Open-label Extension Study in Participants With Early Alzheimer's Disease
Part of paid clinical trials in Maitland, Florida.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT07105709
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- GSK4527226 — DRUGGSK4527226 will be administered.
Study Details
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.
Key Dates
- Start date
- Aug 14, 2025
- Status verified
- Jan 2026
- Primary completion
- Sep 15, 2028
- Completion
- Dec 8, 2028
Study Design
- Enrollment
- 220 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: GSK4527226Participants will receive GSK4527226.
Primary Outcome Measure
Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE [ Time Frame: Up to 112 Weeks ]
Central Contacts
- US GSK Clinical Trials Call Center877-379-3718
- EU GSK Clinical Trials Call Center+44 (0) 20 89904466
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Maitland | Florida | 32752 | Sheila Baez-Torres (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33176 | Ramon Leon (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Stuart | Florida | 34997 | Paayal Patel (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Toms River | New Jersey | 08755 | Arun Singh (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Staten Island | New York | 10314 | Adam Smith (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Matthews | North Carolina | 28105 | Mohammed Bolouri (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | Carl Griffin (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Houston | Texas | 77030 | Claudia Perez (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Fairfax | Virginia | 22031 | Raymond Turner (PRINCIPAL_INVESTIGATOR) |
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