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GSK4527226 · 1 trial · 1 indication
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.
AESIs includes Infusion-related reactions, Amyloid related imaging abnormalities (ARIA) and cerebral macrohemorrhage.
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.
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.
| Arm | Type | Description |
|---|---|---|
| GSK4527226 | EXPERIMENTAL | Participants will receive GSK4527226. |
| Name | Type | Description |
|---|---|---|
| GSK4527226 | DRUG | GSK4527226 will be administered. |
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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the p...
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GSK4527226 is an investigational small molecule being studied for the treatment of Alzheimer's disease. It is specifically being evaluated in participants with early Alzheimer's disease. GSK4527226 has not been approved for any indication and remains in clinical development.
GSK4527226 is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the compound in Alzheimer's disease.
GSK4527226 is in Phase 2 clinical development. The ongoing study is an open-label extension trial in participants with early Alzheimer's disease. GSK4527226 is investigational and has not been approved by the FDA or any other regulatory authority.
GSK4527226 is being evaluated in one clinical trial, NCT07105709, titled Open-label Extension Study in Participants With Early Alzheimer's Disease. The Phase 2 study is currently recruiting and plans to enroll 220 participants across the United States, Argentina, Australia, Canada, Finland, Norway, South Korea, Spain, Sweden, Taiwan, and the United Kingdom.
The NCT07105709 trial of GSK4527226 enrolls participants aged 50 years and older of any sex who have early Alzheimer's disease. Healthy volunteers are not eligible. The study is an open-label extension without a control group.