title: Intake of copper has no effect on cognition in patients with mild Alzheimer's disease: a pilot phase 2 clinical trial.
abstract: Disturbed copper (Cu) homeostasis may be associated with the pathological processes in Alzheimer's disease (AD). In the present report, we evaluated the efficacy of oral Cu supplementation in the treatment of AD in a prospective, randomized, double-blind, placebo-controlled phase 2 clinical trial in patients with mild AD for 12 months. Sixty-eight subjects were randomized. The treatment was well-tolerated. There were however no significant differences in primary outcome measures (Alzheimer's Disease Assessment Scale, Cognitive subscale, Mini Mental Status Examination) between the verum [Cu-(II)-orotate-dihydrate; 8 mg Cu daily] and the placebo group. Despite a number of findings supporting the hypothesis of environmental Cu modulating AD, our results demonstrate that oral Cu intake has neither a detrimental nor a promoting effect on the progression of AD.
authors.affiliation: Department of Psychiatry and Psychotherapy, Saarland University Hospital, Homburg/Saar, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Kessler
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Bayer
authors.forename: Daniela
authors.initials: D
authors.lastname: Bach
authors.forename: Thomas
authors.initials: T
authors.lastname: Schneider-Axmann
authors.forename: Tillmann
authors.initials: T
authors.lastname: Supprian
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Herrmann
authors.forename: Manfred
authors.initials: M
authors.lastname: Haber
authors.forename: Gerd
authors.initials: G
authors.lastname: Multhaup
authors.forename: Peter
authors.initials: P
authors.lastname: Falkai
authors.forename: Frank-Gerald
authors.initials: FG
authors.lastname: Pajonk
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000523:psychology*; D003071:Cognition / Q000187:drug effects*; D003300:Copper / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D003300:Copper