Table of contents
- Trial overview
- Who participated
- What was studied
- Trial phases and design
- Outcomes measured
- Main trial summary
Trial overview
Two completed Phase 2 studies investigated Gsk4527226 in people with early Alzheimer’s disease.[1][2] Both studies were interventional, which means the researchers gave a study treatment and then measured what happened.[1][2]
Who participated
The target population in both trials was participants with early Alzheimer’s disease.[1][2] One study enrolled 282 people, and the open-label extension study enrolled 297 people.[1][2]
In simple terms, these studies were for people who already had early Alzheimer’s disease and met the study rules.[1][2]
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.[2] 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.[2]
The other trial was an open-label extension study in patients with early Alzheimer’s disease.[1] 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.[1]
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.[1] “Randomized treatment arm” means the group a participant was assigned to in the original study.[1]
Trial phases and design
Both trials were Phase 2 studies.[1][2] 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.[2] Placebo means an inactive treatment used for comparison, so researchers can better judge the effect of the study drug.[2]
The extension study was open-label and included participants from the parent study.[1] This design helps researchers collect longer follow-up safety information after the main study ends.[1]
Outcomes measured
The main efficacy study measured change from baseline in CDR-SB across Weeks 52, 64, and 76.[2] 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.[2]
The extension study measured the incidence of treatment-emergent adverse events, including AESIs and SAEs, during the open-label extension.[1] 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.[1]
The extension study also measured the incidence and severity of ARIAs during the open-label extension.[1] ARIAs are brain imaging-related issues that are monitored in Alzheimer’s research.[1]
Main trial summary
NCT06079190 studied whether Gsk4527226 could help people with early Alzheimer’s disease and how safe it was compared with placebo.[2]
2025-521107-42-00 followed participants from the earlier study to learn more about long-term safety and tolerability.[1]
Both studies focused on people with early Alzheimer’s disease.[1][2]
