Huntington's disease (HD) is an inherited autosomal dominant, progressive neurodegenerative disease. Clinically, HD is characterized by a triad of movement disorders, cognitive impairments and psychiatric disturbances. These symptoms represent a tremendous burden for patients and caregivers. HD is a fatal disorder with neither cure, nor evidence-based standard therapy available. The green tea polyphenon (2)-epigallocatechin-3-gallate (EGCG) was shown to have beneficial effects in cell and animal models of HD. The aim of this study is to evaluate the efficacy and tolerability of EGCG in HD. The investigators hypothesize that Sunphenon EGCG administered at a maximal daily dose of 1200 mg compared to placebo during a period of 12 months improves cognition in patients with HD. As primary outcome measure, the change of cognitive functions (as measured by the Unified Huntington's Disease Rating Scale (UHDRS)-Cognition composite score of Stroop test, Verbal fluency \& Symbol Digit Modalities Test) after 12 months in comparison to Baseline was defined. The investigators further expect a positive influence of EGCG on other clinical manifestations of HD, measurable effects of EGCG on HD biomarkers and good safety and tolerability of EGCG in HD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Month 01:400 mg /day (200-0-200) Month 02:800 mg /day (400-0-400) Month 03 -12: 1200 mg /day (600-0-600)
Placebo
Department of Neuropsychiatry
Berlin, Germany
Neurologische Klinik der Ruhr-Universität Bochum
Bochum, Germany
Universitätsklinikum Ulm, Klinik für Neurologie
Ulm, Germany
Change of cognitive functions (UHDRS-Cognition: composite score of Stroop test, Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to baseline
Time frame: Month 0, Month 12
UHDRS Motor Score
Time frame: Month 0, Month 12
UHDRS Behavioural Score
Time frame: Month 0, Month 12
UHDRS Functional Assessment
Time frame: Month 0, Month 12
UHDRS Total Functional Capacity (TFC)
Time frame: Screening, Month 12
Clinical Global Impression (CGI)
Time frame: Month 0, Month 12
Depression: Beck Depression Inventory (BDI)
Time frame: Screening, Month 1, Month 2, Month 3, Month 6, Month 9, Month12, Month 13
Health-related Quality of Life: Short Form (36) Health Survey (SF-36)
Time frame: Month 0, Month 12
Subjective Well-Being: Satisfaction With Life Scale (SWLS)
Time frame: Month 0, Month 12, Month 13
Affective Processing: Positive and Negative Affect Schedule (PANAS)
Time frame: Month 0, Month 12, Month 13
Tonic and phasic Alertness
Time frame: Month 0, Month 12
Global Cognition: Mini Mental State Examination
Time frame: Screening, Month 12, Month 13
Quantitative evaluation of motor functions: Qmotor
Time frame: Month 0, Month 12
Brain atrophy: assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM)
Time frame: Month 0, Month 12
Pharmacokinetics and tolerability of EGCG
assessment of side effects and determination of blood and cerebrospinal fluid (CSF) levels of EGCG
Time frame: Month 1 - Month 12
Determination of huntingtin expression levels
Quantification of huntingtin in blood and CSF (optional)
Time frame: Screening - Month 13
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