Treatment With Copper in Patients With Mild Alzheimer´s Dementia - Full Text View

Sponsors and Collaborators:	University Hospital, Saarland University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
Information provided by:	University Hospital, Saarland
ClinicalTrials.gov Identifier:	NCT00608946

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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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
1: Experimental 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
2: Placebo Comparator 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

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

Dept. of Neurobiology, University of Goettingen (Head: Prof. Dr. T. Bayer) This link exits the ClinicalTrials.gov site

Publications:

Bayer TA, Schäfer S, Simons A, Kemmling A, Kamer T, Tepest R, Eckert A, Schüssel 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. Epub 2003 Nov 14.

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

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Copper

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Trace Elements

Micronutrients
Tauopathies
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009