NCT00951834

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

5.3 years

First QC Date

August 3, 2009

Last Update Submit

July 28, 2021

Conditions

Alzheimer's Disease

Keywords

Alzheimer´s DiseaseEpigallocatechin-GallateNeuroprotectionADAS-COGearly stage of Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • ADAS-COG (Score 0-70) (Baseline to treatment)

    18 months

Secondary Outcomes (7)

  • Safety and tolerability of the verum

    18 months

  • MMSE (Score 0-30) after 18 months compared to baseline

    18 months

  • Time to hospitalisation and Time to death related to AD

    18 months

  • Brain atrophy assessed by brain MRI

    18 months

  • Baseline-ADAS-COG and Baseline-MMSE as covariates

    18 months

  • +2 more secondary outcomes

Study Arms (2)

Epigallocatechin-Gallate

EXPERIMENTAL

* 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) add-on to Donepezil.

Drug: Epigallocatechin-Gallate

Placebo

PLACEBO COMPARATOR

add-on to Donepezil.

Drug: Placebo

Interventions

Epigallocatechin-GallateDRUG

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)

Also known as: Sunphenon EGCG
Epigallocatechin-Gallate
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • early stage of AD (Diagnosis DSM-IV and NINCDS/ADRDA, Dubois-criteria 2007)
  • age 60-100
  • MMSE 20-26
  • patient lives at home with at least one relative who perform external ratings/assessment
  • co-medication with Donepezil (Aricept®, Pfizer Pharma GmbH) with at least 3 months to maximum 6 months of existing stable medication
  • maximum of 2 cups of black tea/die, no green tea, not more than \> 500 ml/die of grapefruit juice

You may not qualify if:

  • familial autosomal-dominant inherited AD
  • instable medical condition
  • other primary psychiatric/neurologic disorders
  • missing informed consent
  • no readiness to save and refer pseudonym personal data
  • hospitalisation due to juridical or legal regulation
  • any condition disturbing or making MRI and other measures impossible
  • clinically relevant GI-disorders at screening and 1 year before
  • clinically relevant lung, infectious, heart or other CNS disorders, clinical or paraclinical suspicion of TBC, history of vascular CNS-disorders at screening and 1 year before
  • clinically relevant liver disorders at screening and 1 year before
  • clinically relevant functional disorders of liver, kidney or bone marrow defined by following lab values at screening:
  • Marrow dysfunction:
  • HB \< 8,5 g/dl
  • WBC \< 2,5/nl
  • Thrombocytes \< 125/nl
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Charite University Medicine Berlin

Berlin, 10117, Germany

Location

Charité Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie

Berlin, 10117, Germany

Location

Klinik für Neurologie

Ulm, 89081, Germany

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Friedemann Paul, MD

    Charite University Medicine Berlin, NeuroCure

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(3)