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)

Zhang, Zhenxin; Hong, Zhen; Wang, Yanping; Wang, Ning; Zhi-gang, Zhao; Zhao, Gang; Shang, Lei; Weisskopf, Marianne; Callegari, Francesca; Strohmaier, Christine

doi:10.1111/cns.12521

Cited by 15 publications

(11 citation statements)

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“…Nine articles (16.1%) [72][73][74][75][76][77][78][79][80] reported results of approved drugs and 47 (83.9%) reported results of experimental drugs. Most articles ( 34[60.7%]) 25,26,28,29,[31][32][33]35,[37][38][39][40][41][42][43][45][46][47][48][49][50]52,53,56,59,60,62,65,67,71,72,75,79,80 reported the sex ratio in the intention-to-treat population (Table 1). Basic information on trials and articles regarding prodromal AD [81][82][83][84][85][86...…”

Section: Basic Characteristics Of Included Articlesmentioning

confidence: 99%

“…In the 56 primary articles on AD dementia, the overall proportion of women was 59.0% (23 348 of 39 575 total participants) (Table 1 and Figure 2). In a preliminary data analysis, on a trial basis, the mean (SD) proportion of women in the trials for approved drugs [72][73][74][75][76][77][78][79][80] was 67.3% (6.9%), whereas in trials for experimental medications, In model 1 (Table 2), in which location variables were excluded, variables significantly associated with the probability that women were enrolled in a study included the status of the drug (approved vs experimental) and the severity of the participants' AD (measured by baseline MMSE). Supporting the preliminary data analysis, trials involving drugs with approved status were associated with a higher probability of including women (odds ratio [OR], 1.26; 95% CI, 1.05-1.52; P = .02).…”

Section: Sex Proportionmentioning

confidence: 99%

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Proportion of Women and Reporting of Outcomes by Sex in Clinical Trials for Alzheimer Disease

et al. 2021

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IMPORTANCE Women represent two-thirds of patients with Alzheimer disease (AD), and sex differences might affect results of randomized clinical trials (RCTs). However, little information exists on differences in sex as reported in RCTs for AD.OBJECTIVE To assess the ratio of females to males and the reporting of sex-stratified data in large pharmaceutical RCTs for AD.DATA SOURCES A search for pharmaceutical RCTs for AD was conducted on September 4, 2019, using ClinicalTrials.gov with the key word Alzheimer disease, and articles related to those trials were

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Section: Basic Characteristics Of Included Articlesmentioning

confidence: 99%

Section: Sex Proportionmentioning

confidence: 99%

Proportion of Women and Reporting of Outcomes by Sex in Clinical Trials for Alzheimer Disease

et al. 2021

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“…1 ), of which 68 were excluded for some reasons (Supplement Table ) [ 8 , 9 , 19 - 24 , 33 - 44 , 76 - 127 ]. Ultimately, 50 articles were included (Supplement Table ) [ 15 - 18 , 128 - 173 ]. Fig.…”

Section: Resultsmentioning

confidence: 99%

The Dose and Duration-dependent Association between Melatonin Treatment and Overall Cognition in Alzheimer’s Dementia: A Network Meta- Analysis of Randomized Placebo-Controlled Trials

Tseng

Zeng

Chen

et al. 2022

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Background: While Alzheimer’s dementia (AD) has a prevalence as high as 3-32% and is associated with cognitive dysfunction and the risk of institutionalization, no efficacious and acceptable treatments can modify the course of cognitive decline in AD. Potential benefits of exogenous melatonin on cognition have been divergent across trials. Objective: The current network meta-analysis (NMA) was conducted under frequentist model to evaluate the potential benefits of exogenous melatonin supplementation on overall cognitive function in participants with AD in comparison with other FDA-approved medications (donepezil, galantamine, rivastigmine, memantine, and Namzaric). Methods: The primary outcome was the changes of the cognitive function [measured by mini-mental state examination (MMSE)] after treatment in patients with Alzheimer’s dementia. The secondary outcomes were change in the quality of life, behavioral disturbance, and acceptability (i.e. drop-out due to any reason and rate of any adverse event reported). Results: The current NMA of 50 randomized placebo-controlled trials (RCTs) revealed that the medium-term low-dose melatonin was associated with the highest post-treatment MMSE (mean difference = 1.48 in MMSE score, 95% confidence intervals [95% CIs] = 0.51 to 2.46) and quality of life (standardized mean difference = -0.64, 95% CIs = -1.13 to -0.15) among all of the investigated medications in the participants with AD. Finally, all of the investigated exogenous melatonin supplements were associated with similar acceptability as was the placebo. Conclusions: The current NMA provides evidence for the potential benefits of exogenous melatonin supplementation, especially medium-term low-dose melatonin, in participants with AD.

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“…A neuropsychological battery for multiple cognitive domains will be performed by neuropsychological assessors who are blind to the following grouping. These tests included MMSE, the Chinese version of Alzheimer’s Disease Assessment Scale-Cognitive subscale(ADAS-Cog) [ 21 ], Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) [ 21 ], the Auditory Verbal Learning Test (AVLT)-Huashan version [ 22 ], the Shape Trail Test (STT, including Part A and B) [ 23 ], the Rey-Osterrieth Complex Figure Test (CFT) [ 24 ], the Stroop Color-World Test (SCWT) and Boston Naming Test (see Additional file 1 ).…”

Section: Methodsmentioning

confidence: 99%

Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology

Lin¹,

Li²,

Tang³

et al. 2018

BMC Neurol

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BackgroundMild cognitive impairment is an early stage of Alzheimer’s disease. Increasing evidence has indicated that cognitive training could improve cognitive abilities of MCI patients in multiple cognitive domains, making it a promising therapeutic approach for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent how it could reduce the convertion rate from MCI to AD.Methods/designThe SIMPLE study is a multicenter, randomized, single-blind prospective clinical trial assessing the effects of computerized cognitive training on different cognitive domains in MCI patients. It is carried out in 7 centers in China. The study population includes patients aged 50–85, and they are randomly allocated to the training or control group. The primary outcome is to compare the conversion rate of MCI within 36-month follow-up. Structural and functional MRI will be used to interpret the effect of cognitive training. The cognitive training comprises a variety of games related with cognitive domains such as attention, memory, visualspatial ability and executive function. We cautiously set 50% reduction in the rate of conversion as estimated effect. With 80–90% statistical power and 12% as the overall probability of conversion within the study period, 600–800 patients are finally required in the study. The first patent has been recruited in April 2017.DiscussionPrevious studies suggested the benefit of cognitive training for MCI, but neither long-time nor Chinese culture were investigated. The SIMPLE designs and utilizes an improved computerized cognitive training approach and assesses its effects on MCI progress. In addition, neural activities explaining the effects on cognition function changes will be revealed, which could in turn to imply more useful therapeutic approaches.Trial registrationClinicalTrials.gov Identifier: NCT03119051.Electronic supplementary materialThe online version of this article (10.1186/s12883-018-1100-x) contains supplementary material, which is available to authorized users.

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

Cited by 15 publications

References 24 publications

Proportion of Women and Reporting of Outcomes by Sex in Clinical Trials for Alzheimer Disease

Proportion of Women and Reporting of Outcomes by Sex in Clinical Trials for Alzheimer Disease

The Dose and Duration-dependent Association between Melatonin Treatment and Overall Cognition in Alzheimer’s Dementia: A Network Meta- Analysis of Randomized Placebo-Controlled Trials

Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology

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