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

NCT01394796 | Completed Phase 2

• 1 other identifier: EGCG/DYRC1A/DS/IMIM/1
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (7)

• 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.

Study Arms (2)

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.

Dietary Supplement: Epigallocatechin-3-gallate (EGCG)

Placebo

PLACEBO COMPARATOR

No active substance is given.

Drug: Placebo

Interventions

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.

Epigallocatechin-3-gallate (EGCG)

Placebo DRUG

No active treatment is given.

Placebo

Eligibility Criteria

• Age: 14 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

MeSH Terms

Conditions

Down Syndrome

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 4, 2011
• First Posted: July 14, 2011
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 13, 2013

Record last verified: 2013-03