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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the long-term safety of GSK4527226 and how well it works in people with early Alzheimer's disease. It is for people who finished treatment in the earlier study, NCT06079190. Everyone in this study receives the study medicine.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You finished the treatment period in the earlier study, NCT06079190.
- You did not stop the study medicine permanently before treatment ended or leave the earlier study. Missed doses or a temporary pause are allowed.
- You can and agree to give consent and follow the study rules.
- An adult who knows you well can share accurate information about your memory and daily skills at clinic visits and sign a study partner consent form.
- Women must not be pregnant or breastfeeding. Women who can become pregnant must follow the study's birth control rules.
- Men must follow the study's birth control rules.
Who can't join
- A heart rhythm test on Day 1 meets the study's rules for stopping treatment, or you take or plan to start a medicine the study does not allow.
- Brain scans show swelling or bleeding that meets the rules for stopping treatment permanently, or a new brain problem that makes joining unsafe, such as an abnormal blood vessel, infection, mass, or tumor.
- You have a newly found infection that may affect the brain or spinal cord.
- You have a new diagnosis of moderate or severe problems with alcohol or drug use.
- You can no longer safely have or tolerate an MRI, a scan that takes pictures inside the body.
- You have newly diagnosed cancer or a newly found inherited risk of blood clots or bleeding.
- You have a newly found severe allergic reaction to certain antibody or fusion protein medicines, which are made from proteins.
- You have another important health change that the study doctor thinks makes this study unsuitable for you.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (9)
FL
- GSK Investigational Site · Maitland, FL 32752US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSheila Baez-Torres · Principal investigatorMore trials in Maitland
- GSK Investigational Site · Miami, FL 33176US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRamon Leon · Principal investigatorMore trials in Miami
- GSK Investigational Site · Stuart, FL 34997US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comPaayal Patel · Principal investigatorMore trials in Stuart
NC
- GSK Investigational Site · Matthews, NC 28105US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMohammed Bolouri · Principal investigatorMore trials in Matthews
NJ
- GSK Investigational Site · Toms River, NJ 08755US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comArun Singh · Principal investigatorMore trials in Toms River
NY
- GSK Investigational Site · Staten Island, NY 10314US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAdam Smith · Principal investigatorMore trials in Staten Island
OK
- GSK Investigational Site · Oklahoma City, OK 73112US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comCarl Griffin · Principal investigatorMore trials in Oklahoma City
TX
- GSK Investigational Site · Houston, TX 77030US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comClaudia Perez · Principal investigatorMore trials in Houston
VA
- GSK Investigational Site · Fairfax, VA 22031US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRaymond Turner · Principal investigatorMore trials in Fairfax