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Frontiers of Neurology and Neuroscience

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https://www.readbyqxmd.com/read/27464072/pharmacogenetics-in-neurodegenerative-diseases-implications-for-clinical-trials
#1
Rosanna Tortelli, Davide Seripa, Francesco Panza, Vincenzo Solfrizzi, Giancarlo Logroscino
BACKGROUND: Pharmacogenetics has become extremely important over the last 20 years for identifying individuals more likely to be responsive to pharmacological interventions. The role of genetic background as a predictor of drug response is a young and mostly unexplored field in neurodegenerative diseases. SUMMARY: Mendelian mutations in neurodegenerative diseases have been used as models for early diagnosis and intervention. On the other hand, genetic polymorphisms or risk factors for late-onset Alzheimer's disease (AD) or other neurodegenerative diseases, probably influencing drug response, are hardly taken into account in randomized clinical trial (RCT) design...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463974/cerebrospinal-fluid-biomarkers-for-target-engagement-and-efficacy-in-clinical-trials-for-alzheimer-s-and-parkinson-s-diseases
#2
Lucilla Parnetti, Paolo Eusebi, Alberto Lleó
BACKGROUND: Cerebrospinal fluid (CSF) is increasingly being used to detect biochemical changes that occur in different neurological conditions. In Alzheimer's disease (AD), three CSF biomarkers (Aβ42, total tau, and phosphorylated tau) are used in clinical practice to support the diagnosis in the prodromal stages of the disease. In Parkinson's disease (PD), the investigation is following the pathway of AD research and some promising markers have been identified, with the main aim to favor an early diagnosis, i...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463823/current-issues-in-randomized-clinical-trials-of-neurodegenerative-disorders-at-enrolment-and-reporting-diagnosis-recruitment-representativeness-of-patients-ethnicity-and-quality-of-reporting
#3
Giancarlo Logroscino, Rosa Capozzo, Rosanna Tortelli, Benoît Marin
BACKGROUND: The investigator is faced with several challenges when planning a randomized clinical trial (RCT). In the early phase, issues are particularly challenging for RCTs in neurodegenerative disorders (NDD). SUMMARY: At the time of inclusion in the study, an early and accurate diagnosis is mandatory. Variability of diagnostic criteria, mostly based on clinical grounds, lag time between onset and enrolment, and phenotypic heterogeneity are the main drivers of diagnostic complexity...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463807/biomarkers-in-randomized-clinical-trials-positron-emission-tomography-and-nuclear-medicine-techniques
#4
Tarun Singhal, Emily Stern
BACKGROUND: Positron emission tomography (PET) and single-photon emission computed tomography (SPECT) are nuclear medicine techniques that utilize the tracer principle to image biological processes using radiolabeled molecules. Numerous PET and SPECT radiopharmaceuticals have been developed over the years that qualify as biomarkers for neurological disorders. SUMMARY: This chapter reviews the use of PET and SPECT in neurological clinical trials, and emphasizes the concepts and lessons learned from these experiences...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463686/peculiarities-of-neurological-disorders-and-study-designs
#5
Ettore Beghi, Elisabetta Pupillo, Giorgia Giussani
BACKGROUND: Neurological disorders are heterogeneous clinical conditions with variable course and outcome. SUMMARY: The basic aspects of the commonest neurological disorders are addressed along with the proposed structure of randomized clinical trials (RCTs). Dementing disorders, including Alzheimer's disease (AD), are clinical conditions in which altered cognitive functions are associated with behavioral and personality changes. Parkinson's disease (PD) is a multisystem disorder characterized by motor dysfunction associated with dysautonomia, sleep and olfactory disturbances, cognitive changes, and depression...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463684/biomarkers-in-randomized-clinical-trials-magnetic-resonance-imaging
#6
Jennifer L Whitwell
BACKGROUND: It is essential that randomized clinical trials (RCTs) incorporate biomarkers of disease progression that would be sensitive to the effects of disease-modifying treatments. Magnetic resonance imaging (MRI) can be safely repeated over time, and is routinely performed in clinical centers, making it an ideal modality to be incorporated into RCTs. SUMMARY: This chapter discusses potential structural MRI biomarkers that have been proposed for a number of different neurodegenerative disorders, including Alzheimer's disease (AD), dementia with Lewy bodies (DLB), frontotemporal dementia (FTD), progressive supranuclear palsy syndrome (PSPS), and Parkinson's disease (PD)...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463525/the-basic-structure-of-a-randomized-clinical-trial
#7
Ettore Beghi
BACKGROUND: According to the Directive 2001/20/EC of the European Union, a clinical trial is any investigation in human subjects intended to (1) discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of one or more investigational medicinal product(s), (2) identify any adverse reactions to one or more investigational medicinal product(s), (3) and/or study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463522/assessing-functional-decline-in-neurological-diseases-clinical-trials-duration-of-follow-up-the-case-of-multiple-sclerosis
