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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Sulforaphane Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD Patients
Actual Study Start Date : November 28, 2021
Estimated Primary Completion Date : November 15, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05084365


Contacts
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Contact: Renrong Wu +8615874179855 wurenrong@csu.edu.cn
Contact: Hainan Zhang +8613508474343 yyzhn@sina.com

Locations
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China, Hunan
Mental Health Institute of Second Xiangya Hospital,CSU Recruiting
Changsha, Hunan, China, 410011
Contact: Renrong Wu, PhD    15874179855    wurenrong2013@163.com   
Sponsors and Collaborators
Central South University
Investigators
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Principal Investigator: Renrong Wu the Second Xiangya hospital, Central South University, 410011, Changsha, China.
More Information
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Responsible Party: Renrong Wu, Professor, Central South University
ClinicalTrials.gov Identifier: NCT05084365    
Other Study ID Numbers: PD-Sulforaphane
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: July 6, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Renrong Wu, Central South University:
Sulforaphane
Parkinson's disease
cognition
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Synucleinopathies
Neurodegenerative Diseases
Sulforaphane
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents