medical Corporation Katayama Medical ClinicRecruiting
Okayama, Japan
Kotobuki Social Medical Corporation Tominaga ClinicRecruiting
Osaka, Japan
The University of Tokyo HospitalRecruiting
Tokyo, Japan
Higashi-Shinjuku ClinicRecruiting
Tokyo, Japan
Brain Research Center Den BoschRecruiting
's-Hertogenbosch, Netherlands
Brain Research Center B.VRecruiting
Amsterdam, Netherlands
Brain Research Center ZwolleRecruiting
Zwolle, Netherlands
O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawieRecruiting
?cinawa, Poland
ProNeuro Centrum MedyczneRecruiting
?ory, Poland
Uniwersytet Medyczny w LodziRecruiting
?ód?, Poland
Syberka-ClinHouse Sp. z o.o.Recruiting
B?dzin, Poland
Podlaskie Centrum PsychogeriatriiRecruiting
Bia?ystok, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Szpital Uniwersytecki w KrakowieRecruiting
Krakow, Poland
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka KomandytowaRecruiting
Późna, Poland
Centrum Medyczne "MEDYK"Recruiting
Rzeszów, Poland
Senior Sp. Z O.O. Poradnia PsychogeriatrycznaRecruiting
Sopot, Poland
NeuroProtectRecruiting
Warsaw, Poland
Pusan National University HospitalRecruiting
Busan, South Korea
Chonnam National University HospitalRecruiting
Gwangju, South Korea
Ajou University Medical CenterRecruiting
Gyeonggi-do, South Korea
St. Vincent's HospitalRecruiting
Gyeonggi-do, South Korea
Gachon University Gil Medical CenterRecruiting
Incheon, South Korea
Inha University HospitalRecruiting
Incheon, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, South Korea
Hanyang University Seoul HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Ewha Womans University Hospital (Seoul)Recruiting
Seoul, South Korea
Korea University Guro HospitalRecruiting
Seoul, South Korea
Hospital Universitario Marques de ValdecillaRecruiting
Santander, Cantabria, Spain
Fundación ACERecruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Victoria EugeniaRecruiting
Seville, Spain
Hospital Virgen del RocíoRecruiting
Seville, Spain
Hospital Universitario la FeRecruiting
Valencia, Spain
Inselspital Bern Medizin NeurologieRecruiting
Bern, Switzerland
Hôpitaux universitaires de GenèveRecruiting
Geneva, Switzerland
CHUV Lausanne Méd.NeurologieRecruiting
Lausanne, Switzerland
Ospedale Regionale di Lugano - CivicoRecruiting
Lugano, Switzerland
ReMind UKRecruiting
Bath, United Kingdom
Re:Cognition Health BirminghamRecruiting
Birmingham, United Kingdom
Scottish Brain SciencesRecruiting
Edinburgh, United Kingdom
Queen Elizabeth University Hospital GlasgowRecruiting
Glasgow, United Kingdom
St George?s HospitalRecruiting
London, United Kingdom
RE:Cognition HealthRecruiting
London, United Kingdom
UCL Institute of NeurologyRecruiting
London, United Kingdom
Manchester Mental Health and Social Care TrustRecruiting
Manchester, United Kingdom
Warneford HospitalRecruiting
Oxford, United Kingdom
Lancashire and South Cumbria NHS Foundation TrustRecruiting
Preston, United Kingdom
Southampton University Hospitals NHS TrustRecruiting
Southampton, United Kingdom
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease · TrialPath