PMID- 31744005
OWN - NLM
STAT- MEDLINE
DCOM- 20201204
LR  - 20201214
IS  - 1875-8908 (Electronic)
IS  - 1387-2877 (Linking)
VI  - 72
IP  - 4
DP  - 2019
TI  - Sixteen-Week Interventional Study to Evaluate the Clinical Effects and Safety of 
      Rivastigmine Capsules in Chinese Patients with Alzheimer's Disease.
PG  - 1313-1322
LID - 10.3233/JAD-190791 [doi]
AB  - BACKGROUND: Rivastigmine is a cholinesterase inhibitor, approved for the 
      treatment of mild-to-moderate dementia of Alzheimer's type. OBJECTIVE: To explore 
      the efficacy and safety of the maximal tolerated dose of rivastigmine capsules in 
      Chinese patients with mild-to-moderate Alzheimer's disease (AD). METHODS: The 
      study was a multicenter, open-label, single-arm, phase IV clinical study in 
      mild-to-moderate drug-naive AD patients treated with rivastigmine capsules. The 
      primary endpoint was the changes in the total scores of Alzheimer's Disease 
      Assessment Scale-Cognitive subscale (ADAS-Cog) from baseline to week 16. 
      Secondary endpoints included changes in the scores of the following assessment 
      scales and safety: Alzheimer's Disease Cooperative Study; Activities of Daily 
      Living; Mini-Mental Status Examination (MMSE); Neuropsychiatry Index (NPI), and 
      Caregiver Burden Inventory. RESULTS: 222 patients were enrolled. Of these, 136 
      (75.1%) patients received and maintained the effective dose (>/=6 mg/d) of 
      rivastigmine for at least 4 weeks. The ADAS-Cog scale score improved in 
      rivastigmine-treated patients at week 16 compared with baseline (p < 0.001) by 
      2.0 (95% CI: -3.0 to -1.1) points, which met the pre-defined superiority 
      criteria. NPI-10 and NPI-12 scores improved by 3.6 and 4.0 points at week 16 
      (p = 0.001, p < 0.001), respectively. A total of 107 patients (59.1%) experienced 
      adverse effects (AEs) during the study; common AEs included nausea (20.5%), 
      vomiting (16.6%), anorexia (7.8%), dizziness (7.7%), and diarrhea (7.2%). 
      CONCLUSION: This was the first phase IV study on rivastigmine in mainland China. 
      The study preliminarily demonstrated that rivastigmine capsules showed good 
      tolerability and efficacy in mild-to-moderate AD patients with the maximal 
      tolerated dose.
FAU - Jia, Jianping
AU  - Jia J
AD  - Innovation Center for Neurological Disorders and Department of Neurology, Xuanwu 
      Hospital, Capital University of Medical Sciences, Beijing, China.
FAU - Ji, Yong
AU  - Ji Y
AD  - Department of Cognitive Disorder, Beijing Tiantan Hospital, Capital Medical 
      University, Beijing, China.
AD  - China National Clinical Research Center for Neurological Disease, Beijing, China.
FAU - Feng, Tao
AU  - Feng T
AD  - China National Clinical Research Center for Neurological Disease, Beijing, China.
AD  - Movement Disorders Center, Department of Neurology, Beijing Tiantan Hospital, 
      Capital Medical University, Beijing, China.
FAU - Ye, Qinyong
AU  - Ye Q
AD  - Department of Neurology, The Affiliated Union Hospital of Fujian Medical 
      University, Fuzhou, China.
FAU - Peng, Dantao
AU  - Peng D
AD  - Department of Neurology, China-Japan Friendship Hospital, Beijing, China.
FAU - Kuang, Weihong
AU  - Kuang W
AD  - Mental Health Center, West China Hospital of Sichuan University, Chengdu, China.
FAU - Ning, Yuping
AU  - Ning Y
AD  - Department of Psychiatry, Affiliated Brain Hospital of Guangzhou Medical 
      University (Guangzhou Huiai Hospital), Guangzhou, China.
FAU - Liang, Zhihou
AU  - Liang Z
AD  - Department of Neurology, Affiliated Union Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Fan, Dongsheng
AU  - Fan D
AD  - Department of Neurology, Peking University Third Hospital, Beijing, China.
FAU - Wei, Wenshi
AU  - Wei W
AD  - Department of Geriatrics, Huadong Hospital, Fudan University, Shanghai, China.
FAU - Li, Yansheng
AU  - Li Y
AD  - Department of Neurology, Renji Hospital, Shanghai Jiaotong University School of 
      Medicine, Shanghai, China.
FAU - Xiao, Shifu
AU  - Xiao S
AD  - Department of Geriatric Psychiatry, Alzheimer's Disease and Related Disorders' 
      Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of 
      Medicine, China.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - J Alzheimers Dis
JT  - Journal of Alzheimer's disease : JAD
JID - 9814863
RN  - 0 (Cholinesterase Inhibitors)
RN  - PKI06M3IW0 (Rivastigmine)
SB  - IM
MH  - Activities of Daily Living
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/diagnosis/*drug therapy
MH  - Cholinesterase Inhibitors/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nausea/*chemically induced
MH  - Rivastigmine/adverse effects/*therapeutic use
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Vomiting/*chemically induced
OTO - NOTNLM
OT  - Alzheimer's disease
OT  - Chinese population
OT  - capsule
OT  - rivastigmine
EDAT- 2019/11/21 06:00
MHDA- 2020/12/15 06:00
CRDT- 2019/11/21 06:00
PHST- 2019/11/21 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2019/11/21 06:00 [entrez]
AID - JAD190791 [pii]
AID - 10.3233/JAD-190791 [doi]
PST - ppublish
SO  - J Alzheimers Dis. 2019;72(4):1313-1322. doi: 10.3233/JAD-190791.