Recruiting · registry statusTesting a medicine for loss of interest and motivation
Researchers study whether IRL757 can be taken safely and tolerated by people with Parkinson’s who experience a lack of motivation or interest.
Testing a treatment or activity · Study reference: NCT07461220
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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Looking for volunteers
- Start (reported actual date)
- 2026-02-18
- Main measurements finished (planned)
- 2027-05
- Study finished (planned)
- 2027-05
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 50 years to 90 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
1. Male and female participants between 50 and 90 years of age, inclusive, with diagnosed Parkinson's disease according to the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's disease.
2. Hoehn and Yahr stage ≤ 4 at screening.
3. MoCA score of 20 or greater at screening and baseline.
4. Meets the ISCTM definition of apathy (criterion B), defined as exhibiting ≥ 1 symptom in ≥ 2 of the following 3 dimensions, that is persistent or frequently recurrent (ie, ≥ 3 days per week) for ≥ 4 weeks prior to screening:
* Diminished initiative (less spontaneous and/or active than usual self; less likely to initiate usual activities such as hobbies, chores, self-care, conversation, work-related or social activities),
* Diminished interest (less enthusiastic about usual activities, less interested in, or less curious about, events in their environment, less interested in activities and plans made by others, less interested in friends and family, less persistence in maintaining or completing tasks or activities), or
* Diminished emotional expression/responsiveness (less spontaneous emotions, less affectionate compared to their usual self, expresses less emotion in response to positive or negative events, less concerned about the impact of their actions on other people, less empathy).
The symptoms must represent a significant change from the participant's usual behaviour and cause significant impairment in personal, social, or occupational functioning. Finally, the symptoms must not be due to psychiatric illness, intellectual disability, physical/motor disabilities, or changes in level of consciousness or the effects of substances.
5. Participants with moderate to severe apathy based on a score of at least -16 on the LARS at screening and baseline.
6. Availability of the primary caregiver, any adult who spends greater than 10 hours a week with the participant and supervises his or her care, to accompany the participant to trial visits and to participate in the trial.
7. 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 during the trial.
Exclusion Criteria:
Participants will be excluded if they meet any of the following exclusion criteria when assessed:
1. Any active, current psychiatric comorbidity (such as major depressive disorder, obsessive-compulsive disorder, etc)
1. as assessed by the MINI at screening,
2. as assessed by the MADRS at the baseline visit with a score \> 18.
2. Score of \> 2 in the MDS-UPDRS Part 1, Question 1.2 (hallucinations and psychosis).
3. Need for acute psychiatric hospitalization.
4. Participants who:
1. Answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) within the last 6 months prior to screening or the baseline visit, OR
2. Answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) within the last 6 months prior to screening or at the baseline visit, OR
3. Answer "Yes" on any of the 5 C-SSRS Suicidal Behaviour Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behaviour) within 2 years prior to screening or at the baseline visit, OR
4. In the opinion of the investigator, present a serious risk of suicide.
5. Subthalamic stimulation of less than 1 year from screening.
6. Subthalamic stimulation without stable parameters for 3 months from screening.
7. Clinically significant impulse control disorders (ICDs) as assessed by the QUIP RS (score \> 6).
8. Renal impairment (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73m2 calculated based on cystatin C).
9. Moderately impaired hepatic function or advanced hepatic dysfunction as assessed by a Child Pugh score B or C.
10. Significant communicative impairments that prohibit meaningful participation in the trial assessments.
11. Central nervous system abnormalities (eg, cerebral aneurysm) and/or other vascular abnormalities such as vasculitis or pre-existing stroke, motor tics, or family history or diagnosis of Tourette's syndrome, seizures (convulsions, epilepsy), or historical clinically significant abnormal electroencephalograms (EEGs).
12. History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non metastatic prostate cancer, or in situ cervical cancer. The cancer must not be active or currently under treatment except for potentially long-term stable medications.
13. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
14. Any planned major surgery within the duration of the trial.
15. Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
16. Any vital signs values outside of the following ranges after 10 minutes of supine rest at the time of screening:
1. Systolic blood pressure (SBP) \> 150 mmHg
2. Diastolic blood pressure (DBP) \> 90 mmHg
3. Heart rate \< 50 or \> 100 beats per minute.
17. Participants with a history of hypertension must have stable blood pressure for the 3 months prior to the trial, defined as blood pressure \< 150/90 mmHg. If this criterion is not met the participant is not eligible for the trial.
18. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 450 msec for male participants or \> 470 msec for female participants, cardiac arrhythmias, or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the investigator.
19. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL757.
