A Phase 2, Parallel Group, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared with Placebo in Patients with Early Alzheimer’s Disease
This research study, called a Phase 2 trial, is looking into a new medicine for people with early Alzheimer's disease. The medicine is called GSK4527226, or AL101 for short. The main goal is to find out if this medicine is safe to use and if it can help slow down changes in memory and thinking skills over 76 weeks, which is about a year and a half. Patients taking part will be split into different groups, some getting the new medicine and others getting a 'dummy' treatment (placebo), without knowing which they receive. Researchers will carefully check how people's symptoms change over time using several tests. The study uses different types of scans and saline solution as part of the overall research.
At a glance
What is this study about?
This study is a research project designed to explore a new potential treatment, GSK4527226 (also called AL101), for people who are in the early stages of Alzheimer's disease. Researchers want to understand if this new medicine is both safe to use and effective in helping with the symptoms of the illness. Finding new and better ways to treat Alzheimer's is really important, and studies like this help us learn more.
The main thing the researchers want to measure is how the medicine affects a person's overall thinking and daily abilities over a period of about 1.5 years. They will use a special scale called the Clinical Dementia Rating – Sum of Boxes (CDR-SB) to track these changes. The study will also look at other important things like how well people manage their daily activities, their memory, and other thinking skills.
By comparing the new medicine to a 'dummy' treatment (placebo), where no active medication is given, the researchers can see if any improvements are truly due to the new medicine or if they might happen anyway. This helps them decide if the medicine could be a promising treatment in the future. The study is a "Phase 2" trial, meaning it's still in the earlier stages of testing to see if the treatment works and is generally safe before it can be studied in even larger groups of people.
Key takeaways
- This study is testing a new medicine (AL101) for early Alzheimer's disease.
- It's a Phase 2 trial, focused on safety and early signs of effectiveness.
- Participants will receive either the medicine or a 'dummy' treatment (placebo).
- The study measures changes in memory, thinking, and daily abilities over 76 weeks.
- Regular clinic visits, tests, and potentially scans are part of taking part.
- You can leave the study at any time without affecting your normal care.
Who may be eligible?
To join this study, people generally need to be adults, aged 18 or older. Both men and women can take part.
Beyond these general points, the study will have specific health requirements. For example, participants would need to have a diagnosis of early Alzheimer's disease, confirmed by doctors through various tests. This ensures the study is testing the medicine on the right group of people.
There might also be certain medical conditions or medications that would prevent someone from joining, to make sure it's safe for everyone involved. A doctor or study staff will review all these details carefully with anyone interested in taking part.
- Am I 18 years old or older?
- Have I been diagnosed with early Alzheimer's disease?
- Am I able to attend regular clinic appointments?
- Am I comfortable with receiving infusions?
- Do I have any other major health conditions that might prevent 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 in this study, you would first go through a screening process to check if you meet all the requirements. This might involve health checks, scans, and answering questions about your medical history.
Once enrolled, you would be randomly assigned to one of two groups: either receiving the new medicine (GSK4527226/AL101) or a placebo (which looks like the medicine but contains no active drug). Neither you nor your study doctor would know which you are receiving. The study medicine would be given as an intravenous infusion, meaning it goes directly into your bloodstream, every so often over the study period.
You would have regular visits to the study clinic for about 76 weeks (roughly 1.5 years). These visits would involve various assessments, such as memory and thinking tests, discussions about your general health and any side effects, and potentially more scans or blood tests. After the main treatment period, there might be follow-up visits to see how you are doing. The total duration of your involvement could extend beyond the 76 weeks of treatment.
Potential risks and benefits
Locations (8)
- —Germany
- —Netherlands
- —Finland
- —France
- —Italy
- —Norway
- —Spain
- —Sweden
Common questions
What is Alzheimer's disease?
Alzheimer's disease is a common condition that affects the brain, causing problems with memory, thinking, and behaviour, and it tends to worsen over time.
What does 'early Alzheimer's disease' mean?
This refers to the stage of the disease where cognitive difficulties are noticeable but not severe enough to significantly impact daily life, though there may be subtle changes.
What does a 'Phase 2' study mean?
A Phase 2 study is an early stage of research where doctors test a new medicine in a small group of people to see if it's safe and if it shows any signs of working.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new medicine.
How long will the study last?
The main treatment part of the study is planned to last about 76 weeks, which is roughly a year and a half. Your total involvement might be slightly longer, including screening and follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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