Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (2)-epigallocatechin-3-gallate (EGCG) | Experimental | Month 01:400 mg /day (200-0-200) p.o. Month 02:800 mg /day (400-0-400) p.o. Month 03 -12: 1200 mg /day (600-0-600) p.o. |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (2)-epigallocatechin-3-gallate (EGCG) | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of cognitive functions (UHDRS-Cognition: composite score of Stroop test, Verbal fluency & Symbol Digit Modalities Test) after 12 months in comparison to baseline | Month 0, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| UHDRS Motor Score | Month 0, Month 12 | |
| UHDRS Behavioural Score | Month 0, Month 12 | |
| UHDRS Functional Assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Josef Priller, MD | Department of Neuropsychiatry, Charité Universitätsmedizin Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neuropsychiatry | Berlin | 10117 | Germany | |||
| Neurologische Klinik der Ruhr-Universität Bochum |
Not provided
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo |
|
| Month 0, Month 12 |
| UHDRS Total Functional Capacity (TFC) | Screening, Month 12 |
| Clinical Global Impression (CGI) | Month 0, Month 12 |
| Depression: Beck Depression Inventory (BDI) | 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) | Month 0, Month 12 |
| Subjective Well-Being: Satisfaction With Life Scale (SWLS) | Month 0, Month 12, Month 13 |
| Affective Processing: Positive and Negative Affect Schedule (PANAS) | Month 0, Month 12, Month 13 |
| Tonic and phasic Alertness | Month 0, Month 12 |
| Global Cognition: Mini Mental State Examination | Screening, Month 12, Month 13 |
| Quantitative evaluation of motor functions: Qmotor | Month 0, Month 12 |
| Brain atrophy: assessed by magnetic resonance imaging (MRI)-voxel-based morphometry (VBM) | Month 0, Month 12 |
| Pharmacokinetics and tolerability of EGCG | assessment of side effects and determination of blood and cerebrospinal fluid (CSF) levels of EGCG | Month 1 - Month 12 |
| Determination of huntingtin expression levels | Quantification of huntingtin in blood and CSF (optional) | Screening - Month 13 |
| Bochum |
| 44791 |
| Germany |
| Universitätsklinikum Ulm, Klinik für Neurologie | Ulm | 89081 | Germany |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |