Early Phase 1 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 clinically diagnosed with primary Parkinson's Disease, according to the 2016 Chinese Diagnostic Criteria for Parkinson's Disease.
• People who are able to understand the details of the trial, including its risks and benefits, and who are willing to sign a consent form. If a person cannot read, a legal representative or impartial witness may read the documents aloud and witness the consent process.
• People aged between 40 and 70 years old (inclusive), of any gender.
• People whose body weight is between 40 kg and 110 kg, and whose Body Mass Index (BMI) is between 18 and 34 kg/m².
• People who have been living with Parkinson's Disease for 5 years or longer.
• People who are medically suitable to undergo surgery under general anaesthesia, and who are able to have CT or MRI scans.
• People whose Parkinson's symptoms, when assessed without medication ("off" state), are rated as stage 4 or 5 on the Hoehn-Yahr scale — a standard measure of how advanced Parkinson's symptoms are.
• People whose movement-related symptoms score 30 or higher on a standard Parkinson's motor assessment (MDS-UPDRS Part III) when assessed without medication, and who show a meaningful improvement in movement (more than 30%) after taking levodopa medication.
• People whose Parkinson's symptoms have not been adequately controlled by standard recommended medications, or who have experienced side effects from those medications that are too difficult to tolerate.
• People who have been on a stable dose of Parkinson's medication for at least 4 weeks before entering the trial.
• People whose blood test results during screening fall within acceptable ranges, specifically: haemoglobin at least 100 g/L; platelets at least 100×10⁹/L; liver enzyme levels (AST and ALT) no more than 1.5 times the upper normal limit; total bilirubin no more than 1.5 times the upper normal limit; and kidney function (creatinine) no more than 1.5 times the upper normal limit.
• People who agree not to take part in any other treatment studies or clinical trials during the main study period.
• People who agree not to receive any other vaccines within 30 days after receiving the study treatment.
• People who are able to live independently or who have a reliable caregiver, are able to attend regular follow-up appointments, and are able to accurately complete a Parkinson's patient diary (with caregiver assistance if needed).
• People whose blood test shows a neutralising antibody level for a specific virus used in the treatment (AAV8) at or below a ratio of 1:90.
• People who meet all the above criteria will also have cancer-related screening conducted, as determined by the principal investigator.

Who may not be able to join:

• People who have an atypical form of parkinsonism, such as Parkinson-plus syndromes, secondary Parkinson's syndrome, or inherited (hereditary) Parkinson's syndrome.
• People who have previously had brain surgery related to Parkinson's Disease, such as pallidotomy, deep brain stimulation (DBS), or other surgeries affecting the brain areas relevant to this trial, or any other surgery that investigators believe could interfere with the study.
• People whose previous CT or MRI scans have shown significant brain abnormalities, such as brain injury, abnormal blood vessels, fluid build-up in the brain, brain tumours, or other changes that would increase the risks of surgery.
• People with a history of serious heart or blood vessel conditions, including severe heart failure, unstable angina, heart attack, serious irregular heartbeat (such as certain types of heart block or prolonged QT interval), Long QT syndrome, prior heart surgery, stroke or mini-stroke (TIA) within the past 3 months, bleeding around the brain (subarachnoid haemorrhage), or other major vascular conditions considered a concern by investigators.
• People who have a history of cancer (malignant tumours).
• People who have previously received cell therapy.
• People who have previously received gene therapy.
• People who have had significant bleeding problems or an active blood-clotting disorder within the 3 months before signing consent, or who cannot safely stop blood-thinning medications before surgery, or whose clotting function has not returned to normal within the required timeframe after stopping such medications.
• People who have received high-dose oral or injected corticosteroids (such as prednisone at 20 mg/day or equivalent) for 14 days or more, or immunosuppressant medications, within 3 months before signing consent (skin-applied treatments are excluded).
• People with psychiatric conditions that investigators consider would make participation unsafe or unsuitable, or people who have had thoughts of suicide or made a suicide attempt within the past year or at the time of screening.
• People who have received botulinum toxin injections (such as Botox) within 6 months before signing consent.
• People with active epilepsy or who are currently taking anti-seizure medications.
• People with a history of dementia or severe cognitive impairment, or who show significant cognitive decline during screening, or who score above 3 on the MDS-UPDRS cognitive impairment sub-score, or whose cognitive difficulties would affect their ability to consent, complete diaries, or follow the study requirements.
• People with severe depression (scoring 24 or higher on the HAM-D17 scale) or severe anxiety (scoring 29 or higher on the HAMA scale) during screening.
• People with significant abnormalities in blood clotting function during screening; or clinically significant immune system abnormalities considered unsuitable by the investigator; or poorly controlled high blood pressure (remaining above 160/100 mmHg despite treatment) or severe drops in blood pressure upon standing; or poorly controlled diabetes (HbA1c above 9.0%, or fasting blood sugar at or above 11.1 mmol/L).
• People for whom brain surgery is not considered safe — for example, those who have a cochlear implant, pacemaker, defibrillator, or similar implanted device; those who have had another surgery in the past six months that investigators believe could affect the trial; those with allergies (such as to contrast dye) that prevent MRI scanning; or those with other reasons surgery would not be safe.
• People with other serious medical conditions affecting major organs, such as severe heart or lung disease (for example, severe COPD where lung function is below 50% of expected).
• People who test positive for HIV, syphilis, active hepatitis C (with detectable viral levels), active hepatitis B (with elevated viral levels), active tuberculosis, or any other active infection that investigators believe could affect the safety of participation or the study results.
• People with alcohol addiction, a positive test for illicit drug use, or a history of drug dependence.
• People who are allergic to or unable to tolerate any of the medications used in the study (such as tacrolimus or levodopa), related drug types, or who have a history of allergies to two or more medications or foods.
• Women who are able to become pregnant and have not been sterilised or reached menopause, or women who are breastfeeding, unless they agree to use medically approved effective contraception for two years after receiving the study drug. Men who have not been sterilised must also agree to use medically approved effective contraception for two years after receiving the study drug.
• People who have received electroconvulsive therapy (ECT) within 30 days before the study treatment is given.
• People who are currently in another clinical trial, or who have received an investigational treatment in another clinical study within the 3 months before the study treatment is given.
• People who investigators believe are unlikely to follow the study requirements reliably.
• People currently receiving apomorphine therapy or levodopa infusion therapy (such as Duodopa®).
• People who have severe movement difficulties in both their medicated and unmedicated states.
• People with serious illness or any other condition that investigators believe could put the participant at risk or affect the reliability of the study assessments.

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