FDA Approves Alzheimer's Drug

Mix of Old and New Medicines Helps Even Severe Cases

The first medicine effective against symptoms of moderate to severe Alzheimer's disease won approval yesterday from the government and could be on the market by January for the more than 2 million Americans battling advanced stages of the debilitating illness.

The new medicine, memantine, works in a different way than the several drugs used to treat early Alzheimer's disease. New research that has not yet been published -- but was evaluated by the Food and Drug Administration in making yesterday's approval -- suggests that a combination of old and new medicines may be especially potent.

Perhaps of greatest interest to patients and caregivers is the glimmer of possibility that memantine may help not only with symptoms, but also in slowing the march of a neurodegenerative illness that has long been considered unstoppable.

The unpublished study showed that patients getting both memantine and an older medicine showed moderate improvement in their cognitive ability. Most doctors have hoped only to stabilize or slow the decline of Alzheimer's patients.

For families struggling with the disease, the loss of a patient's thinking abilities, including the powers of recognition and concentration that make patients feel connected with loved ones, can be especially cruel.

"We're optimistic that this is going to have an impact," said Anton Porsteinsson, an assistant professor of psychiatry at the University of Rochester in New York, who helped conduct the as-yet unpublished study. "There is some possibility that it may have a long-term effect in terms of slowing the course of Alzheimer's disease, but we don't have the studies yet that prove that."

Porsteinsson cited the anecdotal example of an elderly patient who slowly lost the ability to participate in conversations and joke back and forth as her Alzheimer's disease progressed, even though she was taking the popular medicine Aricept.

"Now she was getting more and more passive, not joking around, dozing off -- you didn't feel connected with her," he said in an interview.

The patient's family arranged to add memantine to her treatment -- they brought the medicine from Europe, where it has been available for years.

"She regained the ability to participate, to have interaction with people around her," Porsteinsson said. "She was much more verbal, attentive and not falling asleep all the time -- she regained some of her ability to participate in the conversation and joke around."