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Epigallocatechin-Gallate

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Pulmonx Corporation|Last Updated: Jul 29, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Epigallocatechin-Gallate · 1 trial · 1 indication

Phase 2 1
NCT00951834Sunphenon EGCg (Epigallocatechin-Gallate) in the Early Stage of Alzheimer´s DiseaseAlzheimer's Disease
COMPLETED21 Analytics
PHASE2COMPLETED
Sunphenon EGCg (Epigallocatechin-Gallate) in the Early Stage of Alzheimer´s Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

ADAS-COG (Score 0-70) (Baseline to treatment)
18 months

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Epigallocatechin-GallateEXPERIMENTAL* 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.
PlaceboPLACEBO_COMPARATORadd-on to Donepezil.

Interventions

NameTypeDescription
Epigallocatechin-GallateDRUGEpigallocatechin-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)
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 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...

Countries:Germany
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