Treatment With Copper in Patients With Mild Alzheimer´s Dementia

Alzheimer´s Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608946
• Other study ID #: UKS-PSY-DEM-01
• Secondary ID: UKS-PSY-DEM-01
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2008
• Last updated: February 5, 2008
• Start date: March 2004

Study information

• Verified date: January 2008
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer´s Disease

Intervention

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
placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Saarland	University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of cognitive function, measured by ADAS-cog		one year	No
Secondary	change of beta amyloid in the CSF and volumetric changes in the brain		one year	No

External Links

•   Dept. of Neurobiology, University of Goettingen (Head: Prof. Dr. T. Bayer)