Evidence map›Paper›PMID 27012596›Full record

Trial reportCNS neuroscience & therapeutics2016

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).

Zhen-Xin Zhang, Zhen Hong, Yan-Ping Wang, Li He, Ning Wang, Zhong-Xin Zhao, Gang Zhao, Lan Shang, Marianne Weisskopf, Francesca Callegari and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in CNS neuroscience & therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
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  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Zhen-Xin ZhangPeking Union Medical College Hospital, Beijing, China.
Zhen HongHuashan Hospital Affiliated to Fudan University, Shanghai, China.
Yan-Ping WangNo 2 Hospital affiliated to Guangzhou Medical University, Guangzhou City, China.
Li HeDepartment of Neurology, West China Hospital of Sichuan University, Chengdu, China.
Ning WangDepartment of Neurology, First Affiliated Hospital, Fujian Medical University, Fuzhou, China.
Zhong-Xin ZhaoShanghai Changzhen Hospital, Shanghai, China.
Gang ZhaoXijing Hospital, Shaanxi, China.
Lan ShangHuilongguan Hospital, Beijing, China.
Marianne WeisskopfNovartis Pharma AG, Basel, Switzerland.
Francesca CallegariNovartis Pharma AG, Basel, Switzerland.
Christine StrohmaierNovartis Pharma AG, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo 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).

methodsThe 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.

resultsSimilar 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%).

conclusionRivastigmine patch 9.5 mg/24 h is effective and well tolerated in Chinese patients with probable AD.

Indexed as

AgedAged, 80 and overAlzheimer DiseaseAsian PeopleCognition DisordersDouble-Blind MethodDrug Administration RoutesDrug Administration ScheduleFemaleFollow-Up StudiesHumansMaleMental Status ScheduleMiddle AgedNeuroprotective AgentsRetrospective StudiesNeuroprotective AgentsRivastigmineAlzheimer's diseaseCapsuleChineseRivastigmineTransdermal patch

Identifiers

PMID27012596
PMCPMC6492844

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.