Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effectiveness and Safety of GSK4527226 in Patients with Early Alzheimer's Disease

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment for Alzheimer's Disease, a condition that affects memory and thinking skills. The treatment being tested is called GSK4527226, which is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. The study will compare the effects of this treatment to a placebo in patients who are in the early stages of Alzheimer's Disease.

The purpose of the study is to evaluate how well GSK4527226 works in improving symptoms of Alzheimer's Disease. Participants will receive either the new treatment or a placebo and will be monitored over a period of time to assess changes in their condition. The study will involve regular visits to the clinic for assessments and monitoring of health and cognitive abilities.

In addition to GSK4527226, the study will use other substances such as Normal Saline for infusion purposes. The trial will also involve imaging agents like Florquinitau (18F), Florbetaben (18F), Florbetapir (18F), and Flutemetamol (18F), which are used in brain scans to help visualize changes in the brain associated with Alzheimer's Disease. These agents are administered as solutions for injection. The study aims to provide valuable information on the safety and effectiveness of the new treatment in managing early Alzheimer's Disease.

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

    Joining the study

    Upon joining the study, the participant will be randomly assigned to one of three groups. This process is double-blind, meaning neither the participant nor the researchers know which group the participant is in.

    The groups include two different doses of the medication GSK4527226 and a placebo group.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish a baseline for the participant's condition. This includes measuring cognitive and functional abilities using various scales such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB).

  3. Step 3

    Medication administration

    Participants will receive an intravenous infusion of the assigned treatment. The medication GSK4527226 or placebo will be administered according to the study schedule.

    The frequency and dosage of the medication will be determined by the study protocol and may vary depending on the group assignment.

  4. Step 4

    Ongoing assessments

    Throughout the study, participants will undergo regular assessments to monitor changes in their condition. These assessments will occur at specified intervals, including weeks 52, 64, and 76.

    The assessments will measure changes in cognitive and functional abilities using scales such as the CDR-SB, iADRS, and ADAS-Cog14.

  5. Step 5

    Completion of the study

    At the end of the study period, a final assessment will be conducted to evaluate the overall impact of the treatment.

    Participants will be informed of their group assignment and the results of the study will be shared with them.

Who can join the trial?

18 criteria

  • Participant must be between 50 and 85 years old.
  • Participant must be in the early stages of Alzheimer's, which includes mild cognitive impairment (MCI) or mild Alzheimer's dementia.
  • Participant must show signs of **cerebral amyloidosis**, which means having a buildup of a protein called amyloid in the brain. This can be confirmed by a positive amyloid PET scan or a specific test of the spinal fluid.
  • Participant must meet certain criteria to determine the severity of their condition:
    • **MMSE score** (a test that measures thinking ability) between 21 and 29 points.
    • **CDR-GS** (a scale that measures dementia severity) between 0.5 and 1.0.
    • **CDR Memory Box score** greater than 0.5.
    • **WMS-IV LMII score** (a memory test) at least 1 standard deviation below the average for their age group:
      • 15 or less for ages 50 to 64 years.
      • 12 or less for ages 65 to 69 years.
      • 11 or less for ages 70 to 74 years.
      • 9 or less for ages 75 to 79 years.
      • 7 or less for ages 80 to 90 years.
      • If taking medications for Alzheimer's symptoms, such as donepezil, rivastigmine, galantamine, or memantine, the dosage must have been stable for at least 12 weeks before the study and should not change during the study.
      • If taking other medications for Alzheimer's-related symptoms, the dosage must have been stable for at least 4 weeks before the study and should not change during the study.
      • Participant's body weight must be between 45 kg and 120 kg, with a **BMI** (a measure of body fat based on height and weight) between 17 and 34.9.
      • Female participants must not be pregnant or breastfeeding and must follow specific birth control guidelines.
      • Male participants must follow specific birth control guidelines.
      • Participant must be willing and able to give informed consent, which means they agree to follow the study's rules and requirements.
      • An adult who knows the participant well must be available to provide information about the participant's thinking and daily abilities, attend clinic visits, and sign the consent form as a study partner.

Who cannot join the trial?

10 criteria

  • Participants with any other serious health condition that could interfere with the study.
  • Individuals who have had a recent major surgery or are planning to have one during the study period.
  • People who are currently participating in another clinical trial.
  • Individuals with a history of drug or alcohol abuse.
  • Participants who are unable to comply with the study procedures.
  • Women who are pregnant or breastfeeding.
  • Individuals with a known allergy to the study medication or its ingredients.
  • People with severe liver or kidney disease.
  • Participants with a history of certain mental health disorders.
  • Individuals who have had a stroke or heart attack in the past six months.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

GSK4527226 [AL101] is an investigational medication being studied for its potential to treat early Alzheimer's disease. It is administered through an intravenous infusion. The goal of this medication in the trial is to assess its effectiveness in improving symptoms of Alzheimer's disease, specifically by measuring changes in the Clinical Dementia Rating - Sum of Boxes (CDR-SB), which is a tool used to evaluate the severity of dementia symptoms.

What is already known about the treatment

GSK4527226 – This medication is administered through intravenous infusion and is currently being studied in clinical trials for its potential use in treating early Alzheimer's disease. It is in the experimental phase, with ongoing research to determine its effectiveness and safety. The main therapeutic indication is Alzheimer's disease, specifically in its early stages. The mechanism of action at the molecular level involves targeting pathways associated with the progression of Alzheimer's, although specific details are still under investigation. It is classified pharmacologically as an investigational drug for neurodegenerative conditions.

Investigated diseases

Alzheimer's Disease – Alzheimer's disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. In advanced stages, individuals may lose the ability to carry out daily activities and require full-time care. The exact cause of Alzheimer's is not fully understood, but it involves a combination of genetic, environmental, and lifestyle factors. The progression of the disease varies from person to person, but it generally follows a slow and steady decline in cognitive and functional abilities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505083-11-01Protocol code219867Estimated enrolment282 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.