Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-75
SponsorIRCCS Centro Neurolesi Bonino Pulejo

About this trial

Glucosinolates (GLs) are phytocompounds mainly found in the Cruciferae (Brassicacea) and Moringa oleifera plants. The hydrolysis of GLs by myrosinase led to the production of isothiocyanate (ITCs). ITCs consumption was associated with different health promoting effects, including to neuroprotective, anti-oxidant and anti-inflammatory capacities. In particular, they showed neuroprotective effects in experimental models of neurodegenerative diseases, including multiple sclerosis (MS) and Parkinson's disease (PD). From different GLs, different ITCs are originated. In particular, from glucoraphanin (GRA) the ITC sulforaphane (SFN) is obtained. The PI of the project is one of the proprietor of a patent (EP2908850B1) for the application of (Rs)-GRA with myrosinase in a buffered solution for the treatment of neurodegenerative diseases. The aim of this project is to evaluate the effects of the administration of bioactivated GRA in different cohorts of adult patients, affected by MS and PD, but also a cohort of pediatric patients affected by neuromuscolar and degenerative diseases. The effects of bioactivated (Rs)-GRA administration will be evaluated with a combination of clinical evaluations and a multiomic (metabolomic, genomic) approach.

Eligibility criteria

Qualifiers

Male or female patients aged between 45-75 years old.

Clinical diagnosis of PD according to UK Brain Bank Criteria.

3 months of clinical stability before study enrolment.

Anti-parkinsonian medication is fixed for at least 3 months prior to study entry.

Disqualifiers

Absolute contraindications to Magnetic Resonance Imaging (MRI).

Concomitant neurological disease or severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia, or other central nervous system diseases such as stroke, epilepsy or psychiatric disorders;

Total score of Mini-Mental State Examination (MMSE)<24.

Participating in other clinical trials.

Trial design

Treatments tested in this trial

  • bioactivated GRA for adult patients
  • bioactivated GRA for pediatric patients

Treatment groups

300 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

IRCCS Centro Neurolesi Bonino Pulejo

Lead sponsor

Fondazione Edmund Mach

Collaborator

Vittore Buzzi Children's Hospital

Collaborator

Azienda Sanitaria Provinciale Ragusa

Collaborator