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Treatment With Copper in Patients With Mild Alzheimer´s Dementia

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ClinicalTrials.gov Identifier: NCT00608946
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : February 6, 2008
Sponsor:
Collaborator:
University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
Information provided by:
University Hospital, Saarland

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

Condition or disease Intervention/treatment Phase
Alzheimer´s Disease Dietary Supplement: copper Dietary Supplement: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2004
Actual Primary Completion Date : August 2007


Arm Intervention/treatment
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



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

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


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: February 6, 2008
Last Verified: January 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs