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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Epigallocatechin-Gallate
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer´s Disease, Epigallocatechin-Gallate, Neuroprotection, ADAS-COG, early stage of Alzheimer's Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite University Medicine Berlin
  • Charité Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie
  • Klinik für Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Epigallocatechin-Gallate

Placebo

Arm Description

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.

add-on to Donepezil.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety and tolerability of the verum
MMSE (Score 0-30) after 18 months compared to baseline
Time to hospitalisation and Time to death related to AD
Brain atrophy assessed by brain MRI
Baseline-ADAS-COG and Baseline-MMSE as covariates
CIBIC+ and WHO-QOL-Bref
Trail Making Test and MVGT

Full Information

First Posted
August 3, 2009
Last Updated
July 28, 2021
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00951834
Brief Title
Sunphenon EGCg (Epigallocatechin-Gallate) in the Early Stage of Alzheimer´s Disease
Acronym
SUN-AK
Official Title
Sunphenon EGCg (Epigallocatechin-Gallate) in the Early Stage of Alzheimer´s Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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. Treatment of diseases such as diabetes mellitus, fractures and cardiovascular diseases is more expensive and complicated in patients with dementia compared to those without. The yearly costs for treatment and care of AD patients in the US are estimated to exceed 100 billion USD. Life expectancy is reported to be about 10 years after establishment of the diagnosis and is significantly reduced compared to non-demented subjects of similar age and socio-economic status. Age is the most relevant risk factor for AD, followed by genetic factors. Prevalence is less than 1% amongst individuals aged 50-60, but is reported to double every 5 years beyond the age of 60. The prevalence exceeds 30% in the age of 85-90. The only standard therapy for AD are acetylcholine-esterase inhibitors (AchEI; donepezil, galantamine, rivastigmine). AchEI exhibit a temporary stabilizing mild effect on the progression of AD. Conversion rates from "mild cognitive impairment" to AD do not seem to be beneficially influenced by AchEI. A high percentage of premature study withdrawals owing to adverse events has been observed in AchEI studies published to date. The questionable benefit may further be outweighed by high costs of the AchEI. Therefore, there is a necessity for the development of more efficacious and less expensive disease-modifying drugs with a better safety and tolerability profile. EGCG is a promising compound which has proven efficacious in AD animal models and which has shown an excellent tolerability in our 18-month clinical trial on Multiple Sclerosis currently being performed at our institution (SuniMS study, NCT00525668).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer´s Disease, Epigallocatechin-Gallate, Neuroprotection, ADAS-COG, early stage of Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epigallocatechin-Gallate
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
add-on to Donepezil.
Intervention Type
Drug
Intervention Name(s)
Epigallocatechin-Gallate
Other Intervention Name(s)
Sunphenon EGCG
Intervention Description
Epigallocatechin-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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
ADAS-COG (Score 0-70) (Baseline to treatment)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Safety and tolerability of the verum
Time Frame
18 months
Title
MMSE (Score 0-30) after 18 months compared to baseline
Time Frame
18 months
Title
Time to hospitalisation and Time to death related to AD
Time Frame
18 months
Title
Brain atrophy assessed by brain MRI
Time Frame
18 months
Title
Baseline-ADAS-COG and Baseline-MMSE as covariates
Time Frame
18 months
Title
CIBIC+ and WHO-QOL-Bref
Time Frame
18 months
Title
Trail Making Test and MVGT
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, MD
Organizational Affiliation
Charite University Medicine Berlin, NeuroCure
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University Medicine Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.neurocure.de
Description
Related Info

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

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