Down SyndromePhase 2NCT01394796
Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.
A Phase 2 study testing Epigallocatechin-3-gallate (EGCG) in people with Down Syndrome, run by Parc de Salut Mar.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 29 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Epigallocatechin-3-gallate (EGCG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have been diagnosed of DS neurological disease, aged between 14-29 years, have given the consent to participate (official custody).
Who cannot join
- 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.
About this study
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
- Being tested
- Epigallocatechin-3-gallate (EGCG), Placebo
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
No active treatment is given.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Epigallocatechin-3-gallate (EGCG) |
| Placebo | Placebo comparator | No active substance is given. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory
Memory and learning will be assessed using different neuropsicological tests: Pattern Recognition Memory (PRM), Fuld Object Memory Evaluation (FULD), Paired Associates Learning (PAL).
Measured: 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).
Measured: Predose baseline and 3 months (end of treatment).
Secondary outcomes (7)
Psychomotor speed
Motor Screening test (MOT)
Measured: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Attention
Attention will be assessed using the following tests:
Digit Span: forward recall (from the WMS-III). Spatial Span (SSP): forward recall.
Measured: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
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)
Measured: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Visuomotor coordination
Visuomotor coordination will be assessed following the these tests:
Purdue Pegboard Test Visuomotor precision
Measured: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Functional outcome in daily living and adaptative behaviour
Functional outcome in daily living and adaptative behaviour Inventory for Client and Agency Planning (ICAP).
Measured: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Quality of life
Kidscreen-27
Measured: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Qualitative data on treatment effects
With a brief semi-structured self-made interview
Measured: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394796
- Sponsor's protocol ID
- EGCG/DYRC1A/DS/IMIM/1
- Status last verified
- Mar 2013
- First submitted
- 4 Jul 2011
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals.
- ClinicalTrials.gov ID
- NCT01394796
- Acronym / sponsor ID
- EGCG/DYRC1A/DS/IMIM/1
- Conditions
- Down Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epigallocatechin-3-gallate (EGCG) | Active comparator | 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. |
| Placebo | Placebo comparator | Drug: PlaceboNo active substance is given. |
Who may qualify
- Ages
- 14 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Have been diagnosed of DS neurological disease, aged between 14-29 years, have given the consent to participate (official custody).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Epigallocatechin-3-gallate (EGCG) |
| PlaceboNo active treatment is given. | Drug | Placebo |
Primary outcome
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).
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).
7 secondary outcomes
Psychomotor speed
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Attention
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Executive functions
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Visuomotor coordination
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Functional outcome in daily living and adaptative behaviour
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Quality of life
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Qualitative data on treatment effects
Time frame: Predose baseline: at 1 month, 3 months (end of treatment) plus 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
Related trials for Down Syndrome
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epigallocatechin-3-gallate (EGCG) in people with Down Syndrome, run by Parc de Salut Mar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory (time frame: Predose baseline and 3 months (end of treatment).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.