Challenges in Conducting Trials in Alzheimer's Disease
Tapping new territory for Alzheimer’s drug trials
As the global population ages, pharma is racing to develop therapies that will slow or stop the progression of Alzheimer’s disease. While welcome and necessary, these efforts have saturated the trial environment in developed countries, making treatment-naïve patients more difficult to find and recruit. In response, sponsors are staging a growing number of trials in emerging markets — low- and middle-income countries (LAMIC) such as India and China that are vastly underrepresented in Alzheimer’s disease clinical trial populations.
In a new white paper, Quintiles’ Roza Hayduk, Lynne Hughes and Amir Kalali explore in detail the benefits and challenges of LAMIC-based trials for Alzheimer’s drugs. Experts in neurology and therapeutics, the authors explain why Alzheimer’s studies in emerging markets often draw large groups of participants and motivated clinical investigators, cutting costs in the process. The paper also addresses potential barriers and ways to navigate such hurdles.
About the Authors
Roza Hayduk, MD, Executive Director, Medical and Scientific Services
Dr. Hayduk is a neurologist with more than 25 years of experience in clinical neurology and clinical research. She has been consulting on and participating in drug development programs for neurological diseases, Alzheimer’s disease in particular, through the National Institutes of Health and pharmaceutical company-sponsored projects. She has served as global medical monitor for international clinical trials for symptomatic and disease-modifying treatment of Alzheimer’s disease. Dr. Hayduk is a recipient of the renowned Fulbright Award for Medicine. For several years, she served as an Adjunct Assistant Professor in the Department of Neuropharmacology at the Scripps Research Institute. The author of numerous scientific publications, she is a fellow of various societies, including the American Academy of Neurology, the American Epilepsy Society and the American Academy of Sleep Medicine.
Amir Kalali, MD, Vice President, Medical and Scientific Services, CNS Global Therapeutic Team Leader
Dr. Amir Kalali is an expert in CNS clinical trial methodology and is globally responsible for the medical and scientific aspects of Quintiles’ development programs in psychiatry and neurology. Dr. Kalali is also Professor of Psychiatry at the University of California, San Diego. As the founding Chairman and current Executive Secretary of the Executive Committee of the International Society for CNS Drug Development and as a member of the Scientific Committee of the International Society for CNS Clinical Trials and Methodology, Dr. Kalali actively facilitates scientific collaboration between academicians, government officials and pharmaceutical industry scientists. He is the editor of the journal Psychiatry and has published numerous peer-reviewed papers.
Lynne Hughes, B.Med.Sci., PhD, PMP, Vice President & Global Head of Neurology
With more than 23 years in the pharmaceutical industry, Dr. Hughes has managed a number of Phase III trials in neurology (including Alzheimer’s disease), oncology, acute care and imaging, leading multi-national efforts across Europe, South Africa, Japan, Australia and the US. Her responsibilities have spanned the full duration of studies, from start-up to project close-out and review. Dr. Hughes has participated in the clinical trial development of all Alzheimer’s therapies currently on the market and is heavily involved in a number of disease modification programs. At Quintiles, she sits on several steering committees for sponsors developing Alzheimer’s products and is responsible for a range of consultancy programs for investment opportunities within all areas of neurology.
