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Набира участници Фаза 2 NCT07105709

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Alzheimer's Disease

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
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.
Кой може да участва
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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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. Exclusion Criteria: * 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.
Места на провеждане 11
Argentina (1)
GSK Investigational Site
Buenos Aires
US GSK Clinical Trials Call Center
Австралия (1)
GSK Investigational Site
Macquarie Park , New South Wales
US GSK Clinical Trials Call Center
Канада (1)
GSK Investigational Site
Ottawa , Ontario
US GSK Clinical Trials Call Center
Финландия (1)
GSK Investigational Site
Oulu
US GSK Clinical Trials Call Center
Норвегия (1)
GSK Investigational Site
Bergen
US GSK Clinical Trials Call Center
Южна Корея (1)
GSK Investigational Site
Junggu
US GSK Clinical Trials Call Center
Испания (1)
GSK Investigational Site
Barcelona
US GSK Clinical Trials Call Center
Швеция (1)
GSK Investigational Site
Gothenburg
US GSK Clinical Trials Call Center
Taiwan (1)
GSK Investigational Site
Tainan
US GSK Clinical Trials Call Center
Великобритания (1)
GSK Investigational Site
Birmingham
US GSK Clinical Trials Call Center
САЩ (1)
GSK Investigational Site
Maitland , Florida
US GSK Clinical Trials Call Center
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
50 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
14.08.2025
Крайна дата
08.12.2028
Регистрационен номер
NCT07105709
Източник
anzctr
Запитване за медицински туризъм

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