Tocotrienols in Parkinson's Disease (PD)

Launched by NATIONAL NEUROSCIENCE INSTITUTE · Jul 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a substance called tocotrienols (HOV-12020) on people with Parkinson's disease (PD). Researchers want to see if taking tocotrienols can help delay the motor and non-motor symptoms of PD. To do this, they will enroll 100 participants aged 40 to 90 years who have been diagnosed with idiopathic Parkinson's disease for at least a year. Eligible participants must be stable on their current PD medications and willing to avoid certain vitamin supplements during the study.

Participants in this study will either receive tocotrienols or a placebo (a sugar pill) for two years. They will take a daily dose of 400 mg and will visit the clinic for assessments at specific times to check their motor skills and cognitive abilities. Blood tests will also be done to monitor their health and look for specific markers related to Parkinson's disease. This study aims to find out if tocotrienols can be a helpful treatment for managing Parkinson's symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men or women aged between 40 - 90 years (inclusive).
• • Able to provide written informed consent and able to comply with study protocol.
• • Idiopathic PD of more than 1 years duration from diagnosis. The diagnosis must be confirmed by presence of bradykinesia and at least 1 other cardinal sign (resting tremor, rigidity), without any other known or suspected cause of parkinsonism.
• • Hoehn \& Yahr =\> 2 with treatment.
• • Patients on PD medication(s) e.g. levodopa, dopamine agonists, amantadine and/or Monoamine oxidase (MAO)-B inhibitors, must be on stable dose, for at least 30 days prior to screening. Medication and dose adjustments are allowed but must be documented.
• • Patients on anti-depressant or anxiolytic medication must be on stable dose for at least 90 days prior to screening.
• • The patient is willing to abstain from Vitamin E supplements (tocopherols and tocotrienols) and other dietary supplements which contain Vitamin E (tocopherols and tocotrienols) up to 14 days before baseline visit, and throughout the clinical study, unless prescribed by their physician for medical reasons.
• Exclusion Criteria:
• • Any other neurodegenerative disorder, such as Alzheimer's disease, Huntington's disease, or Creutzfeldt - Jakob disease.
• • Current, clinically-significant hematological, cardiac, pulmonary, metabolic, neurologic or psychiatric disorders, uncontrolled seizures, untreated hypertension, disorders increasing risk of bleeding (Hemophilia), or any other significant active medical condition which, in the Investigator's opinion, would impact participation in this study.
• • History of psychotic symptoms requiring treatment with a neuroleptic medication within the past 12 months.
• • History of surgical or invasive intervention for PD (pallidotomy, thalamotomy, deep brain stimulation, etc.)
• • Medical history indicating drug-induced parkinsonism (e.g., metoclopramide, flunarizine), metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or other atypical Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy).
• • History of myocardial infarction within 3 months prior to Screening, or current active angina pectoris, or symptomatic heart failure.
• • Known liver disease or liver enzymes (AST, ALT) more than 5 times upper limit normal within 1 month of screening and enrolment.
• • eGFR \<60 within 1 month of screening and enrolment.
• • Current participation in another investigational interventional study.