Efficacy and Safety of Donepezil in Chinese Patients with Severe Alzheimer's Disease: A Randomized Controlled Trial.
Donepezil has been used worldwide for the treatment of severe Alzheimer's disease (AD). Whether it is also appropriate for severe AD in Chinese patients remains unknown.



To determine whether donepezil is effective and tolerable for Chinese patients with severe AD.



The present study was a 24-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group study conducted at 38 investigational hospitals in China. Patients with severe AD were enrolled in this trial. Patients were randomly assigned in a 1:1 ratio to receive either donepezil or placebo (5 mg for 6 weeks and10 mg for the remaining 18 weeks). The efficacy for donepezil were evaluated by the SIB, the Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-plus) and the MMSE. Safety parameters were monitored throughout.



A total of 313 patients included the donepezil (n = 157) and the placebo groups (n = 156). Donepezil group improved more in SIB scores (least squares [LS] mean difference: 4.8, 95% CI 1.56 to 8.08, p = 0.004) and CIBIC-plus scores (drug-placebo difference: -0.4, 95% CI -0.66 to 0.03, p = 0.04) than placebo groups at Week 24. The MMSE scores between drug and placebo groups did not differ significantly. Twenty-nine patients with serious adverse events (SAEs) were reported in donepezil (n = 11) and placebo groups (n = 18) (p = 0.08). Most SAEs were not considered drug-related.



Donepezil for 24 weeks was more effective than placebo and showed good safety and tolerability in Chinese patients with severe AD. This study supports utility of the drug in severe stages of AD in the Chinese population.
Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.|Center of Alzheimer's Disease, Beijing Institute for Brain Disorders, Beijing, China.
Jianping
J
Jia
Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.|Center of Alzheimer's Disease, Beijing Institute for Brain Disorders, Beijing, China.
Cuibai
C
Wei
Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.|Department of Neurology, Henry Ford Hospital, Detroit, MI, USA.
Longfei
L
Jia
Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.|Center of Alzheimer's Disease, Beijing Institute for Brain Disorders, Beijing, China.
Yi
Y
Tang
Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.
Junhua
J
Liang
Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.
Aihong
A
Zhou
Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.|Center of Alzheimer's Disease, Beijing Institute for Brain Disorders, Beijing, China.
Fangyu
F
Li
Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.|Center of Alzheimer's Disease, Beijing Institute for Brain Disorders, Beijing, China.
Lu
L
Shi
Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine-Department of Neurology, Houston, TX, USA.
Rachelle S
RS
Doody
D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D002681:China; D002800:Cholinesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000077265:Donepezil; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007189:Indans / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D000073216:Mental Status and Dementia Tests; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D000077265:Donepezil
Alzheimer’s disease; Chinese population; clinical trial; donepezil