scholarly journals The value of assessing cognitive function in drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 183-202 ◽  
Keyword(s):  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Cognitive Functions ◽  
Phase 1 ◽  
Disease Process ◽  
Cognitive Testing ◽  
Assessment System ◽  
Automated System ◽  
The Internet ◽  
Large Patient

This paper reviews the value and utility of measuring cognitive function in the development of new medicines by reference to the most widely used automated system in clinical research. Evidence is presented from phase 1 to 3 of the nature and quality of the information that can be obtained by applying the Cognitive Drug Research computerized assessment system to ongoing clinical trials. Valuable evidence can be obtained even in the first trial in which a novel compound is administered to man. One application of such testing is to ensure that novel compounds are relatively free from cognition-impairing properties, particularly in relation to competitor products. Another is to ensure that unwanted interactions with alcohol and other medications do not occur, or, if they do, to put them in context. In many patient populations, cognitive dysfunction occurs as a result of the disease process, and newer medicines which can treat the symptoms of the disease without further impairing function can often reveal benefits as the disease-induced cognitive dysfunction is reduced. Another major application is to identify benefits for compounds designed to enhance cognitive function. Such effects can be sought in typical phase 1 trials, or a scopolamine model of the core deficits of Alzheimer's disease can be used to screen potential antidernentia drugs. Ultimately, of course, such effects can be demonstrated using properly validated and highly sensitive automated procedures in the target populations. The data presented demonstrate that the concept of independently assessing a variety of cognitive functions is crucial in helping differentiate drugs, types of dementia, and different illnesses. Such information offers a unique insight into how the alterations to various cognitive functions will manifest themselves in everyday behavior. This reveals a major limitation of scales that yield a single score, because such limited information does not permit anything but a quantitative interpretation; and the concept of "more" cognitive function or "less" is manifestly inappropriate for something as complex and diverse as the interplay between cognitive function and human behavior. Finally, the next generations of cognitive testing are described. Testing via the telephone has just been introduced and will have dramatic effects on the logistics of conducting cognitive testing in large patient trials. Testing via the Internet is not far off either, and will come fully into play as the proportion of homes connected to the Internet increases in Europe and North America. There are no sound reasons for not wishing to include cognitive function testing in the development protocol of any novel medicine.

Internet-based cognitive testing in multiple sclerosis

2007 ◽  
Vol 13 (8) ◽  
pp. 1011-1019 ◽  
Author(s):  
M. Younes ◽  
J. Hill ◽  
J. Quinless ◽  
M. Kilduff ◽  
B. Peng ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Function ◽  
Verbal Memory ◽  
Stability Index ◽  
Cross Sectional Study ◽  
Cognitive Testing ◽  
The Internet ◽  
Cross Sectional ◽  
Multiple Sclerosis Patients

Cognitive impairment in multiple sclerosis is difficult to study because of the heterogeneity and variability of this disease. The gold standard for measurement of cognitive function in multiple sclerosis is a full battery of neurocognitive tests, which is time consuming and expensive. Some cognitive tests like the PASAT, a measure of working verbal memory and processing speed, have been proposed for screening and follow-up of cognitive function in clinical trials. We studied whether we could measure cognitive function in multiple sclerosis over the Internet. For this we used the Cognitive Stability Index (CSI)™, developed for persons with known or suspected primary central nervous system illness. The CSI was compared with formal neurocognitive testing (NPsych) and the PASAT in a cross-sectional study of 40 consecutive multiple sclerosis patients with subjective cognitive complaints. NPsych revealed that only 18 of the 40 patients (46%) were cognitively impaired. Although both the CSI and the PASAT were equalivalent in their specificity (86%), the CSI was significantly more sensitive than the PASAT (83% versus 28%). We conclude that the CSI, because of its availability over the Internet, has great potential as a tool for screening and follow up of cognitive function in multiple sclerosis. Multiple Sclerosis 2007; 13: 1011—1019. http://msj.sagepub.com

scholarly journals The Link Between Physical Activity and Cognitive Dysfunction in Alzheimer Disease

2015 ◽  
Vol 95 (7) ◽  
pp. 1046-1060 ◽  
Author(s):  
Cristy Phillips ◽  
Mehmet Akif Baktir ◽  
Devsmita Das ◽  
Bill Lin ◽  
Ahmad Salehi
Keyword(s):  
Physical Activity ◽  
Cognitive Function ◽  
Alzheimer Disease ◽  
Cognitive Decline ◽  
Cognitive Dysfunction ◽  
Physical Therapist ◽  
Disease Process ◽  
Sufficient Evidence ◽  
Brain Disorder ◽  
Neuroprotective Effects

