Treatment With Copper in Patients With Mild Alzheimer´s Dementia

NCT00608946 | Completed Phase 2 DMC

• 1 other identifier: UKS-PSY-DEM-01
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

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)

Outcome Measures

Primary Outcomes (1)

• change of cognitive function, measured by ADAS-cog

  one year

Secondary Outcomes (1)

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

  one year

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

placebo

Dietary Supplement: placebo

Interventions

copper DIETARY_SUPPLEMENT

intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status

1

placebo DIETARY_SUPPLEMENT

placebo

2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead
• University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany: collaborator

Related Publications (1)

• 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.

  PMID: 14617773 BACKGROUND

Related Links

• Dept. of Neurobiology, University of Goettingen (Head: Prof. Dr. T. Bayer)

MeSH Terms

Interventions

Copper

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Frank G Pajonk, M.D., lecturer

  Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: March 1, 2004
• Primary Completion: August 1, 2007
• Last Updated: February 6, 2008

Record last verified: 2008-01