A study using Parkinson's disease animal model, transgenic fruit flies, demonstrated the potential of using tocotrienols (HOV-12020) as a therapeutic agent for delaying Parkinsonian motor dysfunctions. The proposed study aims to enrol 100 PD patients in a randomized placebo-controlled trial to investigate the effects of tocotrienols (HOV-12020) in motor and non-motor outcomes. Patients will be given oral tocotrienols (400mg/day) or placebo for 104 weeks. They will be assessed using the standard assessments scales in PD at baseline, Week 52 and Week 104. Neuropsychological evaluation will also be completed at these intervals to monitor progression of cognitive impairment (if any). Additional PD staging using MDSUPDRS (Part III), Hoehn \& Yahr (H\&Y) will be conducted at Week 26 and week 78. Blood samples will be collected to evaluate PD biomarkers and for safety monitoring (liver function, renal function and hematology).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Dietary supplement: Tocotrienol (HOV-12020) Palm oil-derived vitamin E, tocotrienol
Dietary supplement: Placebo. Placebo.
National Neuroscience Institute
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Mean change from Baseline to Week 104 in Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score
Score range is 0 to 199, with severity increasing with higher scores.
Time frame: 104 weeks
Mean change from baseline to week 104 in disease severity
Time frame: 104 weeks
Mean change from baseline to week 104 in individual cognitive domain z scores on comprehensive neuropsychological testing mean score change from baseline to week 104 in the MDS-UPDRS score for total score
Severity of disease increases with higher score.
Time frame: 104 weeks
Mean change from Baseline to Week 104 in quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-39)
Score range is 0 to 100. A lower score will indicate a better quality of life.
Time frame: 104 weeks
Difference proportion of patients with change from Baseline to Week 104, above or equal to the minimal clinically important difference (MCID) of the motor score, as measured by Part II and III subscales of MDS-UPDRS.
Severity of disease increases with higher score.
Time frame: 104 weeks
Mean change in levels of blood-based biomarkers (including total antioxidant status TAS, oxidative stress biomarkers and αsynuclein).
Time frame: 104 weeks
Between treatment difference of type and incidence of Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: 104 weeks
Mean score change from Baseline to Week 104 in the MDS-UPDRS Part II scale
Severity of disease increases with higher score.
Time frame: 104 weeks
Mean score change from Baseline to Week 104 in the Schwab and England Activities of Daily Living (SE-ADL) scale.
The scale uses percentages to assess the difficulties completing daily activities/chores, from 0% to 100%. A higher percentage will indicate a better outcome (i.e. more independence for an individual).
Time frame: 104 weeks
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