Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT03727295
Eligibility Criteria:
Inclusion Criteria:
* (1) Male or female, age \> 30 years old, ≤ 80 years old;
* (2) Conforms to the "Diagnostic Criteria for Parkinson's Disease" developed by the 2015 International Association of Sports Disabilities (MDS);
* (3) Patients with early Parkinson's disease, duration \<3 years, Hoehn-Yahr classification:1-3, MMSE scale score ≥ 24 points;
* (4)Receiving a stable dose of dopamine agonist or monoamine oxidase type B inhibitor for treatment before the enrollment;
* (5) The subjects need to sign the Informed Consent Form（ICF）
Exclusion Criteria:
* (1)Patients with disturbance of consciousness, aphasia and mental illness; patients with major depression (HAD scale score ≥ 15 points)
* (2)Patients with Parkinson's superimposition syndrome and patients with secondary Parkinson's syndrome (hepatolenticular degeneration, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.)
* (3)Patients who have long-term use of dopamine blockers (such as potent neuroleptics, sibutramine, reserpine, metoclopramide, etc.);
* (4)Patients who have taken coenzyme Q10 or idebenone within three months;
* (5) Patients taking amantadine and levodopa need to stop taking the drug for more than one month before the enrollment;
* (6)Patients with severe cardiopulmonary dysfunction, liver and kidney dysfunction (more than 3 times normal);
* (7)Patients who cannot cooperate with the neuropsychological test;
* (8) Patients with poor compliance, not following the prescribed treatment regimen.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT03727295
Study Brief:
Protocol Section:
NCT03727295