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 — DRUG
    GSK4527226 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: GSK4527226
    Participants 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

Locations (9)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteMaitlandFlorida32752
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Sheila Baez-Torres (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33176
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Ramon Leon (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteStuartFlorida34997
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Paayal Patel (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteToms RiverNew Jersey08755
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Arun Singh (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteStaten IslandNew York10314
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Adam Smith (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMatthewsNorth Carolina28105
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Mohammed Bolouri (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteOklahoma CityOklahoma73112
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Carl Griffin (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteHoustonTexas77030
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Claudia Perez (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteFairfaxVirginia22031
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Raymond Turner (PRINCIPAL_INVESTIGATOR)

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