NCT05084365

A 6-month Study to Evaluate Sulforaphane Effects in PD Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Sulforaphane	Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-11-28
• Primary completion: 2023-11-15
• Completion: 2023-12-31
• First posted: 2021-10-19
• Last updated: 2023-07-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study