Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Memory
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed of DS neurological disease, aged between 14-29 years, have given the consent to participate (official custody).
排除标准
- •Subjects with neurological disease other than DS, relevant medical disease, co-morbid mental disorder or currently taking any treatment that could interfere with cognitive function or alter any key biomarkers and biochemical parameters analyzed.
- •Having suffered from any major illness or undergoing major surgery in the last three months before the study;
- •Regular ingestion of medication in the month preceding the study. Exceptions were made for single doses of symptomatic medication administered up to the week preceding the trial.
- •Current ingestion of vitamin supplements or catechins or AINE in the two weeks preceding the study.
- •History of gastrointestinal, hepatic or renal problems or any other cause that may alter processes of absorption, distribution, metabolism, or excretion of the drug, or that might suggest gastrointestinal irritation to drug.
- •Subjects following a vegetarian diet.
- •Practice of physical exercise for more than 2 hours per day or energy consume/consumption of more than 3000 kcal per week.
研究组 & 干预措施
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.
干预措施: Epigallocatechin-3-gallate (EGCG) (Dietary Supplement)
Placebo
No active substance is given.
干预措施: Placebo (Drug)
结局指标
主要结局
Memory
时间窗: Predose baseline and 3 months (end of treatment).
Memory and learning will be assessed using different neuropsicological tests: Pattern Recognition Memory (PRM), Fuld Object Memory Evaluation (FULD), Paired Associates Learning (PAL).
DYRK1A activity biomarkers
时间窗: Predose baseline and 3 months (end of treatment).
Plasma homocysteine (Abbot AxyM),NAD (P)H: quinone oxireductase (NQOI) activity and dyrk1a gene expression in lymphocytes).
次要结局
- Psychomotor speed(Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.)
- Attention(Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.)
- Executive functions(Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.)
- Visuomotor coordination(Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.)
- Functional outcome in daily living and adaptative behaviour(Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.)
- Quality of life(Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.)
- Qualitative data on treatment effects(Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.)