Phase 2 Parkinson's Disease Trial, Recruiting

Written by an AI model from 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 who have been diagnosed with Parkinson's disease (PD) according to a specific standard set of medical criteria, have not yet received any treatment for PD, and have slowness of movement plus at least one of: muscle stiffness, a resting tremor (shaking at 4–6 cycles per second), or balance problems not caused by eye, ear, or nerve issues.
• People who were diagnosed with Parkinson's disease no more than 1 year ago.
• People whose Parkinson's disease is at an early stage (Modified Hoehn and Yahr stage 1.0 or below) (confirm with trial site).
• People who score 22 or higher on a standard memory and thinking test called the Montreal Cognitive Assessment (MoCA).
• People aged 40 years or older at the time of screening.
• People who are able to understand what the study involves and are willing to sign a written consent form before any study activities begin.
• People who are able to complete all tests and assessments required by the study.
• People who, in the opinion of the study doctor, are able to attend all scheduled visits and are likely to follow the study requirements throughout.
• People who are capable of having children (both men and women) and whose partners are also capable of having children must agree to use highly effective birth control — for men, continuing for 3 months after the last dose, and for women, continuing for 6 months after the last dose.
• Women who are not able to have children must either be post-menopausal (no period for at least 12 months, confirmed by a blood test) or have had a surgical procedure that means they cannot become pregnant, with documentation of that procedure available. All women must have a negative pregnancy test before the study treatment begins.

Who may not be able to join:

• People whose movement symptoms are caused by something other than Parkinson's disease, such as certain medications, infections, stroke, or other brain conditions.
• People with a history of intellectual disability or certain mental health conditions (as defined by standard diagnostic guidelines), except for a mild history of depression or anxiety that has fully resolved for at least the past 3 months.
• People who answer positively to certain questions about suicidal thoughts or plans on a standard safety questionnaire used at screening (confirm with trial site).
• People who test positive for Hepatitis B, Hepatitis C, or HIV at screening.
• People whose liver enzyme levels (ALT or AST) are significantly above the normal range at screening or before the first dose.
• People who have taken part in another clinical trial or used an investigational (experimental) product within approximately the past 90 days or longer, depending on the product involved.
• People who have used certain non-prescription supplements — such as coenzyme Q10, carnitine, creatine, lipoic acid, or vitamin E — that may affect how cells produce energy, within the 30 days before the study starts.
• People who have used certain prescription medications that strongly affect how the body processes drugs (specifically strong CYP3A4 inhibitors or certain CYP3A4-sensitive medications) within the 30 days before the study starts (confirm with trial site).
• People who have had a significant allergic reaction to any of the study medications or their ingredients, or who have a history of allergies that the study doctor believes would make participation unsafe.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months of finishing it.
• People who have, or have had, a condition or surgery that could affect how the body absorbs or processes medications, including those who have had their gallbladder removed.
• People who have, or have had, a clinically significant condition affecting the liver, kidneys, digestive system, heart, hormones, lungs, eyes, immune system, blood, skin, or nervous system (other than Parkinson's disease).
• People who have significant abnormalities in their heart rhythm or electrical activity on a heart trace (ECG) at screening.
• People whose blood pressure or heart rate falls outside acceptable ranges at screening (for example, blood pressure too high or too low, or a heart rate below 45 or above 100 beats per minute).
• People who, in the opinion of the study doctor, are unlikely to follow the study requirements or are unsuitable for any reason — for example, difficulty swallowing tablets.
• People who are capable of having children (men or women) and are unwilling or unable to use accepted contraception for up to 6 months after taking part in the study.
• People who are unable to have an MRI scan for any reason.

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