Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool

Parc de Salut Mar

Status and phase: Completed; Phase 2

Conditions: Down Syndrome (DS)

Treatments: Dietary Supplement: Epigallocatechin-3-gallate (EGCG)

Study type: Interventional

Funder types: Other

Identifiers

NCT01699711

TESDAD

Details and patient eligibility

About

Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease) like progression.

Enrollment: 87 patients

Sex: All

Ages: 14 to 29 years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups, including a placebo group

Dietary Supplement: Epigallocatechin-3-gallate (EGCG)

Active Comparator group

Description:

EGCG normally works as a dietary supplement. EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance. A daily oral dose containing 9 mg/kg (range 6.9-12.7) of EGCG is given during twelve months.

Treatment:

Dietary Supplement: Epigallocatechin-3-gallate (EGCG)

Placebo

Placebo Comparator group

Description:

No active treatment is given.

Treatment:

Dietary Supplement: Epigallocatechin-3-gallate (EGCG)