Treatment With Copper in Patients With Mild Alzheimer´s Dementia

University Hospital, Saarland

Status and phase

Completed

Phase 2

Conditions

Alzheimer´s Disease

Treatments

Dietary Supplement: copper

Dietary Supplement: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00608946

UKS-PSY-DEM-01

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No 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