20. Current nicotine use; irregular nicotine use less than 3 times per week is allowed before the screening visit.
21. Positive screen for illicit drugs (including cannabinoids) and/or abuse or positive screen for alcohol at screening or on Day 1 prior to administration of the IMP.
22. Use of anabolic steroids.
23. Use of antipsychotics.
24. The participant is unwilling or unable to discontinue taking alpha-2 adrenergic receptor antagonists and/or cytochrome P450 (CYP) inhibitor or substrate drugs at least 14 days or 5 times the half-life of the drug (whichever is longer) before randomization.
25. Excessive or variable daily caffeine consumption (ie, exceeding 3 cups per day) for the 2 weeks prior to screening.
26. Plasma donation within 1 month of screening or any blood donation/blood loss \> 450 mL during the 3 months prior to screening.
27. Participants who are breastfeeding.
28. Participants who have a positive pregnancy test result prior to receiving IMP.
29. Heterosexually active participants of reproductive potential (PORP) / POCBP who do not agree to use a highly effective method of birth control or remain fully abstinent from sexual activity with the potential for conception. Female participants of nonchildbearing potential (permanently sterilized \[ie, hysterectomy, bilateral oophorectomy\], postmenopausal for at least 12 months, or otherwise incapable of pregnancy) and male participants who have had a bilateral orchiectomy are eligible for enrolment.
30. Participants who do not agree to refrain from donating sperm or eggs from trial screening through 90 days (for sperm) and 30 days (for eggs) after the last dose of IMP.
31. Participants who have participated in a clinical trial involving an investigational drug or device within the last 90 days or who participated in more than 2 clinical trials involving an investigational drug or device within the past year.
32. The investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.
33. Any condition that, in the opinion of the investigator, makes it medically inappropriate or risky for the participant to enrol in the trial.
Full study name & original research details
Official study 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
Short title used by the registry
Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy
Original description
This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation). In addition, the trial is aiming to learn if IRL757 has effects on the symptoms of Parkinson's disease. Researchers will compare the effects of IRL757 to a placebo (a look-alike substance that contains no drug).
Participants who fit the study criteria will be treated with the study drug (either the active drug IRL757 or placebo) for 12 weeks and will visit the clinic at 5 defined timepoints for check-ups and tests. A follow-up call after the end of treatment will be done 4 weeks after the last study drug intake.
Conditions reported: PARKINSON DISEASE (Disorder); Apathy; Safety
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- IRL757; Placebo
- Phases
- PHASE1; PHASE2
- Sponsor
- Integrative Research Laboratories AB
- Start date reported by registry
- 2026-02-18 (actual)
Registry updated: 2026-09-03 · Status last verified by the registry submitter: 2026-09
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Joakim Tedroff · +46 31 757 38 00 · info@irlab.se
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Medical Center "Galileo" OOD
Pleven, Bulgaria
RecruitingPlamen Bozhinov, Prof.
Medical Center Academica
Pleven, Bulgaria
RecruitingPI Dr. Plamen Tsvetanov
First University Multiprofile Hospital for Active Treatment MHAT - Neurology Clinic
Sofia, Bulgaria
RecruitingPI Prof. Dimitar Maslarov
University Multiprofile Hospital for Active Treatment "Alexandrovska" EAD, Clinic of Neurological Diseases
Sofia, Bulgaria
RecruitingPI Prof. Latchezar Traykov
Neurologie Berlin
Berlin, Germany
RecruitingPI Dr. Marie Perle Brinckmann
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
WithdrawnCentrum Medyczne NEUROMED
Bydgoszcz, Poland
RecruitingPI Dr. Pawel Lisewski
Neuro-Care sp. z o.o. sp. Komandytowa
Katowice, Poland
RecruitingPI Dr. Gabriela Klodowska
NeuroKlinika Prof. Andrzej Bogucki
Lodz, Poland
RecruitingPI Prof. Andrzej Bogucki
EuroMedis Sp. z o.o.
Szczecin, Poland
RecruitingPI Dr. Marcin Ratajczak
Centrum Medyczne NeuroProtect
Warsaw, Poland
RecruitingDr. Maciej Hyla
Hospital de la Santa Creu i Sant Pau, Unidad de trastornos del movimiento
Barcelona, Spain
RecruitingPI Dr. Javier Pagonabarraga Mora
Hospital General Universitario de Elche
Elche, Spain
Not yet recruitingPI Dr. Eric Freyre Alvarez
Hospital Universitario Ramon y Cajal
Madrid, Spain
RecruitingJose Lopez Sendon Moreno
Facility not reported
Bulgaria
Status not reportedFacility not reported
Germany
Status not reportedFacility not reported
Poland
Status not reportedFacility not reported
Spain
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.