Skip to main content

Global Clinical Trials For Alzheimers Disease

In Order to Read Online or Download Global Clinical Trials For Alzheimers Disease Full eBooks in PDF, EPUB, Tuebl and Mobi you need to create a Free account. Get any books you like and read everywhere you want. Fast Download Speed ~ Commercial & Ad Free. We cannot guarantee that every book is in the library!

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer s Disease Book
Author : Menghis Bairu,Michael Weiner
Publisher : Academic Press
Release : 2013-08-28
ISBN : 0124115306
Language : En, Es, Fr & De

GET BOOK

Book Description :

Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease. Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : James (Dachao) Fan,Li Huafang,Jing Yin
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070501
Language : En, Es, Fr & De

GET BOOK

Book Description :

China has the largest number of people with dementia and the incidence is projected to increase much faster than in the developed world. There is a great demand for new drugs that can prevent or treat the disease and great potential for conducting Alzheimer’s disease clinical trials. The majority of Alzheimer’s disease trials that have been conducted in China are local trials. In early years, there were deficiencies in trial design and implementation; however, with more attention from the government and concerted efforts among Alzheimer’s disease experts, the standards for conducting Alzheimer’s disease clinical trials have improved. There are currently 159 clinical trial institutions capable of conducting Alzheimer’s disease trials in China, offering good facilities, experienced investigators and easily accessible patient pools. Recently a few global pharmaceutical companies have expanded their Alzheimer’s disease trials into China. It is expected that with increasing exposure to global standards and improved training, China’s capacity and capability to conduct Alzheimer’s disease trials will be strengthened.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Tal Burt,Lynne Hughes,Amir Kalali,P. Murali Doraiswamy
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070498
Language : En, Es, Fr & De

GET BOOK

Book Description :

There is considerable interest, both nationally and internationally, in conducting dementia research in India. Motivated by a rapid increase in the aging population and a desire for indigenous, self-sufficient healthcare and medical research, dementia research in India is on course for rapid growth in the coming years. Several challenges will have to be overcome along the way. A solid and general clinical research culture and a supportive healthcare system, both tailored to the specific needs of the dementia field and its vulnerable patient population, will have to be established through careful guidance of government regulators and collaborations with academic, industry and public stakeholders both in and outside India.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070528
Language : En, Es, Fr & De

GET BOOK

Book Description :

Turkey straddles the continents of Europe and Asia, and this unique geographical location steers its economy. On the world economic scale, as an exceptional emerging economy, Turkey is the 16th largest economy in the world and the sixth largest economy as compared with the European Union countries, according to gross domestic product. The Turkish pharmaceutical sector is ranked 16th in terms of market value, and it is 36th in terms of the clinical research conducted and the volume of pharmaceutical exports. Investments by foreign companies have increased since 1984 and 19 foreign capital firms have entered the Turkish pharmaceuticals market since 1990. Today, there are approximately 300 entities operating in Turkey. Turkey has a long tradition of providing clinical trial legislation, regulation and guidelines; the country has taken major steps towards harmonizing its legislation with those of the European Union in the field of clinical research. Currently Turkish regulations are completely in line with EC Directives. Clinical trials performed in the field of Alzheimer’s disease in Turkey since 1997, including their rationale, design, summary, and outcomes, are discussed in this chapter.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Michel Grothe,Jens Kurth,Harald Hampel,Bernd J. Krause,Stefan Teipel
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070447
Language : En, Es, Fr & De

GET BOOK

Book Description :

In-vivo imaging markers of neuronal changes related to Alzheimer’s disease (AD) are ideally suited to be employed as diagnostic markers for early and differential diagnosis of AD as well as for the assessment of neurobiological effects of medical treatments in clinical trials. Novel molecular imaging techniques enable in-vivo detection of cerebral amyloid pathology, whereas magnetic resonance imaging (MRI)-based techniques, such as volumetric MRI and diffusion tensor imaging (DTI), provide structural lesion markers that allow tracking disease progression from preclinical through predementia to clinically manifest stages of AD. However, a widespread clinical use of these imaging biomarkers is hampered by considerable multi-centric variability related to differences in scanner hardware and acquisition protocols, but also by the lack of internationally agreed upon standards for analytic design and employed quantitative metrics. Several strategies for reducing multicenter variability in imaging measures have been proposed, including homogenization of the acquisition settings across scanner platforms, stringent quality assurance procedures, and artifact removal by means of post-acquisition image processing techniques. In addition, selection of appropriate statistical models to account for remaining multicenter variability in the data can further improve the accuracy and reproducibility of study results. The first projects for international standardization of image analysis methods and derived quantitative metrics have emerged recently for volumetric MRI measures. In contrast, the standardization and establishment of DTI-derived measures within a multicenter context are less well developed. Although molecular imaging techniques are already widely used in multicenter settings, sources of variability across sites and appropriate methods to reduce multicenter effects are still not explored in detail. Comparability of neuroimaging measures as AD biomarkers in worldwide clinical settings will finally depend on the establishment of internationally agreed upon standards for image acquisition, quality assurance, and employed quantitative metrics.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Jeffrey Cummings,Kate Zhong
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070404
Language : En, Es, Fr & De