Alzheimer disease (AD) is a primary cause of cognitive dysfunction in the elderly population worldwide. Despite the allocation of enormous amounts of funding and resources to studying this brain disorder, there are no effective pharmacological treatments for reducing the severity of pathology and restoring cognitive function in affected people. Recent reports on the failure of multiple clinical trials for AD have highlighted the need to diversify further the search for new therapeutic strategies for cognitive dysfunction. Thus, studies detailing the neuroprotective effects of physical activity (PA) on the brain in AD were reviewed, and mechanisms by which PA might mitigate AD-related cognitive decline were explored. A MEDLINE database search was used to generate a list of studies conducted between January 2007 and September 2014 (n=394). These studies, along with key references, were screened to identify those that assessed the effects of PA on AD-related biomarkers and cognitive function. The search was not limited on the basis of intensity, frequency, duration, or mode of activity. However, studies in which PA was combined with another intervention (eg, diet, pharmacotherapeutics, ovariectomy, cognitive training, behavioral therapy), and studies not written in English were excluded. Thirty-eight animal and human studies met entry criteria. Most of the studies suggested that PA attenuates neuropathology and positively affects cognitive function in AD. Although the literature lacked sufficient evidence to support precise PA guidelines, convergent evidence does suggest that the incorporation of regular PA into daily routines mitigates AD-related symptoms, especially when deployed earlier in the disease process. Here the protocols used to alter the progression of AD-related neuropathology and cognitive decline are highlighted, and the implications for physical therapist practice are discussed.

scholarly journals The Association between Cognitive Impairment and Diabetic Foot Care: Role of Neuropathy and Glycated Hemoglobin

2020 ◽  
Vol 27 (1) ◽  
pp. 14-27
Author(s):  
Lorenzo Brognara ◽  
Iacopo Volta ◽  
Vito Michele Cassano ◽  
Emmanuel Navarro-Flores ◽  
Omar Cauli
Keyword(s):  
Diabetes Mellitus ◽  
Cognitive Impairment ◽  
Cognitive Function ◽  
Glycemic Control ◽  
Cognitive Dysfunction ◽  
Cognitive Functions ◽  
Diabetic Foot ◽  
Glycated Hemoglobin ◽  
Diabetic Patients ◽  
Adherence To Treatment

Diabetes mellitus is associated with impairment in cognitive functions which can complicate adherence to self-care behaviors. We evaluated the incidence of cognitive impairment in patients with diabetes mellitus to determine the strength of the association between diabetic foot (a complication that occurs in about 10% of diabetic patients), adherence to the clinician’s recommendations, glycemic control, and cognitive function. A prospective study was carried out in a probabilistic sample of older patients with diabetic foot living in three nursing homes. Cognitive functions were evaluated by the MMSE (Mini-Mental State Examination), the Trail Making test (TMT), and the Michigan neuropathy screening instrument (MNSI). There were no significant associations between cognitive function and neuropathy or foot alterations, although glycated hemoglobin (HB1Ac > 7%) significantly (p < 0.05) associated with MMSE and adherence to treatment in the 1 month follow-up visit. Receiver operating characteristic curve analysis showed that both HB1Ac and the MNSI score significantly (p < 0.05) discriminate subsequent adherence to treatment for foot complication, with a sensitivity of 80.0–73.3% and specificity 70.6–64.7%, respectively. Proper control of foot complications in diabetic patients involves appropriate glycemic control and less severe neuropathy, and seems to be unrelated to cognitive dysfunction, and warrants further studies in order to tailor appropriate treatments to central and peripheral nervous system disorders. Poor glycemic control (Hb1Ac level > 7%) and a neuropathy score of 5.5 in the MNSI are the best-cut off points to discriminate poor adherence to the clinician’s recommendations for self-care behaviors in people with diabetic foot complication. In this study, we observed that foot disorders were associated with impaired global cognitive function in elderly patients (aged ≥ 65). Podiatrists and physicians should consider cognitive dysfunction as an important chronic complication in the management of diabetic foot.

