Treatment With Copper in Patients With Mild Alzheimer´s Dementia

February 5, 2008 updated by: University Hospital, Saarland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
placebo
Dietary supplement: placebo
placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of cognitive function, measured by ADAS-cog
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
change of beta amyloid in the CSF and volumetric changes in the brain
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

February 6, 2008

Last Update Submitted That Met QC Criteria

February 5, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKS-PSY-DEM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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