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Arch Neurol. 2006;63:18-19.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Open-label extensions of placebo-controlled randomized clinical trials are commonly conducted. At the end of the placebo-controlled period, all patients have their intervention stopped and are re-titrated to optimal therapeutic levels of the active agent. In this month's issue of the Archives of Neurology, Reisberg and colleagues publish their 24-week open-label extension study of memantine in moderate to severe Alzheimer disease (AD).¹ Publication of this extension study raises the question of what we learn from such investigations. Three types of questions arise: (1) What can we learn about memantine? (2) What can we learn about clinical trials? (3) What can we learn about drug development for AD?

WHAT CAN WE LEARN ABOUT MEMANTINE?

The principal data derived from open-label extensions of randomized placebo controlled trials pertain to the safety and tolerability of the treatment. The additional period of observation allows investigators to collect important information regarding longer-term exposure to active pharmacologic compounds. Safety issues that are . . . [Full Text of this Article]

WHAT CAN WE LEARN ABOUT CLINICAL TRIALS?

WHAT CAN WE LEARN ABOUT DRUG DEVELOPMENT?

AUTHOR INFORMATION
Jeffrey L. Cummings, MD

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