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Treatment With Copper in Patients With Mild Alzheimer´s Dementia

Primary Purpose

Alzheimer´s Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
copper
placebo
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer´s Disease focused on measuring efficacy of treatment with copper in patients with mild Alzheimer´s disease, cognitive status over time, CSF and volumetric data over time (1 year)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    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

    placebo

    Outcomes

    Primary Outcome Measures

    change of cognitive function, measured by ADAS-cog

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 23, 2008
    Last Updated
    February 5, 2008
    Sponsor
    University Hospital, Saarland
    Collaborators
    University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00608946
    Brief Title
    Treatment With Copper in Patients With Mild Alzheimer´s Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Saarland
    Collaborators
    University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer´s Disease
    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)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    copper
    Intervention Description
    intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    change of cognitive function, measured by ADAS-cog
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    change of beta amyloid in the CSF and volumetric changes in the brain
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank G Pajonk, M.D., lecturer
    Organizational Affiliation
    Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14617773
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    http://www.alzheimer-bayer.de
    Description
    Dept. of Neurobiology, University of Goettingen (Head: Prof. Dr. T. Bayer)

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    Treatment With Copper in Patients With Mild Alzheimer´s Dementia

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