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A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Sponsor: Hoffmann-La Roche
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).
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)
Key Details
Gender
All
Age Range
50 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2025-11-12
Completion Date
2028-06-07
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Trontinemab
Participants will receive IV trontinemab
Placebo
Participants will receive IV placebo
Locations (135)
Banner Alzheimer?s Institute
Phoenix, Arizona, United States
Sun Valley Research Center, Inc.
Imperial, California, United States
Healthy Brain Clinic
Long Beach, California, United States
Oakland Clinical
Oakland, California, United States
Riverside Clinical
Riverside, California, United States
Cenexel California Neuroscience Research, LLC
Sherman Oaks, California, United States
Yale University
New Haven, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
K2 Medical Research-Winter Garden
Clermont, Florida, United States
Visionary Investigators Network- Neurology Aventura
Miami, Florida, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, United States
Conquest Research - Lake Nona
Orlando, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville
Chicago, Illinois, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
AD-CARE, University of Rochester Medical Center
Rochester, New York, United States
Summit Research Network Inc.
Portland, Oregon, United States
Flourish Research ? Philadelphia
Plymouth Meeting, Pennsylvania, United States
Gadolin Research, LLC
Beaumont, Texas, United States
Kerwin Medical Center
Dallas, Texas, United States
Re:Cognition Health - Fort Worth
Fort Worth, Texas, United States
Mt.Olympus Medical Research
Katy, Texas, United States
Sana Research, LLC
Arlington, Virginia, United States
Re:Cognition Health
Fairfax, Virginia, United States
Fundacion Scherbovsky
Mendoza, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Southern Neurology
Kogarah, New South Wales, Australia
KaRa Institute of Neurological Diseases
Macquarie Park, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
Brasília, Federal District, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Clinica Clinilive ltda
Maringá, Paraná, Brazil
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Neurologica
Joinville, Santa Catarina, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, Brazil
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Parkwood Institute Main Building
London, Ontario, Canada
The Ottawa Memory Clinic
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Genge Partners Inc.
Montreal, Quebec, Canada
Aalborg Universitetshospital
Aalborg, Denmark
Aarhus Universitetshospital Skejby
Aarhus N, Denmark
Rigshospitalet, Hukommelsesklinikken
København Ø, Denmark
CHU Amiens Hopital Sud
Amiens Cedex1, France
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
Bordeaux, France
Groupement Hospitalier Est - Hôpital Neurologique
Bron, France
CHU Dupruytren - Limoges
Limoges, France
Hopital Gui de Chauliac
Montpellier, France
Ch Pitie Salpetriere
Paris, France
CHU de Rouen Hopital
Rouen, France
Hop Guillaume Et Rene Laennec
Saint-Herblain, France
Hôpital Robertsau
Strasbourg, France
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
Ambulates Gesundheitszentrum der Charité GmbH
Berlin, Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, Germany
German Center for Neurodegenerative Diseases (DZNE)
Bonn, Germany
Universitätsklinikum Köln
Cologne, Germany
Medizinische Fakultät Carl Gustav Carus
Dresden, Germany
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
Homburg/Saar, Germany
Universitätsklinikum Jena, Klinik für Neurologie
Jena, Germany
Universität Leipzig
Leipzig, Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany
Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie
Mannheim, Germany
LMU Klinikum, Neurologische Klinik und Poliklinik
München, Germany
Ludwig-Maximilians-Univ.
München, Germany
Universitätsklinikum Münster
Münster, Germany
Ospedale Isola Tiberina - Gemelli Isola
Rome, Lazio, Italy
AO di Perugia - Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
Brain Attack Center Ota Memorial Hospital
Hiroshima, Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, Japan
Kobe University Hospital
Hyōgo, Japan
Kagawa University Hospital
Kagawa, Japan
Kochi Medical School Hospital
Kochi, Japan
Okayama City Hospital
Okayama, Japan
Rijikai Medical Corporation Katayama Medical Clinic
Okayama, Japan
Kotobuki Social Medical Corporation Tominaga Clinic
Osaka, Japan
The University of Tokyo Hospital
Tokyo, Japan
Higashi-Shinjuku Clinic
Tokyo, Japan
Brain Research Center Den Bosch
's-Hertogenbosch, Netherlands
Brain Research Center B.V
Amsterdam, Netherlands
Brain Research Center Zwolle
Zwolle, Netherlands
O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
?cinawa, Poland
ProNeuro Centrum Medyczne
?ory, Poland
Uniwersytet Medyczny w Lodzi
?ód?, Poland
Syberka-ClinHouse Sp. z o.o.
B?dzin, Poland
Podlaskie Centrum Psychogeriatrii
Bia?ystok, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Poland
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Późna, Poland
Centrum Medyczne "MEDYK"
Rzeszów, Poland
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
Sopot, Poland
NeuroProtect
Warsaw, Poland
Pusan National University Hospital
Busan, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Ajou University Medical Center
Gyeonggi-do, South Korea
St. Vincent's Hospital
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Ewha Womans University Hospital (Seoul)
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Fundación ACE
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Victoria Eugenia
Seville, Spain
Hospital Virgen del Rocío
Seville, Spain
Hospital Universitario la Fe
Valencia, Spain
Hôpitaux universitaires de Genève
Geneva, Switzerland
ReMind UK
Bath, United Kingdom
Re:Cognition Health Birmingham
Birmingham, United Kingdom
Scottish Brain Sciences
Edinburgh, United Kingdom
Queen Elizabeth University Hospital Glasgow
Glasgow, United Kingdom
St George?s Hospital
London, United Kingdom
RE:Cognition Health
London, United Kingdom
UCL Institute of Neurology
London, United Kingdom
Manchester Mental Health and Social Care Trust
Manchester, United Kingdom
Warneford Hospital
Oxford, United Kingdom
Lancashire and South Cumbria NHS Foundation Trust
Preston, United Kingdom
Southampton University Hospitals NHS Trust
Southampton, United Kingdom