Jianping Jia1,2, Cuibai Wei1,2, Longfei Jia1,3, Yi Tang1,2, Junhua Liang1, Aihong Zhou1, Fangyu Li1,2, Lu Shi1,2, Rachelle S Doody4. 1. Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China. 2. Center of Alzheimer's Disease, Beijing Institute for Brain Disorders, Beijing, China. 3. Department of Neurology, Henry Ford Hospital, Detroit, MI, USA. 4. Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine-Department of Neurology, Houston, TX, USA.
Abstract
BACKGROUND: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. OBJECTIVE: To determine whether donepezil is effective and tolerable for Chinese patients with severe AD. METHODS: 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. RESULTS: A total of 313 patients included thedonepezil (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. CONCLUSION: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.
RCT Entities:
BACKGROUND: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. OBJECTIVE: To determine whether donepezil is effective and tolerable for Chinese patients with severe AD. METHODS: 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. RESULTS: 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. CONCLUSION: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.
Entities:
Keywords:
Alzheimer’s disease; Chinese population; clinical trial; donepezil
Authors: Teresa Pardo-Moreno; Anabel González-Acedo; Antonio Rivas-Domínguez; Victoria García-Morales; Francisco Jose García-Cozar; Juan Jose Ramos-Rodríguez; Lucía Melguizo-Rodríguez Journal: Pharmaceutics Date: 2022-05-24 Impact factor: 6.525