A Multi-Centre, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 (AL101) in Participants With Early Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 34
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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.
排除标准
- •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.
- •Newly identified severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- •Newly identified genetic predisposition for clotting disorder or hemorrhagic disease.
- •Any other clinically significant change in health status (which, in the opinion of the investigator, would make the participant unsuitable for participation in the OLE study.
研究组 & 干预措施
GSK4527226
Participants will receive GSK4527226.
干预措施: GSK4527226 (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE
时间窗: Up to 112 Weeks
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.
Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE
时间窗: Up to 112 Weeks
AESIs includes Infusion-related reactions, Amyloid related imaging abnormalities (ARIA) and cerebral macrohemorrhage.
Number of Participants with Serious Adverse Events (SAEs) during the OLE
时间窗: Up to 112 Weeks
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.
Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE
时间窗: Up to 112 Weeks
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.
次要结局
- Change from OLE Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Across Weeks 24, 52, 76, and 104(Baseline, Week 24, 52, 76, and 104)
- Change from OLE Baseline in AD Assessment Scale-Cognitive subscale (ADAS-Cog14) Score Across Weeks 24, 52, 76, and 104(Baseline, Week 24, 52, 76, and 104)
- Change from OLE Baseline in Mini - Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104(Baseline, Week 24, 52, 76, and 104)
- Change from OLE Baseline in ADCS-ADL-MCI Score Across Weeks 24, 52, 76, and 104(Baseline, Week 24, 52, 76, and 104)
- Change from OLE Baseline in Integrated Alzheimers Disease Rating Scale (iADRS) Score Across Weeks 24, 52, 76, and 104(Baseline, Week 24, 52, 76, and 104)
- Change from OLE Baseline in Alzheimers Disease Composite Score (ADCOMS) Across Weeks 24, 52, 76 and 104(Baseline, Week 24, 52, 76 and 104)