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

• ClinicalTrials.gov Identifier: NCT05084365
• Recruitment Status: Recruiting
• First Posted: October 19, 2021
• Last Update Posted: July 6, 2023
• Sponsor: Central South University
• Information provided by (Responsible Party): Renrong Wu, Central South University

Tracking Information

• First Submitted Date: October 7, 2021
• First Posted Date: October 19, 2021
• Last Update Posted Date: July 6, 2023
• Actual Study Start Date: November 28, 2021
• Estimated Primary Completion Date: November 15, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 4, 2023)

• Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score [ Time Frame: 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.
• Change of clinical symptoms by UPDRS [ Time Frame: 24 weeks ]
  The change of UPDRS(Unified Parkinson Disease Rating Scale），ranging from 0-199, higher scores mean a worse outcome.

Original Primary Outcome Measures (submitted: October 18, 2021)

• Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score [ Time Frame: 24 weeks ]
  The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure
• Change of clinical symptoms by UPDRS [ Time Frame: 24 weeks ]
  The change of UPDRS at different follow up point

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A 6-month Study to Evaluate Sulforaphane Effects in PD Patients
• Official Title: A 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD Patients
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson Disease

Intervention

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

Study Arms

• Experimental: sulforaphane
  The goal of the study is to investigate whether adding sulforaphane will benefit cognitive function in individuals who have PD.
  Intervention: Drug: Sulforaphane
• Placebo Comparator: placebo
  The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 18, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: November 15, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Renrong Wu; +8615874179855; wurenrong@csu.edu.cn

Contact: Hainan Zhang; +8613508474343; yyzhn@sina.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05084365
• Other Study ID Numbers: PD-Sulforaphane
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Renrong Wu, Central South University
• Original Responsible Party: Renrong Wu,PhD, Central South University, Professor
• Current Study Sponsor: Central South University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Renrong Wu; the Second Xiangya hospital, Central South University, 410011, Changsha, China.

• PRS Account: Central South University
• Verification Date: July 2023