Open-label Extension Study in Participants With Early Alzheimer's Disease

Официальное название

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

Обзор

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.

Вмешательства

• Препарат GSK4527226
  GSK4527226 will be administered.

Первичные конечные точки

• Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE [Срок оценки: Up to 112 Weeks]
• Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE [Срок оценки: Up to 112 Weeks]
• Number of Participants with Serious Adverse Events (SAEs) during the OLE [Срок оценки: Up to 112 Weeks]
• Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE [Срок оценки: Up to 112 Weeks]

Вторичные конечные точки (6)

• Change from OLE Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Across Weeks 24, 52, 76, and 104 [Срок оценки: 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 [Срок оценки: Baseline, Week 24, 52, 76, and 104]
• Change from OLE Baseline in Mini - Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104 [Срок оценки: Baseline, Week 24, 52, 76, and 104]
• Change from OLE Baseline in ADCS-ADL-MCI Score Across Weeks 24, 52, 76, and 104 [Срок оценки: 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 [Срок оценки: Baseline, Week 24, 52, 76, and 104]
• Change from OLE Baseline in Alzheimers Disease Composite Score (ADCOMS) Across Weeks 24, 52, 76 and 104 [Срок оценки: Baseline, Week 24, 52, 76 and 104]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• GSK Investigational Site — Maitland
• GSK Investigational Site — Miami
• GSK Investigational Site — Stuart
• GSK Investigational Site — Toms River
• GSK Investigational Site — Staten Island
• GSK Investigational Site — Matthews
• GSK Investigational Site — Oklahoma City
• GSK Investigational Site — Houston
• … и ещё 1 центр

Канада · 5 центров

• GSK Investigational Site — Ottawa
• GSK Investigational Site — Peterborough
• GSK Investigational Site — Toronto
• GSK Investigational Site — Greenfield Park
• GSK Investigational Site — Sherbrooke

Аргентина · 4 центра

• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Ciudad Autonoma de Buenos Aire
• GSK Investigational Site — Ciudad Autonoma de Bueno

Швеция · 3 центра

• GSK Investigational Site — Gothenburg
• GSK Investigational Site — Malmö
• GSK Investigational Site — Stockholm

Великобритания · 3 центра

• GSK Investigational Site — Birmingham
• GSK Investigational Site — Bristol
• GSK Investigational Site — London

Австралия · 2 центра

• GSK Investigational Site — Macquarie Park
• GSK Investigational Site — Nedlands

Норвегия · 2 центра

• GSK Investigational Site — Bergen
• GSK Investigational Site — Oslo

Тайвань · 2 центра

• GSK Investigational Site — Tainan
• GSK Investigational Site — Taoyuan

Финляндия · 1 центр

• GSK Investigational Site — Oulu

South Korea · 1 центр

• GSK Investigational Site — Junggu

Испания · 1 центр

• GSK Investigational Site — Barcelona

Идентификаторы

NCT: NCT07105709 · 223646 · 2025-521107-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