Active not recruitingPHASE2INTERVENTIONAL

Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease

Scientists are conducting a study to explore a new potential treatment called GSK4527226 for individuals who are in the early phases of Alzheimer's disease. This includes people experiencing mild memory problems (mild cognitive impairment) or early-stage dementia due to Alzheimer's. The main goals are to find out if this new medicine is safe to use and if it can help improve or stabilize symptoms, or slow down the disease's progression. To do this, some participants will receive the new medicine, while others will get a placebo (a dummy pill with no active ingredient). This comparison helps researchers understand the true effects of the real medicine.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

367

Start

20 Oct 2023

Estimated completion

23 Nov 2026

Alzheimer's Disease

What is this study about?

This research study is looking into a new medicine called GSK4527226. Its main purpose is to see if this medicine can help people in the early stages of Alzheimer's disease. This includes those who have mild memory problems that doctors believe are due to Alzheimer's, or those with very early signs of Alzheimer's dementia. The study wants to find out two key things: first, if the medicine is safe for people to take, and second, if it actually works to improve or slow down the changes caused by Alzheimer's.

To understand if the medicine works, some participants will receive the new medicine, while others will receive a 'placebo'. A placebo looks just like the real medicine but contains no active ingredients. This is a standard way to test new medicines, as it helps doctors compare the effects and make sure any changes seen are truly due to the active drug and not just other factors. Participants will be carefully monitored throughout the study.

Finding new treatments for Alzheimer's disease is very important as it can have a big impact on people's lives. Studies like this help us understand more about the disease and potentially develop new ways to manage it, improving the quality of life for those affected.

Key takeaways

This study is testing a new medicine for early Alzheimer's.
It aims to check if the medicine is safe and if it works.
Some people will get the active medicine, others a dummy pill (placebo).
Eligibility includes age, Alzheimer's diagnosis with amyloid, and certain test scores.
Participation involves regular clinic visits and health checks.
You can stop participating at any time.

Who may be eligible?

To join this study, people need to be between 50 and 85 years old. They must also be diagnosed with early Alzheimer's disease, which means they might have mild memory loss (called mild cognitive impairment due to Alzheimer's) or mild Alzheimer's dementia. A key part of the diagnosis is having signs of specific protein clumps in the brain (called amyloid plaques), which can be seen with special brain scans or spinal fluid tests.

Participants will also need to have certain scores on memory and thinking tests, showing some memory problems but still being able to manage daily life. If someone is already taking medicines for Alzheimer's symptoms, like an acetylcholinesterase inhibitor or memantine, their dose must have been stable for at least 12 weeks before joining, and they shouldn't plan to change it during the study. Any other medicines for related symptoms must also be stable.

There are also some general health requirements, such as weighing between 45 kg and 120 kg, and having a specific Body Mass Index (BMI). Women of child-bearing age would need to use approved contraception during the study, and women who are pregnant or breastfeeding cannot take part.

Quick self-check

Are you between 50 and 85 years old?
Have you been diagnosed with early Alzheimer's disease (mild memory problems or mild dementia from Alzheimer's)?
Have tests shown you have amyloid plaques in your brain?
If you take Alzheimer's medicines, has your dose been stable for at least 12 weeks?
Do you weigh between 45kg and 120kg, and is your Body Mass Index (BMI) within a healthy range?
Can you commit to regular clinic visits for checks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would visit the clinic regularly. At each visit, doctors and nurses would check your health, ask about your memory and daily activities, and you might have blood tests, memory tests, or brain scans. You would also receive the study medicine, or placebo, which you would take as instructed.

The study would involve several appointments over a period of time, and the research team would explain how often you need to come in and what each visit would involve. They will also make sure you understand how to take your study medicine. You would be carefully monitored for any side effects or changes in your health throughout your time in the study. The total duration of your participation would be fully explained before you agree to join.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits. You would receive regular health checks and tests related to your Alzheimer's, and you might receive a new medicine that could potentially help. However, there are also potential risks, as with any new medicine. You might experience side effects from the study medicine, or the medicine might not work for you. The study team will explain all known side effects. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (97)

GSK Investigational Site
San Diego, United States
GSK Investigational Site
Lake Mary, United States
GSK Investigational Site
Lake Worth, United States
GSK Investigational Site
Maitland, United States
GSK Investigational Site
Miami, United States
GSK Investigational Site
Orlando, United States
GSK Investigational Site
Orlando, United States
GSK Investigational Site
Stuart, United States
GSK Investigational Site
The Villages, United States
GSK Investigational Site
The Villages, United States
GSK Investigational Site
Decatur, United States
GSK Investigational Site
Elk Grove Village, United States

+85 more sites — see the official record for the full list.

Common questions

What is Alzheimer's continuum?

It's a way to describe different stages of Alzheimer's disease, from very early changes in the brain (even before symptoms appear) to more noticeable memory and thinking problems.

What is amyloid positivity?

This means tests have shown that you have certain protein clumps called 'amyloid plaques' in your brain. These plaques are a key feature of Alzheimer's disease.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but doesn't contain any active drug. It's used in studies to compare against the real medicine.

Will I know if I'm getting the medicine or the placebo?

No, in this type of study, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps make the study results fair and accurate.

How long will the study last?

The full duration of your participation will be discussed with you by the research team if you are eligible for the study.