A trial to investigate the effect on overall health and functioning in patients with Lewy body dementia of memantine as an add-on treatment to a cholinesterase inhibitor
Dementia with Lewy bodies and Parkinson's disease dementia are conditions that affect memory, movement, and day-to-day activities. Many people take standard medicines to help their brain function, known as cholinesterase inhibitors. The COBALT study is looking at whether adding another tablet, called memantine, gives extra benefit. Memantine is already used to treat Alzheimer's disease, but doctors need more evidence to know if it helps with Lewy body conditions. In this study, half of the participants will take memantine tablets alongside their normal treatment, and the other half will take a dummy pill (placebo). Participants will be aged 55 or older and will attend review visits over 6 or 12 months. Because both the patient and their carer attend together, the trial checks how the treatment helps both thinking skills and everyday quality of life at home.
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¿De qué trata este estudio?
Dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD) are complex conditions that can cause problems with memory, movement, sleep, and mood. People living with these conditions often need high levels of support, and their symptoms can change from day to day. Standard medications called cholinesterase inhibitors (such as donepezil or rivastigmine) are commonly prescribed by the NHS to help protect memory and daily abilities. However, doctors are always looking for better ways to relieve symptoms.
Memantine is a well-known medication that protects brain cells and is already widely used for Alzheimer’s disease. Doctors believe it might also help people with DLB or PDD to stay more alert and manage daily tasks more easily. Currently, there is not enough evidence to prove whether adding memantine to existing dementia medications really makes a difference. The COBALT trial was set up to answer this important question.
This Phase III clinical trial is running in NHS hospitals across the UK as well as in Australia. Participants are placed into one of two groups by chance: one group receives memantine, and the other receives a dummy tablet (placebo) with no active medicine. Neither the patient nor their doctor will know which pill they are taking. By tracking both groups over time, researchers hope to see if memantine truly improves quality of life and whether it is cost-effective for health services.
Puntos clave
- Tests whether adding memantine to standard dementia medicines helps people with Lewy body or Parkinson's dementia.
- Participants take either memantine or a dummy pill (placebo) alongside their usual treatments.
- Open to people aged 55 and over who have been on steady dementia medication for at least 12 weeks.
- A carer, friend, or partner must take part to help report on daily living.
- Involves memory tests and health checks over 6 to 12 months with plenty of rest breaks provided.
¿Quién puede ser elegible?
You may be able to join this study if you are 55 or older and have a diagnosis of either Dementia with Lewy bodies or Parkinson’s disease dementia. You must already be taking a steady dose of a standard dementia medicine (a cholinesterase inhibitor) for at least three months, with no plans to change your dose.
Because this trial looks at memory and day-to-day skills, your thinking abilities must be within a mild to moderate range, which the study team can check using a simple memory test. If you take any other medications for mood or Parkinson's symptoms, those should have been stable for at least four weeks before joining.
You will also need a carer, partner, or close friend who can attend appointments with you and answer questions about your daily routine. If a person with dementia is unable to make the decision to take part themselves, a family member or nominated representative can give permission on their behalf. Women taking part must be past the menopause.
¿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.
- You are aged 55 or older.
- You have a diagnosis of Dementia with Lewy bodies or Parkinson's disease dementia.
- You have been taking a stable dose of a standard dementia tablet for at least 12 weeks.
- Any medications for mood or Parkinson's symptoms have been unchanged for at least 4 weeks.
- You have a carer, relative, or friend who can attend study visits with you.
- Female participants are post-menopausal.
¿En qué consiste la participación?
Taking part in the trial lasts either 26 weeks (about six months) or 52 weeks (one year). You will continue to take your normal prescribed medications, along with the study tablets once a day. For the first four weeks, the study tablet starts at a low dose and slowly increases to help your body get used to it.
You and your carer will have full assessment visits at the start of the study, at six months, and potentially at one year. During these visits, the research team will check your physical health, ask you to complete memory tests, and ask your carer questions about how you are managing at home. These visits can take between one and two hours. You will be given regular rest breaks, and you can pause or stop the tests at any time if you feel tired.
Riesgos y beneficios potenciales
Ubicaciones (29)
- The Newcastle upon Tyne Hospitals NHS Foundation TrustSolo ciudadNewcastle upon Tyne, England
- South London and Maudsley NHS Foundation TrustSolo ciudadBeckenham, England
- Cambridgeshire and Peterborough NHS Foundation TrustSolo ciudadCambridge, England
- Essex Partnership University NHS Foundation TrustApproximateWickford, England
- Norfolk and Suffolk NHS Foundation TrustSolo ciudadNorwich, England
- Hampshire and Isle of Wight Healthcare NHS Foundation TrustNo verificadoSouthampton, England
- Hospital Universitario Reina IsabelNo verificadoGlasgow, Scotland
- Sussex Partnership NHS Foundation TrustNo verificadoWorthing, England
- Devon Partnership NHS TrustNo verificadoExeter, England
- North Bristol NHS TrustNo verificadoBristol, England
- Sheffield Health & Social Care NHS Foundation TrustNo verificadoSheffield, England
- Tees, Esk and Wear Valleys NHS Foundation TrustNo verificadoDarlington, England
Preguntas comunes
Will I definitely receive the real memantine medicine?
No. A computer will randomly assign you to receive either memantine or a dummy pill (placebo) so researchers can fairly measure the drug's effects. Neither you nor your doctor will know which one you are taking.
Do I have to stop my current dementia medication?
No. You must stay on your regular prescribed dementia tablet throughout the study. The trial is testing memantine as an add-on treatment, not a replacement.
Does my family member or carer have to take part?
Yes. The trial requires a carer or close companion to attend visits because their feedback about your daily activities and well-being is a key part of the research.
What happens if the memory tests make me feel too tired?
You can take breaks whenever you need to. You can also skip questions or tests, and if you need a longer rest, the appointment can be finished within seven days.
¿Puedo abandonar el estudio si cambio de opinión?
Yes. You can leave the study at any point without giving a reason. Leaving will not affect the standard NHS care or treatment you receive.
Cómo obtener más información
Andrew Swain
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.