Treatment With Copper in Patients With Mild Alzheimer´s Dementia

Study Overview
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Brief Summary
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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.

Conditions
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Alzheimer´s Disease

Intervention / Treatment
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* Dietary Supplement: copper
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status<br>|
| Placebo Comparator: 2<br>placebo | Dietary Supplement: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy of treatment with copper in patients with mild Alzheimer´s disease, cognitive status over time, CSF and volumetric data over time (1 year)