PARKINSON DISEASE (Disorder)Phase 1/2LIFT-PDNCT07461220
Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy
A Phase 1/2 study testing IRL757 in people with PARKINSON DISEASE (Disorder) and Apathy, run by Integrative Research Laboratories AB at 14 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Apathy, Safety
- What is being tested?
- IRL757
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 18 Feb 2026to May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Hoehn and Yahr stage ≤ 4 at screening.
- MoCA score of 20 or greater at screening and baseline.
- 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
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- 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.
- Participants with moderate to severe apathy based on a score of at least -16 on the LARS at screening and baseline.
- 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.
- 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.
Who cannot join
- Participants will be excluded if they meet any of the following exclusion criteria when assessed:
- Any active, current psychiatric comorbidity (such as major depressive disorder, obsessive-compulsive disorder, etc)
- as assessed by the MINI at screening,
- as assessed by the MADRS at the baseline visit with a score > 18.
- Score of > 2 in the MDS-UPDRS Part 1, Question 1.2 (hallucinations and psychosis).
- Need for acute psychiatric hospitalization.
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- Participants who:
- 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
- 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
- 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
- In the opinion of the investigator, present a serious risk of suicide.
- Subthalamic stimulation of less than 1 year from screening.
- Subthalamic stimulation without stable parameters for 3 months from screening.
- Clinically significant impulse control disorders (ICDs) as assessed by the QUIP RS (score > 6).
- Renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m2 calculated based on cystatin C).
- Moderately impaired hepatic function or advanced hepatic dysfunction as assessed by a Child Pugh score B or C.
- Significant communicative impairments that prohibit meaningful participation in the trial assessments.
- 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).
- 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.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Any planned major surgery within the duration of the trial.
- Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
- Any vital signs values outside of the following ranges after 10 minutes of supine rest at the time of screening:
- Systolic blood pressure (SBP) > 150 mmHg
- Diastolic blood pressure (DBP) > 90 mmHg
- Heart rate < 50 or > 100 beats per minute.
- 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.
- 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.
- 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.
- Current nicotine use; irregular nicotine use less than 3 times per week is allowed before the screening visit.
- 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.
- Use of anabolic steroids.
- Use of antipsychotics.
- 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.
- Excessive or variable daily caffeine consumption (ie, exceeding 3 cups per day) for the 2 weeks prior to screening.
- Plasma donation within 1 month of screening or any blood donation/blood loss > 450 mL during the 3 months prior to screening.
- Participants who are breastfeeding.
- Participants who have a positive pregnancy test result prior to receiving IMP.
- 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.
- 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.
- 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.
- The investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.
- Any condition that, in the opinion of the investigator, makes it medically inappropriate or risky for the participant to enrol in the trial.
Trial locations and contacts
14 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 4 countries
Poland5 sites, 5 recruiting
- Recruiting
Centrum Medyczne NEUROMED
Bydgoszcz
PI Dr. Pawel Lisewski
- Recruiting
Neuro-Care sp. z o.o. sp. Komandytowa
Katowice
PI Dr. Gabriela Klodowska
- Recruiting
NeuroKlinika Prof. Andrzej Bogucki
Lodz
PI Prof. Andrzej Bogucki
- Recruiting
EuroMedis Sp. z o.o.
Szczecin
PI Dr. Marcin Ratajczak
- Recruiting
Centrum Medyczne NeuroProtect
Warsaw
Dr. Maciej Hyla
Bulgaria4 sites, 4 recruiting
- Recruiting
Medical Center "Galileo" OOD
Pleven
Plamen Bozhinov, Prof.
- Recruiting
Medical Center Academica
Pleven
PI Dr. Plamen Tsvetanov
- Recruiting
First University Multiprofile Hospital for Active Treatment MHAT - Neurology Clinic
Sofia
PI Prof. Dimitar Maslarov
- Recruiting
University Multiprofile Hospital for Active Treatment "Alexandrovska" EAD, Clinic of Neurological Diseases
Sofia
PI Prof. Latchezar Traykov
Spain3 sites, 3 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau, Unidad de trastornos del movimiento
Barcelona
PI Dr. Javier Pagonabarraga Mora
- Not yet recruiting
Hospital General Universitario de Elche
Elche
PI Dr. Eric Freyre Alvarez
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid
Jose Lopez Sendon Moreno
Germany2 sites, 1 recruiting
- Recruiting
Neurologie Berlin
Berlin
PI Dr. Marie Perle Brinckmann
- Withdrawn
Universitaetsklinikum Carl Gustav Carus
Dresden
About this study
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
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
- PARKINSON DISEASE (Disorder), Apathy, Safety
- Being tested
- IRL757, Placebo
- Medical subject headings
- Parkinson Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRL757Drug
IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration.
PlaceboDrug
The study drug is administered daily for 12 weeks. The placebo is available in form of capsules to be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| IRL757 Low Dose | Experimental | This is the low dose IRL757. IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration. Receives: Drug: IRL757 |
| IRL757 High Dose | Experimental | This is the low dose IRL757. IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration. Receives: Drug: IRL757 |
| Placebo | Placebo comparator | The study drug is administered daily for 12 weeks. The placebo is available in form of capsules to be administered orally, not containing the active substance. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of IRL757 after repeated daily dosing for 12 weeks in participants with PD who have moderate to severe symptoms of apathy
Number of participants with adverse events, classified by severity and relationship to study drug.
