Open-Label Extension Study of PRX012 in Subjects with Alzheimer’s Disease Who Were Enrolled in Study PRX012-101 or PRX012-102
This study is for people living with Alzheimer's disease who have already participated in one of two specific earlier studies (called PRX012-101 or PRX012-102). It's an 'open-label' extension, which means that all participants will receive the study medication, PRX012. The main goal is to continue observing how the treatment affects people over a longer period. This type of study helps researchers collect more information about the drug's safety and how well it works when taken for an extended time. It's part of the early stages of developing new medicines, known as a Phase I study, focusing on understanding the drug in humans.
At a glance
What is this study about?
This research is an extension study for people who have Alzheimer's disease and have previously taken part in one of two specific studies: PRX012-101 or PRX012-102. Think of it as a continuation chapter in the story of understanding a new potential Alzheimer's treatment called PRX012. Because it's an 'open-label' study, all participants will know they are receiving the study medication, and everyone will actually receive it.
The main purpose of this extension study is to gather more information about PRX012 over a longer period. Researchers want to see how safe the medication is when used for an extended time and if it continues to show any helpful effects for people with Alzheimer's disease. This is a common step in developing new medicines, allowing scientists to build a complete picture of the treatment.
This study is part of the initial phase of human testing for a new medication (often called Phase I, even though this is an extension). This means that while some information has already been gathered in the previous studies, researchers are still learning a lot about how PRX012 works in people. Your participation helps further this important research into potential new treatments for Alzheimer's.
Key takeaways
- This study is an extension for people already in a PRX012 Alzheimer's disease study.
- Everyone in this study will receive the PRX012 medication.
- It aims to understand the long-term safety and effects of PRX012.
- Participation involves regular health checks and assessments.
- You must be 18 or older with Alzheimer's disease and have been in a previous PRX012 study.
Who may be eligible?
To be considered for this study, you must have Alzheimer's disease and you must have already taken part in a previous study called PRX012-101 or PRX012-102. This is a critical requirement, as the study is designed to follow up on people who have already started the treatment in those earlier trials.
Participants must be 18 years old or older. There is no upper age limit, meaning people of all adult ages can potentially join if they meet the other criteria. Both men and women are welcome to participate.
- I have been diagnosed with Alzheimer's disease.
- I am 18 years old or older.
- I previously took part in either the PRX012-101 or PRX012-102 study.
- I understand that both men and women can participate.
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 will continue to receive the study medication, PRX012, which you've already been taking in a previous study. You will have regular appointments at the study clinic where the research team will check on your health, observe any changes, and monitor how the treatment is affecting you. These visits might include blood tests, physical examinations, and assessments of your memory and thinking abilities.
The research team will provide you with all the details about the medication, how to take it, and any potential side effects to watch out for. They will also tell you how often you need to come for visits and what each visit will involve. The total duration of your participation will be fully explained to you before you agree to join.
Potential risks and benefits
Locations (2)
- —Spain
- —Poland
Common questions
What is an 'open-label' study?
An open-label study means everyone who takes part knows they are receiving the study medication, and everyone actually receives it.
Do I need to have Alzheimer's disease to join?
Yes, this study is specifically for people who have been diagnosed with Alzheimer's disease.
What does 'extension study' mean?
An extension study is a follow-up study for people who have already participated in an earlier trial of the same medication, allowing researchers to gather more long-term information.
Is there an age limit for this study?
You must be 18 years or older, but there is no upper age limit for participation.
What is PRX012?
PRX012 is the name of the investigational medication being studied in this research for Alzheimer's disease.
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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