Status:

COMPLETED

Treatment With Copper in Patients With Mild Alzheimer´s Dementia

Lead Sponsor:

University Hospital, Saarland

Collaborating Sponsors:

University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany

Conditions:

Alzheimer´s Disease

Eligibility:

All Genders

50-80 years

Phase:

PHASE2

Brief Summary

The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid protein in the CSF and volumetric changes in the brain will be examined in a first double-blind, placebo-cont...

Eligibility Criteria

Inclusion

  • male or female patients
  • between 50 and 80 years
  • criteria of mild dementia
  • probable Alzheimer´s dementia according to NINCDS-ADRDA criteria
  • given written informed consent
  • having a relative who can fill out questionnaire; caregiver consent
  • free of serious and unstable somatic illness

Exclusion

  • unable to give informed consent
  • unable to take cholinesterase inhibitors
  • unapproved medication
  • moderate to severe Alzheimer´s disease
  • dementia of other etiology
  • history of alcohol, drug or medication abuse
  • other psychiatric disorder, e. g. schizophrenia
  • known copper and zinc storage disease
  • known copper and zinc intolerance
  • vegans
  • known severe allergies or intolerances
  • insufficient knowledge of the German language
  • female patients of childbearing potential, pregnant or nursing patients
  • participation in a clinical trial within the past 30 days before onset of this study
  • severe somatic diseases and high mortality rate AST, ALT, GGT, GLDH, AP or bilirubin being a two-fold above the normal range

Key Trial Info

Start Date :

March 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

68 Patients enrolled

Trial Details

Trial ID

NCT00608946

Start Date

March 1 2004

Last Update

February 6 2008

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