Forest Laboratories' Namenda, an Alzheimer's med, didn't help stave off cognitive decline in patients with a mild form of the disease, researchers said, casting doubt on this off-label use of the drug. About 20 percent of patients diagnosed with mild Alzheimer's are prescribed Namenda, but those patients see their disease progress at the same rate as patients with similar symptoms who take no medications, the Archives of Neurology study found.
As the Los Angeles Times reports, the researchers gathered clinical trials that tested Nameda's effectiveness in patients with mild to moderate Alzheimer's or mild cognitive impairment. After pooling and analyzing the data, they found that neither the individual trials nor the pooled data suggested that Namenda was effective in these patients.
"There were no significant differences between memantine [Namenda] and placebo on any outcome for patients with mild AD, either within any trial or when data were combined," Dr. Lon Schneider of the University of Southern California wrote in the Archives (as quoted by Reuters).
In 2005, the FDA refused to expand Namenda's approval to cover mild to moderate Alzheimer's. But as the study figures show, doctors still prescribe the drug to one in five patients with mild disease. And given that this new study is a meta-analysis, rather than a purpose-designed trial, it may not affect prescription habits much, Alzheimer's Association CMO Bill Thies told Reuters. In practice, patients' response to Namenda varies widely; some get a big benefit, but others don't at all, Thies said.