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Clinical Trials in the UK / NCT07105709
Recruiting Phase 2

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

NCT07105709 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 2
Started
2025-08-14
Last updated
2026-02-02

Condition(s) studied

Alzheimer's Disease

Investigational drug(s) / intervention(s)

GSK4527226

GSK4527226: GSK4527226 will be administered.

Study summary

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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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

Trial sites (33)

FacilityCityRegionStatus
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

More GlaxoSmithKline trials in the UK

Other trials for the same condition

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.

View NCT07105709 on ClinicalTrials.gov ↗ ← All trials in the UK