Trial designs

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Any therapy, whether pharmacological or not, requires proof of safety and efficacy. This chapter outlines the various trial designs that have been used for the pharmacological treatment of Alzheimer’s disease (AD). The experience gained so far has been predominately in the symptomatic treatment of AD, using parallel group designs over 3-12 months, and rarely a survival design to a disease milestone. A number of randomized clinical studies attempting to modify progression of AD have been completed or are under way, using parallel group designs over 12-18 months.