Open-label Extension Study in Participants With Early Alzheimer's Disease
Eligible age
50–85 yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: GlaxoSmithKline
You may qualify if…
- ✓ 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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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 information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, and signs the study partner ICF.
- ✓ A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of childbearing potential follows contraception requirements outlined in the protocol.
- ✓ A male participant is eligible to participate if he follows contraception requirements outlined in the protocol.
You may not qualify if…
- ✕ QT interval corrected (QTc) assessment at Day 1 that meets the stopping criteria described in the protocol.
- ✕ Participant is taking or will be starting a prohibited medication described in the protocol.
- ✕ Evidence of any Amyloid related imaging abnormalities (ARIA) or cerebral macrohemorrhage that meets the permanent discontinuation criteria described in the protocol.
- ✕ Other newly identified intracranial hemorrhage aneurysm, vascular malformation, infective lesion, space occupying lesion or brain tumor, or other Magnetic resonance imaging (MRI) findings contraindicating participation in the study.
- ✕ Newly identified infection(s) that may affect the Central nervous system (CNS).
- ✕ New diagnosis of moderate to severe alcohol and/or substance use disorder.
- ✕ Change in participant's ability to tolerate MRI procedures, contraindication to MRI, or any other clinical history or examination finding that would pose a potential hazard in combination with MRI.
- ✕ Newly diagnosed cancer.
Where it's recruiting
Maitland · Miami · Stuart
Toms River
Staten Island
Matthews
Oklahoma City
Houston
Fairfax
Source: ClinicalTrials.gov · NCT07105709 · last updated 2026-02-02