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FDA Approves Alzheimer's Drug
Mix of Old and New Medicines Helps Even Severe Cases

By Shankar Vedantam , Washington Post Staff Writer
 
 
October 18, 2003

 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The unpublished study showed that patients getting both Memantine and an older medicine showed moderate improvement in their cognitive ability.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an assistant professor of psychiatry at the University of Rochester in New York , who helped conduct the as-yet unpublished study.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."

The advent of Memantine has generated excitement among physicians and patients, but Porsteinsson and other physicians warned that it is not a magic bullet.

His research has been presented at professional meetings but has not yet been published in a peer-reviewed journal. He said the study evaluated the benefits of adding Memantine to existing treatments for patients with moderate and severe Alzheimer's -- people who need assistance with daily living.

Patients taking Memantine and the older medicine still declined in daily functioning -- such as in the ability to dress and bathe on their own -- but those in the group taking only the older medicine had even steeper declines.

Another scale used to measure behavior problems in Alzheimer's patients showed that patients who got Memantine were stable at the end of the six-month trial, whereas there was a decline in the other group of patients.

As with an earlier study that had evaluated Memantine against dummy pills, the drug appeared to be well tolerated.

"There are very few side effects with Memantine," said Steven Ferris of the Alzheimer's Disease Center at New York University 's Silberstein Institute, who helped conduct the other study that the FDA used as a basis for approving the drug.

Ferris said Memantine focuses on a brain receptor system called NMDA, which regulates the entry of calcium into brain cells. The entry of calcium is involved in cell death in several neurodegenerative conditions -- and blocking its action may explain Memantine's benefits, Ferris said. The previous class of medicines, including drugs such as Aricept, work on a different receptor system in the brain.

While cautioning that Memantine is not a cure, Ferris said, "Lots of small steps add up to a big benefit to patients."

 

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