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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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.
Primary outcome measure(s)
Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE — 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 — 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 — 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 — 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.
Trial sites (33)
Facility
City
Region
Status
GSK Investigational Site
Maitland
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Stuart
Florida
Recruiting
GSK Investigational Site
Toms River
New Jersey
Recruiting
GSK Investigational Site
Staten Island
New York
Recruiting
GSK Investigational Site
Matthews
North Carolina
Recruiting
GSK Investigational Site
Oklahoma City
Oklahoma
Recruiting
GSK Investigational Site
Houston
Texas
Recruiting
GSK Investigational Site
Fairfax
Virginia
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Buenos Aires
Argentina
Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire
Argentina
Recruiting
GSK Investigational Site
Ciudad Autonoma de Bueno
Argentina
Recruiting
GSK Investigational Site
Macquarie Park
New South Wales
Recruiting
GSK Investigational Site
Nedlands
Western Australia
Recruiting
GSK Investigational Site
Ottawa
Ontario
Recruiting
GSK Investigational Site
Peterborough
Ontario
Recruiting
GSK Investigational Site
Toronto
Ontario
Recruiting
GSK Investigational Site
Greenfield Park
Quebec
Recruiting
GSK Investigational Site
Sherbrooke
Quebec
Recruiting
GSK Investigational Site
Oulu
Finland
Recruiting
GSK Investigational Site
Bergen
Norway
Recruiting
GSK Investigational Site
Oslo
Norway
Recruiting
GSK Investigational Site
Junggu
South Korea
Recruiting
GSK Investigational Site
Barcelona
Spain
Recruiting
GSK Investigational Site
Gothenburg
Sweden
Recruiting
GSK Investigational Site
Malmö
Sweden
Recruiting
GSK Investigational Site
Stockholm
Sweden
Recruiting
GSK Investigational Site
Tainan
Taiwan
Recruiting
GSK Investigational Site
Taoyuan
Taiwan
Recruiting
GSK Investigational Site
Birmingham
United Kingdom
Recruiting
GSK Investigational Site
Bristol
United Kingdom
Recruiting
GSK Investigational Site
London
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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