Status:
COMPLETED
Sunphenon EGCg (Epigallocatechin-Gallate) in the Early Stage of Alzheimer´s Disease
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE2
PHASE3
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 mod...
Detailed Description
Alzheimer's disease (AD) is a progressive dementia characterised by an ongoing loss of memory function and of at least one additional cognitive domain resulting in impairment of daily life functioning...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00951834
Start Date
October 1 2009
End Date
February 1 2015
Last Update
July 29 2021
Active Locations (3)
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1
Charite University Medicine Berlin
Berlin, Germany, 10117
2
Charité Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie
Berlin, Germany, 10117
3
Klinik für Neurologie
Ulm, Germany, 89081