Actively Recruiting
Phase III Study of Intravenous Trontinemab Compared to Placebo in Early Symptomatic Alzheimers Disease
Led by Hoffmann-La Roche · Updated on 2026-05-11
800
Participants Needed
150
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 years who have early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia. The study is a phase III trial designed to compare trontinemab with a placebo to better understand its impact on cognitive decline in Alzheimers patients. Participants will be randomly assigned to receive either intravenous IV trontinemab or an IV placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Treatment and monitoring will continue for 72 weeks, during which various cognitive and biological measures will be assessed. Throughout the study, participants will undergo regular assessments including cognitive tests like the Clinical Dementia Rating, Sum of Boxes CDR-SB, and the Mini-Mental State Examination MMSE. Brain imaging scans such as amyloid and tau PET scans, as well as MRI, will be used to observe changes in brain pathology. Researchers will also monitor safety by tracking adverse events, infusion reactions, and the presence of antibodies against trontinemab. Participants will be supported by a study partner and will be closely followed during the entire study period.
CONDITIONS
Brief Title
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness and ability to complete all study aspects including MRI, genotyping, and PET imaging or CSF for the study duration
- Adequate vision and hearing to perform neuropsychological testing (with aids allowed)
- Confirmed Alzheimer's disease pathology by amyloid PET scan or CSF tau181/Aβ42 ratio
- Probable Alzheimer's dementia or mild cognitive impairment due to Alzheimer's (clinical Stage 3 or 4)
- Screening Mini-Mental State Examination (MMSE) score of 22 or higher and Clinical Dementia Rating Global Score (CDR-GS) of 0.5 or 1.0
- History of gradual cognitive decline over the past year reported by participant or informant
- Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or higher
- Availability of a study partner as defined by the protocol
You will not qualify if you...
- Any condition other than Alzheimer's disease that may affect cognition
- History or presence of significant cerebrovascular disease
- History of severe central nervous system trauma with persistent neurological deficit or brain damage
- History or presence of significant intracranial mass
- MRI evidence of major cerebral abnormalities or inability to tolerate MRI
- Unstable or uncontrolled medical conditions that could affect safety or study assessments
- History of malignancy except if cured or with negligible risk of spread or death
Research Team
R
Reference Study ID Number: WN45447 https://forpatients.roche.com/
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