Testing Cognitive Function at the Bedside

2017 ◽  
Author(s):  
John R. Hodges
Keyword(s):  
Executive Function ◽  
Cognitive Function ◽  
Semantic Memory ◽  
Cognitive Dysfunction ◽  
Response Inhibition ◽  
Cognitive Functions ◽  
Verbal Fluency ◽  
Right Hemisphere ◽  
Spoken Language ◽  
Set Shifting

This chapter explores the second component of assessment in patients with suspected cognitive dysfunction: testing cognitive function at the bedside. The first part of the examination should assess distributed cognitive functions, notably orientation and attention, episodic and semantic memory, and frontal executive function (initiation in the form of verbal fluency, abstraction, response inhibition, and set shifting); deficits in these indicate damage to particular brain systems, but not to focal areas of one hemisphere. The second part of the assessment deals with localized functions, divided into those associated with the dominant (i.e. the left side, in right-handers) and non-dominant hemispheres. The former relates largely to tests of spoken language with supplementary tests of reading, writing, calculation, and praxis when applicable. Testing right hemisphere function focuses on neglect (personal and extrapersonal), visuospatial and constructional abilities, and the agnosias including object and face agnosia.

scholarly journals Cognitive function of pregnant women: the problem of postoperative cognitive dysfunction in women after labor

2020 ◽  
Vol 69 (1) ◽  
pp. 7-16
Author(s):  
Aleksey V. Shchegolev ◽  
Dmitry M. Shirokov ◽  
Oksana A. Chernykh ◽  
Irina V. Vartanova ◽  
Maria V. Khrabrova
Keyword(s):  
Cognitive Function ◽  
Pregnant Women ◽  
Cognitive Dysfunction ◽  
Cognitive Functions ◽  
Postoperative Cognitive Dysfunction ◽  
Depression Scale ◽  
Cognitive Status ◽  
Reproductive Age ◽  
Memory And Attention ◽  
The Impact

The problem of postoperative cognitive dysfunction is relevant in obstetrics due to the initial psychophysiological state of a pregnant woman and the high frequency of abdominal delivery everywhere. When choosing the optimal method of anesthesia for a cesarean section, which would minimally affect cognitive functions, it is necessary to consider the impact of anesthesia on the memory and attention of puerperas, as well as their initial cognitive status. To assess memory and attention in women of reproductive age, in our opinion, the most appropriate tests are the MoCA-test, Benton test, Wechsler test, hospital anxiety and depression scale, and a self-assessment questionnaire. These tests are recommended by psychophysiologists and have proven themselves to be well applied in daily clinical practice. Standard test kits with a formalized (quantitative) evaluation of the results allow a rapid assessment of several cognitive functions in a limited time. This review article presents the problem of the cognitive function of pregnant women and postoperative cognitive dysfunction during pregnancy.

IRISK METHOD FOR SECURITY ESTIMATION OF THE SIMULATION POLYGON FOR THE PROTECTION OF CRITICAL INFORMATION RESOURCES

2019 ◽  
Author(s):  
Bogdan Korniyenko ◽  
Lilia Galata
Keyword(s):  
Risk Assessment ◽  
Information System ◽  
Information Security ◽  
Risk Analysis ◽  
Information Resources ◽  
Security System ◽  
Assessment System ◽  
Automated System ◽  
Information Risk ◽  
Critical Information

In this article, the research of information system protection by ana­ ly­ zing the risks for identifying threats for information security is considered. Information risk analysis is periodically conducted to identify information security threats and test the information security system. Currently, various information risk analysis techni­ ques exist and are being used, the main difference being the quantitative or qualitative risk assessment scales. On the basis of the existing methods of testing and evaluation of the vulnerabilities for the automated system, their advantages and disadvantages, for the possibility of further comparison of the spent resources and the security of the information system, the conclusion was made regarding the deter­ mi­ nation of the optimal method of testing the information security system in the context of the simulated polygon for the protection of critical information resources. A simula­ tion ground for the protection of critical information resources based on GNS3 application software has been developed and implemented. Among the considered methods of testing and risk analysis of the automated system, the optimal iRisk methodology was identified for testing the information security system on the basis of the simulated. The quantitative method Risk for security estimation is considered. Generalized iRisk risk assessment is calculated taking into account the following parameters: Vulnerabili­ ty  — vulnerability assessment, Threat — threat assessment, Control — assessment of security measures. The methodology includes a common CVSS vul­ nerability assessment system, which allows you to use constantly relevant coefficients for the calculation of vulnerabilities, as well as have a list of all major vulnerabilities that are associated with all modern software products that can be used in the automated system. The known software and hardware vulnerabilities of the ground are considered and the resistance of the built network to specific threats by the iRisk method is calculated.

Arterial Stiffness, Cognitive Dysfunction and Adherence to Antihypertensive Agents. Is there a Link to Hypertensive Patients?

