A 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD Patients
Trial ID: NCT05084365
Interventional - Phase 2 - Unknown status
Parkinson's disease (PD) is a second common neurodegenerative disease. More than 6 million individuals worldwide have Parkinson disease. No disease-modifying pharmacologic treatments are available. Current medical treatment is symptomatic, focused on improvement in motor (eg, tremor, rigidity, bradykinesia) and nonmotor (eg, constipation, cognition, mood, sleep) signs and symptoms. Accumulating evidence suggests the important role for inflammation and oxidative stress in the pathogenesis of PD. Sulforaphane extracted from broccoli sprout is an agent with potent anti-oxidant and anti-inflammatory activity. Previous studies suggested sulforaphane is useful in dopaminergic neuron survival. In this study, the investigator attempts to evaluate the efficacy and safety of sulforaphane in PD patients.
Conditions
Parkinson Disease
Interventions
Sulforaphane
Placebo
Eligibility
Inclusion criteria
Age range from 40 to 75, regardless of ethnic group or gender;
2. Meeting the criteria for clinically established PD (2015) by Movement Disorder Association（MDS）; duration < 5 years;
3. Mini-Mental State Examination (MMSE) ≤ 27 points, but ≥20 points. Hoehn-Yahr stage ≤ 3;
4. Before enrollment, patients should take a stable dose of dopamine-based therapies drugs;
5. No obvious visual or hearing impairment;
6. More than 9 years of education;
7. Patients understand and comply with the study procedure, and are able to complete all tests and examinations required by the program. Sign the informed consent.
Exclusion criteria
Patients who have received globus pallidotomy, thalamotomy, deep brain stimulation (DBS), or stem cell therapy;
2. Other causes of parkinsonism: medications (e.g., metoclopramide, flunarizine), metabolic neurogenetic disorders (e.g., Wilson's disease), encephalitis, cerebrovascular diseases, or degenerative disorders (e.g., progressive supranuclear palsy);
3. Central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
4. Have liver, kidney function insufficiency;
5. Unstable or severe diseases of the heart, lung, liver, kidney and hematopoietic system according to the judgment of the researchers;
6. Participated in other clinical trials within 3 months before screening visit;
7. Other conditions are unsuitable for participating in this study according to the judgement of researchers.