Testing GSK4527226 for Alzheimer's disease
Official title: Open-label Extension Study in Participants With Early Alzheimer's Disease
A Multi-Centre, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 (AL101) in Participants With Early Alzheimer's Disease
Interventions
GSK4527226
GSK4527226 will be administered.
Canadian Sites (5)
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Peterborough, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Greenfield Park, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, 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 protocolProtocolThe detailed plan a study must follow.Read more →.
- +A male participant is eligible to participate if he follows contraception requirements outlined in the protocol.
Exclusion
- −Newly identified severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- −QT interval corrected (QTc) assessment at Day 1 that meets the stopping criteria described in the protocolProtocolThe detailed plan a study must follow.Read more →.
- −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 genetic predisposition for clotting disorder or hemorrhagic disease.
- −Any other clinically significant change in health status (which, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would make the participant unsuitable for participation in the OLE study.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: GSK4527226.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 50 years to 85 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 220 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: Up to 112 Weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of Participants with Treatment Emergent Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) during the OLE — measured over Up to 112 Weeks.
Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE — measured over Up to 112 Weeks.
Number of Participants with Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) during the OLE — measured over Up to 112 Weeks.
Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE — measured over Up to 112 Weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07105709 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About GSK4527226Drug
GSK4527226 will be administered.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 50 years to 85 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 50 years to 85 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 112 Weeks.
The study as a whole is currently expected to finish around 2028-12-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 220 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Ottawa, Ontario, Canada; Peterborough, Ontario, Canada; Toronto, Ontario, Canada; Greenfield Park, Quebec, Canada; Sherbrooke, Quebec, Canada; Staten Island, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (1)
GSK Investigational Site
Staten Island, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.