Using tocotrienols to treat Parkinson's disease

Tocotrienols in Parkinson's Disease (PD): A Pilot, Randomised, Placebo-controlled Trial

This study is testing whether tocotrienols can help people with Parkinson's disease manage their symptoms better over two years compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years to 90 Years
• Sex: All
• Sponsor: National Neuroscience Institute (Academic / other)
• Locations: 2 sites (Singapore and 1 other locations)
• Trial ID: NCT04491383 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of tocotrienols (HOV-12020) on patients with Parkinson's disease through a randomized placebo-controlled trial. A total of 100 participants will receive either tocotrienols or a placebo for 104 weeks, with assessments conducted at baseline, Week 52, and Week 104 to evaluate motor and non-motor outcomes. The study will also monitor cognitive impairment and collect blood samples for safety and biomarker analysis. The goal is to determine the efficacy of tocotrienols in delaying Parkinsonian motor dysfunctions.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 40-90 with idiopathic Parkinson's disease diagnosed for more than one year.

Not a fit: Patients with other known causes of parkinsonism or those not willing to abstain from Vitamin E supplements may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for managing Parkinson's disease symptoms and progression.

How similar studies have performed: While tocotrienols have shown promise in animal models, this approach is relatively novel in human trials for Parkinson's disease.

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.

Where this trial is running

Singapore and 1 other locations

• National Neuroscience Institute — Singapore, Singapore (Recruiting)
• Singapore General Hospital — Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Eng King Tan — National Neuroscience Institute Singapore
• Study coordinator: Elaine Ang

Conditions Neuro-Degenerative Disease; Parkinson Disease; Vitamin E; Neurodegenerative Disease; Neurology