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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Epigallocatechin gallate

Criteria

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 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

Exclusion Criteria:

• co-medication with NSAIDs (longterm medication) (ASS is not an exclusion criteria), Gingko- or other natural extracts, other anti-dementiva except of Donepezil

• 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

• Kidney dysfunction:

• Creatinin-Clearance according to Cockcroft-Gault-Formula: Cl < 110ml/min (male) resp. Cl < 95ml/min (female), from the age of 30 decline of 10ml/min per decade

• Liver dysfunction:

• ASAT/ALAT > 3.5 x higher than the upper reference value

• Bilirubin > 2.0 mg/dl

• known allergy of elements of Sunphenon EGCg or additives of Sunphenon EGCg resp. placebo

• long-term hepatotoxic medication

• current intake of cytochrom P450 3A4-inhibitors or -inductors, such as antimycotics of the azol-type or macrolide-antibiotics

• clinical-anamnestic or paraclinical manifestations suggesting an alcohol or drug abuse

• participation in any clinical trial < 3 months prior to screening or ongoing

• any medical, psychiatric or other condition which might constrain the ability of the patient to understand the informed consent, to give consent, to adhere to the protocol or to accomplish the study

• massive and extended sun exposure