2020 ◽  
Vol 18 (4) ◽  
pp. 410-417 ◽  
Author(s):  
Rigas G. Kalaitzidis ◽  
Thalia Panagiotopoulou ◽  
Dimitrios Stagikas ◽  
Kosmas Pappas ◽  
Olga Balafa ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Arterial Stiffness ◽  
Cognitive Dysfunction ◽  
Antihypertensive Drugs ◽  
Patient Adherence ◽  
Antihypertensive Agents ◽  
Treatment Compliance ◽  
Poor Adherence ◽  
Large Artery ◽  
Adherence To Medication

:The incidence of hypertension (HTN) and its cardiovascular (CV) complications are increasing throughout the world. Blood pressure (BP) control remains unsatisfactory worldwide. Medical inertia and poor adherence to treatment are among the factors that can partially explain, why BP control rate remains low. The introduction of a method for measuring the degree of adherence to a given medication is now a prerequisite. Complex treatment regimes, inadequate tolerance and frequent replacements of pharmaceutical formulations are the most common causes of poor adherence. In contrast, the use of stable combinations of antihypertensive drugs leads to improved patient adherence.:We aim to review the relationships between arterial stiffness, cognitive function and adherence to medication in patients with HTN.:Large artery stiffening can lead to HTN. In turn, arterial stiffness induced by HTN is associated with an increased CV and stroke risk. In addition, HTN can induce disorders of brain microcirculation resulting in cognitive dysfunction. Interestingly, memory cognitive dysfunction leads to a reduced adherence to drug treatment. Compliance with antihypertensive treatment improves BP control and arterial stiffness indices. Early treatment of arterial stiffness is strongly recommended for enhanced cognitive function and increased adherence.

scholarly journals SAT0623-HPR THE LIVED EXPERIENCES OF COGNITIVE DYSFUNCTION IN ADULTS WITH FIBROMYALGIA: A QUALITATIVE SYSTEMATIC REVIEW

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1271.1-1272
Author(s):  
S. Derham ◽  
J. Lewis ◽  
E. Dures ◽  
F. Cramp
Keyword(s):  
Clinical Practice ◽  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Lived Experiences ◽  
Critical Appraisal ◽  
Negative Impact ◽  
Practice Research ◽  
Future Research ◽  
Poor Sleep ◽  
Cognitive Changes

Background:Adults with fibromyalgia frequently report symptoms of cognitive dysfunction, often referred to as fibrofog. However primary research exploring cognitive dysfunction in the lives of adults with fibromyalgia is very limited (Kravitz and Katz, 2015).Objectives:The aim of this review was to (i) synthesise the qualitative literature on the lived experiences of cognitive dysfunction in adults with fibromyalgia, (ii) develop common themes through thematic analysis and (iii) identify knowledge gaps to inform future research and clinical practice in this area.Methods:Seven electronic databases (MEDLINE, Embase, CINAHL, PsycINFO, Amed, Scopus and OpenGrey), reference lists of key articles and two high impact qualitative journals were searched from 1990 to November 2018. Articles were eligible for inclusion if they reported primary qualitative data exploring the experiences of cognitive dysfunction in adults with fibromyalgia. Included studies were appraised using the Critical Appraisal Skills Programme (CASP) qualitative checklist and extracted data analysed using narrative synthesis. SD conducted critical appraisal and data extraction on all included studies. FC, JL and ED reviewed five papers each. All papers were reviewed by two co-authors. Of the 1413 records identified, 15 studies were selected for inclusion.Results:These studies included 208 women and 22 men with fibromyalgia, aged 18 to 72 years and representing seven different countries. Duration of diagnosis was four months to 34 years. Fourteen studies used interviews and one used focus groups. None of the included studies focussed exclusively on cognitive function in adults with fibromyalgia. Three studies identified themes specific to cognitive dysfunction and fibromyalgia symptoms. The remaining 12 studies presented relevant data intertwined with the overall lived experiences of fibromyalgia.Cognitive dysfunction, as a part of fibromyalgia, was often unpredictable. Problems with memory and concentration that were most commonly reported were emotionally distressing and affected functional and vocational activities. Participants found communication effortful, with a negative impact on work, leisure and social activities. Stress, fear and worry around perceived cognitive changes were commonly expressed. Lost employment or changed work roles and relationships, due to cognitive difficulties, had negative impacts for many participants. The terms cognitive dysfunction and fibrofog were used interchangeably within the studies, but lacked common definition. This introduced uncertainty around whether participants and authors were describing the same phenomenon.Conclusion:Adults with fibromyalgia experience unpredictable and emotionally impactful difficulties related to cognitive dysfunction. Functional impact was broad-reaching, particularly around work ability and lost employment opportunities. It is unclear how cognitive symptoms in fibromyalgia related to co-morbid symptoms such as pain, fatigue and poor sleep. Further research focusing on the full impact of cognitive function on the lives of adults with fibromyalgia is recommended to inform clinical practice. Research to establish clarity of definition of the terms cognitive dysfunction and fibrofog within fibromyalgia is highly recommended.References:[1]Kravitz H, Katz R. Fibrofog and fibromyalgia: a narrative review and implications for clinical practice. Rheumatology International. 2015;35(7):1115-25.Acknowledgments:This work is supported by the National Institute for Heath Research [ICA-PCAF-2018-01-078 to SD]Disclosure of Interests:Sandra Derham: None declared, Jenny Lewis: None declared, Emma Dures Grant/research support from: Independent Learning Grant from Pfizer, combined funding for a research fellow from Celgene, Abbvie and Novartis, Paid instructor for: A fee from Novartis to deliver training to nurses., Fiona Cramp: None declared

