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

Sponsor

Central South University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05084365

Collaborator

(none)

100

Enrollment

Arms

14.7

Anticipated Duration (Months)

Study Details

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.

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Oct 10, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Primary Outcome Measures

Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score [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 [24 weeks]
The change of UPDRS at different follow up point

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Renrong Wu,PhD, Professor, Central South University

ClinicalTrials.gov Identifier:

NCT05084365

Other Study ID Numbers:

PD-Sulforaphane

First Posted:

Oct 19, 2021

Last Update Posted:

Oct 19, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

Keywords provided by Renrong Wu,PhD, Professor, Central South University

Sulforaphane

Parkinson's disease

cognition

Additional relevant MeSH terms:

Parkinson Disease

Sulforaphane

Study Results

No Results Posted as of Oct 19, 2021