Sunphenon EGCg (Epigallocatechin-Gallat) in the early stage of Alzheimer´s Disease - SUN-AK
- Conditions
- Alzheimer´s disease (early stage)
- Registration Number
- EUCTR2009-009656-20-DE
- Lead Sponsor
- Charite Universitaetsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
• Early stage of AD (Diagnosis DSM-IV and NINCDS/ADRDA, Dubois-criteria 2007)
• Age 60-100
• MMSE 18-26
• Patient lives at home with at least one relative who perform external ratings/assessment
• co-medication with Donepezil (Aricept®, Pfizer Pharma GmbH) or Rivastigmin (Exelon®,
Novartis Pharma) or Galantamin
(Reminyl®, Janssen-Cilag) with at least 3 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
• co-medication with NSAIDs (longterm medication) (ASS is not an exclusion criteria), Gingko- or other natural extracts, other anti-dementiva except of Donepezil, Rivastigmin, Galantamin and Amantadin-Derivaten, wie Memantine (Axura®, Ebixa®)
• familial autosomal-dominant inherited AD
• instable medical condition
• other primary psychiatric/neurologic disorders (psychiatric/neurologic changes in the context of the AD are no exclusion criteria)
• 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 inpossible
• 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 (for definion see protocol)
• known allergy of Gd-DTPA
• known allergy of elements of Sunphenon EGCg or additives of Sunphenon EGCg resp. placebo
• longterm livertoxic medication
• Cuurent intake of cytochrom P450 3A4-inhibitors or -inductors, such as antimycotics of the azol-type or macrolid-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 protocl or to accomplish the study
• massive and extended sun exposure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method