Intake of copper has no effect on cognition in patients with mild Alzheimer's disease: a pilot phase 2 clinical trial.
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.
Kessler
Holger
H
Department of Psychiatry and Psychotherapy, Saarland University Hospital, Homburg/Saar, Germany.
Bayer
Thomas A
TA
Bach
Daniela
D
Schneider-Axmann
Thomas
T
Supprian
Tillmann
T
Herrmann
Wolfgang
W
Haber
Manfred
M
Multhaup
Gerd
G
Falkai
Peter
P
Pajonk
Frank-Gerald
FG
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
D003300:Copper