Treatment Effect Difference in Multiple-Regional Trials for Alzheimer’s Disease
*Jingyu Luan, FDA 

Keywords: Multi-regional trials, Alzheimer's Disease

Alzheimer’s Disease (AD), a progressive neurodegenerative disorder, is a cognitive disorder of the elderly population. AD begins with memory loss and progresses to severe impairment of activities of daily living, leading to death approximately 8 years on average from time of diagnosis of dementia. The prevalence of AD in people over the age of 65 is 5-10%, increasing up to 50% in those over the age of 85. Alzheimer's Disease affects approximately 4.5 million people in the United States. Currently, there are five drugs (Cognex®, Aricept®, Exelon®, Razadyne®, Namenda®) marketed for Alzheimer's Disease in the US. Approximately 70% of the registration trials for Alzheimer’s Disease drugs were multi-regional clinical trials. In this presentation, the speaker will share results of a meta-analysis of the available registration trials for approved AD drugs. The talk will address whether there are any meaningful differences between US and non-US studies and among multiple regions and how these differences, if any, may impact future study designs, trial conducts and data analyses.