scholarly journals Cognitive Function in Adults with Enduring Anorexia Nervosa

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 859
Author(s):  
Maria Seidel ◽  
Helen Brooker ◽  
Kamilla Lauenborg ◽  
Keith Wesnes ◽  
Magnus Sjögren
Keyword(s):  
Anorexia Nervosa ◽  
Cognitive Function ◽  
Episodic Memory ◽  
Reaction Times ◽  
Assessment System ◽  
Cognitive Test ◽  
Attention Tasks ◽  
Inclusion Study ◽  
Prospective Longitudinal

Anorexia Nervosa (AN) is a severe and often enduring disorder characterized by restriction of food intake, low body weight, fear of weight gain, and distorted body image. Investigations on cognition performance in AN patients have yielded conflicting results. Using an established and sensitive computerized cognitive test battery, we aimed to assess core aspects of cognitive function, including attention span, information processing, reasoning, working and episodic memory, in AN patients and controls. Patients were recruited from the Danish Prospective Longitudinal all-comer inclusion study in Eating Disorders (PROLED). Included were 26 individuals with AN and 36 healthy volunteers (HV). All were tested with CogTrack (an online cognitive assessment system) at baseline, and AN patients were tested again at a follow-up time point after weight increase (n = 13). At baseline, AN patients showed faster reaction times in the attention tasks, as well as increased accuracy in grammatical reasoning compared to HV. There were no differences in cognitive function between AN patients and HV in the other cognitive domains measured (sustained attention, working and episodic memory, speed of retrieval, and speed of grammatical reasoning). No differences were visible in the AN sample between baseline and follow-up. Performance did not correlate with any clinical variables in the AN sample. These findings supplement results from other studies suggesting increased concentration and reasoning accuracy in patients suffering from AN, who showed increased performance in cognitive tasks despite their illness.

scholarly journals Study of cognitive functions in major idiopathic interstitial pneumonias

2020 ◽  
Vol 14 (1) ◽  
Author(s):  
Mohamed W. Zakaria ◽  
Reem I. El-Korashy ◽  
Mostafa O. Shaheen ◽  
Samah Selim ◽  
Kwashi J. Amum
Keyword(s):  
Cognitive Impairment ◽  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Mini Mental State Examination ◽  
Mmse Score ◽  
Control Group ◽  
Healthy Individuals ◽  
Co Morbidity ◽  
Impaired Lung Function ◽  
State Examination

Abstract Background Cognitive dysfunction in idiopathic interstitial pneumonia (IIP) is an important clinical co-morbidity that is associated with impaired lung function. The aim of the work is to assess cognitive function in major IIP and to find out the relation between cognitive dysfunction and the oxygenation parameters. Results Fifty individuals were involved in the study; 30 patients with major IIP and 20 healthy individuals. Patients with IIP had significantly lower mini mental state examination (MMSE) score compared to the control group (P < 0.001). Wechsler Deterioration Index (WDI) revealed that 33.3% (n = 10) of the patients with IIP had sure cognitive impairment and 26.6% (n = 8) had ongoing cognitive deterioration. Patients with idiopathic pulmonary fibrosis (IPF) had lower cognitive function than other IIP. Conclusion There is an impairment of cognitive function in patients with major IIP, particularly in IPF, as measured by WDI and MMSE. Further large studies are needed to assess the possible predictors of cognitive impairment and their effects on the patients’ outcome.

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