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 signed an informed consent form agreeing to take part in the study
• Men or women between 40 and 80 years of age
• People who have not smoked (including tobacco, marijuana, or vaping) for at least 5 years
• People who do not live with anyone who smokes in the home
• People whose body weight is between 60 kg and 110 kg, and whose body mass index (a measure of body weight relative to height) is below 30 at the time of screening
• People diagnosed with Parkinson's disease (according to a recognised medical standard) within the past 60 months before screening
• People whose Parkinson's disease is at a moderate or milder stage of progression (confirm with trial site)
• People who have been taking a stable dose of levodopa (at least 100 mg three times daily, or an equivalent amount) along with other Parkinson's medications for at least 30 days
• People whose treating doctor considers them to be responding well to levodopa therapy
• Women who could become pregnant must return a negative pregnancy test result
• People who are willing to use reliable contraception throughout the study and for 45 days afterward — specific methods apply depending on whether the participant is male or female (confirm with trial site for details)
• People whose liver function, kidney function, blood sugar levels, and carbon monoxide blood levels fall within acceptable ranges as determined by the trial site
• People who are in generally good health based on physical examination, blood pressure, heart rate, breathing, heart tracing (ECG), and blood tests, as assessed by the trial site
• People who have someone (a study partner) available to observe them for at least 4 hours after taking the study drug on days when they are at home, to watch for any signs of carbon monoxide-related concerns
• People who live within approximately 100 miles of the trial site (exceptions may be considered with sponsor approval if the study drug can be transported home within two hours)

Who may not be able to join:

• People whose Parkinson's symptoms suggest a different type of movement disorder rather than standard Parkinson's disease — this includes those with drug-induced parkinsonism, certain brain diseases, or other neurodegenerative conditions
• People who have difficulty controlling eye movements in certain directions (confirm with trial site)
• People showing signs of dementia, including a score below 22 on a standard cognitive test
• People with a history of repeated strokes where Parkinson's-like symptoms worsened in steps
• People with a history of repeated head injury
• People with a history of confirmed brain inflammation (encephalitis)
• People with signs of problems with balance and coordination linked to the cerebellum (a part of the brain)
• People with early and severe involvement of the body's automatic functions (such as blood pressure or bladder control)
• People with certain abnormal reflex signs detected on physical examination
• People who have difficulty swallowing liquids
• People who have previously been treated with, or are currently taking, antipsychotic medications (neuroleptics)
• People with a history of dementia
• People whose blood oxygen level is at or below 95% when measured through the skin, confirmed on a repeat test
• People with significant heart or electrical abnormalities detected on ECG, or blood pressure or heart rate outside acceptable ranges, as determined by the trial site
• People who need dialysis or other kidney replacement treatment
• People with a history of serious heart conditions, including angina, heart attack, heart failure, serious irregular heartbeat, or stroke
• People with a history of significant brain or blood vessel disease, including tumours or lesions in the brain
• People with severe, uncontrolled high blood pressure
• People with severe lung disease, such as asthma or chronic obstructive pulmonary disease (COPD)
• People with certain psychiatric conditions, including hallucinations, delusions, pathological gambling, or alcohol or substance use disorders
• People with a history of diabetes (any type), pre-diabetes, metabolic syndrome, or gestational diabetes
• People who have had a lung infection or pneumonia within 6 months before screening, or any active infection within 14 days before screening
• People with a history of seizures or epilepsy
• People with an autoimmune disease requiring ongoing prescribed treatment to modify the immune system
• People who have drunk alcohol heavily within the past year, or more than 14 standard units of alcohol per week in the past 6 months (1 unit = approximately 150 mL wine, 360 mL beer, or 45 mL of spirits)
• People with a history of drug abuse or dependence
• People who test positive on a drug screen for THC, cocaine, opiates, or methamphetamine
• People with a history of cancer, except for certain minor skin cancers treated more than 3 months ago
• People who use home oxygen
• People who test positive for hepatitis B, hepatitis C, or HIV
• People who have tested positive for COVID-19 within 10 days before starting the study drug
• People whose weight has changed by more than 5 kg in the 3 months before screening
• People who have had a fever or active infection within 10 days before starting the study drug
• People with moderate or severe depression, based on a standard depression scale score
• People who have attempted suicide or had serious thoughts of suicide within the past 5 years, or whom the trial site considers to be at serious risk of suicide
• Women who are pregnant or breastfeeding
• People who have taken part in another clinical drug or medical device study within 60 days before screening, or who are currently taking part in another such study
• People with ongoing anaemia with very low haemoglobin levels (below 9 g/dL)
• People who have received a blood transfusion within 42 days before starting the study drug
• People who have received a live vaccine within 28 days before starting the study drug
• People who have fainted or lost consciousness for any reason within the past 2 years
• People who are unwilling or unable to respond to follow-up phone calls or communicate with the trial site by telephone
• People who are unable or unwilling to follow the requirements of the study
• People with any other illness or condition that, in the trial site's opinion, could affect the safety or results of the study
• People with a history of allergic reactions to any ingredient in the study drug
• People for whom a lumbar puncture (spinal tap) would not be safe — this includes those with a history of very low platelet counts, blood clotting problems, current use of blood-thinning medications (such as warfarin or clopidogrel), a history of lumbar spine surgery or severe spinal arthritis, or a current skin infection at the puncture site

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