Resumen

El medicamento en estudio GSK4527226 está siendo investigado en participantes con enfermedad de Alzheimer (EA) en el estudio 219867 (el estudio principal, NCT06079190). Este nuevo estudio es una extensión de ese estudio principal denominada extensión de etiqueta abierta (OLE). Una OLE es un ensayo clínico en el que todos los participantes reciben el mismo medicamento en estudio. Los participantes ya deben estar en el estudio 219867 para poder participar en este estudio. Este estudio evaluará la seguridad y eficacia a largo plazo de GSK4527226 en participantes con EA temprana (incluido el deterioro cognitivo leve [DCL] y la demencia leve debida a EA) que hayan completado el estudio principal.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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.

Criterios de exclusión

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.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

Estudio de extensión multicéntrico, de brazo único y abierto para evaluar la seguridad y eficacia a largo plazo de GSK4527226 (AL101) en participantes con enfermedad de Alzheimer temprana

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

GSK4527226

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores

Contactos

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center