Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy
This research study is looking into a new medication called IRL757. It's for people who have Parkinson's disease and are also experiencing apathy, which means having a noticeable lack of interest or motivation. The main goals are to check if IRL757 is safe to use and if it's well-tolerated by patients. Scientists also want to find out if this medicine might help improve or lessen the symptoms of Parkinson's disease. To do this, some participants will receive IRL757, while others will get a placebo – a pill that looks the same but contains no active drug. This comparison helps researchers understand the true effects of IRL757. Participants will be involved for about 12 weeks of treatment and will have regular check-ups.
At a glance
What is this study about?
This study is about a new medicine called IRL757, and it's for people living with Parkinson's disease who also experience 'apathy'. Apathy isn't just feeling a bit down; it's a significant lack of interest, motivation, or drive in things you'd usually care about, like hobbies, talking to friends, or even daily tasks. It can be a really challenging part of living with Parkinson's.
The main aim of this research is to discover two important things about IRL757. Firstly, is it safe for people to take, and does it cause any uncomfortable side effects? This is known as checking its 'safety and tolerability'. Secondly, the researchers want to see if IRL757 can actually make a positive difference to the symptoms of Parkinson's disease itself, especially when apathy is present.
To ensure they get clear results, the study will compare IRL757 with a 'placebo'. A placebo is a dummy pill that looks exactly like the real medicine but contains no active ingredients. This helps doctors tell if any changes in people's symptoms are really due to IRL757 or just to other factors. By taking part, you could be helping to find new ways to manage Parkinson's disease and its related symptoms like apathy, which could benefit many people in the future.
Key takeaways
- Tests a new medicine (IRL757) for Parkinson's with apathy.
- Aims to check safety and how well the medicine is tolerated.
- Compares IRL757 to a dummy pill (placebo).
- Participation involves 12 weeks of treatment and 5 clinic visits.
- Requires a caregiver to attend appointments with you.
- Could help find new treatments for Parkinson's and apathy.
Who may be eligible?
To be considered for this study, you need to be between 50 and 90 years old and have a confirmed diagnosis of Parkinson's disease. Doctors will also check that your Parkinson's is not too advanced.
A key part of this study is for people who are experiencing apathy. This means having a significant lack of interest, motivation, or emotional expression that has been regular for at least a month and causes problems in your daily life. It's important that these feelings aren't due to other mental health conditions, physical problems, or other substances.
Finally, you'll need to have a primary caregiver – an adult who spends at least 10 hours a week with you and helps with your care – who can come with you to your appointments during the study. This helps ensure you have support throughout.
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.
- Are you between 50 and 90 years old?
- Do you have a confirmed diagnosis of Parkinson's disease?
- Do you experience a significant lack of interest or motivation (apathy) that affects your daily life and has lasted over a month?
- Do you have a caregiver (an adult who spends at least 10 hours/week with you) who can come to appointments?
What does participation involve?
If you join this study, your involvement will last for about 16 weeks in total. For 12 of those weeks, you will be taking medication – either the new drug IRL757 or a placebo (a dummy pill). You won't know which one you're receiving.
During these 12 weeks, you'll need to attend clinic appointments at five specific times for check-ups and tests. These visits will allow the doctors to see how you're responding to the medication and monitor your health. After you finish taking the study medication, there will be one final follow-up phone call about four weeks later to see how you are doing.
Potential risks and benefits
Locations (13)
- Medical Center "Galileo" OODVerified postcodePleven, Bulgaria· Recruiting
- First University Multiprofile Hospital for Active Treatment MHAT - Neurology ClinicVerified postcodeSofia, Bulgaria· Recruiting
- University Multiprofile Hospital for Active Treatment "Alexandrovska" EAD, Clinic of Neurological DiseasesVerified postcodeSofia, Bulgaria· Not yet recruiting
- Neurologie BerlinVerified postcodeBerlin, Germany· Recruiting
- Universitaetsklinikum Carl Gustav CarusVerified postcodeDresden, Germany· Not yet recruiting
- Centrum Medyczne NEUROMEDVerified postcodeBydgoszcz, Poland· Recruiting
- Neuro-Care sp. z o.o. sp. KomandytowaVerified postcodeKatowice, Poland· Recruiting
- NeuroKlinika Prof. Andrzej BoguckiVerified postcodeLodz, Poland· Recruiting
- EuroMedis Sp. z o.o.Verified postcodeSzczecin, Poland· Recruiting
- Centrum Medyczne NeuroProtectVerified postcodeWarsaw, Poland· Not yet recruiting
- Hospital de la Santa Creu i Sant Pau, Unidad de trastornos del movimientoVerified postcodeBarcelona, Spain· Recruiting
- Hospital General Universitario de ElcheVerified postcodeElche, Spain· Not yet recruiting
Common questions
What is apathy in Parkinson's disease?
Apathy in Parkinson's disease means a noticeable lack of interest, motivation, or drive that is different from your usual self and can affect your daily life.
What is a 'placebo'?
A placebo is a pill that looks just like the study medicine but doesn't contain any active drug. It helps researchers compare the real effects of the medicine.
Will I know if I'm getting the real medicine or the placebo?
No, during the study, neither you nor the study team will know if you are receiving the real medicine (IRL757) or the placebo. This is to ensure fair and accurate results.
How long will I need to be in the study?
If you join, you will take the study medication for about 12 weeks, and the total study involvement, including follow-up, will be around 16 weeks.
Do I need a caregiver to join?
Yes, an adult caregiver who spends at least 10 hours a week with you and helps with your care will need to come with you to clinic appointments.
How to find out more
Joakim Tedroff
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.