Open-label Extension Study in Participants With Early Alzheimer's Disease
Recruiting
Phase 2Interventional Study
Alzheimer's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for
This trial is looking for people with early Alzheimer's disease who have completed a previous study. Participants will receive the study medicine GSK4527226 and help researchers learn about its long-term safety and effectiveness.
Are You a Good Fit for This Trial?
Rules you outAmyloid related imaging abnormalities (ARIA)Cerebral macrohemorrhageIntracranial hemorrhageIntracranial aneurysmIntracranial vascular malformationInfective lesionSpace occupying lesionBrain tumor
You may be able to join if
I have completed the Treatment Period in the previous study.
I have missed doses or was temporarily suspended but was not permanently discontinued.
I am willing to give informed consent.
I have an adult who can provide information about my condition.
I am female and not pregnant or breastfeeding, or I use contraception if of childbearing potential.
I am male and follow the contraception requirements.
You may not be able to join if
I have a QT interval issue that meets the stopping criteria.
I am taking, or will start, a prohibited medication.
I have evidence of Amyloid related imaging abnormalities (ARIA) or cerebral macrohemorrhage.
I have a newly identified intracranial issue that affects my participation.
I have a newly identified infection affecting my central nervous system.
I have a new diagnosis of moderate to severe alcohol or substance use disorder.
I cannot tolerate MRI procedures or have any history that makes MRI unsafe.
I have a newly diagnosed cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. T…
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.
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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 p…
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.
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