Treatment With Copper in Patients With Mild Alzheimer´s Dementia

This study has been completed.
Sponsor:
Collaborator:
University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00608946
First received: January 23, 2008
Last updated: February 5, 2008
Last verified: January 2008
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of beta amyloid in the CSF and volumetric changes in the brain [ Time Frame: one year ] [ Designated as safety issue: No ]

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
placebo
Dietary Supplement: placebo
placebo

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00608946

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

Additional Information:
Publications:
Responsible Party: Frank-Gerald Pajonk, M.D., Lecturer, Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital
ClinicalTrials.gov Identifier: NCT00608946     History of Changes
Other Study ID Numbers: UKS-PSY-DEM-01, UKS-PSY-DEM-01
Study First Received: January 23, 2008
Last Updated: February 5, 2008
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Copper
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 23, 2014