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 are between 40 and 72 years old and have been officially diagnosed with Parkinson's disease according to established medical diagnostic standards.
• People who have had a confirmed Parkinson's disease diagnosis for at least 4 years.
• People whose Parkinson's symptoms are not fully controlled despite being on a stable, optimised medication regimen that includes levodopa/carbidopa (with or without other Parkinson's medicines) for at least 2 months before the screening visit.
• People whose Parkinson's symptoms show at least a 30% improvement in response to levodopa medication when tested during screening.
• People whose Parkinson's disease is rated at stage 3 or 4 on the Modified Hoehn and Yahr scale when they are in an "off" state (when their medication is not working at its best).
• People who have had a specific type of brain scan (18F-DOPA PET scan) before the trial that shows results consistent with Parkinson's disease.
• People who experience both "on" periods (when medication is working) and "off" periods (when medication is not working well), as shown by standard assessments and a patient diary.
• People who meet specific race criteria for the early group: up to 2 of the first 5 participants must be of Asian race, defined as having at least 2 grandparents who are Japanese, Taiwanese, Korean, or Chinese; participants in the second group can be of any race.
• People who are approved to join by a special eligibility review committee after all screening information has been assessed.

Who may not be able to join:

• People who have a type of parkinsonism other than Parkinson's disease, such as progressive supranuclear palsy, multiple system atrophy, dementia with Lewy bodies, corticobasal degeneration, or vascular parkinsonism, among others.
• People who have neurological symptoms or brain conditions unrelated to Parkinson's disease — such as a brain tumour, history of stroke, brain bleeding, Alzheimer's disease, or other brain disorders — based on brain scans or medical history.
• People who have significant psychiatric symptoms, memory or thinking problems, depression, dementia, or other behavioural conditions that the trial doctor determines would prevent safe participation.
• People who have previously had certain brain treatments for Parkinson's disease, including deep brain stimulation, surgical procedures such as pallidotomy or thalamotomy, implanted cell or gene therapy, or focused ultrasound therapy.
• People who experience severe involuntary movements (called dyskinesia) at peak medication times that meet specific severity thresholds on standard rating scales, or who have an unusual pattern of dyskinesia (confirm with trial site).
• People who have a history of, or currently have, abnormal immune system function that could affect how well the cell implants used in this trial take hold in the body.
• People whose blood test results at screening fall outside acceptable ranges, including low white blood cell or platelet counts, abnormal liver function results, elevated bilirubin levels, reduced kidney function, or poorly controlled blood sugar in people with diabetes.
• People who have any condition that makes general anaesthesia, sedation, or brain surgery unsafe for them.
• People who have any serious unstable medical condition or significant ongoing illness that could put them at risk or affect the trial's results.

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