Alzheimer´s disease (early stage)
Conditions
Interventions
Product Name: Sunphenon EGCG
Pharmaceutical Form: Capsule, hard
Other descriptive name: Sunphenon EGCG
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 200-
P
Sponsors
Charite Universitaetsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
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, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy and safety of Sunphenon EGCG in early stage Alzheimer´s disease. Primary outcome: delay of progression of early stage Alzheimer´s Disease (AD), defined by the deterioration in the ADAS-COG 18 months after treatment compared to baseline - in comparison to placebo. ;Secondary Objective: As secondary outcomes, several clinical parameters will be assessed, such as MMSE, CIBIC+, and ADCS-ADL. Furthermore, brain atrophy will be assessed via MRI, as well as safety and tolerability. ;Primary end point(s): ADAS-COG (Score 0-70): Baseline to Visit+18months;Timepoint(s) of evaluation of this end point: +18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): MMSE (Score 0-30, diskret) Baseline to Visit+18months Baseline-ADAS-COG und Baseline-MMSE as covariates Quality of life (CIBIC+, WHO-QOL-Bref) Trail Making Test MVGT Semantic word fluency test;Timepoint(s) of evaluation of this end point: +18 months | — |
Countries
Germany
Outcome results
None listed