A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
NCT ID: NCT07169578
Last Updated: 2025-11-10
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
2025-09-17
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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Inglewood Clinicals
Inglewood, California, United States
Irvine Center for Clinical Research
Irvine, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
K2 Medical Research - The Villages
Lady Lake, Florida, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Axiom Brain Health LLC
Tampa, Florida, United States
Charter Research - Lady Lake/The Villages
The Villages, Florida, United States
Alzheimer?s Research and Treatment Center
Wellington, Florida, United States
Conquest Research, LLC
Winter Park, Florida, United States
Accel Research Sites-NeuroStudies
Decatur, Georgia, United States
Basil Clinical
Laurelton, New York, United States
Adams Clinical Harlem
New York, New York, United States
Triad Clinical Trials
Greensboro, North Carolina, United States
Kerwin Research Center, LLC
Dallas, Texas, United States
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States
Richmond Clinical Trials
Richmond, British Columbia, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Huashan Hospital, Fudan University
Shanghai, , China
National Hospital Organization Utano National Hospital
Kyoto, , Japan
Mie University Hospital
Mie, , Japan
Memory Clinic Ochanomizu
Tokyo, , Japan
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tokyo, , Japan
Yamagata Tokusyukai Hospital
Yamagata, , Japan
Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Recognition Health Bristol
Bristol, , United Kingdom
Surrey and Borders NHS Foundation Trust
Chertsey, , United Kingdom
RE:Cognition Health
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: WN45443 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728
Email: [email protected]
Other Identifiers
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2024-518006-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
WN45443
Identifier Type: -
Identifier Source: org_study_id