Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy

ConditionsPARKINSON DISEASE (Disorder)Apathy Safety

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age50-90

SponsorIntegrative Research Laboratories AB

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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),

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

IRL757
Drug
IRL757 will be administered daily for 12 weeks. The study drug is available as capsules for oral administration.
Placebo
Drug
The study drug is administered daily for 12 weeks. The placebo is available in form of capsules to be administered orally.

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: IRL757 Low DoseExperimental treatment 1 intervention

Group B: IRL757 High DoseExperimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

From enrollment [signature of informed consent form] to end of study [4 weeks after last study drug administration]

Secondary outcomes

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.

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)

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.

Time frame

From baseline [last assessment before the first administration of the study drug] until end of treatment at 12 weeks