Global Clinical Trials for Alzheimer's Disease


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




Alzheimer's Disease Drug Development


Book Description

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.




Alzheimer Disease


Book Description

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.




Alzheimer's Disease


Book Description

"This is the book edition of the Journal of Alzheimer's Disease, Volume 9, No.3 Supplement (2006)"--T.p. verso.




Alzheimer's Disease


Book Description

How current biomarkers are modernizing the diagnosis of Alzheimer's disease Expanding knowledge on genetic and epigenetic risk factors is rapidly enhancing our understanding of the complex molecular interactions and systems involved in the pathogenesis of Alzheimer's disease. In this publication, leading experts discuss emerging novel conceptual models of the disease along with advances in the development of surrogate markers that will not only improve the accuracy of diagnostic technologies but also improve the prospects of developing disease-modifying interventions. The novel framework of the disease presented here highlights research on biological markers as well as efforts to validate technologies for early and accurate detection. It also introduces notion of a complex systems dysfunction that extends beyond prevailing ideas derived from the amyloid' or tau' hypotheses. This outstanding publication provides researchers, clinicians, students and other professionals interested in neurodegenerative disorders with a comprehensive update on current trends and future directions in therapy development, with special focus on advances in clinical trial designs.




Global Clinical Trials for Alzheimer’s Disease


Book Description

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) may thus be the key issues on the road to prevent or delay the onset of AD. As the pathologic processes leading to AD may take decades to develop, it is crucial to identify optimal time windows for preventive efforts. Targeting several risk factors simultaneously and long duration of the intervention may be needed for the optimal preventive effect. As many persons are affected, relatively small effects of an integrative intervention on common risk factors may have a huge public health impact. Usage of biomarkers may help in identifying different risk phenotypes and in monitoring effects of the interventions. International collaboration is necessary to initiate future large-scale dementia prevention studies that are needed to formulate evidence-based preventive measures in cognitive decline and dementia.




Global Clinical Trials for Alzheimer’s Disease


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


Book Description

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


Book Description

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 overall efficiency of the sites’ and countries’ performance.




Global Clinical Trials for Alzheimer’s Disease


Book Description

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.