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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
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.
No active treatment is given.
Memory
Memory and learning will be assessed using different neuropsicological tests: Pattern Recognition Memory (PRM), Fuld Object Memory Evaluation (FULD), Paired Associates Learning (PAL).
Time frame: 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).
Time frame: Predose baseline and 3 months (end of treatment).
Psychomotor speed
Motor Screening test (MOT)
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Functional outcome in daily living and adaptative behaviour
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Functional outcome in daily living and adaptative behaviour Inventory for Client and Agency Planning (ICAP).
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Quality of life
Kidscreen-27
Time frame: 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
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.