Galantamine versus donepezil in Chinese patients with Alzheimer’s disease: results from a randomized, double-blind study

Abstract

Zhenxin Zhang,1 Lu Yu,2 Maren Gaudig,3 Barbara Schäuble,4 Ute Richarz51Department of Neurology of Peking Union Medical College Hospital, 2Xi’an Janssen Pharmaceutical Ltd, Beijing, China; 3Health Economics and Reimbursement, Janssen-Cilag EMEA, Neuss, Germany; 4Formerly of EMEA Medical Affairs, Janssen-Cilag EMEA, Neuss, Germany; 5Global Medical Affairs, Janssen Global Services LLC, Janssen-Cilag AG, Baar, SwitzerlandBackground: Acetylcholinesterase inhibitors are considered standard of care for Alzheimer’s disease in many countries. Galantamine is an acetylcholinesterase inhibitor that may also act via allosteric modulation of nicotinic acetylcholine receptors. Therefore, it may provide benefits compared with other acetylcholinesterase inhibitors. The present study compared galantamine (n = 116) with donepezil (n = 117) in a double-blind trial at nine hospitals in China.Methods: After washout of any previous acetylcholinesterase inhibitors, subjects with mild to moderate Alzheimer’s disease received galantamine or donepezil for 16 weeks.Results: Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog/11) scores improved significantly from baseline in both treatment arms, with a significant difference in favor of galantamine on the “language” functional area (P = 0.035). Significantly more galantamine-treated patients responded to treatment (defined as a reduction in ADAS-cog/11 score of >4, >7, or >10 points; all P < 0.05), and had an ADAS-cog/11 score < 20 at end point (P = 0.015). Both treatments were well tolerated, although fewer galantamine-treated patients experienced gastrointestinal adverse events compared with donepezil (30% versus 48%).Conclusion: Cognitive function improved significantly in subjects with mild to moderate Alzheimer’s disease treated with galantamine or donepezil, and both treatments were generally well tolerated. Significant benefits for galantamine over donepezil were observed for language and response to treatment.Keywords: Chinese, donepezil, galantamine, randomized controlled trial, Alzheimer’s disease