Back to resultsEgcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.
Primary Purpose
Down Syndrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Epigallocatechin-3-gallate (EGCG)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Epigallocatechin-3-gallate (EGCG)
Placebo
Arm Description
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 substance is given.
Outcomes
Primary Outcome Measures
Memory
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
Plasma homocysteine (Abbot AxyM),NAD (P)H: quinone oxireductase (NQOI) activity and dyrk1a gene expression in lymphocytes).
Secondary Outcome Measures
Psychomotor speed
Motor Screening test (MOT)
Attention
Attention will be assessed using the following tests:
Digit Span: forward recall (from the WMS-III). Spatial Span (SSP): forward recall.
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)
Visuomotor coordination
Visuomotor coordination will be assessed following the these tests:
Purdue Pegboard Test Visuomotor precision
Functional outcome in daily living and adaptative behaviour
Functional outcome in daily living and adaptative behaviour Inventory for Client and Agency Planning (ICAP).
Quality of life
Kidscreen-27
Qualitative data on treatment effects
With a brief semi-structured self-made interview
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01394796
Brief Title
Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.
Official Title
Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epigallocatechin-3-gallate (EGCG)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No active substance is given.
Intervention Type
Dietary Supplement
Intervention Name(s)
Epigallocatechin-3-gallate (EGCG)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
No active treatment is given.
Primary Outcome Measure Information:
Title
Memory
Description
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).
Title
DYRK1A activity biomarkers
Description
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).
Secondary Outcome Measure Information:
Title
Psychomotor speed
Description
Motor Screening test (MOT)
Time Frame
Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Title
Attention
Description
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.
Title
Executive functions
Description
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.
Title
Visuomotor coordination
Description
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.
Title
Functional outcome in daily living and adaptative behaviour
Description
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.
Title
Quality of life
Description
Kidscreen-27
Time Frame
Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Title
Qualitative data on treatment effects
Description
With a brief semi-structured self-made interview
Time Frame
Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.
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