Tocotrienols in Parkinson's Disease (PD)

This is an interventional treatment trial for Neuro-Degenerative Disease focused on measuring Parkinson Disease, Vitamin E, Neurodegenerative Disease, Neurology Read More

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.