Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage

NCT04252261 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 202001005
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

High rates of patients with frontal brain damage show serious cognitive functional deficits, which negatively impact their quality of life and are linked with poor clinical outcomes. Sulforaphane has shown significant antioxidant and cellular protective effects in animal models associated with oxidative stress, such as focal cerebral ischemia, brain inflammation, and intracranial hemorrhage. Preclinical research has shown that sulforaphane can significantly improve spatial localization and working memory impairment after brain damage. The primary aim of this clinical trial is to assess the efficacy of sulforaphane for improving cognitive function in patients with frontal brain damage.

Conditions

Frontal Lobe Dysfunction

Keywords

Sulforaphane; frontal brain damage; cognitive deficits; cognitive function; brain metabolites; gut microbiota

Outcome Measures

Primary Outcomes (1)

• Changes from baseline cognitive tests scores at 3 months

  The battery of cognitive tests include different domains of cognitive tests, higher scores indicates better cognition.

  Week 1 and week 12.

Secondary Outcomes (2)

• the resting state MRI (rsMRI)

  Week 0 and 12.

• T1-weighted spin-echo MRI

  Week 0, 4, and 12.

Study Arms (2)

sulforaphane

EXPERIMENTAL

To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage

Drug: sulforaphane

placebo

PLACEBO COMPARATOR

To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage

Drug: placedo

Interventions

sulforaphane DRUG

To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage

sulforaphane

placedo DRUG

To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage

placebo

Eligibility Criteria

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

You may qualify if:

• years old
• Focal lesions were confined to the frontal brain, which is verified by CT or MRI
• Clinical diagnosis of Cognitive deficits using the Chinese version of the Montreal Cognitive Assessment (MoCA-C) with scores \< 26 will be assessed as having cognitive deficits (\<25 for patients educated \<12 years)
• be adherent to the continued sulforaphane treatment medication

You may not qualify if:

• Previous history of cognitive impairment
• Brain MRI indicating damage was not restricted to the frontal lobe.
• Inability to cooperate with cognitive testing for disturbance of consciousness or mental disorder
• Pregnancy or maternal lactation
• Life expectancy \< 3 months
• CO poisoning, autoimmune encephalitis, intracranial infection, or other types of diffuse intracranial disease.
• plan to receive radiotherapy during the trial period
• Laboratory examination showing liver and kidney insufficiency or other severe complications; the presence of diseases which may interfere with the results of the evaluation
• Involvement in other trials 1 month prior to the start of the trial or during the trial period

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Related Publications (1)

• Liu F, Huang J, Hei G, Wu R, Liu Z. Effects of sulforaphane on cognitive function in patients with frontal brain damage: study protocol for a randomised controlled trial. BMJ Open. 2020 Oct 16;10(10):e037543. doi: 10.1136/bmjopen-2020-037543.

  PMID: 33067279 DERIVED

MeSH Terms

Conditions

Cognition Disorders

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Zhixiong Liu

CONTACT

+8615874290600; zhixiongliu@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and researchers are blind to the treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2021-2022
• Access Criteria: The sharing data for this study are available on request to the corresponding author