NCT01394796

Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 14 Years – 29 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Epigallocatechin-3-gallate (EGCG)	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.
DRUG	Placebo	No active treatment is given.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-07-14
• Last updated: 2013-03-13