In short
Clinical trials are investigating 2-(4-(2-[18F]FLUORO-2,2-DIDEUTERO ETHYL)PIPERIDIN-1-YL)BENZO[4,5]IMIDAZO[1,2-A]PYRIMIDINE in people with early Alzheimer’s disease. These studies aim to understand how the related imaging agents are used in research and how treatment effects are measured in participants with prodromal or mild disease.
Key points
- One clinical trial in the provided data studied people with prodromal or mild Alzheimer’s disease. It was a Phase 2 interventional study with 466 participants and was completed. The main goal was to compare bepranemab with placebo. The main result measured was the change in the Clinical Dementia Rating Scale Sum of Boxes from baseline to Week 80. The trial also included imaging agents in the study materials, but the key focus was on outcomes in early Alzheimer’s disease.
Trial overview
The provided data include one interventional study, which means researchers gave study treatments and compared results between groups. The study focused on people with Alzheimer’s disease, especially those in prodromal or mild stages.
Who the study included
The trial enrolled 466 participants. The brief summary says the study involved people with prodromal or mild Alzheimer’s disease, so the target population was adults in the early part of the illness.
What was studied
The trial title says it studied whether bepranemab was safe and whether it worked in early Alzheimer’s disease. The intervention list also included placebo, which is a look-alike treatment with no active substance, used for comparison.
The data also list Neuraceq 300 MBq/mL solution for injection and (18F) GTP1 among the interventions. These were part of the study materials recorded in the trial data, but the key clinical question in the summary was the effect of bepranemab versus placebo on disease change over time.
Main outcome measure
The primary outcome was the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score. This score helps measure changes in memory, thinking, and daily function in people with dementia.
Researchers measured the change from baseline to Week 80. Baseline means the first measurement before study follow-up begins, and Week 80 means the result after 80 weeks of study time.
Study design and phase
This was a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may help and continue to check safety in a defined patient group.
The study status was Completed. That means the planned study activities were finished according to the trial record.
Key trial facts
In simple terms, this trial asked whether bepranemab could change the course of early Alzheimer’s disease compared with placebo. The main result was based on the CDR-SB score, which tracks how a person is doing over time. The study was designed for people with early disease, not advanced Alzheimer’s disease.
- Trial ID: NCT04867616.
- Phase: Phase 2.
- Condition: Alzheimer’s disease.
- Population: People with prodromal or mild Alzheimer’s disease.
- Enrollment: 466 participants.
- Main endpoint: Change in CDR-SB from baseline to Week 80.