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Alzheimer's DiseasePhase 2/3SUN-AKNCT00951834

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

A Phase 2/3 study testing Epigallocatechin-Gallate in people with Alzheimer's Disease, run by Charite University, Berlin, Germany at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Epigallocatechin-Gallate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
3 sitesGermany
Study dates
Oct 2009to Feb 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Charite University Medicine Berlin

    Berlin, 10117

  • Charité Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie

    Berlin, 10117

  • Klinik für Neurologie

    Ulm, 89081

Other trials in Germany

About this study

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.

Read the 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).

Being tested
Epigallocatechin-Gallate, Placebo
Keywords
Alzheimer´s Disease, Epigallocatechin-Gallate, Neuroprotection, ADAS-COG, early stage of Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epigallocatechin-GallateDrug

    Also called Sunphenon EGCG

    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)

  • PlaceboDrug

    Placebo

Study groups in NCT00951834
Study groupRoleWhat they receive
Epigallocatechin-GallateExperimental* 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.
Receives: Drug: Epigallocatechin-Gallate
PlaceboPlacebo comparatoradd-on to Donepezil.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 18 months

Secondary outcomes (7)

  1. Safety and tolerability of the verum

    Measured: 18 months

  2. MMSE (Score 0-30) after 18 months compared to baseline

    Measured: 18 months

  3. Time to hospitalisation and Time to death related to AD

    Measured: 18 months

  4. Brain atrophy assessed by brain MRI

    Measured: 18 months

  5. Baseline-ADAS-COG and Baseline-MMSE as covariates

    Measured: 18 months

  6. CIBIC+ and WHO-QOL-Bref

    Measured: 18 months

  7. Trail Making Test and MVGT

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00951834
Sponsor's protocol ID
SUN-AK
Acronym
SUN-AK
Status last verified
Jul 2021
First submitted
3 Aug 2009
Last updated
29 Jul 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Epigallocatechin-Gallate in people with Alzheimer's Disease, run by Charite University, Berlin, Germany at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADAS-COG (Score 0-70) (Baseline to treatment) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00951834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.

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