#8
Filippo Martinelli Boneschi, Giancarlo Comi
BACKGROUND: The main objective in the treatment of multiple sclerosis is to prevent or postpone the long-term disability caused by the disease, which in most cases occurs over years. However, most randomized clinical trials (RCTs) assessing the efficacy and safety of disease-modifying drugs have been designed to measure the short-term efficacy of disease-modifying drugs (up to 2-4 years) in reducing relapse rate and disease activity at magnetic resonance imaging (MRI). SUMMARY: In this chapter we will discuss how drug efficacy in reducing short-term relapse rate and MRI activity impact on delaying the accumulation of long-term disability, and we will summarize the available literature on the long-term efficacy of the drugs as assessed by the few long-term observational and long-term extension RCTs on available drugs, focusing on interferon-β treatment as the one with a more extensive literature...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463375/disease-course-outcome-measures-and-prognostic-predictors-in-epilepsy-opportunities-for-improving-outcome-of-drug-trials
#9
Dieter Schmidt
BACKGROUND: A major concern over the development of new antiepileptic drugs (AEDs) is that the new AEDs have not added substantial clinical benefit over available antiseizure treatment. Additionally, current AEDs have neither improved the health of epilepsy patients nor been shown to prevent epilepsy or to improve the disease. SUMMARY: This chapter reviews new data on patterns of epilepsy with remission and relapse, prognostic factors for seizure outcome, and innovative patient-related outcome measures...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463228/age-comorbidity-frailty-in-observational-and-analytic-studies-of-neurological-diseases
#10
Jan Novy, Josemir W Sander
BACKGROUND: Comorbidities are rarely taken into account in studies of neurological conditions although they may be a confounder of the outcome and treatment. The relationship between comorbidities and neurological conditions is also problematic as comorbidities may be symptoms of the underlying cause of the neurologic condition or long-term adverse effects of the treatment. SUMMARY: There is evidence that several common neurological conditions have an increased burden of somatic and psychiatric comorbidities compared with matched samples from the general population...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463096/composite-scores-and-other-outcome-measures-in-stroke-trials
#11
Francesca Pistoia, Simona Sacco, Raffaele Ornello, Diana Degan, Cindy Tiseo, Antonio Carolei
BACKGROUND: Randomized controlled trials represent the most useful tool to evaluate the effectiveness of a treatment in medical research. When designing a clinical trial, the choice of end points, assessment tools, and scores is crucial as they represent the prerequisites for the evaluation of outcomes and for the critical appraisal of findings. SUMMARY: In stroke research, outcomes are mainly represented by composite end points focusing on the occurrence of cardiovascular and cerebrovascular events in trials on primary and secondary prevention and by measures of recovery and residual disability in acute stroke trials...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463091/general-overview-conclusions-and-future-directions
#12
Ettore Beghi, Giancarlo Logroscino
BACKGROUND: The traditional design of the randomized clinical trial (RCT) is challenged by the peculiarities of the genotype and phenotype of neurological disorders. SUMMARY: RCTs are intended to verify the net effect of an investigational treatment on the outcome of a disease. This implies the inclusion of strictly homogeneous sample of patients that represent only in part the full disease spectrum. For this reason, pragmatic trials on representative samples of the general population are welcome...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27462982/modeling-and-prediction-in-neurological-disorders-the-biostatistical-perspective
#13
Massimiliano Copetti, Andrea Fontana, Fabio Pellegrini
BACKGROUND: Statistical methods are often considered as mere tools to address research questions. The lack of critical understanding can make their use sometimes highly questionable if not inappropriate. Biostatistics should be seen more as a paradigm than a set of tools. Knowledge of methods means a flexible utilization of them, in which modeling and prediction correspond more to an art than to a routine use dictated by circumstances and habits. SUMMARY: Tree-based methods (or tree-growing techniques) are discussed here as a flexible statistical framework for modeling and prediction to address key questions such as prognostic stratification and treatment effects heterogeneity in both randomized clinical trials and observational studies...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27462978/the-right-therapy-for-neurological-disorders-from-randomized-trials-to-clinical-practice-patients-versus-investigator-expectations-and-needs
#14
Lucie I Bruijn, Steve Kolb
