Test IRL757 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
- Test IRL757 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
Plain-Language Summary
The goal is to treat moderate to severe apathy in people with Parkinson's, helping restore initiative, interest, and emotional responsiveness that make daily life and relationships harder. IRL757 is an experimental oral medicine given in repeated doses and compared with placebo to test safety and tolerability; it aims to boost motivation by modulating brain neurotransmitter systems that drive goal-directed behavior, and it will be tested while participants stay on stable Parkinson and permitted antidepressant treatments. The trial is enrolling adults 50 to 90 years old with Parkinson's (Hoehn and Yahr stage up to 4), with preserved cognition (MoCA ≥ 20) and moderate to severe apathy on the Lille Apathy Rating Scale, and it requires a primary caregiver to help with visits. People with active major psychiatric illness or suicidal ideation, certain cardiac, liver, or kidney problems, recent substance or nicotine use, current antipsychotic use, pregnancy, unstable deep brain stimulation, or other medical risks are not eligible.
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
Frequently Asked Questions
- What is this trial testing?
- This trial is studying IRL757. The goal is to treat moderate to severe apathy in people with Parkinson's, helping restore initiative, interest, and emotional responsiveness that make daily life and relationships harder. IRL757 is an experimental oral medicine given in repeated doses and compared with placebo to test safety and tolerability; it aims to boost motivation by modulating brain neurotransmitter systems that drive goal-directed behavior, and it will be tested while participants stay on stable Parkinson and permitted antidepressant treatments. The trial is enrolling adults 50 to 90 years old with Parkinson's (Hoehn and Yahr stage up to 4), with preserved cognition (MoCA ≥ 20) and moderate to severe apathy on the Lille Apathy Rating Scale, and it requires a primary caregiver to help with visits. People with active major psychiatric illness or suicidal ideation, certain cardiac, liver, or kidney problems, recent substance or nicotine use, current antipsychotic use, pregnancy, unstable deep brain stimulation, or other medical risks are not eligible.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 1 year and 2 months.