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

NCT05084365 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: PD-Sulforaphane
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Sulforaphane; Parkinson's disease; cognition

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

sulforaphane

EXPERIMENTAL

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

Drug: Sulforaphane

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sulforaphane DRUG

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

sulforaphane

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Renrong Wu

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renrong Wu

CONTACT

+8615874179855; wurenrong@csu.edu.cn

Hainan Zhang

CONTACT

+8613508474343; yyzhn@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 19, 2021
• Study Start: November 28, 2021
• Primary Completion: November 15, 2023
• Study Completion: December 31, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

CN (1)