3 October 2005
As one of the services for patients with Alzheimer's disease, the Department of Psychiatry at the Saarland University Medical Center offers participation in a clinical phase II trial. This clinical trial aims to elucidate a potential beneficial effect of copper orotate (an organic copper salt), which is given together with a standard cholinesterase inhibitor. A diagnosis of mild to moderate dementia of the Alzheimer type is a prerequisite. Besides clinical investigations, laboratory investigations of blood and cerebrospinal fluid, and magnet resonance imaging of the brain will be carried out. The study is being conducted by Professor Dr. Thomas Bayer, the Head of the Division of Neurobiology, and Dr. Frank Pajonk, a Psychiatrist, at the Department of Psychiatry, Saarland University Medical Center.
Treatment starts after all prerequisites to participate have been met. Half of the patients receive 8 mg copper orotate per day, the other half a placebo. Both patients and psychiatrists are blinded. During the 12-month long double-blind phase, there will be extensive laboratory, clinical and neuropsychological tests. After the double-blind phase, we offer an open-label phase for all patients. At present, 15 patients have finished the double-blind phase. The copper medication is well tolerated.
Alzheimer is characterized by the presence of amyloid plaques, which are composed primarily of Aß peptide. Aß is produced within neurons and is liberated from the larger amyloid ß protein precursor (AßPP). Lower levels of copper have been reported in the brain of AßPP transgenic mice and post-mortem in AD patients. This concept has been found to be true also in vitro by Professor Dr. Gerd Multhaup (FU Berlin) in 1999. Two recent papers, which have been published in PNAS in 2003 have proven a beneficial effect of elevated copper in transgenic AßPP mice. In the present study, the teams led by Bayer and Multhaup have found that low copper level in blood correlates with advanced memory deficits, as tested by the well established ADAS-cog neuropsychological test battery. Patients with higher blood copper levels make fewer mistakes in this memory test. This result supports the notion of a mild copper deficiency in AD patients. An increased uptake of dietary copper may therefore be therapeutically relevant.
Contact: Dr. Thomas Bayer