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Sunphenon EGCg (Epigallocatechin-Gallate) in the Early Stage of Alzheimer´s Disease

NCT00951834 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-07-29

No results posted yet for this study

Summary

EGCG has shown a neuroprotective effect in cell-experimental and animal studies. The neuroprotective mechanism of EGCG probably bases - besides the known antioxidant effect - amongst others on the modulation of several signal transduction pathways, the influence on the expression of genes which regulate cell survival resp. programmed cell death, as well as the modulation of the mitochondrial function. In different Alzheimer models EGCG seems to cause an induction of alpha-secretase and the endothelin-converting-enzyme, as well as to prevent the aggregation of beta-amyloid to toxic oligomers through the direct binding to the unfolded peptide.

The investigators therefore expect EGCG to have a positive influence on the course of the Alzheimer´s Disease.

Conditions

Interventions

DRUG

Epigallocatechin-Gallate

Epigallocatechin-Gallate (EGCG) - Sunphenon EGCg: * Months 1-3: 200 mg EGCG/die (200-0-0 mg) * Months 4-6: 400 mg EGCG/die (200-0-200 mg) * Months 7-9: 600 mg EGCG/die (400-0-200 mg) * Months 10-18: 800 mg EGCG/die (400-0-400 mg)

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Friedemann Paul, MD · Charite University Medicine Berlin, NeuroCure

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00951834 on ClinicalTrials.gov