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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Placebo; Drug: Sulforaphane

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
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Renrong Wu; Phone Number: +8615874179855; Email: wurenrong@csu.edu.cn
• Study Contact Backup: Name: Hainan Zhang; Phone Number: +8613508474343; Email: yyzhn@sina.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • Mental Health Institute of Second Xiangya Hospital,CSU
      • Contact: Renrong Wu, PhD; Phone Number: 15874179855; Email: wurenrong2013@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.	Drug: Placebo; Placebo
Experimental: sulforaphane; The goal of the study is to investigate whether adding sulforaphane will benefit cognitive function in individuals who have PD.	Drug: Sulforaphane; Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2021
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cognition; Sulforaphane; Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; Sulforaphane
• Other Study ID Numbers: PD-Sulforaphane

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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