Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK4527226 · 2 trials · 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.
The CDR-SB score is a quantitative general index that provides more precision in participants with mild dementia. The CDR scale is a clinician-rated dementia staging system tracks the progression of. cognitive impairment in 6 categories (memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5- point scale in which None=0, Questionable=0.5, Mild=1, Moderate=2, and Severe=3. The CDR-SB is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
| Arm | Type | Description |
|---|---|---|
| GSK4527226 | EXPERIMENTAL | Participants will receive GSK4527226. |
| GSK4527226 Dose 1 | EXPERIMENTAL | Participants will receive GSK4527226 Dose 1 |
| GSK4527226 Dose 2 | EXPERIMENTAL | Participants will receive GSK4527226 Dose 2 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo. |
| Name | Type | Description |
|---|---|---|
| GSK4527226 | DRUG | GSK4527226 will be administered. |
| Placebo | OTHER | Placebo 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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the p...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 developed for the treatment of early Alzheimer's Disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in participants aged 50 years and older with early-stage Alzheimer's Disease.
GSK4527226 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the efficacy and safety of this investigational drug for early Alzheimer's Disease.
GSK4527226 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated in two Phase 2 trials for early Alzheimer's Disease, with one trial actively recruiting participants and another that has completed enrollment.
GSK4527226 is being studied in two Phase 2 clinical trials. The first trial, NCT06079190, is an efficacy and safety study in participants with early Alzheimer's Disease and is active but not recruiting. The second trial, NCT07105709, is an open-label extension study that is currently recruiting participants. Both trials enroll adults aged 50 years and older.
Yes, GSK4527226 is also known as AL101. The clinical trial NCT06079190, which evaluates the efficacy and safety of GSK4527226 in early Alzheimer's Disease, refers to the drug as GSK4527226 [AL101]. This alternative name may be used in research publications and other contexts.