RECENTLY, MEDICATIONS for treating the cognitive symptoms of Alzheimer disease (AD) and possibly for delaying progression of this illness have begun to be used in clinical practice. Wider acceptance of these drugs has raised questions of whether it is still ethical to use placebo-controlled investigational trials in the development process for future drugs. In this issue of the ARCHIVES, Knopman et al1 and Karlawish and Whitehouse2 explore the ethical implications of withholding these modestly effective therapies from patients with dementia because they are not able to give their true informed consent for participation in investigational trials. Both sets of authors argue that substantial changes are needed in existing designs for AD treatment trials.
Farlow MR. New Treatments in Alzheimer Disease and the Continued Need for Placebo-Controlled Trials. Arch Neurol. 1998;55(11):1396-1398. doi:10.1001/archneur.55.11.1396