An Open-Label Phase 2a Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)
This research study is investigating a new medicine called neflamapimod for people diagnosed with Dementia with Lewy Bodies (DLB). It's an early-stage study (Phase 2a), which means the main goals are to understand how safe the medicine is at different doses (either twice or three times a day) and how the body processes it. Researchers will be monitoring participants over 24 weeks to see if there are any side effects. Additionally, the study will explore whether neflamapimod might improve various symptoms often experienced by people with DLB, such as memory, thinking skills, movement, and mood. This information will help decide if future, larger studies are worthwhile.
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¿De qué trata este estudio?
This study is looking into a new medicine called neflamapimod for people who have Dementia with Lewy Bodies, often shortened to DLB. DLB is a type of dementia that can affect memory, thinking, movement, and sometimes cause visual hallucinations. This particular study is in an early stage, which means the main focus is on checking if the medicine is safe and how well people tolerate it, rather than proving it's a cure.
Researchers want to find out if taking 80mg of neflamapimod, either twice or three times a day, for 24 weeks causes any problems or side effects. They'll also be tracking how the medicine moves through the body. This information is really important because it helps scientists understand the right dosage and if the medicine is safe enough to be studied more widely in the future.
Beyond safety, the study will also gently explore if neflamapimod might help with some of the symptoms of DLB. They'll be looking at things like changes in memory, how people manage daily tasks, their balance and walking, mood, and even how often they might experience hallucinations. The hope is that this study will give valuable clues as to whether neflamapimod could be a helpful treatment option for people with DLB in the future.
Puntos clave
- This is an early-stage study for Dementia with Lewy Bodies (DLB).
- It tests a new medicine called neflamapimod.
- The main goals are to check safety and how the body handles the medicine.
- It also looks for potential improvements in memory, movement, and mood.
- Participation involves taking medicine daily and regular clinic visits over 24 weeks.
¿Quién puede ser elegible?
To be considered for this study, you would need to have a diagnosis of Dementia with Lewy Bodies (DLB). The study is open to both men and women.
Participants must be at least 18 years old. There isn't an upper age limit mentioned, so older adults would also be considered as long as they meet the other study requirements.
Ultimately, a medical team would carefully review your medical history and current health to determine if this study is suitable and safe for you to join.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Do I have a diagnosis of Dementia with Lewy Bodies (DLB)?
- Am I at least 18 years old?
- Am I able to attend regular clinic visits and take daily medication?
- Am I comfortable with medical tests, including potential blood tests and scans?
- Am I willing to consider the potential risks and benefits of a new medicine?
¿En qué consiste la participación?
If you decide to take part in this study, you would be given the medicine neflamapimod, either twice or three times a day, for a period of 24 weeks (which is about six months). You would have regular visits to the clinic so the research team can monitor your health and how you're reacting to the medicine.
During these visits, you can expect to have various assessments. These might include blood tests to check how the medicine is working in your body, simple memory and thinking tests, questions about your mood and daily activities, and perhaps even some light physical activity tests like walking. There might also be a brain scan (MRI) before and after the study to see if there are any changes.
The research team will explain everything in detail, including how often you'd need to visit and what each visit involves. You will be closely supported throughout your time in the study.
Riesgos y beneficios potenciales
Ubicaciones (1)
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Preguntas comunes
What is Dementia with Lewy Bodies (DLB)?
DLB is a type of dementia that affects memory, thinking, movement, and can cause visual hallucinations or changes in alertness.
What is neflamapimod?
Neflamapimod is a new medicine being tested. It's designed to target certain processes in the brain that might be involved in DLB.
¿Por qué se está realizando este estudio?
The main reason is to see if neflamapimod is safe for people with DLB and how well their body handles it. It also explores if it helps with symptoms.
¿Cuánto tiempo estaré en el estudio?
You would take the study medicine for 24 weeks, which is about six months. There might be some follow-up visits afterwards.
Will I get the actual medicine or a dummy pill?
This study gives everyone the active medicine, neflamapimod. There is no 'dummy pill' (placebo) used in this specific trial.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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