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 50 to 80 years old at the time of screening, both male and female.
• People who are able to understand the consent form and agree to take part voluntarily in writing.
• People who are willing and able to attend scheduled visits, follow the study plan, and complete all required tests and procedures.
• People who have a confirmed diagnosis of idiopathic Parkinson's Disease (Parkinson's that arose on its own, not from another cause), diagnosed according to 2015 Movement Disorder Society criteria.
• People whose Parkinson's symptoms, when assessed in an "off" medication state, are below a certain level of severity on a standard rating scale called the Hoehn & Yahr scale (below Stage 3).
• People who have been on a stable dose of L-dopa (with or without other Parkinson's medications) for at least 30 days before joining, and whose dose is expected to stay the same throughout the study.
• People who are in generally stable overall health, based on their medical history, a physical examination, blood tests, and a heart tracing test (ECG).
• People whose blood test results are normal or show no medically important problems, including tests for blood clotting, blood cell counts, organ function, and kidney function (confirm with trial site for specific values).
• People who test negative for illicit drugs on a urine test and negative for alcohol on a breath test at screening.
• People who agree not to use any other experimental or unapproved medications during the trial.
• Male participants who have not had a vasectomy, and their female sexual partners, must agree to use contraception during the study and for 2 months after the last dose of the study drug.
• Male participants must agree not to donate sperm during the study and for 12 months after the last dose of the study drug.
• Female participants must not be pregnant or breastfeeding, and must either be postmenopausal for at least 1 year (confirmed by a blood test at screening), or have had a sterilisation procedure for at least 3 months, or agree to use two highly effective forms of non-hormonal contraception from at least 28 days before joining until 2 months after the last dose of the study drug (confirm specific contraception requirements with trial site).
• People who can speak, read, and understand English well enough to complete all study assessments.

Who may not be able to join:

• People whose Parkinsonism is caused by something other than idiopathic Parkinson's Disease, such as medications, toxins, a metabolic condition, a past brain infection, blood vessel disease, or another degenerative brain condition.
• People with a family history of early-onset Parkinson's Disease (diagnosed before age 50), or who have a known genetic cause of their Parkinson's.
• People who have been diagnosed with another significant neurological disease that could make it hard to assess how the study drug affects Parkinson's symptoms.
• People whose Parkinson's is not well-controlled on their current medications, or who are likely to need changes to their L-dopa dose during the study.
• People who have Parkinson's-related psychosis or dementia, or other psychiatric or mental health conditions that would prevent them from giving informed consent or following the study requirements.
• People who experience severe uncontrolled involuntary movements (dyskinesia) during a typical day, severe enough to interfere with completing study assessments.
• People who have had brain surgery for Parkinson's or tremor.
• People with any other significant medical, surgical, or laboratory abnormality considered important by the study investigator.
• People with serious or unstable heart disease (including a heart attack within the past year), kidney, liver, lung, digestive, blood, hormonal, or infectious diseases (including HIV).
• People with significantly abnormal results on vital sign checks, blood tests, or ECG at screening, or people who have poor vein access for blood draws.
• People with a family history of serious heart conditions, such as sudden death in a parent or sibling, or a heart attack in a close family member before age 50.
• People with a history of conditions affecting the adrenal glands or their hormonal control systems, including adrenal insufficiency, Cushing's syndrome, or conditions affecting reproductive hormone levels such as hypogonadism.
• People whose blood tests at screening show abnormal levels of certain hormones or stress-related chemicals, including renin, aldosterone, cortisol, ACTH response, or reproductive hormones such as FSH, LH, testosterone (for males), or estradiol (for females who are not postmenopausal).
• People who have used steroid medications (topical, oral, or intravenous) within the past 12 weeks, or steroid injections into a joint within the past 6 months, or who plan to use them during the study.
• People who have used chemotherapy within 5 years before screening, or who have a personal or close family history of cancer (other than fully removed, non-spreading skin cancer) that suggests an elevated cancer risk.
• People who have used, within 14 days of being assigned to a study group, or plan to use during the study, certain prescription or over-the-counter medications that strongly or moderately affect how the body processes a specific liver enzyme pathway (CYP3A4) (confirm specific medications with trial site).
• People who have consumed, within 14 days of being assigned to a study group, or plan to consume during the study, certain foods or supplements that strongly or moderately affect that same liver enzyme pathway, such as grapefruit juice.
• People who have difficulty swallowing oral medications.
• People who have taken another experimental drug within 1 month before joining, or within 5 half-lives of that drug, whichever period is longer.
• People who have a documented history of difficult lumbar puncture (spinal tap) procedures, based on the investigator's judgement.

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