Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Summary

MSA is a rapidly progressive disorder with an average survival time of about 7 years after the first clinical manifestation. No potent symptomatic treatment is currently available. A disease-modifying therapy does not exist either. The growing understanding in recent years of the underlying pathological mechanisms of the disease allows the development of new treatment options that have a modifying effect on the disease progression. Therefore, treatments are urgently required that effect the central underlying pathological mechanism, which appears to be the intracellular aggregation of toxic oligomers of α-synuclein.

EGCG, a polyphenol found in green tea, has shown to inhibit the formation of toxic α-synuclein oligomers in vitro and has shown to transform α-synuclein-oligomers in non-toxic oligomer species. There is also evidence for a neuroprotective effect in MPTP-mouse models of PD and is an antioxidant and iron chelator. There are currently 63 clinical studies (http://clinicaltrial.gov) in which EGCG was applied for various indications, such as Multiple Sclerosis, various forms of cancer and Huntington's disease. All of which have shown good tolerability and safety with the applied doses of EGCG of up to 1200 mg per day, demonstrating the safety of the drug under controlled clinical conditions (see 5.3.1 for hepatotoxicity in uncontrolled conditions).

These data provide a solid rationale for testing in a clinical trial if supplementation of EGCG can interfere with the core disease mechanism in MSA and consequently retard the clinical progression of the MSA-related disability.

Conditions

• Multiple System Atrophy

Interventions

DRUG

EGCG as putative neuroprotective agent

Treatment with 800 mg - 1200 mg EGCG as putative neuroprotective agent

DRUG

Placebo

Placebo

Sponsors & Collaborators

• German Center for Neurodegenerative Diseases (DZNE)

  collaborator OTHER

• Deutsche Parkinson Vereinigung

  collaborator OTHER

• German Foundation for Neurology

  collaborator OTHER

• ParkinsonFonds Deutschland gGmbH

  collaborator OTHER

• Dr. Johannes Levin

  lead OTHER

Principal Investigators

• Johannes Levin, MD · Ludwig Maximilians University, Department of Neurology

• Günter Höglinger, MD · Deutsches Zentrum für Neurodegenerative Erkrankungen e.V.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2016-09-30

Completion

2016-12-31

Countries

• Germany

Study Locations