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CompletedNCT00608946Updated Feb 6, 2008

Treatment With Copper in Patients With Mild Alzheimer´s Dementia

A Phase 2 interventional study of copper and placebo in Alzheimer´s Disease, sponsored by University Hospital, Saarland. Completed. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-02-06.

Sponsored by University Hospital, Saarland · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer´s Disease

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Keywords

  • efficacy of treatment with copper in patients with mild Alzheimer´s disease
  • cognitive status over time
  • CSF and volumetric data over time (1 year)
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 68 is close to the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University Hospital, Saarland is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • 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

  • Placebo comparator
    2

    placebo

    Dietary Supplement: placebo

Interventions

  • Dietary supplementcopper

    intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status

  • Dietary supplementplacebo

    placebo

06

What researchers measure

Primary outcomes

  1. change of cognitive function, measured by ADAS-cog

    Time frame: one year

Secondary outcomes

  1. change of beta amyloid in the CSF and volumetric changes in the brain

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 14617773 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00608946
Lead sponsor
University Hospital, Saarland
Collaborators
University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
First posted
Feb 6, 2008
Start date
Mar 2004
Primary completion
Aug 2007
Last update
Feb 6, 2008

Study contacts

Frank G Pajonk, M.D., lecturer
principal investigator · Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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