scholarly journals DL-3-n-butylphthalide Delays Cognitive Decline in Patients With Mild to Moderate Alzheimer's Disease Already Receiving Donepezil: A Multicenter, Prospective Cohort Study

2020 ◽  
Author(s):  
Jin Wang ◽  
Xiaojuan Guo ◽  
Wenhui Lu ◽  
Jie Liu ◽  
Hong Zhang ◽  
...  

Abstract Background:Vascular factors and mitochondria dysfunction contributeto thepathogenesis of Alzheimer’s Disease (AD).DL-3-n-butylphthalide (NBP)has an effect in protecting mitochondria and improving microcirculation. We investigated the effect of NBP in patients with mild-moderate AD already receiving donepezil.Methods: It was a prospective cohort study. 92 mild-moderate AD patients were classified into the donepezil alone group (n=43) or the donepezil combined NBP group (n=49) for 48 weeks. The primary outcome was change of Alzheimer’s disease assessment scale-cognitive subscale (ADAS-cog) from baseline after treatment 48 weeks. All patients were also evaluated with clinician’s interview-based impression of change plus caregiver input (CIBIC-plus), Alzheimer's disease cooperative study-activities of daily living (ADCS-ADL) and neuropsychiatric inventory (NPI) every 12 weeks. All patients were monitored for adverse events (AEs). The efficacy was analyzed using logistic regression analysis.Results:The univariate analysis showed that age wasolder in donepezil alone group(P=0.005), prevalence of hypertension was higher in donepezil alone group(P=0.026).The ADAS-cog score change from baseline in thedonepezil alone group was significant than that in the donepezil combined NBP group at 48 weeks(1.82±5.20 vs -0.38±4.46, P=0.048). The multivariate logistic regression analysis showed that between the 2 groups, there were significant differencesin changes on the ADAS-cog(OR=0.879,95% CI:[0.785,0.984],P=0.026),MMSE(OR=1.270,95% CI:[1.036,1.557],P=0.021), and ADCS-ADL(OR=1.067,95% CI:[1.002,1.136],P=0.042) but no significant differences for changes on the NPI(OR=0.955,95% CI:[0.901,1.013],P=0.125)and CIBIC-plus (OR=0.356,95% CI:[0.093,1.364],P=0.132). The occurrence of AEs was similar in the 2 groups.Conclusions:Over the 48-week treatment period, donepezil combined NBP group had slower cognitive decline and better activities of daily living in patients with mild to moderate AD. These indicated that the multi-target therapeutic effect of NBP may be a new choice for AD treatment.Trial registration:Clinical trial registration URL:https://clinicaltrials.gov/ct2/show/NCT02711683?term=NCT02711683&draw=2&rank=1ClinicalTrials.gov Identifier: NCT02711683. Date of registration: March 14,2016.

2021 ◽  
Vol 80 (2) ◽  
pp. 673-681
Author(s):  
Jin Wang ◽  
Xiaojuan Guo ◽  
Wenhui Lu ◽  
Jie Liu ◽  
Hong Zhang ◽  
...  

Background: Vascular factors and mitochondria dysfunction contribute to the pathogenesis of Alzheimer’s disease (AD). DL-3-n-butylphthalide (NBP) has an effect in protecting mitochondria and improving microcirculation. Objective: The aim was to investigate the effect of donepezil combined NBP therapy in patients with mild-moderate AD. Methods: It was a prospective cohort study. 92 mild-moderate AD patients were classified into the donepezil alone group (n = 43) or the donepezil combined NBP group (n = 49) for 48 weeks. All patients were evaluated with Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-cog), Clinician’s Interview-Based Impression of Change plus caregiver input (CIBIC-plus), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), and Neuropsychiatric Inventory (NPI) every 12 weeks. All patients were monitored for adverse events (AEs). The efficacy was analyzed using multivariate logistic regression analysis. Results: The multivariate logistic regression analysis showed that the changes of ADAS-cog score (OR = 2.778, 95% CI: [1.087, 7. 100], p = 0.033) and ADCS-ADL score (OR = 2.733, 95% CI: [1.002, 7.459], p = 0.049) had significant difference between donepezil alone group and donepezil combined NBP group, while the changes of NPI (OR = 1.145, 95% CI: [0.463, 2.829], p = 0.769), MMSE (OR = 1.563, 95% CI: [0.615, 3.971], p = 0.348) and CIBIC-plus (OR = 2.593, 95% CI: [0.696, 9.685], p = 0.156) had no significant difference. The occurrence of AEs was similar in the two groups. Conclusion: Over the 48-week treatment period, donepezil combined NBP group had slower cognitive decline and better activities of daily living in patients with mild to moderate AD. These indicated that the multi-target therapeutic effect of NBP may be a new choice for AD treatment.


