A 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of clinical symptoms by UPDRS
研究概览
简要总结
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.
详细描述
The study will recruit 100 PD patients, and then these patients will be randomized to sulforaphane group or placebo group (50 patients per arm) for 24 weeks clinic trial. Participants will receive 24 weeks of either sulforaphane or placebo per day, in addition to the existing treatment. Baseline assessments include demographics, a comprehensive medical history, anthropometric measurements (weight and height), physical examination, and lab work. The motor symptoms and cognitive function will be assessed by the Unified Parkinson's Disease Rating Scale (UPDRS) and MATRICS Consensus Cognitive Battery #MCCB#, respectively, at baseline, week 12 and week 24. The cranial MRI is examined at baseline and repeated at week 24. The primary outcomes will be the cognitive function improvement. Secondary outcomes include motor symptoms, biological data, MRI, safety and tolerability. During the study period, safety index including blood routine, liver and kidney function and adverse reactions report will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 40 to 75, regardless of ethnic group or gender;
- •Meeting the criteria for clinically established PD (2015) by Movement Disorder Association（MDS）; duration < 5 years;
- •Mini-Mental State Examination (MMSE) ≤ 27 points, but ≥20 points. Hoehn-Yahr stage ≤ 3;
- •Before enrollment, patients should take a stable dose of dopamine-based therapies drugs;
- •No obvious visual or hearing impairment;
- •More than 9 years of education;
- •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.
排除标准
- •Patients who have received globus pallidotomy, thalamotomy, deep brain stimulation (DBS), or stem cell therapy;
- •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);
- •Central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
- •Have liver, kidney function insufficiency;
- •Unstable or severe diseases of the heart, lung, liver, kidney and hematopoietic system according to the judgment of the researchers;
- •Participated in other clinical trials within 3 months before screening visit;
- •Other conditions are unsuitable for participating in this study according to the judgement of researchers.
研究组 & 干预措施
sulforaphane
The goal of the study is to investigate whether adding sulforaphane will benefit cognitive function in individuals who have PD.
干预措施: Sulforaphane (Drug)
placebo
The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of clinical symptoms by UPDRS
时间窗: 24 weeks
The change of UPDRS(Unified Parkinson Disease Rating Scale），ranging from 0-199, higher scores mean a worse outcome.
Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
时间窗: 24 weeks
The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.The MCCB total score is about 50 in healthy participants, the higher the score, the better the cognition performance.
次要结局
未报告次要终点
研究者
Renrong Wu
Professor
Central South University