Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia
This research study is investigating an innovative approach for individuals living with Alzheimer's disease or a mix of Alzheimer's and vascular dementia who experience apathy – a feeling of disinterest or lack of motivation. The study aims to find out if combining two treatments can be effective. One treatment is a non-invasive brain stimulation technique, meaning it doesn't involve surgery, called intermittent theta burst stimulation (iTBS). The other is a medication called methylphenidate, which is already used in medicine for other conditions. Researchers want to see if this combined approach can help reduce apathy in people with these types of dementia.
At a glance
What is this study about?
This study is focused on helping people with Alzheimer's disease or a combination of Alzheimer's and vascular dementia. A common challenge for individuals with these conditions is apathy, which means feeling a lack of motivation, interest, or enthusiasm for daily activities. This can be distressing for both the person experiencing it and their loved ones.
The researchers are exploring a new treatment idea that brings together two different methods. The first is a type of brain stimulation called intermittent theta burst stimulation (iTBS). This involves placing a device on the head that delivers gentle magnetic pulses, aiming to encourage certain brain areas to work more effectively. It's non-invasive, like having a special kind of scan, and doesn't involve any surgery. The second part of the treatment is a medicine called methylphenidate, which helps to change brain chemicals.
The main goal of this study is to see if using both iTBS and methylphenidate together is a safe and effective way to reduce feelings of apathy in people with these forms of dementia. If successful, this could offer a new option to improve the quality of life for those affected.
Key takeaways
- This study explores a new way to help with apathy in Alzheimer's and mixed dementia.
- It combines gentle magnetic brain stimulation with existing medication.
- The goal is to see if this combined treatment can improve motivation and interest.
- A care partner's involvement is important for this research.
- It's a Phase 2 study, meaning it's still in relatively early stages of testing for effectiveness.
Who may be eligible?
To be considered for this study, you would need to have been diagnosed with Alzheimer's disease or a combination of Alzheimer's disease and vascular disease. Your memory and thinking abilities, as measured by a specific test, should fall within a certain range. It's also important that you are experiencing feelings of apathy that are significant enough to affect your daily life. If you are currently taking other mental health medications, their dosage should be stable, meaning it hasn't changed recently.
Also, a care partner – someone who spends at least 10 hours a week with you – must be available to participate alongside you. This is because their observations about your daily life are very important for the study.
Some things that would prevent you from joining include having a major depressive episode, or experiencing significant agitation, hallucinations (seeing or hearing things that aren't there), or delusions (strong beliefs that aren't true). If you're currently taking certain medications that affect brain chemicals (dopamine) other than methylphenidate, or if you have certain metal implants or a history of seizures, you might not be able to take part due to safety reasons related to the brain stimulation. The study doctor would also need to confirm that it's medically safe for you to join.
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.
- Do I have Alzheimer's disease or a mix of Alzheimer's and vascular dementia?
- Do I experience significant feelings of apathy or lack of motivation?
- Is a care partner available who spends at least 10 hours a week with me?
- Have I been stable on any existing mental health medications?
- Do I have any metal implants or a history of seizures that might prevent brain stimulation?
What does participation involve?
If you decide to take part in this study, you would likely have several visits to the study clinic. These visits would involve various assessments, such as memory and thinking tests, and questionnaires to understand your feelings and motivation. You would receive either the active brain stimulation and medication, or a 'dummy' (placebo) version of one or both, depending on which group you are assigned to. This is common in research to fairly test new treatments.
You would have regular check-ups to monitor your health and any effects of the treatment. Your care partner would also be involved, helping to provide information about your well-being. The total duration of your participation, including all treatments and follow-up appointments, would be explained to you in detail by the study team.
Potential risks and benefits
Locations (1)
- Sunnybrook Research InstituteVerified postcodeToronto, Canada· Recruiting
Common questions
What is apathy in dementia?
Apathy means a lack of interest, motivation, or enthusiasm. In dementia, it can make someone seem indifferent to activities or less engaged with others.
What is brain stimulation (iTBS)?
iTBS is a non-invasive technique that uses magnetic pulses to gently stimulate specific areas of the brain to try and improve their function.
What is methylphenidate?
Methylphenidate is a medication that affects certain chemicals in the brain and is used for other conditions to improve focus and attention.
Will I know if I'm getting the real treatment or a placebo?
No, in this type of study, participants usually don't know if they are receiving the active treatment or a placebo to ensure unbiased results. The study team also won't know.
Do I need a care partner to join?
Yes, having a care partner who spends at least 10 hours a week with you is a requirement for participating in this specific study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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