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
GlaxoSmithKline
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
- Age range
- 50–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Completion of the Treatment Period in the parent study (NCT06079190). * Participants may have missed doses during the Treatment Period or may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study. * Willing and able to give informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). * Availability of an adult person who has frequent and sufficient contact with the participant, is able to provide accurate informatio…
Interventions
- DrugGSK4527226
GSK4527226 will be administered.
Locations (33)
- GSK Investigational SiteMaitland, Florida
- GSK Investigational SiteMiami, Florida
- GSK Investigational SiteStuart, Florida
- GSK Investigational SiteToms River, New Jersey
- GSK Investigational SiteStaten Island, New York
- GSK Investigational SiteMatthews, North Carolina