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RecruitingPHASE2INTERVENTIONAL

Open-label Extension Study in Participants With Early Alzheimer's Disease

This study is an extension of an earlier research project called 219867, which is looking at a new medication, GSK4527226, for early Alzheimer's disease. If you've already taken part in the previous study, you might be eligible for this one. In this 'open-label' extension, everyone who joins will receive the study medication. Doctors and researchers want to understand how safe and helpful GSK4527226 is over a longer period for people with early Alzheimer's, including those with mild memory problems or mild dementia. This is a chance to continue receiving the potential treatment and help us learn more about it.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
GlaxoSmithKline
Enrolment target
220
Start
14 Aug 2025
Estimated completion
08 Dec 2028

What is this study about?

This study is an important next step for people who have already been taking part in a previous research study looking at a new medication called GSK4527226 for early Alzheimer's disease. Alzheimer's disease can affect memory and thinking, and 'early Alzheimer's' includes people with mild memory problems (often called 'mild cognitive impairment' or MCI) and those with mild dementia due to Alzheimer's.

The main goal of this new study is to continue watching how participants respond to GSK4527226 over a longer time. The doctors and researchers want to find out more about the treatment's safety and whether it helps with the symptoms of early Alzheimer's. This is an 'open-label' study, which means that everyone who joins will receive the study medication. This is different from some studies where people might get a placebo (a dummy treatment).

By taking part, you'd be helping scientists gather more information about how this potential new medicine works over time. This kind of research is vital for developing new treatments that could improve the lives of people living with Alzheimer's disease in the future. Remember, participating in a study is always a personal choice.

Key takeaways

  • This is an extension for people already in a specific Alzheimer's study.
  • Everyone in this part of the study will receive the medication, GSK4527226.
  • It aims to check the long-term safety and effectiveness for early Alzheimer's.
  • A study partner who knows you well must also be involved.
  • You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must have already completed the treatment part of the previous study (called 219867 or NCT06079190). It's okay if you missed a few doses or had a temporary break from the medication in the past, but you cannot have permanently stopped the study medication or left the previous study early.

You also need to be willing and able to understand and sign a consent form, which explains everything about the study. A trusted adult who knows you well and sees you often (like a family member or close friend) also needs to be available to provide information about your memory and daily activities, and they will need to sign a consent form too.

There are also some health conditions or medications that might mean you can't join. For example, if you have certain heart rhythm issues, specific brain conditions identified on an MRI scan, or new serious infections, you would likely not be able to take part. Women who are pregnant, breastfeeding, or of childbearing potential and not using specific contraception also can't participate. Both men and women need to follow contraception rules during the study. Participants should be between 50 and 85 years old.

Quick self-check
  • Did I complete the treatment part of the previous study (NCT06079190)?
  • Am I between 50 and 85 years old?
  • Do I have a trusted adult who can be my study partner and attend visits?
  • Am I willing and able to follow study instructions and give my consent?
  • Are there any new major health issues, like certain heart problems or brain scan findings, that might prevent my participation?

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, you will continue to receive the study medication, GSK4527226. You will have regular visits to the clinic where the study doctors and nurses will monitor your health, memory, and thinking. These visits will help them understand how the medication is affecting you. They will also do tests and scans, which might include MRI scans, to check for any changes. Your study partner will also need to attend these visits to provide important information about your daily life and abilities. The total length of your participation will be discussed with you in detail, but it involves continued treatment and regular check-ups to assess the long-term effects of the medication.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as continuing to receive a study medication that may help with early Alzheimer's symptoms. You would also be playing a key role in advancing medical understanding of this condition. However, like all medications, GSK4527226 may have side effects, and some tests, like MRI scans, have their own risks. It's important to weigh these carefully. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (33)

  • GSK Investigational Site
    Maitland, United States· Recruiting
  • GSK Investigational Site
    Miami, United States· Recruiting
  • GSK Investigational Site
    Stuart, United States· Recruiting
  • GSK Investigational Site
    Toms River, United States· Recruiting
  • GSK Investigational Site
    Staten Island, United States· Recruiting
  • GSK Investigational Site
    Matthews, United States· Recruiting
  • GSK Investigational Site
    Oklahoma City, United States· Recruiting
  • GSK Investigational Site
    Houston, United States· Recruiting
  • GSK Investigational Site
    Fairfax, United States· Recruiting
  • GSK Investigational Site
    Buenos Aires, Argentina· Recruiting
  • GSK Investigational Site
    Buenos Aires, Argentina· Recruiting
  • GSK Investigational Site
    Ciudad Autonoma de Buenos Aire, Argentina· Recruiting

+21 more sites — see the official record for the full list.

Common questions

What is an 'open-label' study?

An open-label study means that everyone taking part will receive the actual study medication, not a dummy treatment (placebo).

Do I have to have been in the previous study to join this one?

Yes, you must have already completed the main treatment period of the earlier study (called 219867 or NCT06079190) to be eligible for this extension study.

Who is GSK4527226 designed for?

This study medication is being investigated for people with early Alzheimer's disease, including those with mild memory issues or mild dementia due to Alzheimer's.

What is the age range for participants?

Participants should be between 50 and 85 years old.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your future medical care.

How to find out more

US GSK Clinical Trials Call Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Open-label Extension Study in Participants With Early Alzhei…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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