title: Rivastigmine Patch in Chinese Patients with Probable Alzheimer's disease: A 24-week, Randomized, Double-Blind Parallel-Group Study Comparing Rivastigmine Patch (9.5 mg/24 h) with Capsule (6 mg Twice Daily).
abstract: OBJECTIVE
  To compare the once-daily rivastigmine patch 9.5 mg/24 h (10 cm(2) ) versus twice-daily capsule (12 mg/day) in Chinese patients with probable Alzheimer's disease (AD) (mini-mental state examination [MMSE] scores of 10-20).
  
  
  METHODS
  The primary objective was to demonstrate the noninferiority of patch to capsule in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) change from baseline to 24 week. Secondary endpoints included cognition (MMSE), overall clinical response (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change [ADCS-CGIC]), activities of daily living (Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL]), behavior (Neuropsychiatric Inventory [NPI-12]), and safety.
  
  
  RESULTS
  Similar cognitive improvement was observed in both patch (n = 248) and capsule (n = 253) groups. Statistical noninferiority for ADAS-Cog was not established (least-square means difference, 0.1; 95% confidence interval, -1.2; 1.5). Considering all efficacy parameters into account, both treatments showed similar performance at Week 24. Treatment-related adverse events (AEs) were lower for patch (39.7%) compared with capsule (49.8%). Application site pruritus was reported in 10.9% of patients receiving patch; most cases were mild. Gastrointestinal AEs including nausea, vomiting, and diarrhea occurred less frequently in the patch group (15.8% vs. 28.7%).
  
  
  CONCLUSIONS
  Rivastigmine patch 9.5 mg/24 h is effective and well tolerated in Chinese patients with probable AD.
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Zhen-Xin
authors.initials: ZX
authors.lastname: Zhang
authors.affiliation: Huashan Hospital Affiliated to Fudan University, Shanghai, China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Hong
authors.affiliation: No 2 Hospital affiliated to Guangzhou Medical University, Guangzhou City, China.
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Wang
authors.affiliation: Department of Neurology, West China Hospital of Sichuan University, Chengdu, China.
authors.forename: Li
authors.initials: L
authors.lastname: He
authors.affiliation: Department of Neurology, First Affiliated Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Ning
authors.initials: N
authors.lastname: Wang
authors.affiliation: Shanghai Changzhen Hospital, Shanghai, China.
authors.forename: Zhong-Xin
authors.initials: ZX
authors.lastname: Zhao
authors.affiliation: Xijing Hospital, Shaanxi, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Zhao
authors.affiliation: Huilongguan Hospital, Beijing, China.
authors.forename: Lan
authors.initials: L
authors.lastname: Shang
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Marianne
authors.initials: M
authors.lastname: Weisskopf
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Francesca
authors.initials: F
authors.lastname: Callegari
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Christine
authors.initials: C
authors.lastname: Strohmaier
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000150:complications / Q000188:drug therapy*; D044466:Asian People; D003072:Cognition Disorders / Q000188:drug therapy / Q000209:etiology; D004311:Double-Blind Method; D004333:Drug Administration Routes; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008609:Mental Status Schedule; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage*; D012189:Retrospective Studies; D000068836:Rivastigmine / Q000008:administration & dosage*; D018709:Statistics, Nonparametric; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D018696:Neuroprotective Agents; D000068836:Rivastigmine
keywords: Alzheimer's disease; Capsule; Chinese; Rivastigmine; Transdermal patch