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OpenTrials
Completed

NCT Number: NCT00608946

Treatment With Copper in Patients With Mild Alzheimer´s Dementia

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-controlled human clinical trial conducted in 70 patients with mild Alzheimer´s dementia.

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Key information

Conditions

Alzheimer´s Disease

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Copper

Dietary Supplement

intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status

Placebo

Dietary Supplement

placebo

Primary outcomes

  1. change of cognitive function, measured by ADAS-cog

    Time frame: one year

Secondary outcomes

  1. change of beta amyloid in the CSF and volumetric changes in the brain

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Collaborators

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

Registry information

Important dates

Study start
2004
Primary completion
2007
First posted
Feb 6, 2008
Registry last updated
Feb 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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