scholarly journals Randomized controlled trials in mild cognitive impairment

Neurology ◽  
2017 ◽  
Vol 88 (18) ◽  
pp. 1751-1758 ◽  
Author(s):  
Ronald C. Petersen ◽  
Ronald G. Thomas ◽  
Paul S. Aisen ◽  
Richard C. Mohs ◽  
Maria C. Carrillo ◽  
...  

Objective:To examine the variability in performance among placebo groups in randomized controlled trials for mild cognitive impairment (MCI).Methods:Placebo group data were obtained from 2 National Institute on Aging (NIA) MCI randomized controlled trials, the Alzheimer's Disease Cooperative Study (ADCS) MCI trial and the Alzheimer's Disease Neuroimaging Initiative (ADNI), which is a simulated clinical trial, in addition to industry-sponsored clinical trials involving rivastigmine, galantamine, rofecoxib, and donepezil. The data were collated for common measurement instruments. The performance of the placebo participants from these studies was tracked on the Alzheimer's Disease Assessment Scale–cognitive subscale, Mini-Mental State Examination, and Clinical Dementia Rating–sum of boxes, and for progression on these measures to prespecified clinical study endpoints. APOE status, where available, was also analyzed for its effects.Results:The progression to clinical endpoints varied a great deal among the trials. The expected performances were seen for the participants in the 2 NIA trials, ADCS and ADNI, with generally worsening of performance over time; however, the industry-sponsored trials largely showed stable or improved performance in their placebo participants. APOE4 carrier status influenced results in an expected fashion on the study outcomes, including rates of progression and cognitive subscales.Conclusions:In spite of apparently similar criteria for MCI being adopted by the 7 studies, the implementation of the criteria varied a great deal. Several explanations including instruments used to characterize participants and variability among study populations contributed to the findings.

2013 ◽  
Vol 26 (1) ◽  
pp. 7-7 ◽  
Author(s):  
Nicola T. Lautenschlager

With the global aging of our societies and predicted increase of cognitive impairment and dementia, it is no surprise that there is an increasing interest in the research community, but also among clinicians and the general population to learn more about how to focus on modifiable protective factors and how to avoid modifiable risk factors. A recent review of systematic reviews and meta-analyses on significant risk factors for Alzheimer's disease (AD) highlighted the importance of diabetes, hypertension, obesity, smoking, depression, cognitive inactivity, and physical inactivity (Barnes and Yaffe, 2011). For physical inactivity, for example, the authors reported that up to one million cases of AD could be prevented globally if a physical inactivity could be reduced by 25%. However, we should not forget about the various stages of prevention, and especially in the field of psychogeriatrics should also ask what preventative measures might be effective for older adults who have already experienced cognitive impairment. So we could focus on a secondary prevention approach for individuals with mild cognitive impairment (MCI) or on a tertiary preventative approach for patients with dementia. The number of randomized controlled trials (RCT) investigating the effectiveness of physical activity on cognition is limited for healthy participants and those with MCI, but is even more sparse for those with dementia. Even with the limited number of studies it often is difficult to compare RCTs due to the huge variation in inclusion and exclusion criteria, methodology, instruments used and outcomes, intervention and duration of interventions, and observations.


2020 ◽  
Vol 37 (4) ◽  
pp. 209-223
Author(s):  
Jin Hyeon Shin ◽  
Hye Jeong Shin ◽  
Eui Byeol Kim ◽  
Yun Young An ◽  
Tae Han Yook ◽  
...  

