IRL757 for Parkinson's (NCT07461220)
New medication to reduce apathy
- Trial ID
- NCT07461220
- Official Title
- A Phase 1b, Prospective, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Tolerability of Multiple Oral Doses of IRL757 in Participants With Parkinson's Disease and Apathy
- Goal
- New medication to reduce apathy
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- Integrative Research Laboratories AB
- Study Type
- INTERVENTIONAL
- Enrollment
- 75 participants
- Conditions
- PARKINSON DISEASE (Disorder), Apathy, Safety
- Interventions
- IRL757, Placebo
- Registry Record Last Updated
- 2026-03-10 (4 months ago)
- Estimated Commitment
- Lower commitment estimated from the protocol (based on: placebo or control group). This reflects time and procedures only — confirm details with the study coordinator.
Summary For Families
The trial is testing whether a new medication, IRL757, is safe and well tolerated in people with Parkinson's who have apathy, and it will also look for any effects on Parkinson's symptoms compared with a placebo. Participants take the medicine or a matching placebo by mouth for 12 weeks, visit the clinic at five set times for checks and tests, and get a follow-up phone call four weeks after the last dose. They are looking for people aged 50 to 90 with a confirmed Parkinson's diagnosis at stage 4 or earlier, who score at least 20 on a basic thinking test, meet the study’s criteria for moderate to severe apathy, can bring a primary caregiver, and have had stable Parkinson's or antidepressant medications for at least one month.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 1 to 5
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "Treatment with anti-Parkinson drugs, antidepressants (except for those listed as prohibited medications in the protocol), and Choline esterase inhibitors is permitted if doses are stable for 1 month before randomization and remain stable...")
- Thinking test (MoCA): MoCA memory and thinking score of at least 20 (criteria text: "moca score of 20 or greater at screening and baseline")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 50 to 90.
- This trial requires Hoehn and Yahr stage 1 to 5.
- This trial requires a MoCA thinking-test score of at least 20.
Locations
- Medical Center "Galileo" OOD, Pleven, Bulgaria
- First University Multiprofile Hospital for Active Treatment MHAT - Neurology Clinic, Sofia, Bulgaria
- University Multiprofile Hospital for Active Treatment "Alexandrovska" EAD, Clinic of Neurological Diseases, Sofia, Bulgaria
- Neurologie Berlin, Berlin, Germany
- Universitaetsklinikum Carl Gustav Carus, Dresden, Germany
- Centrum Medyczne NEUROMED, Bydgoszcz, Poland
- Neuro-Care sp. z o.o. sp. Komandytowa, Katowice, Poland
- NeuroKlinika Prof. Andrzej Bogucki, Lodz, Poland
- EuroMedis Sp. z o.o., Szczecin, Poland
- Centrum Medyczne NeuroProtect, Warsaw, Poland
- Hospital de la Santa Creu i Sant Pau, Unidad de trastornos del movimiento, Barcelona, Spain
- Hospital General Universitario de Elche, Elche, Spain
- Hospital Universitario Ramon y Cajal, Madrid, Spain
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07461220. It is the one about "New medication to reduce apathy". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Participants will have 5 clinic visits during a 12-week treatment period, with a follow-up call 4 weeks after the last study drug intake. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 3 groups, and 1 is a placebo group. Whether you are placed in the placebo group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the placebo group would be.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying IRL757. The trial is testing whether a new medication, IRL757, is safe and well tolerated in people with Parkinson's who have apathy, and it will also look for any effects on Parkinson's symptoms compared with a placebo. Participants take the medicine or a matching placebo by mouth for 12 weeks, visit the clinic at five set times for checks and tests, and get a follow-up phone call four weeks after the last dose. They are looking for people aged 50 to 90 with a confirmed Parkinson's diagnosis at stage 4 or earlier, who score at least 20 on a basic thinking test, meet the study’s criteria for moderate to severe apathy, can bring a primary caregiver, and have had stable Parkinson's or antidepressant medications for at least one month.
- Who can participate?
- Participants must be between 50 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 13 locations.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 1 year and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 3 groups, and 1 is a placebo group. Whether you are placed in the placebo group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the placebo group would be.
- How many visits does this trial involve?
- Participants will have 5 clinic visits during a 12-week treatment period, with a follow-up call 4 weeks after the last study drug intake.