Measured: From enrollment [signature of informed consent form] to end of study [4 weeks after last study drug administration]
To evaluate the safety and tolerability of IRL757 after repeated daily dosing for 12 weeks in participants with PD who have moderate to severe symptoms of apathy
Number of abnormal clinically significant measures in vital signs (blood pressure, heart rate, respiratory rate) and electrocardiogram (ECG parameters) assessments.
Measured: From enrollment [signature of informed consent form] to end of study [4 weeks after last study drug administration]
To evaluate the safety and tolerability of IRL757 after repeated daily dosing for 12 weeks in participants with PD who have moderate to severe symptoms of apathy
Number of participants with abnormal clinically significant findings at physical examination.
Measured: From enrollment [signature of informed consent form] to end of study [4 weeks after last study drug administration]
Secondary outcomes (2)
To assess the change from baseline in apathy symptoms using the Neuropsychiatric Inventory Clinician (NPI-C)
Change from baseline in the apathy domain of the Neuropsychiatric Inventory Clinician (NPI-C).
Higher NPI-C scores indicate more severe behavioral symptoms and higher caregiver burden.
Measured: From baseline [last assessment before the first administration of the study drug] until end of treatment at 12 weeks
To assess the change from baseline in apathy symptoms using the Lille Apathy Rating Scale (LARS)
The Lille Apathy Scale (LARS) is a semi-structured interview used to assess apathy and its severity in participants with Parkinson's disease. The global score ranges from -36 to +36, with higher scores indicating a greater degree of apathy.
Measured: From baseline [last assessment before the first administration of the study drug] until end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start18 Feb 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Research Laboratories AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461220
- Sponsor's protocol ID
- IRL757C003
- Acronym
- LIFT-PD
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07461220
- Acronym / sponsor ID
- LIFT-PD / IRL757C003
- Conditions
- PARKINSON DISEASE (Disorder), Apathy, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Integrative Research Laboratories ABIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IRL757 Low Dose | Experimental | Drug: IRL757This is the low dose IRL757. IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration. |
| IRL757 High Dose | Experimental | Drug: IRL757This is the low dose IRL757. IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration. |
| Placebo | Placebo comparator | Drug: PlaceboThe study drug is administered daily for 12 weeks. The placebo is available in form of capsules to be administered orally, not containing the active substance. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Hoehn and Yahr stage ≤ 4 at screening.
- MoCA score of 20 or greater at screening and baseline.
- 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:
- 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.
Key exclusion criteria (43 listed)
- Participants will be excluded if they meet any of the following exclusion criteria when assessed:
- Any active, current psychiatric comorbidity (such as major depressive disorder, obsessive-compulsive disorder, etc)
- Score of > 2 in the MDS-UPDRS Part 1, Question 1.2 (hallucinations and psychosis).
- Need for acute psychiatric hospitalization.
- Participants who:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRL757IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration. | Drug | IRL757 High Dose, IRL757 Low Dose |
| PlaceboThe study drug is administered daily for 12 weeks. The placebo is available in form of capsules to be administered orally. | Drug | Placebo |
Primary outcome
To evaluate the safety and tolerability of IRL757 after repeated daily dosing for 12 weeks in participants with PD who have moderate to severe symptoms of apathy
Time frame: From enrollment [signature of informed consent form] to end of study [4 weeks after last study drug administration]
Number of participants with adverse events, classified by severity and relationship to study drug.
To evaluate the safety and tolerability of IRL757 after repeated daily dosing for 12 weeks in participants with PD who have moderate to severe symptoms of apathy
Time frame: From enrollment [signature of informed consent form] to end of study [4 weeks after last study drug administration]
Number of abnormal clinically significant measures in vital signs (blood pressure, heart rate, respiratory rate) and electrocardiogram (ECG parameters) assessments.
To evaluate the safety and tolerability of IRL757 after repeated daily dosing for 12 weeks in participants with PD who have moderate to severe symptoms of apathy
Time frame: From enrollment [signature of informed consent form] to end of study [4 weeks after last study drug administration]
Number of participants with abnormal clinically significant findings at physical examination.
2 secondary outcomes
To assess the change from baseline in apathy symptoms using the Neuropsychiatric Inventory Clinician (NPI-C)
Time frame: From baseline [last assessment before the first administration of the study drug] until end of treatment at 12 weeks
To assess the change from baseline in apathy symptoms using the Lille Apathy Rating Scale (LARS)
Time frame: From baseline [last assessment before the first administration of the study drug] until end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IRL757 in people with PARKINSON DISEASE (Disorder) and Apathy, run by Integrative Research Laboratories AB at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Poland, Bulgaria, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joakim Tedroff (+46 31 757 38 00, info@irlab.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of IRL757 after repeated daily dosing for 12 weeks in participants with PD who have moderate to severe symptoms of apathy (time frame: From enrollment [signature of informed consent form] to end of study [4 weeks after last study drug administration]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.