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A Study to Test the Long-term Safety and Benefits of GSK4527226 in Patients with Early Alzheimer's Disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Alzheimer's Disease in its early stages. Alzheimer's Disease is a condition that affects memory, thinking, and behavior, gradually worsening over time. The treatment being tested is called GSK4527226, which is given through a drip into a vein, known as an infusion. This medication is designed to target specific processes in the brain that may slow down the progression of the disease.

The purpose of this study is to evaluate the long-term safety and how well GSK4527226 works in people with early Alzheimer's Disease. This is an extension study, which means it follows people who have already completed a previous study with the same medication. The study will look at any side effects that occur and will pay special attention to certain brain-related imaging findings that can sometimes happen with this type of treatment. These findings are monitored using brain scans to ensure participant safety throughout the study.

Participants will continue receiving GSK4527226 for up to 104 weeks, which is about two years. During this time, they will attend regular clinic visits where doctors will check their health and monitor for any unwanted effects. The study will also measure changes in memory, thinking abilities, and daily functioning using various assessments and questionnaires. A study partner, such as a family member or close friend who spends regular time with the participant, will need to attend some visits to provide information about how the participant is managing daily activities. All participants in this study will receive the active medication, as this is not a comparison study with placebo.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Entry into the extension study

    This study is an extension of a previous study identified as NCT06079190. Entry into this extension study occurs after completing the treatment period in that previous study.

    Before starting, informed consent must be provided. If there is difficulty providing consent independently, a legally authorized representative may provide consent on behalf of the participant, and the participant must provide agreement according to local regulations.

    A study partner is required for participation. This is an adult who has regular contact with the participant for at least 8 hours per week in person. The study partner must be able to provide accurate information about cognitive and functional abilities and must sign a consent form.

    The same study partner from the previous study should continue in this extension study whenever possible. If the original study partner cannot continue, a replacement study partner meeting the same requirements must be available.

    Female participants must not be pregnant or breastfeeding. Those who can become pregnant must use highly effective birth control methods starting at least 14 days before the first dose and continuing until at least 12 weeks after the last dose. A negative pregnancy test is required within 24 hours before the first dose.

    Male participants must agree not to donate sperm during the study. If engaging in sexual intercourse with a woman who can become pregnant, a condom must be used, and the female partner must use an additional highly effective birth control method.

  2. Step 2

    Treatment with GSK4527226

    The study medication is GSK4527226, which is given as a solution for infusion. This means the medication is delivered directly into a vein through an intravenous line.

    This is an open-label study, meaning both the participant and the medical team know which treatment is being given.

    The study evaluates the long-term safety and effectiveness of GSK4527226 in participants with early Alzheimer's disease. Alzheimer's disease is a condition that affects memory and thinking abilities.

    Specific dosage, frequency, and duration of the medication administration are determined according to the study protocol and individual participant needs.

  3. Step 3

    Safety monitoring

    Throughout the study, safety will be monitored by tracking any adverse events. An adverse event is any unwanted medical occurrence or symptom that happens during the study.

    Special attention will be given to serious adverse events, which are medical problems that require hospitalization, are life-threatening, or result in significant disability.

    Adverse events of special interest will also be monitored. These are specific types of side effects that are particularly important to track for this medication.

    The study will specifically monitor for ARIAs, which stands for amyloid-related imaging abnormalities. These are changes that can be seen on brain scans and may include swelling or small areas of bleeding in the brain.

    The severity of any ARIAs that occur will be assessed and recorded.

  4. Step 4

    Cognitive and functional assessments

    Various assessments will be performed to measure changes in thinking abilities and daily functioning from the beginning of this extension study.

    The CDR-SB (Clinical Dementia Rating - Sum of Boxes) will be used to assess overall dementia severity and functioning in different areas.

    The ADAS-Cog14 (Alzheimer's Disease Assessment Scale - Cognitive Subscale with 14 items) will measure cognitive abilities including memory, language, and other thinking skills.

    The MMSE (Mini-Mental State Examination) will assess general cognitive function through questions and tasks.