BACKGROUND: People living with amyotrophic lateral sclerosis (ALS) are now more proactive in making decisions about their treatment options, in particular with increased awareness through social media and the Internet. Together with increased awareness about the disease comes increased frustration that there is still only one Food and Drug Administration (FDA)-approved drug that modestly improves survival. SUMMARY: While efforts are underway to improve clinical trial design, patient involvement in trial design, clinical outcomes, and risk/benefit evaluations have become more recognized and will play a major role in the future success of clinical trials...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27462704/how-to-distinguish-between-statistically-significant-results-and-clinically-relevant-results
#15
Derrick A Bennett
BACKGROUND: A practicing clinician will often be confronted with the results of a new clinical trial in their relevant field and will be faced with the dilemma of determining whether these results are clinically relevant to their own work. This chapter aims to describe the concepts of statistical significance in randomized clinical trials from a mainly classical statistical inference perspective. This chapter describes approaches to assess clinical significance and illustrates these approaches with examples from the contemporary neurological literature...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27462701/randomized-trials-in-developing-countries-different-priorities-and-study-design
#16
Benoît Marin, Gino Cédric Agbota, Pierre-Marie Preux, Farid Boumédiene
BACKGROUND: Clinical trials are increasingly conducted in the field of neurology in developing countries. To our knowledge, no review has been performed to date about the temporal evolution, geographical distribution, pathological fields, and types of trials conducted. Besides, the validity of those clinical trials needs to be evaluated. SUMMARY: Our main aim was to describe, using a systematic literature review, the clinical trials performed in the field of neurology in developing countries...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27035922/nostalgia-in-the-army-17th-19th-centuries
#17
Michèle Battesti
People died from nostalgia in the army in the 17th-19th centuries. The term 'nostalgia', created by the doctor Johannes Hofer (1669-1752), from Mulhouse, came from the Germanic Heimweh, or 'homesickness'. It affected the young people enrolled in the army, such as Swiss mercenaries. Longing for their native land, they were consumed by an ongoing desire to return home. If it was impossible to do so, they sank into 'a sadness accompanied with insomnia, anorexia and other unpleasant symptoms' that could lead to death...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27035915/elaboration-of-the-visual-pathways-from-the-study-of-war-related-cranial-injuries-the-period-from-the-russo-japanese-war-to-world-war-i
#18
Douglas J Lanska
As a result of the wars in the early 20th century, elaboration of the visual pathways was greatly facilitated by the meticulous study of visual defects in soldiers who had suffered focal injuries to the visual cortex. Using relatively crude techniques, often under difficult wartime circumstances, investigators successfully mapped key features of the visual pathways. Studies during the Russo- Japanese War (1904-1905) by Tatsuji Inouye (1881-1976) and during World War I by Gordon Holmes (1876-1965), William Lister (1868-1944), and others produced increasingly refined retinotopic maps of the primary visual cortex, which were later supported and refined by studies during and after World War II...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27035838/german-emergency-care-in-neurosurgery-and-military-neurology-during-world-war-ii-1939-1945
#19
Frank W Stahnisch
A critical analysis of the historical involvement of neurology and neurosurgery in military emergency care services enables us to better contextualize and appreciate the development of modern neurology at large. Wartime neurosurgery and civil brain science during the German Nazi period tightly coalesced in examining the specific injury types, which military neurosurgeons such as Wilhelm Toennis, Klaus Joachim Zuelch, and Georg Merrem encountered and treated based on their neurophysiological understanding gained from earlier peacetime research...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27035830/post-traumatic-stress-disorder-among-french-armed-forces-members-in-afghanistan-a-new-approach
#20
Frédéric Paul, Catherine Marimoutou, Vincent Pommier de Santi, Patrick Clervoy
During the 20th century, the management of war-related psychological trauma shifted from neurology to psychiatry. After September 11, 2001, the French forces participated in a multinational force deployed in Afghanistan to fight against terrorism. Post-traumatic stress disorder (PTSD) became a priority. We report the daily work of the psychiatrists involved in this mission and the organization developed to psychologically support wounded military personnel. The doctrine of early intervention psychiatrization and the technique of collective debriefing are the key points of this procedure...
2016: Frontiers of Neurology and Neuroscience
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