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
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
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
NCT ID
NCT00608946
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
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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