Evaluating the effects of sulforaphane in Parkinson's disease patients

A 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD Patients

This study is testing if a compound from broccoli sprouts called sulforaphane can help improve thinking and movement in people with Parkinson's disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Central South University (Academic / other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05084365 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of sulforaphane, a compound derived from broccoli sprouts, in patients with Parkinson's disease. A total of 100 participants will be randomly assigned to receive either sulforaphane or a placebo for 24 weeks, alongside their existing treatments. The study will evaluate cognitive function and motor symptoms using standardized scales at baseline, 12 weeks, and 24 weeks, while also monitoring safety through various health assessments. The primary focus is on improving cognitive function, with secondary outcomes including motor symptom assessment and biological data analysis.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 75 with clinically established Parkinson's disease for less than 5 years and specific cognitive function criteria.

Not a fit: Patients who have undergone certain surgical interventions for Parkinson's disease or have other causes of parkinsonism will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for improving cognitive function in Parkinson's disease patients.

How similar studies have performed: While sulforaphane has shown promise in previous studies for neuroprotection, this specific approach in Parkinson's disease is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. 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:

1. 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.

Where this trial is running

Changsha, Hunan

• Mental Health Institute of Second Xiangya Hospital,CSU — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Renrong Wu — the Second Xiangya hospital, Central South University, 410011, Changsha, China.
• Study coordinator: Renrong Wu

Conditions Parkinson Disease; Sulforaphane; Parkinson's disease; cognition