A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
NCT ID: NCT07170150
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2025-11-12
2028-06-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Trontinemab
Participants will receive intravenous (IV) trontinemab.
Trontinemab
Participants will receive IV trontinemab
Placebo
Participants will receive IV placebo.
Placebo
Participants will receive IV placebo
Interventions
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Trontinemab
Participants will receive IV trontinemab
Placebo
Participants will receive IV placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
90 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
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
Adams Clinical Watertown
Watertown, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States
Summit Research Network Inc.
Portland, Oregon, United States
Flourish Research ? Philadelphia
Plymouth Meeting, Pennsylvania, United States
Kerwin Medical Center
Dallas, Texas, United States
Mt.Olympus Medical Research
Katy, Texas, United States
Re:Cognition Health
Fairfax, Virginia, United States
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
Box Hill Hospital
Box Hill, Victoria, Australia
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
The Ottawa Memory Clinic
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
Aalborg Universitetshospital
Aalborg, , Denmark
Aarhus Universitetshospital Skejby
Aarhus N, , Denmark
Rigshospitalet, Hukommelsesklinikken
København Ø, , Denmark
Groupement Hospitalier Est - Hôpital Neurologique
Bron, , 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
Ambulates Gesundheitszentrum der Charité GmbH
Berlin, , Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Medizinische Fakultät Carl Gustav Carus
Dresden, , Germany
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
Okayama City Hospital
Okayama, , Japan
Rijikai Medical Corporation Katayama Medical Clinic
Okayama, , Japan
Kotobuki Social Medical Corporation Tominaga Clinic
Osaka, , Japan
Higashi-Shinjuku Clinic
Tokyo, , Japan
O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie
?cinawa, , Poland
Uniwersytet Medyczny w Lodzi
?ód?, , Poland
Podlaskie Centrum Psychogeriatrii
Bia?ystok, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Senior Sp. Z O.O. Poradnia Psychogeriatryczna
Sopot, , Poland
NeuroProtect
Warsaw, , Poland
Pusan National University Hospital
Busan, , South Korea
Ajou University Medical Center
Gyeonggi-do, , South Korea
St. Vincent's Hospital
Gyeonggi-do, , South Korea
Inha University Hospital
Incheon, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Ewha Womans University Hospital (Seoul)
Seoul, , South Korea
Fundación ACE
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Hospital Universitario la Fe
Valencia, , Spain
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
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
Countries
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Central Contacts
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Reference Study ID Number: WN45447 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728
Email: [email protected]
Other Identifiers
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WN45447
Identifier Type: -
Identifier Source: org_study_id