Study bolsters evidence for memantine (Namenda)
A six-month extension to a large clinical trial offers further evidence that memantine (Namenda) may help individuals with advanced Alzheimer’s disease, according to a report in the January Archives of Neurology.
Results showed that participants who received the placebo in the original six-month trial and switched to memantine in the extension declined more slowly than they had on placebo in assessments of memory, daily activities and overall function. Those who stayed on memantine throughout maintained their slower rate of decline seen in the first trial.
“This new data increases our confidence that the effect we’re seeing is real and seems to continue for at least a year,” says William H. Thies, Alzheimer’s Association vice president, medical and scientific affairs. “While the long-term solution to Alzheimer’s clearly lies in prevention and in drugs that stop the progression of the disease, it’s good to know we’re on solid footing with what we have to offer now.”
In the original trial, individuals with moderate to severe Alzheimer’s received either 10 mg of memantine twice a day or a placebo. Those on memantine fared better on assessments of memory, thinking and daily activities, as well as on a measure that gauges the doctor’s and caregiver’s overall impression of how a person is doing.
That trial was one of two large studies the U.S. Food and Drug Administration (FDA) said provided convincing evidence for memantine’s safety and effectiveness in treating moderate to severe Alzheimer’s. Those two trials provided the basis for FDA’s October 2003 approval of memantine.
When the original trial ended, participants were given the option to continue, and most did. Everyone in the extension received memantine, but neither researchers nor patients knew who had originally taken memantine or the placebo until the extension ended.
Data from the original trial were first reported in July 2000 in Washington, D.C., at the Alzheimer’s Association World Alzheimer Congress and later published in the April 3, 2003, New England Journal of Medicine.
