Global Clinical Trials for Alzheimers Disease: Design, Implementation, and Standardization

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 trialsA 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 areaIncludes 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

Section I – Global Alzheimer’s Disease Clinical Trials

Ch 1 – Introduction and Overview of Global Clinical Trials

Ch 2 – Dementia and Neurodegenerative Diseases: Global and Local Public Health Burden

Section II – Challenges and Opportunities to conduct Alzheimer’s Disease Trials

Ch 3 – Global Issues in Drug Development

Ch 4 – Patient Populations and Evolution of Diagnostic and Therapeutic Standards

Ch 5 – Opportunities for Standardization of Diagnostic and Outcome Measures

Section III – Operationalization of Global Alzheimer’s Disease Trials

Ch 6 - The Increasing Competition for Clinical Trial Sites and Traditional Markets – Issues and Opportunities

Section IV – Enhancing Low and Middle Income Countries Capacities

Ch 7 – Strengthening/Building AD Global Clinical Trial Sites – Lessons Learned

Section V – Pharmacogenomics and Ethical Considerations

Ch 8 – Definitions

Ch 9 – Pharmacogenomics in Clinical Trials

Ch 10 – Pharmacogenomics in AD Clinical Trials

Ch 11 – Conduct of Global Clinical Trials in Vulnerable Populations (Ethical Considerations)

Ch 12 – Next Steps Towards Global Clinical Trials of CNS Disease

Section VI – Human Resources Planning

Ch 13 – Talent Management

Section VII – Appendices

Ch 14 – Useful Online Appendices