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A Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer’s Disease (MCI to Mild Dementia Due to AD)
EU CTIS ID: 2024-518008-33-00
What this study is testing
To evaluate the effect of trontinemab on clinical progression at Week 72 as compared with placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Fluency in the language of the tests used at the study site
- Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing
- Evidence of AD pathological process as confirmed by amyloid positron emission tomography (PET) scan or CSF
- Screening Mini-Mental State Examination (MMSE) score ≥ 22 and Clinical Dementia Rating, Global Score (CDR-GS) of 0.5 or 1.0
- A Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index (DMI) score of 85 or lower
- Availability of an appropriate study partner
You likely can't join if
- Any evidence of a condition other than AD that may affect cognition
- 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 or presence of clinically significant cerebrovascular disease
- Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline
- History of hypersensitivity to biologic agents or any of the excipients in the formulation.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
- United Kingdom
- Brazil
- Argentina
- Australia
- Canada
- Switzerland
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of; United Kingdom; Brazil; Argentina; Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.