Treatment With Copper in Patients With Mild Alzheimer´s Dementia
NCT ID: NCT00608946
Last Updated: 2008-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
copper
intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status
2
placebo
placebo
placebo
Interventions
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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
placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
80 Years
ALL
No
Sponsors
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University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
OTHER
University Hospital, Saarland
OTHER
Responsible Party
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Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital
Principal Investigators
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Frank G Pajonk, M.D., lecturer
Role: PRINCIPAL_INVESTIGATOR
Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital
References
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Bayer TA, Schafer S, Simons A, Kemmling A, Kamer T, Tepest R, Eckert A, Schussel K, Eikenberg O, Sturchler-Pierrat C, Abramowski D, Staufenbiel M, Multhaup G. Dietary Cu stabilizes brain superoxide dismutase 1 activity and reduces amyloid Abeta production in APP23 transgenic mice. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14187-92. doi: 10.1073/pnas.2332818100. Epub 2003 Nov 14.
Related Links
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Dept. of Neurobiology, University of Goettingen (Head: Prof. Dr. T. Bayer)
Other Identifiers
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UKS-PSY-DEM-01
Identifier Type: -
Identifier Source: secondary_id
UKS-PSY-DEM-01
Identifier Type: -
Identifier Source: org_study_id
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