NCT07105709 Open-label Extension Study in Participants With Early Alzheimer's Disease
| NCT ID | NCT07105709 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | GlaxoSmithKline |
| Condition | Alzheimer's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-08-14 |
| Primary Completion | 2028-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2025-08-14 with a primary completion date of 2028-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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.
Contact & Investigator
GSK Clinical Trials
STUDY DIRECTOR
GlaxoSmithKline
Frequently Asked Questions
Who can join the NCT07105709 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Alzheimer's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07105709 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07105709 currently recruiting?
Yes, NCT07105709 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07105709 trial being conducted?
This trial is being conducted at Maitland, United States, Miami, United States, Stuart, United States, Toms River, United States and 11 additional locations.
Who is sponsoring the NCT07105709 clinical trial?
NCT07105709 is sponsored by GlaxoSmithKline. The principal investigator is GSK Clinical Trials at GlaxoSmithKline. The trial plans to enroll 220 participants.
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