Efficacy and Safety of AL101 in patients with early Alzheimers Disease
Research type
Research Study
Full title
A Phase 2, Parallel Group, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared with Placebo in Patients with Early Alzheimer’s Disease
IRAS ID
1007656
Contact name
Paul Clifford
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2023-505083-11
Research summary
Alzheimer's disease (AD) is a brain disease that gets worse over time. It causes gradual decline in memory, thinking, behavior and social skills together referred to as dementia, affecting a person's ability to function. Risk factors for developing AD include age, genetics, and medical conditions like heart or blood vessels disease.
GSK4527226 (also known as AL101) is a new medicine that works by increasing levels of a protein called progranulin which may improve the health of various types of brain cells affected in early AD. Hence, this study will assess the efficacy and safety of GSK4527226 in participants with early AD during 76 weeks of treatment (about 18 months).
Trial design Participants will be randomly divided into 3 groups: 2 groups will receive one of the two doses of GSK4527226 (dose 1 and dose 2) and 1 group will receive placebo.
Inclusion criteria • Men and women aged 50-85 years with confirmed early AD. • Clinical severity within a specific range as measured by intellectual and functional scales. • For participant receiving AD medications, the dose must be stable for at least 12 weeks before study start.
• For participant receiving medications for AD-related symptoms or associated conditions the dose must be stable at least 12 weeks before study start.
Exclusion criteria • Participants with brain related disorders other than Alzheimer's Disease (AD) e.g. brain tumour.
• Use of medicines which slow decline in AD, e.g., anti-amyloid medicines, within 6 months of study start.
• History of some types of heart or blood vessels disorder, uncontrolled high blood pressure, liver or kidney disease, or immune-related disease.
• Chronic active immune disorder which suppress the immune system within 6 months before study start.
Interventions Participants will be assigned by chance to either receive GSK4527226 or placebo. These will be given every 4 weeks for 18 months directly into a vein via infusion, over about an hour.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0265
Date of REC Opinion
26 Feb 2024
REC opinion
Further Information Favourable Opinion