Global clinical trials for Alzheimer's disease : design, implementation, and standardization
Menghis Bairu (Editor), Michael W. Weiner (Editor)
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
1 online resource (xii, 428 pages) : illustrations (some color)
9780124115309, 9780124114647, 9780124114647, 0124115306, 0124114644, 0124114644
1087041017
Front Cover; Global Clinical Trials for Alzheimer's Disease; Copyright Page; Contents; Preface; About the Editors; List of Contributors; Dedication; I: ALZHEIMER'S DISEASE: THE TWENTY-FIRST CENTURY EPIDEMIC; 1. The Epidemiology and Prevention of Alzheimer's Disease and Projected Burden of Disease; 1.1 Occurrence of Dementia and Alzheimer's Disease; 1.2 Risk Factors for Dementia and AD; 1.2.1 Genetic, Socio-demographic, and Socio-economic Risk Factors; 1.2.2 Vascular Risk Factors; 1.2.3 Lifestyle-related Risk Factors; 1.3 Interventions to Prevent the Disease 1.3.1 Pre-symptomatic AD Treatment: Anti-amyloid Drugs1.4 Population Aging and Projected Burden of Disease; 1.5 Conclusion; References; 2. Developing a National Plan to Address Alzheimer's Disease; 2.1 introduction; 2.2 National Models; 2.2.1 France; 2.2.1.1 Background; 2.2.2 India; 2.2.2.1 Background; 2.2.2.2 Health Interventions; 2.2.2.3 Social Interventions; 2.2.2.4 Policy Initiatives; 2.2.3 United Kingdom; 2.2.3.1 Background; 2.2.3.2 Suffering, Isolation and Abandonment; 2.2.4 United States of America; 2.2.4.1 Background; 2.2.4.2 The National Alzheimer's Project Act 2.3 Demographics and Destiny2.4 National Dementia Plans; References; 3. Preventing Alzheimer's Disease; 3.1 Introduction; 3.1.1 Definitions; 3.2 Improved Understanding of the AD Process; 3.3 Previous Prevention Trials; 3.4 New Clinical Trial Approaches; 3.5 Lifestyle Factors, Diet, and Alcohol; 3.6 The Future; References; II: GLOBAL ALZHEIMER'S DISEASE: CLINICAL TRIALS; 4. Overview of Global Clinical Trials: Drivers/Issues/Opportunities of Globalization; 4.1 Introduction; 4.2 Growth of Global Clinical Trials; 4.3 Drivers of Globalization; 4.4 Issues of Globalization 4.5 Control and Inspections of Foreign Sites4.6 Ethnic and Genetic Issues; 4.7 Usability of International Clinical Data in Regulatory Filings; References; III: CHALLENGES AND OPPORTUNITIES TO CONDUCT GLOBAL ALZHEIMER'S DISEASE CLINICAL TRIALS; 5. Challenges and Opportunities to Conduct Global Alzheimer's Disease Clinical Trials; 5.1 Introduction; 5.2 What is Globalization?; 5.3 Why Globalization?; 5.4 How Common are Globalized Trials?; 5.5 Globalization and Clinical Trial Instrumentation; 5.6 Global Effects on Diagnosis of Alzheimer's Disease 5.7 Patient-Related Factors to be Considered in Globalized Trials5.8 Disease-Related Factors to be Considered in Globalized Trials; 5.9 Pharmacokinetic- and Pharmacodynamic-Related Factors to be Considered in Globalized Trials; 5.10 Site-Related Factors to be Considered in Globalized Trials; 5.11 Other Considerations in Globalized Trials; 5.12 Recommendations; References; 6. Lessons Learned from Major Clinical Trials Conducted Over the Past Decades; 6.1 Introduction; 6.2 The Amyloid Approach; 6.2.1 Reduce Hypercholesterolemia; 6.2.2 Limit or Prevent Plaque Formation