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New Treatments in Alzheimer Disease and the Continued Need for Placebo-Controlled Trials
Arch Neurol. 1998;55:1396-1398.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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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.
Knopman et al1 propose moving beyond placebo-controlled trials in AD research. They suggest that, except for early-phase studies, placebo controls be abandoned and that future trials use add-on or active-control designs with cholinesterase inhibitors and/or vitamin E . . . [Full Text of this Article]
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