2013 ◽  
Vol 12 (4) ◽  
pp. 357-367 ◽  
Author(s):  
Victor L Villemagne ◽  
Samantha Burnham ◽  
Pierrick Bourgeat ◽  
Belinda Brown ◽  
Kathryn A Ellis ◽  
...  

2018 ◽  
Vol 22 (5) ◽  
pp. 417-423 ◽  
Author(s):  
Jessica Gonçalves ◽  
Juliana Hotta Ansai ◽  
Fernando Arturo Arriagada Masse ◽  
Francisco Assis Carvalho Vale ◽  
Anielle Cristhine de Medeiros Takahashi ◽  
...  

2020 ◽  
Vol 75 (2) ◽  
pp. 417-427
Author(s):  
Yi-Fang Chuang ◽  
Vijay Varma ◽  
Yang An ◽  
Toshiko Tanaka ◽  
Christos Davatzikos ◽  
...  

2006 ◽  
Vol 18 (4) ◽  
pp. 681-700 ◽  
Author(s):  
Stephen Vida ◽  
Guillaume Galbaud du Fort ◽  
Ritsuko Kakuma ◽  
Louise Arsenault ◽  
Robert W. Platt ◽  
...  

Objectives: To examine delirium, chronic medical problems and sociodemographic factors as predictors of activities of daily living (ADL), basic ADL (BADL) and instrumental ADL (IADL).Methods: A prospective cohort study of four groups of elderly patients examined in the emergency department (ED): those with delirium, dementia, neither, and both. All were aged 66 years or older and living at home. Delirium was assessed with the Confusion Assessment Method and dementia with the Informant Questionnaire on Cognitive Decline in the Elderly. Demographic variables and chronic medical problems were ascertained with questionnaires. Outcome was ADL at 6, 12 and 18 months, measured with the ADL subscale of the Older Americans Resources and Services instrument.Results: Univariate analyses suggested significantly poorer ADL, particularly IADL, at 18 months in the delirium versus the non-delirium group, in the absence of dementia only. Statistically significant independent predictors of poorer ADL at 18 months in the non-dementia groups were poorer initial ADL, stroke, Parkinson's disease, hypertension and female sex. Independent predictors of poorer BADL at 18 months in the non-dementia groups were poorer initial BADL, Parkinson's disease, stroke, cancer, colds/sinusitis/laryngitis, female sex and hypertension. Independent predictors of poorer IADL at 18 months in the non-dementia groups were poorer initial IADL, stroke, never-married status, colds/sinusitis/laryngitis, arthritis and hypertension, with Parkinson's disease showing a non-significant but numerically large regression coefficient.Conclusion: Rather than finding delirium to be a predictor of poorer functional outcome among survivors, we found an interaction between delirium and dementia and several plausible confounders, primarily chronic medical problems, although we cannot rule out the effect of misclassification or survivor bias.


2019 ◽  
Author(s):  
Kwabena Acheampong ◽  
Xiongfeng Pan ◽  
Aizhong Liu

Abstract Background: Data examining whether anemia during different trimesters of pregnancy affects maternal and birth outcomes is lacking. Studies typically look at associations between risk factors and anemia or anemia and birth outcomes but have limited information as to whether birth outcomes differ with different trimesters of anemia. The main objective of this study is to determine whether anemia during different trimesters of pregnancy and hypertension disorders is associated with adverse maternal and perinatal outcomes in Ghana.Methods: This will be a primary analysis of data from a hospital-based prospective cohort study in four selected hospitals in the Bekwai Municipality, Ghana from February 2020 to August 2020. All singleton pregnancy at less than 20 weeks to women with at least one hemoglobin measure during pregnancy will be included. The risk of maternal and perinatal outcomes will be measured. Descriptive statistics will be used to describe the baseline characteristics of our cohort. Baseline characteristics of the two groups will be compared using Pearson Chi-square (χ2) test for categorical variables; the independent t-test and Mann–Whitney U test for parametric and nonparametric continuous variables, respectively. The risk associated with anemia and maternal and perinatal outcomes, using the history of anemia (Hb<11g/dL) in different trimesters will be calculated by logistic regression analysis, conditional on the baseline covariates. Possible confounding variables will be identified from background data, obstetric risk factors, and health behaviors. Multivariate analysis of significant effects (p<0.05) will be based on multiple logistic regression analysis. Confidence intervals will be evaluated at 95%. Data will be coded and examined using the SPSS program IBM version 20.Discussion: The better understanding of whether anemia during different trimesters of pregnancy and hypertension disorders is associated with adverse maternal and perinatal outcomes in Bekwai Municipality of Ghana. This study will establish targets for early intervention and identify risk factors to save and improve the lives of pregnant women and inborn by developing solutions that promote the quality and accountability of health services for the most vulnerable. These findings will be served as a policy document to governments in designing effective programs to curb the increasing prevalence of anemia and its associated health consequences.


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