Phase 2 Parkinson's Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 50 and 90 years old (inclusive) who have been diagnosed with Parkinson's disease using recognised medical diagnostic standards.
• People whose Parkinson's disease is rated at stage 4 or below on a standard disease severity scale called the Hoehn and Yahr scale.
• People who score 20 or higher on a standard memory and thinking test called the MoCA at the screening and baseline appointments.
• People who have been experiencing apathy — meaning reduced motivation, reduced interest in usual activities, or reduced emotional expression — that is noticeably different from their usual self, occurs at least 3 days per week, has lasted for at least 4 weeks before screening, and significantly affects their daily personal, social, or work life. The apathy must not be caused by a psychiatric illness, intellectual disability, physical disability, or substance use.
• People who have moderate to severe apathy, as measured by a score of -16 or lower on a standard apathy rating scale called the LARS, at both screening and baseline appointments.
• People who have a primary caregiver — meaning an adult who spends more than 10 hours per week with them and helps oversee their care — who is able to attend trial visits with them and take part in the trial.
• People who are already taking Parkinson's medications, antidepressants (except those listed as prohibited in the trial), or cholinesterase inhibitors, provided the doses have been stable for at least 1 month before joining the trial and remain stable throughout.

Who may not be able to join:

• People who currently have an active psychiatric condition (such as major depression or obsessive-compulsive disorder), as assessed by standard psychiatric screening tools at the screening and baseline visits.
• People who score above 2 on the hallucinations and psychosis question of a standard Parkinson's assessment tool called the MDS-UPDRS.
• People who currently need to be hospitalised for a psychiatric condition.
• People who, within the past 6 months, have reported having thoughts of suicide with some intention to act on them, or who have had specific plans and intent to end their life, or who have made a suicide attempt or taken preparatory steps toward suicide in the past 2 years — as measured by a standard assessment tool called the C-SSRS — or whom the investigator considers to be at serious risk of suicide.
• People who have had deep brain stimulation of the subthalamic nucleus (a brain region involved in Parkinson's) within the past year before screening.
• People who have had subthalamic deep brain stimulation but whose device settings have not been stable for at least 3 months before screening.
• People who have clinically significant problems with impulse control (such as compulsive gambling or shopping), as measured by a standard questionnaire called the QUIP-RS, with a score above 6.
• People with significantly reduced kidney function, defined as a filtration rate below 30 mL/min/1.73m² based on a specific blood marker called cystatin C.
• People with moderately or severely reduced liver function, as measured by a scoring system called Child-Pugh, at grade B or C.
• People with communication difficulties significant enough to prevent meaningful participation in trial assessments.
• People with certain brain or blood vessel abnormalities (such as a cerebral aneurysm, vasculitis, or a previous stroke), a personal or family history of Tourette's syndrome, a history of seizures or epilepsy, or a history of significant abnormal brain wave test (EEG) results.
• People who have had a cancer diagnosis within the past 5 years, with some exceptions for certain treated, non-active skin, bladder, prostate, or cervical cancers (confirm with trial site).
• People who have had a significant illness, medical or surgical procedure, or injury within 4 weeks of the first dose of the trial medication.
• People who have a major surgery planned during the trial period.
• People who test positive for hepatitis B, hepatitis C, or HIV at screening.
• People whose blood pressure or heart rate falls outside specific ranges after resting for 10 minutes at screening — specifically, a systolic blood pressure above 150 mmHg, a diastolic blood pressure above 90 mmHg, or a heart rate below 50 or above 100 beats per minute.
• People with a history of high blood pressure whose blood pressure has not been consistently below 150/90 mmHg for the 3 months before the trial.
• People with certain heart rhythm or electrical abnormalities detected on a heart tracing (ECG) at screening, including a prolonged QT interval beyond specific thresholds for men and women.
• People with a history of a severe allergic reaction, or an ongoing allergy, to drugs in a similar class to the trial medication IRL757.
• People who currently use nicotine regularly (use less than 3 times per week before the screening visit may be permitted — confirm with trial site).
• People who test positive for illicit drugs (including cannabis) or alcohol at screening or on the first day of the trial.
• People who use anabolic steroids.
• People who use antipsychotic medications.
• People who are unwilling or unable to stop taking certain medications — specifically alpha-2 adrenergic receptor antagonists and certain other drugs that affect how the body processes medications — at least 14 days (or longer, depending on the drug) before joining the trial.
• People who consume more than 3 cups of caffeinated drinks per day, or whose caffeine intake varies considerably, in the 2 weeks before screening.
• People who have donated plasma within 1 month of screening, or who have donated blood or lost more than 450 mL of blood in the 3 months before screening.
• People who are currently breastfeeding.
• People who have a positive pregnancy test before receiving the trial medication.
• People of reproductive potential who are sexually active in a way that could result in pregnancy and who do not agree to use a highly effective form of contraception or remain fully abstinent throughout the trial. People who cannot become pregnant due to surgery, menopause (for at least 12 months), or other reasons, and men who have had both testicles removed, may still be eligible (confirm with trial site).
• People who do not agree to refrain from donating sperm for 90 days, or eggs for 30 days, after their last dose of trial medication.
• People who have taken part in a clinical trial involving an investigational drug or device in the past 90 days, or who have participated in more than 2 such trials in the past year.
• People whom the trial investigator considers unlikely to follow the trial's procedures and requirements.
• People who have any other condition that the investigator considers makes it medically inappropriate or risky for them to take part in the trial.

Important: Always verify eligibility with the trial site directly before applying.