GET BOOK

Book Description :

Globalization is increasingly common as a means of more rapidly recruiting patients, shortening clinical trials, abbreviating clinical development cycle times, and preparing for marketing in non-US markets. Globalization refers to the inclusion of trial sites in three or more international regions. Globalization is common and most drug development programs include both US and non-US sites. There has been limited evaluation of the transnational performance of clinical trial instrumentation used in drug development programs. The performance across nations, languages and cultures of the ADAS-Cog, Clinical Dementia Rating, Neuropsychiatric Inventory, quality of life measures, pharmacoeconomic measures, and activities of daily living tools has been inadequately researched. The creation of a library of well-tested and shared instruments would be of value in globalized trials. The approach to diagnosis of Alzheimer’s disease may vary across trial sites and create undesirable heterogeneity within clinical trials. Biological factors such as differences in liver metabolism enzymes, diet, education and head size may all create differences in treatment response in different ethnic settings. Sites across the globe may differ in terms of experience, and institutional review boards may also perform variably with regard to informed consent and human safety. These require vigilance by sponsors performing globalized trials. International efforts such as the Alzheimer’s Disease Neuroimaging Initiative provide data that will help reduce the variance and improve clinical trial quality. Improved understanding of the effects of globalization will enhance clinical trials and speed the development of new medications for patients with AD.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : H. Michael Arrighi
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070463
Language : En, Es, Fr & De

GET BOOK

Book Description :

Alzheimer’s disease (AD) confers an additional risk of death. The magnitude of this impact is related to the person’s underlying mortality and current AD stage. When planning clinical trials, estimating the number of deaths prior to study initiation, and periodically during the study as participants are enrolled, assists in providing an informative context, particularly if there are few life events. Additionally, deaths have the potential to introduce a bias, thus, equal follow-up needs to ensure for participants assigned to either active or placebo, particularly if the period of observation for safety events extends beyond the end of the study. During AD clinical trials, patients discontinue for reasons other than death and at substantially high rates, which has the potential to introduce significant bias. Planning and incorporating strategies to improve retention and identify successful techniques should be an integral part of the study process.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Hans J. Möbius
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070420
Language : En, Es, Fr & De

GET BOOK

Book Description :

Regulatory approval of the first rational AD therapeutic tacrine occurred in 1993, followed by the approval of three other, AChEIs, and the NMDA antagonist memantine in 2002 (EMA) and 2003 (FDA) respectively. Since then, despite an enormous research and development effort, the past 10 years have seen a series of failures to translate pathophysiological understanding of dementia into new medicines. This includes a move away from neurotransmission to a focus on underlying pathological processes. The major reason for these failures was probably the continued absence of a unified disease theory of AD and too narrow a focus on the potential aetiologies of this complex disorder. To foster progress and not repeat mistakes of the past it is time to critically analyze the past approach. This chapter serves as a reminder of potential shortcomings in the field across the complete spectrum flow from animal testing through regulatory approval to daily practice.

Global Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer   s Disease Book
Author : Roy W. Jones
Publisher : Elsevier Inc. Chapters
Release : 2013-08-28
ISBN : 0128070382
Language : En, Es, Fr & De

GET BOOK

Book Description :

Current drug treatments for Alzheimer’s disease (AD) appear to be symptomatic. There is an increasing priority to find effective and safe disease-modifying and preventive treatment strategies for cognitive decline, AD, and dementia. Recent developments have allowed the identification of possible pathogenic processes and pathways, and potential targets for intervention. Cerebrospinal fluid (CSF) biomarkers of ß-amyloid and tau, and neuroimaging including amyloid PET tracer retention show that the pathogenic process begins many years before symptoms appear. A number of preventive trials have been completed but so far none has demonstrated significant benefits and some were potentially harmful. New preclinical treatment trials are underway in people at the highest risk of developing AD in the following few years. A US National Institutes of Health panel found no evidence of even moderate scientific quality to clearly support the association of any modifiable factors with a reduced risk of cognitive decline or AD. The best current evidence suggests that heart-healthy eating patterns such as the Mediterranean diet may help to protect the brain. Future preventive approaches will need to harness the increased technological advances concerning biomarkers with new hypotheses driven by a better understanding of the relevant risk factors.

