In short
Clinical trials of Gsk4527226 are studying people with early Alzheimer’s disease. These studies look at both safety and how well the treatment may work over time. The trials include a main treatment study and an open-label extension, which follows participants longer after the parent study.
Key points
- Clinical trials of Gsk4527226 are studying early Alzheimer’s disease. Both trials are Phase 2 and were completed. One study focused on efficacy and safety compared with placebo, while the other was an open-label extension focused on long-term safety and tolerability. The main patient group was people with early Alzheimer’s disease. The studies measured change in CDR-SB and treatment-emergent side effects, including serious events and ARIAs.
Trial overview
Two completed Phase 2 studies investigated Gsk4527226 in people with early Alzheimer’s disease. Both studies were interventional, which means the researchers gave a study treatment and then measured what happened.
Who participated
The target population in both trials was participants with early Alzheimer’s disease. One study enrolled 282 people, and the open-label extension study enrolled 297 people.
In simple terms, these studies were for people who already had early Alzheimer’s disease and met the study rules.
What was studied
One trial was titled “EFFICACY AND SAFETY OF GSK4527226 [AL101] IN PATIENTS WITH EARLY ALZHEIMER’S DISEASE” and compared Gsk4527226 dose 1 with placebo. The brief summary says the study aimed to evaluate efficacy, which means whether the treatment may help, and safety in participants with early Alzheimer’s disease.
The other trial was an open-label extension study in patients with early Alzheimer’s disease. An open-label extension means a follow-up study after the parent study, where the main goal is often to learn more about longer-term use.
The extension study focused on the long-term safety and tolerability of Gsk4527226 in all participants from the earlier study, both overall and by randomized treatment arm. “Randomized treatment arm” means the group a participant was assigned to in the original study.
Trial phases and design
Both trials were Phase 2 studies. Phase 2 studies are usually done after early first testing and help researchers see whether a treatment may work and how safe it appears in a larger group.
The main efficacy study included comparison groups and used placebo as a control. Placebo means an inactive treatment used for comparison, so researchers can better judge the effect of the study drug.
The extension study was open-label and included participants from the parent study. This design helps researchers collect longer follow-up safety information after the main study ends.
Outcomes measured
The main efficacy study measured change from baseline in CDR-SB across Weeks 52, 64, and 76. Baseline means the starting point before treatment begins, and CDR-SB stands for Clinical Dementia Rating-Sum of Boxes, a score used to track changes in thinking and daily function.
The extension study measured the incidence of treatment-emergent adverse events, including AESIs and SAEs, during the open-label extension. Treatment-emergent adverse events are health problems that begin or worsen after treatment starts, AESIs are adverse events of special interest, and SAEs are serious adverse events.
The extension study also measured the incidence and severity of ARIAs during the open-label extension. ARIAs are brain imaging-related issues that are monitored in Alzheimer’s research.
Main trial summary
- NCT06079190 studied whether Gsk4527226 could help people with early Alzheimer’s disease and how safe it was compared with placebo.
- 2025-521107-42-00 followed participants from the earlier study to learn more about long-term safety and tolerability.
- Both studies were Phase 2 and were completed.
- Both studies focused on people with early Alzheimer’s disease.