Global Clinical Trials for Alzheimer's Disease
Global Clinical Trials for Alzheimer's Disease

Author: Menghis Bairu

Publisher: Academic Press

Published: 2013-08-28

Total Pages: 428

ISBN-13: 0124115306

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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

Alzheimer's Disease Drug Development
Alzheimer's Disease Drug Development

Author: Jeffrey Cummings

Publisher: Cambridge University Press

Published: 2022-03-31

Total Pages: 575

ISBN-13: 1108838669

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Provides a definitive overview of the complex ecosystem facilitating Alzheimer's Disease drug research and development. Demonstrates a drug's journey from in the lab, clinical trial testing, regulatory review, and marketing by pharmaceutical companies. Details the use of artificial intelligence, clinical trial management, and financing models.

Global Clinical Trials for Alzheimer’s Disease
Global Clinical Trials for Alzheimer’s Disease

Author: James (Dachao) Fan

Publisher: Elsevier Inc. Chapters

Published: 2013-08-28

Total Pages: 22

ISBN-13: 0128070501

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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.

Alzheimer Disease
Alzheimer Disease

Author: Robert Becker

Publisher: Springer Science & Business Media

Published: 1996-12-01

Total Pages: 636

ISBN-13: 9780817638795

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This volume reviews the new potential treatments and research in the area of Alzheimer's disease. Special attention is given to international developments in all fields relevant to new drug development. Topics discussed include: progress in the international harmonization of drug development guidelines for dementia drugs; bioethics and law; development of rating instruments; behavioural treatments; and the activities of the Reagan Foundation. The text integrates basic and clinical research findings, and provides evaluation of new approaches to therapy by world leaders in the field. The potential benefit for Alzheimer patients and families resulting from these research programmes, from molecular biology to clinical pharmacology, is reviewed and evaluated.

Global Clinical Trials for Alzheimer’s Disease
Global Clinical Trials for Alzheimer’s Disease

Author: Yağız Üresin

Publisher: Elsevier Inc. Chapters

Published: 2013-08-28

Total Pages: 21

ISBN-13: 0128070528

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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

Author: Jeffrey Cummings

Publisher: Elsevier Inc. Chapters

Published: 2013-08-28

Total Pages: 22

ISBN-13: 0128070404

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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

Author: Seong Yoon Kim

Publisher: Elsevier Inc. Chapters

Published: 2013-08-28

Total Pages: 24

ISBN-13: 0128070544

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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 to be US$ 1,700 million. Past experiences in clinical research or drug trials for AD have taught us several lessons: 1) cognitive tests and function measurements need careful interpretation due to the unstable educational system in Korea between 1940 and 1970, and the rapid industrialization of modern Korean society; 2) in a governmental drive to encourage clinical research, several national collaborative research networks will work as a solid base for future clinical trials; 3) recent revision of clinical research-related regulations, and a change in the general public's views on drug trials, can be both an advantage and a disadvantage for drug trials at the same time.

Global Clinical Trials for Alzheimer’s Disease
Global Clinical Trials for Alzheimer’s Disease

Author: Sidney A. Spector

Publisher: Elsevier Inc. Chapters

Published: 2013-08-28

Total Pages: 15

ISBN-13: 0128070560

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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, for example, in the field of oncology, cardiology and psychiatry, based on an individual’s underlying genotypic variance of phenotypically expressed pathogenic targets and pathways. Translational pharmacogenomic research in Alzheimer’s disease has emerged as a viable alternative to the study of large populations with similar phenotypic expression of symptoms through stratification of sub-groups based on ApoE carrier status in clinical trials. When initiating a global research protocol, it is incumbent upon sponsors to actively engage stakeholders in developing and underdeveloped countries, including local government authorities, regulatory bodies, ethics review boards, community representatives and participants, to address all aspects of the clinical trial, especially informed consent, which may be more challenging in countries where local customs and practices dictate the need for innovative approaches. Implementation of pharmacogenomics in the clinical trial requires further attention to ethical detail related to what kind of informed consent is needed for use of stored DNA samples for future, unforeseen related or unrelated research, whether and to whom to disclose current and future study results, and ways by which the benefits of current and future discoveries are shared by stakeholders in developed and underdeveloped or developing countries.

Global Clinical Trials for Alzheimer’s Disease
Global Clinical Trials for Alzheimer’s Disease

Author: Tal Burt

Publisher: Elsevier Inc. Chapters

Published: 2013-08-28

Total Pages: 24

ISBN-13: 0128070498

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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

Author: Lynne Hughes

Publisher: Elsevier Inc. Chapters

Published: 2013-08-28

Total Pages: 24

ISBN-13: 0128070455

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This chapter reviews significant recent clinical trials involving potential disease-modifying drugs, including active immunotherapy, passive immunotherapy, γ-secretase inhibitors and modulators, β-secretase inhibitors, and amyloid-beta (Aβ) anti-aggregants. The challenges and opportunities involved in global trials are then discussed, such as variability in diagnosis and patient selection; patient endpoints for both symptomatic therapies and disease-modifying drugs; rater training and global validation of rating scales; competition to recruit the pool of patients available for clinical trials; and emerging logistical concerns related to the use of biomarkers.