Neurodegenerative Dementias

Neurodegenerative Dementias Book
Author : Christopher Clark,John Q. Trojanowski
Publisher : Appleton & Lange
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Presents a logical and elegant review of basic science, diagnosis, and treatment of the most heavily researched and most commonly encountered group of devastating neurologic illnesses: the neurodegenerative dementias.

Clinical Diagnosis and Management of Alzheimer s Disease

Clinical Diagnosis and Management of Alzheimer s Disease Book
Author : Serge Gauthier
Publisher : Butterworth-Heinemann Medical
Release : 1996
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Alzheimer's disease is not only a dementia, to the lay public it is the dementia. Clinical Diagnosis and Management of Alzheimer's Disease, under the editorial guidance of Serge Gauthier, is written by an international and multidisciplinary team which represents the reality of Alzheimer's disease. Contributors from different institutions, and different countries, have collaborated on individual chapters so that the reader is offered an international and personal perspective. Alzheimer's disease has no boundaries: it is a condition which affects all people of all countries; a condition that requires the help of both doctor and family, the community and the individual. The information provided here reflects work in progress on aetiology, clinical and laboratory assessment, natural evolution, medical and non-medical management.

Principles of Neuroepidemiology

Principles of Neuroepidemiology Book
Author : Tracy Batchelor,Merit E. Cudkowicz
Publisher : Butterworth-Heinemann Medical
Release : 2001
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

This unique text offers practitioners both a review of the basic concepts of epidemiology, statistics, and clinical trials and a discussion of the epidemiologic aspects of many neurological diseases. Much of the information contained in Principles of Neuroepidemiology, such as cost-effectiveness analyses, has been difficult for busy practitioners to find in the past. By reading this book, physicians will acquire the skills they need to critically evaluate randomized trials that have affected the clinical practice of neurology. * Useful resource for neurologists interested in brushing up on basic epidemiologic concepts * Emphasizes demographics, costs to society, risk factors, recent therapeutic advances, and treatment options for a wide range of neurologic disorders * Helpful tables compare and contrast important clinical trials

Global Clinical Trials Playbook

Global Clinical Trials Playbook Book
Author : Menghis Bairu,Richard Chin
Publisher : Academic Press
Release : 2012-06-12
ISBN : 0124158609
Language : En, Es, Fr & De

GET BOOK

Book Description :

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Today s Therapeutic Trends

Today s Therapeutic Trends Book
Author : Anonim
Publisher : Unknown
Release : 1997
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Today s Therapeutic Trends book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Biopsychology 2000 2001

Biopsychology  2000 2001 Book
Author : Boyce Jubilan
Publisher : McGraw-Hill/Dushkin
Release : 1999-12
ISBN : 9780072363937
Language : En, Es, Fr & De

GET BOOK

Book Description :

This annually updated reader is a compilation of current newspaper, magazine, and journal articles on biopsychology.

Multiple Sclerosis

Multiple Sclerosis Book
Author : Donald E. Goodkin,Richard A. Rudick
Publisher : Springer
Release : 1998-05-26
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

This book reviews the therapeutic developments in clinical trial design that have resulted in new treatment options for patients suffering from MS. Important ethical considerations that arise with the new treatments are included, as well as the perspective on the emergence of MS as a treatable disease.

Clinical Evidence

Clinical Evidence Book
Author : Stuart Barton
Publisher : Wiley-Blackwell
Release : 2001-12
ISBN : 9780727915092
Language : En, Es, Fr & De

GET BOOK

Book Description :

Clinical Evidence is a six-monthly updated compendium of evidence on the effects of common clinical interventions. It is published twice a year in print and online formats, and draws together user-friendly summaries of the best available evidence on prevention and treatment. Features include: choice of topics and questions guided by clinicians and patients; summaries written by practising clinicians; easy-to-follow numerical information; guidance on applying evidence in practice; and coverage of medical, surgical, nursing and complementary interventions.

Research and Practice in Alzheimer s Disease

Research and Practice in Alzheimer s Disease Book
Author : Anonim
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Research and Practice in Alzheimer s Disease book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Current Medical Research and Opinion

Current Medical Research and Opinion Book
Author : Anonim
Publisher : Unknown
Release : 2005
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download Current Medical Research and Opinion book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

International Journal of Fertility and Women s Medicine

International Journal of Fertility and Women s Medicine Book
Author : Anonim
Publisher : Unknown
Release : 2001
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download International Journal of Fertility and Women s Medicine book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.