Treatment With Copper in Patients With Mild Alzheimer´s Dementia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00608946

Enrollment

Registered

2008-02-06

Start date

2004-03-31

Completion date

Unknown

Last updated

2008-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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)

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
change of cognitive function, measured by ADAS-cog	one year

Secondary

Measure	Time frame
change of beta amyloid in the CSF and volumetric changes in the brain	one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026