An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
This ongoing study is investigating a new medication called ML-007C-MA. It's for adults living with Alzheimer's disease who are also experiencing hallucinations (seeing or hearing things that aren't there) and delusions (strong beliefs that aren't true). The main purpose of this study is to closely watch for any side effects or problems with the drug over a long period. Researchers want to make sure the treatment is safe and that people can take it without too much discomfort. This is considered a 'Phase II' study, which means it's an earlier stage of research designed to gather more information about safety and how well the drug might work, building on initial findings.
At a glance
What is this study about?
This research study is looking at a new medication called ML-007C-MA. It's designed for people who have Alzheimer's disease and are also experiencing distressing symptoms like hallucinations and delusions. Hallucinations mean seeing, hearing, smelling, tasting, or feeling things that aren't real, while delusions are strong, false beliefs that a person holds, even when shown evidence they're not true. These symptoms can be very upsetting for people with Alzheimer's and their families. This study is trying to find a way to help reduce these experiences safely.
The main goal of this particular study is to understand the long-term safety of ML-007C-MA and whether people can comfortably take it over time. This means doctors will be very carefully looking out for any side effects, both minor and serious. They will also assess how well the medication might be helping with the hallucinations and delusions, and how it impacts quality of life and daily activities.
This is an 'open-label' study, which means both the participants and the study team will know that the active drug is being given. This is part of the ongoing process of developing new medicines, ensuring they are safe and effective for patients who need them.
Key takeaways
- This study is for adults with Alzheimer's disease who have hallucinations or delusions.
- It aims to check the long-term safety and whether the new drug, ML-007C-MA, is well-tolerated.
- Participants will have regular health checks and tests.
- It's a Phase II study, focusing on safety and early signs of effectiveness.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 years or older. The study is open to both men and women.
The most important requirement is that you must have been diagnosed with Alzheimer's disease and are currently experiencing hallucinations or delusions linked to your condition. These are the specific symptoms the study medication aims to help with.
There would also be other detailed medical criteria that the study doctors would check to make sure the study is right and safe for you. For example, they might look at your overall health, other medicines you are taking, and specific medical test results.
- Are you 18 years old or older?
- Do you have a diagnosis of Alzheimer's disease?
- Are you currently experiencing hallucinations or delusions linked to your Alzheimer's?
- Are you able to attend regular clinic visits?
- Are you willing to take a new study medication?
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 receive the study medication, ML-007C-MA, for a period of time. You would have regular visits to the clinic where the study team would monitor your health very closely. These visits would involve various assessments, such as reviewing any side effects you might be experiencing, checking your medical history, and performing physical examinations.
You would also have blood tests, heart rhythm checks (ECG), vital sign measurements (like blood pressure and pulse), and weight checks. Additionally, you would complete questionnaires to assess your symptoms, memory, and how you are feeling generally. The total duration of your participation, including follow-up appointments, would be explained fully by the study team.
Potential risks and benefits
Locations (9)
- —Italy
- —Poland
- —Czechia
- —Portugal
- —Bulgaria
- —France
- —Slovakia
- —Romania
- —Hungary
Common questions
What are hallucinations and delusions in Alzheimer's?
Hallucinations mean seeing or hearing things that aren't really there. Delusions are strong, false beliefs that a person holds, even when shown they're not true. Both can be distressing for people with Alzheimer's.
What is a 'Phase II' study?
Phase II means it's an earlier stage of research. The main goals are to gather more information about how safe the new drug is, what doses might work best, and to see if it shows signs of being effective for the condition it’s meant to treat.
What does 'open-label' mean?
Open-label means that everyone involved – both the people taking part in the study and the doctors and nurses – will know that the active study medication is being given, rather than a dummy pill (placebo).
Will I have to pay to join this study?
No, you should not have to pay to participate in a clinical trial. All study-related medication and assessments are usually provided free of charge.
What if I experience side effects?
The study team will monitor you very closely for any side effects. If you experience any problems, you should tell the study team immediately so they can assess you and provide appropriate care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.