NCT07105709

Open-label Extension Study in Participants With Early Alzheimer's Disease

A Multi-Centre, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 (AL101) in Participants With Early Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The study medicine GSK4527226 is being studied in participants with Alzheimer's Disease (AD) in study 219867 (the parent study, NCT06079190). This new study is an extension of that parent study called an open-label extension (OLE). An OLE is a clinical trial where all participants receive the same study medicine. Participants must already be in study 219867 to be able to take part in this study. This study will assess the long-term safety and efficacy of GSK4527226 in participants with early AD (including mild cognitive impairment \[MCI\] and mild dementia due to AD) who have completed the parent study.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	GSK4527226	GSK4527226 will be administered.

Timeline

• Start date: 2025-08-14
• Primary completion: 2028-09-15
• Completion: 2028-12-08
• First posted: 2025-08-06
• Last updated: 2026-02-02

Locations

33 sites across 11 countries: United States, Argentina, Australia, Canada, Finland, Norway, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study