As one of the services for patients with Alzheimer's disease,the Department of Psychiatry at the Saarland University Medical Centeroffers participation in a clinical phase II trial. This clinical trialaims to elucidate a potential beneficial effect of copper orotate (anorganic copper salt), which is given together with a standardcholinesterase inhibitor. A diagnosis of mild to moderate dementia ofthe Alzheimer type is a prerequisite. Besides clinical investigations,laboratory investigations of blood and cerebrospinal fluid, and magnetresonance imaging of the brain will be carried out. The study is beingconducted by Professor Dr. Thomas Bayer, the Head of the Division ofNeurobiology, and Dr. Frank Pajonk, a Psychiatrist, at the Departmentof Psychiatry, Saarland University Medical Center.
Treatmentstarts after all prerequisites to participate have been met. Half ofthe patients receive 8 mg copper orotate per day, the other half aplacebo. Both patients and psychiatrists are blinded. During the12-month long double-blind phase, there will be extensive laboratory,clinical and neuropsychological tests. After the double-blind phase, weoffer an open-label phase for all patients. At present, 15 patientshave finished the double-blind phase. The copper medication is welltolerated.
Alzheimer is characterized by the presence of amyloidplaques, which are composed primarily of Aß peptide. Aß is producedwithin neurons and is liberated from the larger amyloid ß proteinprecursor (AßPP). Lower levels of copper have been reported in thebrain of AßPP transgenic mice and post-mortem in AD patients. Thisconcept has been found to be true also in vitro by Professor Dr. GerdMulthaup (FU Berlin) in 1999. Two recent papers, which have beenpublished in PNAS in 2003 have proven a beneficial effect of elevatedcopper in transgenic AßPP mice. In the present study, the teams led byBayer and Multhaup have found that low copper level in blood correlateswith advanced memory deficits, as tested by the well establishedADAS-cog neuropsychological test battery. Patients with higher bloodcopper levels make fewer mistakes in this memory test. This resultsupports the notion of a mild copper deficiency in AD patients. Anincreased uptake of dietary copper may therefore be therapeuticallyrelevant.
The study has been published in the September2005 issue of the Journal of Alzheimer's Disease, Volume 8, Issue 1published by IOS Press: "Cognitive decline correlates with low plasmaconcentrations of copper in patients with mild to moderate Alzheimer'sdisease" (JAD, Vol. 8, Issue 1).
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