ABSTRACT
The successful introduction of efficacious, nontoxic treatment options for Alzheimer’s disease (AD)1-7 in most of the world has transformed both the design and execution of clinical trials for antidementia agents. The availability of these compounds, although variable and not universal, has significantly changed patient characteristics and availability for this kind of research.8 In addition to the target population and its definition, the question of the use of placebo-controlled trial designs, the involvement of treated reference groups, and the intended mode of treatment (symptomatic versus disease-modifying), as well as the emergence of surrogate markers, will all play a key role on a go-forward basis.
