Back to search results

Open-label Extension Study for Early Alzheimer's Disease with GSK4527226

This study is an extension of a previous trial (NCT06079190) and is looking at the long-term safety and effectiveness of GSK4527226 for people with early Alzheimer's disease, including those with mild cognitive impairment (MCI) and mild dementia. All 220 participants in this study will receive GSK4527226. The main goal is to track any side effects (adverse events) that happen over a period of up to 112 weeks. To join this study, you must have already completed the treatment period of the parent study (NCT06079190). The current status of this study is unclear.

Study design
This is an open-label extension study, meaning all participants receive the same study medicine, GSK4527226. It plans to enroll 220 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 112 weeks to monitor for adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07105709

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

Recruiting
PHASE2Ages 50–85InterventionalTreatment
GlaxoSmithKline
~220 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:GSK4527226

At a glance

Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE
Measured over Up to 112 Weeks
+3 more outcomes measured

Conditions

Alzheimer's Disease

Explore related trials

Alzheimer's Disease

Where it's being run

33 sites across 19 states
Argentina4
Florida3
Ontario3
Sweden3
United Kingdom3
Quebec2
Norway2
Taiwan2

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLEUp 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 OLEUp 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 OLEUp 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 OLEUp 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.