    The ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study - Activities of Daily Living scale for Mild Cognitive Impairment) will evaluate the ability to perform everyday activities.

    The iADRS (Integrated Alzheimer's Disease Rating Scale) combines measures of cognition and daily function.

    The ADCOMS (Alzheimer's Disease Composite Score) is a combined measure that tracks disease progression.

    The study partner will need to be present at specific visits to provide input for some of these assessments.

  5. Step 5

    Study duration and completion

    The study is expected to begin enrollment in December 2025.

    The estimated completion date for the study is November 2028.

    The exact duration of individual participation will depend on when enrollment occurs and the specific study protocol requirements.

    Regular visits will be scheduled throughout the study period for medication administration, safety monitoring, and assessments.

Who can join the trial?

5 criteria

  • You must have completed the treatment period in the previous study. You may have missed some doses or had a temporary pause in taking the medicine, but you must not have stopped the treatment permanently or left the previous study early.
  • You must be willing and able to give your agreement to participate in the study. This means you understand and agree to follow all the requirements. If you are not able to give this agreement yourself due to your condition, a legally authorized person can give agreement on your behalf, and you must show that you understand and agree as much as possible.
  • You must have an adult person, called a study partner, who spends enough time with you each week, at least 8 hours of face-to-face contact. This person must know you well enough to answer questions about your memory, thinking abilities, and daily activities. They must agree to attend some clinic visits with you and sign an agreement form. The study partner should be the same person from the previous study if possible, but if that person cannot continue, you must have another suitable person available. The study partner does not need to live with you, but must have regular contact with you.
  • If you are a woman, you must not be pregnant or breastfeeding. You must be either unable to become pregnant, or if you can become pregnant, you must use a highly effective birth control method that has less than 1% chance of failure. You must use this birth control starting at least 14 days before taking the first dose of the study medicine and continue until at least 12 weeks after your last dose. If you can become pregnant, you must have a negative pregnancy test within 24 hours before starting the study medicine.
  • If you are a man, you must agree not to donate sperm during the study. You must also either avoid sexual intercourse with women who can become pregnant as your usual lifestyle, or if you do have sexual intercourse with a woman who can become pregnant, you must use a condom and your female partner must use an additional highly effective birth control method with less than 1% chance of failure.

Who cannot join the trial?

4 criteria

  • The source data does not provide specific exclusion criteria for this clinical trial
  • This study is designed to evaluate the long-term safety of an investigational medication called GSK4527226 in people with early Alzheimer's Disease, which is a brain condition that affects memory and thinking
  • The study accepts both male and female participants
  • Without detailed exclusion criteria listed in the provided information, it is not possible to specify which conditions or situations would prevent someone from participating
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Investigated drugs

GSK4527226 is an experimental medication being studied for the treatment of early Alzheimer's disease. This medicine is also known by the code name AL101. The study is looking at how safe this medication is when taken over a long period of time and whether it helps improve or maintain thinking and memory abilities in people with early stages of Alzheimer's disease.

What is already known about the treatment

GSK4527226 (AL101) – This is an experimental medication being studied in tablet or capsule form for the treatment of early Alzheimer's Disease, a brain disorder that affects memory and thinking abilities. The drug is currently in clinical trials and is not yet approved for general use, as researchers are testing its long-term safety and effectiveness in patients. GSK4527226 works by targeting specific proteins in the brain that are believed to contribute to the development of Alzheimer's Disease, though the exact molecular mechanism is still being investigated. This medication belongs to a new class of drugs designed to modify the progression of Alzheimer's Disease rather than just treating its symptoms.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive brain disorder that gradually destroys memory and thinking skills. It is the most common cause of dementia in older adults. The disease begins with mild memory loss and confusion, making it difficult to remember recent events or conversations. As it progresses, individuals experience increasing difficulty with language, problem-solving, and performing everyday tasks. Over time, people with this condition may have trouble recognizing family members and need full-time assistance with daily activities. The disease occurs due to abnormal protein deposits in the brain that damage and kill brain cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521107-42-00Protocol code223646Estimated enrolment297 patientsSponsorGlaxosmithkline Research & Development Limited

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