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

NCT ID: NCT05084365

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-28
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sulforaphane

The goal of the study is to investigate whether adding sulforaphane will benefit cognitive function in individuals who have PD.

Group Type: EXPERIMENTAL

Sulforaphane

Intervention Type: DRUG

Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.

placebo

The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Sulforaphane

Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Renrong Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renrong Wu

Role: PRINCIPAL_INVESTIGATOR

the Second Xiangya hospital, Central South University, 410011, Changsha, China.

Locations

Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Renrong Wu

Role: CONTACT

wurenrong@csu.edu.cn

+8615874179855

Hainan Zhang

Role: CONTACT

yyzhn@sina.com

+8613508474343

Facility Contacts

Renrong Wu, PhD

Role: primary

wurenrong2013@163.com

15874179855

Other Identifiers

PD-Sulforaphane

Identifier Type: -

Identifier Source: org_study_id