Open-label Extension Study in Participants With Early Alzheimer's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
GSK4527226: GSK4527226 will be administered.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE — Up to 112 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. - Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE — Up to 112 Weeks
AESIs includes Infusion-related reactions, Amyloid related imaging abnormalities (ARIA) and cerebral macrohemorrhage. - Number of Participants with Serious Adverse Events (SAEs) during the OLE — Up to 112 Weeks
A SAE is defined as any untoward medical occurrence that, at any dose, results in death and is life threatening requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect or congenital anomaly. - Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE — Up to 112 Weeks
Magnetic resonance imaging (MRIs) will be used to monitor for abnormalities in the brain such as brain swelling and/or brain bleeding, which are termed as ARIAs.
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Maitland | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Stuart | Florida | Recruiting |
| GSK Investigational Site | Toms River | New Jersey | Recruiting |
| GSK Investigational Site | Staten Island | New York | Recruiting |
| GSK Investigational Site | Matthews | North Carolina | Recruiting |
| GSK Investigational Site | Oklahoma City | Oklahoma | Recruiting |
| GSK Investigational Site | Houston | Texas | Recruiting |
| GSK Investigational Site | Fairfax | Virginia | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aire | Argentina | Recruiting |
| GSK Investigational Site | Ciudad Autonoma de Bueno | Argentina | Recruiting |
| GSK Investigational Site | Macquarie Park | New South Wales | Recruiting |
| GSK Investigational Site | Nedlands | Western Australia | Recruiting |
| GSK Investigational Site | Ottawa | Ontario | Recruiting |
| GSK Investigational Site | Peterborough | Ontario | Recruiting |
| GSK Investigational Site | Toronto | Ontario | Recruiting |
| GSK Investigational Site | Greenfield Park | Quebec | Recruiting |
| GSK Investigational Site | Sherbrooke | Quebec | Recruiting |
| GSK Investigational Site | Oulu | Finland | Recruiting |
| GSK Investigational Site | Bergen | Norway | Recruiting |
| GSK Investigational Site | Oslo | Norway | Recruiting |
| GSK Investigational Site | Junggu | South Korea | Recruiting |
| GSK Investigational Site | Barcelona | Spain | Recruiting |
| GSK Investigational Site | Gothenburg | Sweden | Recruiting |
| GSK Investigational Site | Malmö | Sweden | Recruiting |
| GSK Investigational Site | Stockholm | Sweden | Recruiting |
| GSK Investigational Site | Tainan | Taiwan | Recruiting |
| GSK Investigational Site | Taoyuan | Taiwan | Recruiting |
| GSK Investigational Site | Birmingham | United Kingdom | Recruiting |
| GSK Investigational Site | Bristol | United Kingdom | Recruiting |
| GSK Investigational Site | London | United Kingdom | Recruiting |
More GlaxoSmithKline trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07105709 on ClinicalTrials.gov ↗ ← All trials in Spain