The purpose of this study was to evaluate the effectiveness of acupuncture treatment for the symptoms of Alzheimer’s disease (AD). There were 11 databases searched for randomized controlled trials using acupuncture treatment for AD. The risk-of-bias assessment tool of the Cochrane Library was used to evaluate the quality of each study. Using the Review Manager (RevMan), a meta-analysis was performed using risk ratio, mean difference, 95% confidence interval, and random effect model. There were 32 studies selected, all of which were conducted in China. There were 16 studies where acupuncture was used as the intervention, and 23 studies used Donepezil as the control group. Acupoint GV20 was most frequently selected during the treatment. The Mini Mental State Examination (MMSE) was the most frequently used outcome variable. A period of 12 weeks was the most common treatment duration. As a result of meta-analysis (<i>n</i> = 25), acupuncture improved the MMSE and activities of daily living scores. Electroacupuncture improved the Alzheimer Disease Assessment Scale-Cognitive Subscale, and scalp acupuncture improved the MMSE score for AD. Acupuncture alleviates the symptoms of AD. However, further research is necessary to provide a better level of evidence.


2018 ◽  
Vol 15 (12) ◽  
pp. 1151-1160 ◽  
Author(s):  
Zihan Jiang ◽  
Huilin Yang ◽  
Xiaoying Tang

Objective: In this study, we investigated the influence that the pathology of Alzheimer’s disease (AD) exerts upon the corpus callosum (CC) using a total of 325 mild cognitive impairment (MCI) subjects, 155 AD subjects, and 185 healthy control (HC) subjects. Method: Regionally-specific morphological CC abnormalities, as induced by AD, were quantified using a large deformation diffeomorphic metric curve mapping based statistical shape analysis pipeline. We also quantified the association between the CC shape phenotype and two cognitive measures; the Mini Mental State Examination (MMSE) and the Alzheimer’s Disease Assessment Scale-Cognitive Behavior Section (ADAS-cog). To identify AD-relevant areas, CC was sub-divided into three subregions; the genu, body, and splenium (gCC, bCC, and sCC). Results: We observed significant shape compressions in AD relative to that in HC, mainly concentrated on the superior part of CC, across all three sub-regions. The HC-vs-MCI shape abnormalities were also concentrated on the superior part, but mainly occurred on bCC and sCC. The significant MCI-vs-AD shape differences, however, were only detected in part of sCC. In the shape-cognition association, significant negative correlations to ADAS-cog were detected for shape deformations at regions belonging to gCC and sCC and significant positive correlations to MMSE at regions mainly belonging to sCC. Conclusion: Our results suggest that the callosal shape deformation patterns, especially those of sCC, linked tightly to the cognitive decline in AD, and are potentially a powerful biomarker for monitoring the progression of AD.


Author(s):  
Zahra Ayati ◽  
Guoyan Yang ◽  
Mohammad Hossein Ayati ◽  
Seyed Ahmad Emami ◽  
Dennis Chang

Abstract Background Saffron (stigma of Crocus sativus L.) from Iridaceae family is a well-known traditional herbal medicine that has been used for hundreds of years to treat several diseases such as depressive mood, cancer and cardiovascular disorders. Recently, anti-dementia property of saffron has been indicated. However, the effects of saffron for the management of dementia remain controversial. The aim of the present study is to explore the effectiveness and safety of saffron in treating mild cognitive impairment and dementia. Methods An electronic database search of some major English and Chinese databases was conducted until 31st May 2019 to identify relevant randomised clinical trials (RCT). The primary outcome was cognitive function and the secondary outcomes included daily living function, global clinical assessment, quality of life (QoL), psychiatric assessment and safety. Rev-Man 5.3 software was applied to perform the meta-analyses. Results A total of four RCTs were included in this review. The analysis revealed that saffron significantly improves cognitive function measured by the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinical Dementia Rating Scale-Sums of Boxes (CDR-SB), compared to placebo groups. In addition, there was no significant difference between saffron and conventional medicine, as measured by cognitive scales such as ADAS-cog and CDR-SB. Saffron improved daily living function, but the changes were not statistically significant. No serious adverse events were reported in the included studies. Conclusions Saffron may have the potential to improve cognitive function and activities of daily living in patients with Alzheimer’s disease and mild cognitive impairment (MCI). However, due to limited high-quality studies there is insufficient evidence to make any recommendations for clinical use. Further clinical trials on larger sample sizes are warranted to shed more light on its efficacy and safety.


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