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Treatment With Copper in Patients With Mild Alzheimer´s Dementia

This study has been completed.
University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
Information provided by:
University Hospital, Saarland Identifier:
First received: January 23, 2008
Last updated: February 5, 2008
Last verified: January 2008
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.

Condition Intervention Phase
Alzheimer´s Disease
Dietary Supplement: copper
Dietary Supplement: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • change of cognitive function, measured by ADAS-cog [ Time Frame: one year ]

Secondary Outcome Measures:
  • change of beta amyloid in the CSF and volumetric changes in the brain [ Time Frame: one year ]

Enrollment: 68
Study Start Date: March 2004
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
efficacy of the intake of 8 mg of copper daily per os for one year under observation of cognitive status unless unacceptable side effects appear
Dietary Supplement: copper
intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status
Placebo Comparator: 2
Dietary Supplement: placebo


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00608946

Sponsors and Collaborators
University Hospital, Saarland
University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
Principal Investigator: Frank G Pajonk, M.D., lecturer Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital
  More Information

Additional Information:
Responsible Party: Frank-Gerald Pajonk, M.D., Lecturer, Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital Identifier: NCT00608946     History of Changes
Other Study ID Numbers: UKS-PSY-DEM-01
Study First Received: January 23, 2008
Last Updated: February 5, 2008

Keywords provided by University Hospital, Saarland:
efficacy of treatment with copper in patients with mild Alzheimer´s disease
cognitive status over time
CSF and volumetric data over time (1 year)

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on April 28, 2017