A Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-552 in Participants with Mild Alzheimer's Disease.
This research study is looking at a new medicine called ABBV-552 for individuals who have early (mild) Alzheimer's disease. It's a 'Phase II' study, which means we're still in the relatively early stages of understanding this medicine. The main goals are to check if ABBV-552 is safe to use, how effective it is in helping with memory and thinking, and how the body processes it. Participants will be given either a low dose, a medium dose, a high dose of ABBV-552, or a 'dummy' medicine (placebo) that looks the same but contains no active drug. This helps us understand the medicine's true effects. Researchers will measure changes in memory and thinking over 12 weeks.
At a glance
What is this study about?
This study is a research project designed to learn more about a new medicine called ABBV-552. It's specifically for people who have been diagnosed with mild Alzheimer's disease. The main purpose of this study is to see if ABBV-552 could be a helpful treatment for this condition.
Researchers want to find out several things: Is ABBV-552 safe enough for people to take? Does it actually help with the symptoms of Alzheimer's, like memory or thinking problems? They also want to understand how the medicine behaves inside the body – how it's absorbed, used, and cleared out. This information is crucial for developing new medicines.
This is a 'Phase II' study, which means it's still relatively early in the development of ABBV-552. If the results from this study are positive, it might move on to larger studies involving more people. The hope is that ABBV-552 could someday offer a new way to help people living with mild Alzheimer's disease.
Key takeaways
- This study is testing a new medicine (ABBV-552) for mild Alzheimer's disease.
- It aims to check if the medicine is safe and if it helps with memory and thinking.
- Participants will receive either different doses of ABBV-552 or a 'dummy' medicine (placebo).
- The study lasts 12 weeks with regular clinic visits.
- It's a 'Phase II' study, gathering early information about the new treatment.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you need to have a diagnosis of mild Alzheimer's disease. You must be at least 18 years old, and there is no upper age limit, meaning people of any age over 18 can potentially join.
Both men and women are welcome to take part in this research.
The research team will have a full list of things they look for to make sure the study is a good fit for you and that taking part would be safe. This includes a review of your overall health and any other medications you might be taking.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you diagnosed with mild Alzheimer's disease?
- Are you 18 years old or older?
- Are you comfortable attending regular clinic visits for 12 weeks?
- Are you able to take study medication as required?
- Are you willing to undergo assessments like memory tests and general health checks?
What does participation involve?
If you decide to take part in this study, you will be assigned to one of four groups. Three groups will receive different doses of ABBV-552 (1mg, 5mg, or 10mg capsules), and one group will receive a 'placebo' capsule, which looks identical but contains no active medicine. Neither you nor your study doctor will know which you are receiving, which helps us get unbiased results.
You will have several clinic visits over a period of 12 weeks. During these visits, the research team will perform assessments to check your memory and thinking, and monitor your general health. This will involve regular check-ups, potentially blood tests, and questionnaires. You'll take the study medicine as directed between visits. After the 12-week treatment period, there will also be follow-up appointments to ensure your well-being.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is mild Alzheimer's disease?
Mild Alzheimer's disease is the early stage of the condition, where people might notice subtle changes in memory and thinking that don't significantly affect daily life yet.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real thing but has no active ingredients. It's used in studies to help researchers see if the real medicine is actually working better than no treatment.
Why don't I know if I'm getting the real medicine or the placebo?
This is called 'double-blind,' and it's done so that neither you nor the study team knows who is receiving which treatment. This helps ensure the study results are fair and accurate, without anyone's expectations influencing the outcomes.
How long will I be in the study?
The main part of the study where you take the medicine will last 12 weeks. There may also be some follow-up visits after this period.
What does a 'Phase II' study mean?
Phase II studies are still in the early stages of testing a new medicine. They focus on finding the right dose and further checking the medicine's safety and how well it works before it can be tested in much larger groups of people.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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