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There is a mounting evidence of the modulation properties of the major catechin in green tea, epigallocatechin-3-gallate (EGCG), on dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) gene overexpression in the brains of DS mouse models.The aims are to investigate the clinical benefits and safety of EGCG administration in young adults with DS, to establish short-term EGCG effects (three months) on neurocognitive performance, and to determine the persistency or reversibility of EGCG related effects after three months of discontinued use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epigallocatechin-3-gallate (EGCG) | Active Comparator | EGCG normally works as a dietary supplement. EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance.A a daily oral dose containing 9 mg/kg (range 6.9-12.7) of EGCG is given during three months. |
|
| Placebo | Placebo Comparator | No active substance is given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin-3-gallate (EGCG) | Dietary Supplement | EGCG normally works as a dietary supplement. EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance.A a daily oral dose containing 9 mg/kg (range 6.9-12.7) of EGCG is given during three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Memory | Memory and learning will be assessed using different neuropsicological tests: Pattern Recognition Memory (PRM), Fuld Object Memory Evaluation (FULD), Paired Associates Learning (PAL). | Predose baseline and 3 months (end of treatment). |
| DYRK1A activity biomarkers | Plasma homocysteine (Abbot AxyM),NAD (P)H: quinone oxireductase (NQOI) activity and dyrk1a gene expression in lymphocytes). | Predose baseline and 3 months (end of treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Psychomotor speed | Motor Screening test (MOT) | Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months. |
| Attention | Attention will be assessed using the following tests: Digit Span: forward recall (from the WMS-III). Spatial Span (SSP): forward recall. |
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Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2016 | |
| Reset | Mar 9, 2016 | |
| Release | Mar 18, 2016 | |
| Reset | Apr 20, 2016 | |
| Release | Feb 9, 2017 | |
| Reset | Mar 28, 2017 | |
| Release | May 8, 2019 | |
| Reset | May 30, 2019 | |
| Release | Jul 29, 2019 | |
| Reset | Aug 19, 2019 | |
| Release | Jun 10, 2021 | |
| Reset | Jun 30, 2021 | |
| Release | Nov 21, 2024 | |
| Reset | Dec 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2016 | Mar 9, 2016 | |||
| Mar 18, 2016 |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
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|
| Placebo | Drug | No active treatment is given. |
|
| Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months. |
| Executive functions | Executive functions will be assessed using the following tests: Digits Span: backward recall (from the WMS-III). Spatial Span (SSP): backward recall. Word fluency. Intra/Extra dimensional Set Shift (IED) | Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months. |
| Visuomotor coordination | Visuomotor coordination will be assessed following the these tests: Purdue Pegboard Test Visuomotor precision | Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months. |
| Functional outcome in daily living and adaptative behaviour | Functional outcome in daily living and adaptative behaviour Inventory for Client and Agency Planning (ICAP). | Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months. |
| Quality of life | Kidscreen-27 | Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months. |
| Qualitative data on treatment effects | With a brief semi-structured self-made interview | Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months. |
| Apr 20, 2016 |
| Feb 9, 2017 | Mar 28, 2017 |
| May 8, 2019 | May 30, 2019 |
| Jul 29, 2019 | Aug 19, 2019 |
| Jun 10, 2021 | Jun 30, 2021 |
| Nov 21, 2024 | Dec 16, 2024 |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |