Global Clinical Trials for Alzheimer s Disease

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

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  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Pages : 432 pages
  • ISBN : 0124115306
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKGlobal Clinical Trials for Alzheimer s Disease

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
  • Author : Menghis Bairu,Michael Weiner
  • Publisher : Academic Press
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer's Disease

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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : James (Dachao) Fan,Li Huafang,Jing Yin
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Jeffrey Cummings,Kate Zhong
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Menghis Bairu,Sidney A. Spector,Richard Chin
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

A rapid increase in the globalization of clinical trials is being driven by a need for lower cost, greater speed, and higher quality. Increasing costs—approximately 20% per year—account for much of this effort. Trials in developing countries—done with rigorous controls and safeguards—can lower the cost of drugs, distribute modern science and medicine, and enhance the health of patients around the world. Lesser developed countries offer a large pool of willing, treatment-naïve patients. Globalization of clinical trials

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Seong Yoon Kim
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Prevalence of dementia in Korea is 9.1% of the elderly population, and those with dementia are thus estimated to be nearly 750,000. Dementia due to Alzheimer’s disease (AD) accounts for 45–75% of all dementia syndromes, whereas vascular dementia accounts for about 12–37%. Clinical research on AD has been greatly expanded in volume and quality in the last 10 years in Korea, partly due to public and governmental awareness of the increase of the elderly population. The national drug market for dementia in 2020 is estimated

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yoko Fujimoto,Takeshi Iwatsubo
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Considering the difficulty of clinical development for Alzheimer’s Disease (AD), understanding each country’s specific situation is an important first step in reducing the operational burden on clinical trials while maintaining the quality of the study. In this chapter, the long history of clinical development for AD in Japan is introduced. There has been a lot of experience in Japan of AD clinical development from the time of developing donepezil to the current global development of AD disease-modifying drugs.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Lynne Hughes
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

This chapter provides an overview of the increasingly important role of emerging markets in Alzheimer’s disease trials, particularly Eastern Europe, where there is a robust population of accurately diagnosed subjects for trial participation, and recruitment rates are on a par with those in Western Europe and the USA. Some of the challenges and opportunities involved in global trials are discussed, such as the potential for high recruitment, availability and compliance with biomarker assessments, reimbursement of background medications, and the

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Tal Burt,Lynne Hughes,Amir Kalali,P. Murali Doraiswamy
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Nadina C. Jose,Lorne Cheeseman,Stephanie Danandjaja
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

The incidence of Alzheimer’s disease is increasing worldwide. The need to fortify global resources conducting clinical trials becomes of paramount importance for sponsors to ensure less delay in marketing their products. This chapter provides a concise and practical approach to building capacity and capability in emerging or developing markets. Lessons learned from countries like China and India, where the top 12 pharmaceutical and biotech companies have become deeply entrenched in the last 10 years, serve as important benchmarks which can be

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Peter Schüler,Klaudius Siegfried,Michael Hüll
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

To date (2013), we have witnessed over 100 years of research on Alzheimer’s disease (AD). In the past century, this gave new and deep insights into its pathophysiology. However, no new treatment with an innovative mode of action has found its way to the patients since the first targeted therapies with cholinergic drugs like Tacrin. So far A-beta and related targets have shown negative results in pivotal Phase III studies, after showing promising trends in Phase II. Thus the question arises

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Menghis Bairu
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

More than 35 million people worldwide are living with dementia, the vast majority Alzheimer’s disease (AD)-related. By 2050, Alzheimer’s disease cases will triple to 115 million—one new case every four seconds—placing untold stress on overburdened social service and healthcare delivery systems, a potentially catastrophic global epidemic. Sixty percent of Alzheimer’s disease victims now live in lesser developed countries. In 2050, these countries will account for 71% of the total Alzheimer’s disease caseload. In 2010, the annual cost of AD

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Muriel O’ Byrne,Menghis Bairu
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Data from clinical trials in emerging markets are becoming a standard component of the regulatory package being provided to support pharmaceutical marketing authorizations including the FDA New Drug Application (NDA) and the EMA Marketing Authorization Application (MAA). In this chapter, the highlights of the requirements for Alzheimer’s disease interventions are summarized, including a review of trial enrichment strategies. The topic of acceptance of foreign clinical data is also reviewed.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Sidney A. Spector
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Decades ago, pharmacogenetic research established that one’s genetic profile might predict efficacy and safety of medicines. Polymorphic expression of isoenzymes of the cytochrome P-450 enzyme system explains a significant amount of the variability of inter-individual responses to medicines. In Alzheimer’s disease, the highly variable clinical response to cholinesterase inhibitors metabolized by the liver is explained on this basis. More recently, translation of basic pharmacogenomic research through the drug development process has led to the approval of ”personalized“ medicines,

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Tiia Ngandu,Francesca Mangialasche,Miia Kivipelto
  • Publisher : Elsevier Inc. Chapters
  • Release : 28 August 2013
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Today there are more than 36 million demented persons worldwide. With the aging of populations, the prevalence of dementia and Alzheimer’s disease (AD) is expected to more than triple in the coming 40 years. Besides high age and genetic factors, evidence from observational studies shows that many modifiable vascular and lifestyle-related risk factors at midlife affect the risk of the disease. Control of vascular and metabolic risk factors, healthy diet, and maintenance of AN active lifestyle (physical, mental, and social components)