*Open-Label Extension Study of AL101 in Participants with Early Alzheimer’s Disease
Research type
Research Study
Full title
A Multi-Center, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 [AL101] in Participants with Early Alzheimer’s Disease.
IRAS ID
1012164
Contact name
NA NA
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2025-521107-42
Research summary
Alzheimer's disease (AD) is a brain disease that gets worse over time. It causes gradual decline in memory, thinking, behaviour and social skills, referred to as dementia. It can affect a person's ability to function. Current treatments offer limited and short-term benefits and some do not stop the disease from worsening. GSK4527226 (also known as AL101) is a new medicine that works by increasing levels of a protein called progranulin, which may help improve brain cell health in early AD.
GSK4527226 is already being studied in participants with AD in study 219867 (the parent study). 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 study medicine, and both researchers and participants will know which treatment is given. The main goal of the study is to determine if GSK4527226 is safe and well-tolerated over time.
Eligible participants are those who have early AD and must have completed treatment in the parent study. Participants must agree to the study's requirements and restrictions and have an adult study partner who can provide accurate information about their thinking and daily abilities. Participants will be excluded if they have certain health issues making them unsuitable for the study, or are taking medications not allowed in the study
The study will be conducted globally at multiple sites and will last approximately 27 months, including a 104-week treatment period and a follow-up visit 12 weeks after the final dose.
Participants will receive GSK4527226 via infusion directly into a vein. The study will monitor the occurrence of any medical problems, brain swelling, and brain bleeding through blood and urine tests, electrocardiograms (ECGs) and MRI scans. Researchers will also measure any changes in participants' thinking and daily functioning abilities using standardised tests.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0181
Date of REC Opinion
22 Jul 2025
REC opinion
Further Information Favourable Opinion