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OpenTrials
Completed

NCT Number: NCT01394796

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

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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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

14 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have been diagnosed of DS neurological disease, aged between 14-29 years, have given the consent to participate (official custody).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Placebo

Drug

No active treatment is given.

Primary outcomes

  1. Memory

    Time frame: 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).

  2. DYRK1A activity biomarkers

    Time frame: 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).

Secondary outcomes

  1. Psychomotor speed

    Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.

    Motor Screening test (MOT)

  2. Attention

    Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.

    Attention will be assessed using the following tests:

    Digit Span: forward recall (from the WMS-III). Spatial Span (SSP): forward recall.

  3. Executive functions

    Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.

    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)

  4. Visuomotor coordination

    Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.

    Visuomotor coordination will be assessed following the these tests:

    Purdue Pegboard Test Visuomotor precision

  5. Functional outcome in daily living and adaptative behaviour

    Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.

    Functional outcome in daily living and adaptative behaviour Inventory for Client and Agency Planning (ICAP).

  6. Quality of life

    Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.

    Kidscreen-27

  7. Qualitative data on treatment effects

    Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.

    With a brief semi-structured self-made interview

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 14, 2011
Registry last updated
Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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