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

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sulforaphane

Placebo

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Sulforaphane, Parkinson's disease, cognition

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age range from 40 to 75, regardless of ethnic group or gender;
Meeting the criteria for clinically established PD (2015) by Movement Disorder Association（MDS）; duration < 5 years;
Hoehn-Yahr stage ≤ 3;
Before enrollment, patients should take a stable dose of dopamine-based therapies drugs;
No obvious visual or hearing impairment;
More than 9 years of education;
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:

The total score of Mini-Mental State Examination (MMSE) ≤ 25 points;
Patients who have received globus pallidotomy, thalamotomy, deep brain stimulation (DBS), or stem cell therapy;
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);
Central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
Have liver, kidney function insufficiency;
Unstable or severe diseases of the heart, lung, liver, kidney and hematopoietic system according to the judgment of the researchers;
Participated in other clinical trials within 3 months before screening visit;
Other conditions are unsuitable for participating in this study according to the judgement of researchers.

Sites / Locations

Mental Health Institute of Second Xiangya Hospital,CSURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sulforaphane

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05084365

First Posted

October 7, 2021

Last Updated

July 4, 2023

Sponsor

Central South University

1. Study Identification

Unique Protocol Identification Number

NCT05084365

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 28, 2021 (Actual)

Primary Completion Date

November 15, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Sulforaphane, Parkinson's disease, cognition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sulforaphane

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sulforaphane

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score

Description

Time Frame

24 weeks

Title

Change of clinical symptoms by UPDRS

Description

The change of UPDRS(Unified Parkinson Disease Rating Scale），ranging from 0-199, higher scores mean a worse outcome.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age range from 40 to 75, regardless of ethnic group or gender; Meeting the criteria for clinically established PD (2015) by Movement Disorder Association（MDS）; duration < 5 years; Mini-Mental State Examination (MMSE) ≤ 27 points, but ≥20 points. Hoehn-Yahr stage ≤ 3; Before enrollment, patients should take a stable dose of dopamine-based therapies drugs; No obvious visual or hearing impairment; More than 9 years of education; 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: Patients who have received globus pallidotomy, thalamotomy, deep brain stimulation (DBS), or stem cell therapy; 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); Central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.); Have liver, kidney function insufficiency; Unstable or severe diseases of the heart, lung, liver, kidney and hematopoietic system according to the judgment of the researchers; Participated in other clinical trials within 3 months before screening visit; Other conditions are unsuitable for participating in this study according to the judgement of researchers.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Renrong Wu

Phone

+8615874179855

wurenrong@csu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Hainan Zhang

Phone

+8613508474343

yyzhn@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renrong Wu

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mental Health Institute of Second Xiangya Hospital,CSU

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renrong Wu, PhD

Phone

15874179855

wurenrong2013@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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