Actively Recruiting
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Trontinemab in Participants With Early Symptomatic Alzheimers Disease MCI to Mild Dementia
Led by Hoffmann-La Roche · Updated on 2026-06-03
800
Participants Needed
143
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia caused by Alzheimers. This Phase III study is designed as a multicenter, randomized, double-blind, placebo-controlled trial to better understand how trontinemab may impact cognitive and functional changes in this population. Participants will be randomly assigned to receive either intravenous IV trontinemab or an IV placebo. The treatment period lasts for 72 weeks, during which participants will receive regular infusions. This trial includes detailed monitoring of brain changes using PET scans, cerebrospinal fluid and blood biomarkers, and cognitive assessments. Throughout the study, participants will undergo multiple evaluations including cognitive tests such as the Clinical Dementia Rating Scale and MMSE, brain imaging scans for amyloid and tau, and safety monitoring for adverse events and immune responses. The study will also assess everyday functioning and collect data on biomarkers related to Alzheimers disease. Participation requires a study partner and involves visits over approximately 72 weeks.
CONDITIONS
Brief Title
A Study 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 as applicable
- Adequate vision and hearing to perform neuropsychological testing
- Evidence of Alzheimer's disease pathology confirmed by amyloid PET or CSF tau181/A2 ratio
- Diagnosis of probable Alzheimer's dementia or mild cognitive impairment due to Alzheimer's (clinical Stage 3 or 4)
- Screening MMSE score of 22 or higher and CDR-Global Score of 0.5 or 1.0
- History of cognitive decline with gradual onset and progression over the past year before screening
- Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index 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 clinically significant cerebrovascular disease
- History of severe central nervous system trauma causing persistent neurological deficit or brain damage
- Clinically significant intracranial mass
- MRI evidence of significant brain abnormalities or contraindications to MRI
- Unstable or inadequately controlled medical conditions that may affect safety or study assessments
- History of malignancy except if cured or with negligible risk of metastasis or death
Research Team
R
Reference Study ID Number: WN45443 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
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